Decree 155-2018

DECREE 155
AMENDING
INVESTMENT AND BUSINESS CONDITIONS UNDER THE MANAGEMENT
OF THE MINISTRY OF HEALTH
12 November 2018
CONTENTS
Food Safety Sector....................................................................................................................................... 2
Article 1To repeal a number of provisions on food safety.....................................................................2
Article 2To amend a number of articles of Decree 67 dated 1 July 2016 regulating business
conditions for producing and trading food in sectors managed by the Ministry of Health. 3
Article 3To amend a number of articles of Decree 15 dated 2 February 2018 regulating the Law on
Food Safety...................................................................................................................... 5
Pharmacy Sector.......................................................................................................................................... 6
Article 1To repeal a number of articles of Decree 54 dated 8 May 2017 with regulations for
implementation of the Law on Pharmacy..........................................................................6
Article 2To amend a number of articles of Decree 54 dated 8 May 2017 with regulations for
implementation of the Law on Pharmacy..........................................................................9
Sector being Tissue Banks and Human Organ Transplantation.............................................................29
Article 1To repeal a number of provisions of Decree 118 dated 22 July 2016 amending Decree 56
dated 29 April 2008 on organization and operation of tissue banks and the National Co-
ordination Centre for human organ transplantation........................................................29
Article 2To amend a number of provisions of Decree 118 dated 22 July 2016 amending Decree 56
ordination Centre for human organ transplantation........................................................29
Insecticidal Chemicals and Germicidal [Anti-Bacteria] Chemicals in both the Domestic and Medical
Sectors......................................................................................................................................................... 30
Article 1To repeal a number of provisions of Decree 91 dated 1 July 2016 regulating management of
insecticidal and germicidal chemicals in both the domestic and medical sectors...........30
Article 2To amend a number of provisions of Decree 91 dated 1 July 2016 regulating management of
insecticidal and germicidal chemicals in both the domestic and medical sectors...........31
Medical Examination and Treatment Sector.............................................................................................33
Article 1To repeal a number of provisions of Decree 109 dated 1 July 2016 regulating grant of
practising certificates and operational licences for medical examination and treatment
establishments ["healthcare facilities"]............................................................................33
Article 2To amend a number of provisions of Decree 109 dated 1 July 2016 regulating grant of
practising certificates and licences for medical examination and treatment
establishments ["healthcare facilities"]............................................................................34
Cosmetics Sector....................................................................................................................................... 43
Article 1Repeal of some legal instruments in the cosmetic sector......................................................43
Article 2Article 4.3(a) of Decree 93 dated 1 July 2016 regulating conditions for producing cosmetics is
amended as follows:....................................................................................................... 44
Sector of Prevention and Control of Infectious Diseases.......................................................................44
Article 1To repeal a number of provisions in the sector of prevention and control of infectious
diseases......................................................................................................................... 44
Article 2To amend a number of provisions in the sector of prevention and control of infectious
diseases......................................................................................................................... 44
Sector being HIV/AIDS Prevention and Treatment...................................................................................47
Article 1To repeal a number of articles in the HIV/AIDS prevention and treatment sector..................47
Article 2To amend a number of articles of Decree 75 dated 1 July 2016 regulating conditions for
conducting HIV testing.................................................................................................... 47
 Allens - Vietnam Laws Online Database on www.vietnamlaws.com

Reproductive Health................................................................................................................................... 48
Article 1To repeal a number of provisions on reproductive health......................................................48
Article 2To amend a number of provisions in the reproductive health sector......................................48
Implementing Provisions........................................................................................................................... 49
Article 1Effectiveness......................................................................................................................... 49
Article 2Transitional Provision............................................................................................................. 49
Article 3Effectiveness......................................................................................................................... 50
GOVERNMENT SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
No. 155/2018/ND-CP
Ha Noi, 12 November 2018
DECREE
AMENDING
INVESTMENT AND BUSINESS CONDITIONS UNDER THE MANAGEMENT
OF THE MINISTRY OF HEALTH
Pursuant to the Law on Organization of the Government dated 19 June 2015;

On the proposal of the Minister of Health;
The Government hereby issues this Decree amending a number of provisions relevant to investment and
business conditions under the management of the Ministry of Health [MoH].
CHAPTER 1
Food Safety Sector
Article 1 To repeal a number of provisions on food safety
1. The following are repealed: article 2 in Chapter 1, and Chapters 4 and 5 of Decree 67 dated 1 July
2016 regulating business conditions for producing and trading food in sectors managed by the
Ministry of Health (MoH) ("Decree 67").
[Article 2 of Chapter 1: Applicable entities.
Chapter 4: Conditions applicable to establishments producing and trading food additives and food
processing aids.
Chapter 5: Conditions applicable to establishments producing and trading natural mineral water,
bottled drinking water, and instant ice.]1
2. The following is repealed: article 5.2(c) of Decree 15 dated 2 February 2018 regulating the Law on
Food Safety ("Decree 15").
[Article 5.2(c): Sequence and procedure for product self-declaration.]
3. The following is repealed: Circular 15/2018/TT-BYT of MoH dated 12 September 2012 regulating
general conditions for ensuring food safety applicable to food production and trading establishments
["food producers and traders"].
1 Allens footnote: Where practical, the text of the repealed provisions is given in square brackets and in smaller font.

4. The following is repealed: Circular 16/2012/TT-BYT of MOT dated 22 October 2012 regulating food
safety conditions applicable to food producers and traders, and to food instruments, packages and
containers under the management of MoH.
5. The following is repealed: Circular 26/2012/TT-BYT of MoH dated 30 November 2012 regulating
issuance of Certificates of satisfaction of food safety conditions applicable to producers and traders
of functional foods, micro-nutrient fortified foods, food additives; applicable to food processing aids;
natural mineral water, bottled water; and to food instruments, packages and containers under the
management of MoH.
6. The following is repealed: Circular 30/2012/TT-BYT of MoH dated 5 December 2012 regulating food
safety conditions applicable to street traders of food and drink.
7. The following is repealed: Circular 47/2014/TT-BYT of MoH dated 11 December 2014 regulating food
safety applicable to food and drink service providers ["caterers"].
8. The following are repealed: Clauses 1 and 3 of article 14, and article 15.1 of Circular 43/2014/TT-
BYT of MoH dated 24 November 2014 regulating management of functional foods.
[Article 14.1: In the case of producing functional foods, the physical facilities, tools, raw materials for
production, packaging, and direct producers must comply with article 3 of Circular 16/2012/TT-BYT of
MoH dated 22 October 2012 regulating food safety conditions applicable to food producers and
traders.
Article 14.3: Regulations of MoH apply to the roadmap for introducing compulsory application of the
good manufacturing practice (GMP) system and the hazard analysis and critical control points
(HACCP) system.
Article 15.1: In the case of trading, preserving/storing and transporting functional foods, the physical
facilities, tools, raw materials for production, packaging, and direct producers must comply with
articles 4, 5 and 6 of Circular 16/2012/TT-BYT referred to above.]
Article 2 To amend a number of articles of Decree 67 dated 1 July 2016 regulating business conditions
for producing and trading food in sectors managed by the Ministry of Health
1. Article 1 of Chapter 1 is amended as follows:
"This Decree regulates the conditions for producing and trading food and the application file,
sequence, procedures and authority to issue Certificates of satisfaction of food safety conditions
(hereinafter abbreviated as SC Certificates) in sectors under the management of MoH applicable to
establishments producing and trading the food products and food groups set out in Appendix 2
issued with Decree 15 (hereinafter abbreviated as food producers and traders) and to food and drink
caterers. Decree 15 dated 2 February 2018 applies to the conditions for production and trading and
to the file, sequence, procedures and authority to issue and reissue SC Certificates required by good
manufacturing practice standards (GMP)."
2. Chapter 2 is amended as follows:
"CHAPTER 2
Conditions for Ensuring Food Safety Applicable to Food Producers and Traders Under the
Management of the Ministry of Health, and to Food and Drink Service Providers [Caterers]
Article 4 Food producers and traders under the management of the Ministry of Health
1. They must comply with articles 19, 20, 21, 22, 25, 26 and 27 of the Law on Food Safety and
the following specific requirements:
(a) The food production process must be arranged on the principle of a one-way route from the
stage of raw material input up until the stage of the final product;
(b) The walls, ceiling and floors of production, trading and storage areas must be waterproof, and
must not be cracked or mouldy;
(c) Equipment and instruments directly contacting food products must be easy to clean, must not
release toxic or polluted substances into food nor pollute the food;

(d) Special footwear must be worn in food production areas;
(dd) There must be no insects or other harmful fauna permitted to come into food production or
storage areas or to get into food raw materials; chemicals to kill rats, insects and other harmful
fauna must not be used in food production areas or in areas storing food and food raw
materials;
(e) Chemicals used for other purposes must not be displayed at establishments trading food
additives and food processing aids.
2. People directly engaged in producing or trading food must have been trained in food safety
knowledge as certified by the owner of the establishment, and must not have the diseases
being cholera, typhoid, type A or E hepatitis, a skin infection, tuberculosis, or acute diarrhoea
when producing or trading food.
Article 5 Food and drink service providers [caterers]
1. They must comply with articles 28, 29 and 30 on the Law on Food Safety and the following
specific requirements:
(a) They must perform three-step verification and store food samples in accordance with
guidelines of MOT;
(b) Equipment, transport vehicles and equipment for preserving food must ensure hygiene and not
pollute the food.
2. People directly processing food must have been trained in food safety knowledge as certified
by the owner of the establishment, and such people must not have the diseases being cholera,
typhoid, type A or E hepatitis, a skin infection, tuberculosis, or acute diarrhoea when producing
or trading food."
3. Chapter 3 is amended as follows:
"CHAPTER 3
Authority, Application File and Procedures for Issuance of Certificates of Satisfaction of Food
Safety Conditions to Food Producers Under the Management of the Ministry of Health, and to Food
and Drink Caterers
Article 6 Authority, file and procedures for issuance of Certificates of satisfaction of food safety
conditions ("SC Certificates")
1. Authority to issue SC Certificates:
MoH issues or delegates authority to issue SC Certificates to producers of the various types of
food under the management of MoH as prescribed in article 37.5 and Appendix 2 of
Decree 15. Appendix 2 sets out the list of food products and groups of food products under the
management of MoH.
2. An application file for issuance of an SC Certificate is prepared in accordance with article 36.1
of the Law on Food Safety and the following specific requirements:
(a) Request for issuance of an SC Certificate on standard form 1 in the Appendix issued with this
Decree;
(b) Copy business registration certificate or enterprise registration certificate specifying the
industry or trade consistent with the type of food the establishment produces (certified by the
establishment);
(c) List of people producing food or providing the catering services who have completed the
training course on food safety knowledge, as certified by the owner of the establishment.
3. Procedures for issuance of an SC Certificate must satisfy the provisions in article 36.2 of the
Law on Food Safety and the following specific requirements:
(a) An application file is prepared in accordance with clause 2 of this article and lodged via the
on-line services system [internet] or in the post or directly at the file-receiving agency;

(b) If the file-receiving agency requires the file to be amended or supplemented, then within
five (5) business days after receipt, it provides a written notice to the establishment; if the
establishment fails to complete or supplement the file as required within thirty (30) days after
receipt of the notice, then the application file shall no longer be valid and an applicant must
lodge a new file in order to be issued with an SC Certificate;
(c) If there is no request to amend or supplement the file, the file-receiving agency establishes an
evaluation team or authorizes an evaluation and then prepares minutes of evaluation on
standard form 2 within fifteen (15) business days after receipt of the file. In the case of
delegation of authority, there must be a written authorization document;
The agency competent to issue SC Certificates or the agency delegated with authority to
conduct an evaluation shall issue a decision establishing an evaluation team comprising
three (3) to five (5) members, of whom at least two (2) must work in food safety (and experts in
the relevant food production sector may also be invited);
(d) If the evaluation results satisfy the requirements, then within five (5) business days after such
results, the file-receiving agency issues an SC Certificate on standard form 2 in the Appendix
issued with this Decree;
(dd) If the evaluation results fail to satisfy the requirements and the problem can be remedied, then
the evaluation team specifies in the evaluation minutes what needs to be remedied and the
time-limit for remedying the problem, such time-limit to be no later than thirty (30) days.
After the establishment provides a report on remedying the problem, within five (5) business
day the evaluation team assesses such results and records its conclusion in the evaluation
minutes. If the remedial results satisfy the requirements, then the SC Certificate is issued in
accordance with sub-clause (d) above; otherwise, the file-receiving agency reports in writing to
the establishment and also reports to the local managing agency that the establishment has
failed to satisfy the requirements;
(e) If the evaluation results fail to satisfy the requirements, then the file-receiving agency provides
written notice to the local managing agency to supervise and require the establishment not to
operate until it is issued with an SC Certificate.
4. If there is a change of name of the enterprise or owner or a change of address but without
changing the food production process or the food catering business and the SC Certificate is
still valid, then the establishment sends a notice of the change of information set out in the
SC Certificate and encloses lawful documents expressing such change to the agency which
issued the SC Certificate, by sending same via the internet or in the post or lodging it directly
at the agency.
5. Any SC Certificate issued prior to the effective date of this Decree may continue to be used
until expiry of the term recorded in such certificate.
Article 3 To amend a number of articles of Decree 15 dated 2 February 2018 regulating the Law on
Food Safety
1. Article 5.2(a) [File and procedures for product-self declaration] is amended as follows:
"(a) The organization or individual [entity concerned] shall self-declare its products on the mass
media or on its website or shall publicly list same at its headquarters and announce same on
the system of updated information about food safety (if there is not yet such system, then the
entity shall lodge one (1) copy of its self-declaration by sending it in the post or by lodging it
directly with the competent State agency appointed by the provincial people's committee in
order to archive files and publish names of entities and self-declared products on the website
of the file-receiving agency; and if the entity has two or more production establishments
producing the same products, it shall only lodge its file with one State agency in the locality of
one of such establishments as selected by the entity; and having selected one State agency
with which to lodge the file, the entity must continue to lodge later self-declarations with the
same agency."
2. Clause 6 is added to article 40 [Responsibilities of provincial people's committees] as follows:

"6. To arrange issuance of SC Certificates to establishments producing bottled water, natural
mineral water, ice (instant ice and ice used for food processing); and to establishments
producing health/dietary supplements, medically nutritious foods, foods for special dietary
uses, nutritional food for children aged below thirty six (36) months, additives, food processing
aids, and food supplements; and to establishments producing other foods not on the lists
managed by the Ministry of Industry and Trade and the Ministry of Agriculture and Rural
Development, and shall also issue SC Certificates to caterers."
CHAPTER 2
Pharmacy Sector
Article 1 To repeal a number of articles of Decree 54 dated 8 May 2017 with regulations for
implementation of the Law on Pharmacy
1. Sub-clauses (c) and (g) of article 3.1 [Application file for issuance of a pharmacy practising
certificate].
2. Article 4.1(b) [Application file for re-issuance of a pharmacy practising certificate].
3. Articles 9 to 13 inclusive [Provisions on pharmacy refresher training].
4. Clauses 1, 3 and 4 of article 14 [Responsibilities of training establishments].
5. Article 19.4 [Practical training or internship establishments].
6. Sub-clauses (a), (b), (c), (d), (dd) and (e) of article 21.2 [Specific duration of professional
training/internship of persons with post-graduate qualifications].
7. Article 23.2 [Requirements applicable to organizations which arrange exams for issuance of
pharmacy practising certificates "exam centres'].
8. Article 24 [Application file for announcement as an exam centre].
9. Article 25 [Request to be announced as an exam centre].
10. Article 26 [Cancellation of announcement as an exam centre].
11. Article 27 [Procedures for rescinding announcement as an exam centre].
12. Article 28.1 [Conditions applicable to an exam centre].
13. Provisions on data in article 32.2(b) in an application file for a Certificate of satisfaction of conditions
"SC Certificate for pharmacy business"].
14. Article 32.3 [Requirement to seal data in an application file for an SC Certificate for pharmacy
business].
15. Article 38.5 [Conditions for a mobile drug retailing operation].
16. Article 40.2 [Notification of a mobile drug retailing operation].
17. Sub-clauses 1(d); 2(dd); sub-clauses (b) and (c) of clause 3; clause 4(d); clause 5(c); clause 7(d);
sub-clauses (b) and (d) of clause 10; and sub-clauses (b) and (c) of clause 11 or article 43 [Provision
on material facilities of traders of drugs subject to special control "controlled drugs"].
18. Provisions in clauses 1(a), 2(a), 5(a) and 7(a) of article 43 [Stores and separate areas must have
solid walls and ceilings made of solid materials].
19. Clauses 1(c), 2(c), 3(b), 4(b), 5, 6(c), 7 and 12(b) of article 44 [Personnel of establishments trading
controlled drugs].
20. Article 49.2 [Application file for a licence to trade controlled drugs].
21. Article 50 [Provisions on issuance of an SC Certificate to trade controlled drugs].

22. Article 52 [Advisory council on licencing trading of addictive drugs, psychotropic drugs, precursors,
and drug ingredients/raw materials being addictive substances, psychotropic substances and
precursors used for drugs "group of addictive drugs" 2, and radioactive drugs"].
23. Article 53.1(b) [Application file for a licence to purchase the group of addictive drugs; and application
file for a licence to sell drug raw materials being addictive substances, psychotropic substances and
precursors used for drugs].
24. Sub-clauses (b) and (c) of article 58.2 [Criteria and application file for a licence to export radioactive
drugs, drugs and substances on the list of drugs forbidden to be used in certain industries and
trades, and toxins and toxic ingredients].
25. Sub-clauses 3(c), 4(a) and 5(a) of article 60 [Provisions on licensing non-commercial export of
controlled drugs].
26. Clauses 2(c) and 4(b) of article 62 [Requirements and application file for export of controlled drugs
for clinical trial, bioequivalence study, bioavailability assessment, as test samples, for scientific
research, and as registration samples].
27. Clauses 1(c) and 2(i) of article 65 [Requirements and application file for a permit to import drugs
containing substances without a drug registration certificates or drugs containing substances used in
Vietnam for the first time].
28. Requirements on the necessity to have a drug business/sales results report in the application file in
article 65.2(g), article 66.2(h) and article 69.2(e).
29. Requirement to have a certificate of good manufacturing practice [GMP] in article 65.2(h), 66.2(i),
69.2(g), 71.2(h), and 72.2(i).
30. Article 66.2(k) [Requirements and application file for a permit to import drugs containing substances
with a drug registration certificate but not satisfying [insufficient quantities for] treatment needs, and
drugs containing substances which have been used in Vietnam but which are insufficient for
treatment needs].
31. Clauses 1(a) and 2 of article 68 [Requirements and application file for an import permit for drugs for
special treatment purposes].
32. Requirement for an original undertaking of the foreign manufacturer/exporter ensuring quality when
importing drugs [vaccines and bio-=products] as set out in article 68.3(e).
33. Article 69.2(h) [Requirements and application file for a permit to import rare drugs].
34. Article 70.2(b) [Requirements and application file for a permit to import drugs with the same trade
name, active ingredients, content or concentration, and form of preparation as the brand name drug
with a registration certificate in Vietnam, manufactured by the same manufacturer as that of the
brand name drug or by a manufacturer authorized by the manufacturer of the brand name drug, and
with a lower price than that of the brand name sold in Vietnam].
35. Article 71.2(i) [Requirements and application file for a permit to import drugs serving a State medical
program].
36. Article 73.2(dd) [Requirements and application file for a permit to import drugs for clinical trial,
bioequivalence study, bioavailability assessment, as test samples or for scientific research].
37. Article 74.1(b) [Requirements and application file for a permit to import drugs to exhibit at a trade
exhibition or fair].
38. Clauses (b) and (d) of article 75.3 [Requirements and application file for a permit for non-commercial
import of drugs pursuant to article 60.2(i) [for other purposes] of the Law on Pharmacy].
39. Requirement in article 76.1 to prepare separate purchase orders when importing some drugs.
40. Article 76.3(b) [Requirement on consularization of documents in the application file for a permit to
import drugs].
2 Allens footnote: For ease of reference, "group of addictive drugs" is used instead of the literal translation "addictive drugs,
psychotropic drugs, precursors, and drug ingredients/raw materials being addictive substances, psychotropic substances and
precursors used for drugs".

41. Requirement on consularization of documents in article 76.3(d).
42. Requirement that a pharmaceutical product certificate must specify that the product is actually
circulating [sold] in the country issuing such certificate as set out in article 76.4(dd).
43. Article 78.2 [Management of import of drugs without registration certificates in Vietnam].
44. Article 82.2(b) [Requirements and application file for a permit to import herbal substances and
ingredients, semi-finished drugs and semi-finished herbal ingredients as samples for testing or
research].
45. Sub-clauses (b) and (c) of article 84.1 [Application file for a permit to import ingredients, semi-
finished drugs and semi-finished herbal ingredients be used to produce export drugs].
46. Article 85.2(dd) [Requirements and application file for a permit to import ingredients, semi-finished
drugs and semi-finished herbal ingredients to be used to produce drugs to serve the requirements of
national defence and security, epidemic control or disaster or fire relief].
47. Article 86.1(b) [Application file for a permit to import adjuvants/excipients, softgel/capsule shells and
packaging directly contacting drugs ("primary packages"), and reference materials].
48. That the provision in article 91.15 on eligibility to sign a contract with an importer applies to an
establishment providing controlled drug raw materials and importing same for testing in articles 80,
82 to 85 (inclusive).
49. Requirement that a sealed copy of the testing certificate from the importer must be lodged for each
consignment as set out in article 92.4(c) when import is conducted pursuant to sub-clauses (a) and
(b) of article 72 clause 1.
50. Requirement on lodging sealed copy of a power of attorney or sale licence for humanitarian aid
imports as prescribed in article 92.2(d).
51. Requirement on lodging sealed copy of documents as required by article 92.4(dd) for imports
pursuant to article 68 or 72.
52. Parts of article 93.1 [Compulsory registration of herbal ingredients, adjuvants/excipients and
softgel/capsule shells].
53. Clauses 2(d) and (dd), 3(b) and (c), and 4(c) of article 98 [Application file for assessment of
satisfaction of GMP standards].
54. Article 100.2(h) [An application file is rejected if information on the drug label is not updated as
requested by MoH].
55. Article 104.4 [Procedures for re-export of drug ingredients/raw materials after their recall].
56. Clauses 2 and 3 of article 107 [Issuance of certificates of confirmation of information contents about
a drug].
57. Clauses 1(dd) and 2(dd) of article 108 [Application file for a certificate of confirmation of information
contents about a drug].
58. Article 109 [Reissuance of certificates of confirmation of information contents about a drug].
59. Article 110 [Application file for amendment of the information contents about a drug for which a
certificate has already been issued].
60. Article 111.4 [Requirements regarding data in an application file for issuance or reissuance of a
certificate of confirmation of information contents about a drug].
61. Article 114 [Procedures for reissuance of a certificate of confirmation of information contents about a
drug].
62. Article 115 [Procedures for amendment of information contents about a drug for which a certificate
has already been issued].
63. Clauses 2 and 3 of article 120 [Circumstances in which a certificate of contents of a drug
advertisement are issued or reissued, and amendment of such contents].

64. Clauses 1(dd) and 2(dd) of article 121 [Application file for issuance of a certificate confirming
contents of a drug advertisement].
65. Article 122 [Application file for reissuance of a certificate confirming contents of a drug
advertisement].
66. Article 123 [Application file for amendment of a certificate confirming contents of a drug
advertisement].
67. Article 124.4 [Requirements regarding the application file for issuance or reissuance of a certificate
confirming contents of a drug advertisement].
68. Article 130.4(b) [File for declaration of drug prices].
69. Sub-clauses (dd), (e) and (g) of article 131.4 [Receipt of declarations of drug prices and amendments
to same].
70. Clauses 2, 3 and 4 of article 134 [Principles for reviewing and announcing the declared prices of
drugs].
71. Provisions on the schedule for fulfilling the requirement that the chief pharmacist and person
responsible for ensuring drug quality in a production establishment must have a pharmacy practising
certificate as prescribed in clauses 1 and 4 of article 140.
72. Standard forms in Appendix 1 namely 8, 9, 10, 11, 13, 14, 15, 16 and 17.
73. Lines 120 and 159 in Appendix 5.
74. Standard forms 3 and 4 in Appendix 6.
Article 2 To amend a number of articles of Decree 54 dated 8 May 2017 with regulations for
implementation of the Law on Pharmacy
1. Article 2.2 is amended as follows:
"Article 2 Definitions
2. Drug introduction seminar means a drug introduction session or specialized discussion related
to drugs, for medical and pharmaceutical practitioners".
2. Article 3.1(a) is amended as follows:
"Article 3 Detailed provisions on an application file requesting a pharmaceutical practising
certificate
(a) A request for issuance of a pharmaceutical practising certificate on standard form 2 in
Appendix 1 issued with this Decree."
"Article 4 Detailed provisions on an application file requesting a pharmaceutical practising
certificate
(a) A request for re-issuance of a pharmaceutical practising certificate on standard form 4 in
Appendix 1 issued with this Decree."
"Article 5 Detailed provisions on application file for amendment of the contents of a
pharmaceutical practising certificate
(a) An application file for amendment of the contents of the pharmaceutical practising certificate
on standard form 5 on Appendix 1."
5. Sub-clauses (a) and (c) of article 6.3 are amended as follows:
"Article 6 Detailed provisions on procedures for issuance, reissuance and amendment of
pharmaceutical practising certificates

3. The certificate-issuing agency is responsible
(a) To issue the certificate within fifteen (15) days [formerly 20] after the date recorded on the
receipt for the file;
(c) To reissue or amend the certificate within five (5) business days [formerly 10] after the date
recorded on the receipt for the file;"
6. Article 8 is amended as follows:
"Article 8 Pharmaceutical training establishments
1. Establishment providing training and updating professional knowledge on pharmacy
["Pharmacy training establishment"] means one of the following: a vocational educational
establishment which also provides specialized training in the medical and pharmaceutical
sectors; a training establishment which has a training branch code for the health science
sector; a research institute with the function of providing specialized training in the medical and
pharmaceutical sectors; an establishment with the function of training medical health
manpower; and a pharmaceutical professional association.
2. A pharmacy training establishment must formulate a training program with the following main
contents:
(a) Training contents comprising:
- Specialized branch knowledge;
- Law on pharmacy and professional management of pharmacy;
(b) There must be a minimum eight (8) hours of training/refreshing on pharmacy.
7. Clauses 1(a) and 2(a) of article 15 [Responsibilities of State agencies managing pharmacy] are
amended as follows:
"1. The Ministry of Health is responsible:
(a) To check and supervise the pharmacy training establishments prescribed in article 8 of this
Decree;
2. Departments of Health are responsible:
(a) To check, supervise and co-ordinate with the local pharmacy training establishments
prescribed in article 8 in conducting training on pharmacy;"
"Article 21 Duration of internship applicable to post-graduate degree holders
2. The specific internship duration of a post-graduate degree holder as specified in articles 15 to
22 inclusive of the Law on Pharmacy is reduced as follows:
(a) Three quarters of the time applicable to holders of a Ph.D. or SL2 degree;
(b) Half of the time applicable to a person with a masters or SL1 degree".
9. Article 28.3 [Conditions applicable to an exam centre] is amended as follows:
"3. If there is no exam centre available to hold exams for issuance of pharmacy practising
certificates, then the Ministry of Health shall appoint an organization which satisfies all the
conditions in article 23 to hold such exams".
10. Article 31 [Conditions for trading traditional drugs] is amended as follows:
"5. Conditions applicable to a retailer of herbal ingredients and substances, and traditional drugs:
(b) Having a discreet and firmly built store of a size appropriate for the business scope; which is
situated in a high place and well ventilated, safe, and at a safe distance from pollution sources;

(c) The storage area and equipment for preservation must satisfy the storage/preservation
requirements recorded on the drug label.
Toxic drug ingredients (if any) must be displayed and stored in a separate area; but if they are
in fact displayed and stored in the same area as other pharmaceutical materials then there
must be a special label reading "toxic" in order to avoid confusion.
Any establishment specializing in retail of pharmaceutical ingredients and traditional drugs or
specializing in retail of herbal substances must have separate storage/preservation areas for
these items."
11. Article 32.2(a) [Application file for issuance of an SC Certificate for pharmacy business] is amended
as follows:
"2. Technical documents prescribed in article 38 of the Law on Pharmacy and also the following:
(a) In the case of a manufacturer of drugs or drug raw materials, there must be data on the
location, factory, testing laboratory, storage area, ancillary system, machinery and equipment
for manufacturing, testing and storing the drugs, a quality control system, and data about
technologies and personnel in accordance with GMP principles on manufacture of drugs and
drug raw materials.
If the applicant requests an SC certificate permitting sale or delivery [supply] of drugs and drug
raw materials it manufactures to wholesalers, retailers and medical treatment and consultation
establishments ("clinics"), then there must be additional data on technologies and personnel in
accordance with the GMP principles on distribution of drugs and drug raw materials, except
where the goods are delivered at the warehouse of the manufacturer".
12. Clauses 3 and 4 of article 33 [Procedures for issuance of an SC Certificate for pharmacy business]
are amended as follows:
"3. The file-receiving agency shall:
(a) Issue the SC Certificate within twenty (20) days [formerly 30] after the date of receipt recorded
on the receipt for the file when the material and technical facilities and personnel have been
inspected and assessed as satisfying GMP standards applicable to the scope of business,
without having to arrange an actual assessment on site at the establishment requesting the
SC Certificate;
4. If the application file is incomplete, then within seven (7) business days [formerly 10] after the
date of receipt recorded on the receipt slip, the file-receiving agency shall send a written notice
to the applicant specifying in detail the data which needs to be amended or added".
13. Article 34.3(a) [Procedures for reissuance or amendment of an SC Certificate for pharmacy business]
is amended as follows:
"(a) The SC Certificate shall be reissued (or reissued as amended) within fifteen (15) days
[formerly 20] after the date of receipt in the cases prescribed in clause 2(a) and clause 3 of
article 36 of the Law on Pharmacy;
14. Article 40.3 [Notification of a mobile drug retailing operation] is amended as follows:
"3 Within five (5) business days after receipt of the notice from the establishment operating the
mobile drug store, the Department of Health shall publish information about same on its
website and also notify the district health authority in the province for supervisory purposes".
15. Article 41.2 [List of radioactive substances permitted for use in the health sector and issuance of a
list of drugs and substances prohibited from use in a number of industries and trades] is amended as
follows:
15. [The heading is changed to:] Announcement of the list of drugs and substances prohibited from
use in a number of industries and trades:
(b) After receiving lists of prohibited substances from ministries, Mohr shall announce on its
website a list of drugs and substances prohibited from use in certain industries and trades.
16. Article 42.2 [Conditions for trading controlled drugs] is amended as follows:

"2 If the province does not have an establishment trading controlled drugs, then the Department
of Health shall appoint a wholesaler or retailer to conduct such trading or shall appoint a
hospital dispensary which retails such drugs to ensure an adequate supply for patients".
17. Article 43.4(a) [Essential facilities of traders of controlled drugs] is amended as follows:
"(a) Having a separate store or area that satisfies GMP principles for storing drugs and drug raw
materials namely addictive drugs, psychotropic drugs, precursors, and drug ingredients/raw
materials being addictive substances, psychotropic substances and precursors used for drugs.
Such store or area must have robust doors and sturdy locks;".
"6. An exporter, importer or wholesaler of radioactive drugs must have a management system and
must have a set of monitoring books pursuant to regulations of the MoH".
"8. A retailer of addictive drugs, psychotropic drugs and precursors must:
(a) Have a separate cabinet or drawers for the above-named with a sturdy lock;"
"12 Any establishment providing services of drug clinical trials, bioequivalence testing services or
testing controlled drugs must, except for the cases prescribed in clause 11 above, store
addictive drugs, psychotropic drugs, precursors, and drug raw materials with active addictive
substances, active psychotropic substances and active precursors, and combination drugs
containing any addictive substance, combination drugs containing any psychotropic substance,
and combination drugs containing any precursor in a separate and locked area, or in cabinets
or drawers with robust locks".
21. Article 44 [Personnel of establishments trading controlled drugs] is amended as follows:
"The requirements of having been an intern or having worked for two (2) years in clauses 1, 2, 4, 6
and 10 is replaced by "12 months"."
"9. In the case of a retailer of radioactive drugs, the person responsible for retailing must have an
intermediate or higher level graduation certificate in pharmacy".
23. Article 46.2(c) [Trading in controlled drugs] is amended as follows:
"(c) An establishment which has an SC Certificate for pharmacy including export, import and
wholesale of drugs may only sell drugs to other establishments which also have such an
SC Certificate for those sectors, and to clinics, research and testing establishments,
compulsory rehabilitation centres, establishments providing opioid substitution treatment,
medical and pharmaceutical training establishments and to drug stores throughout the country,
and may select one wholesaler within the province to sell all of the products in which such
establishment trades;"
24. Article 46.2(d) is amended as follows:
"(d) A wholesaler is only permitted to sell drugs to clinics, research and testing establishments,
compulsory rehabilitation centres, establishments providing opioid substitution treatment,
medical and pharmacy training establishments, to other non-commercial drug [pharmaceutical]
establishments and to drug stores in the province where such wholesale establishment has a
trading location.
25. Article 46.2(dd) is amended as follows:
"(dd) Clinics, compulsory rehabilitation centres, and establishments providing opioid substitution
treatment are permitted to purchase drugs at the establishments prescribed in sub-clauses (a)
to (d) above pursuant to bidding results of the establishment or a tendering/bidding plan
approved by the authorized person. Private hospitals are permitted to purchase drugs from the

establishments prescribed in sub-clauses (a) to (d) inclusive above pursuant to a drug order
approved by the authorized agency."
26. Article 48.2 [Destruction of drugs subject to special control] is amended as follows:
"2. Procedures for granting permission to destroy the group of addictive drugs:
(a) The establishment applying for destruction shall submit a written request by lodging it or
sending it in the post to MoH if the applicant is a manufacturer, importer or exporter, otherwise
to the Department of Health in the province where the establishment has its business; or to the
Department for Management of Medicine under the Ministry of Defence in the case of an
establishment managed by such ministry;".
27. Article 48.2(c) and (d) is amended as follows:
"(c) If there is no request to make an amendment or addition, the file-receiving agency shall issue a
written permission for destruction within twenty (20) days [formerly 30] after the date of receipt
recorded on the receipt for the file;
(d) If there is a need to amend the application file for destruction, then within twenty (20) days
[formerly 30) after the date of receipt recorded on the receipt for the file, the file-receiving
agency shall provide a written request to the applicant to amend the application file;"
"3. The destruction of narcotic drugs, psychotropic drugs, precursors, or drug raw materials which
contain active narcotic ingredients, active psychotropic ingredients or drug precursors may
only be carried out after there is written permission from MoH or from the Department of Health
in the place where the establishment has its trading location or from the Ministry of Defence."
29. Article 48.4(b) is amended as follows:
"(b) Destruction of drug raw materials must be witnessed by a representative of the Department of
Health of the same province or by the Ministry of Defence and minutes of destruction must be
prepared on standard form 16 in Appendix 2 issued with this Decree."
30. Article 48.4(c) is amended as follows:
"(c) Within ten (10) days after completing destruction of the drugs or drug raw materials, the
establishment concerned must provide a report on such destruction on standard form 17
enclosing minutes of destruction and send same to MoH, the Department of Health or the
Ministry of Defence."
31. Article 49.1 [Application file requesting permission to trade drugs subject to special control "controlled
drugs"] is amended as follows:
"1. Data showing how the establishment has taken measures to ensure security and prevent loss
of controlled drugs on standard form 18 in Appendix 2".
32. Article 51 [The previous heading was: Procedures for issuance of an SC Certificate for traders of
combined drugs containing narcotic active ingredients or psychotropic active ingredients or
precursors (except for manufacturers prescribed in article 50); and to traders of toxic drugs and so
forth] is amended as follows:
"Article 51 Sequence and procedures for issuance of an SC Certificate to traders of controlled
drugs
1. The sequence and procedures for issuance of an SC Certificate to trade controlled drugs are
implemented in accordance with article 33 of this Decree.
2. If the establishment has already been issued with an SC Certificate for pharmacy business or
satisfies the GMP standards prescribed in article 33 of the Law on Pharmacy and requests an
added business in controlled drugs, then the file-receiving agency shall only assess the file
lodged pursuant to article 49 of this Decree".

33. Article 53 [Application file for permission to purchase narcotic drugs, psychotropic drugs, precursors
or drug raw materials which have active narcotic ingredients, active psychotropic ingredients or drug
precursors] is amended as follows:
"2. An application for permission to purchase drug raw materials which are active narcotic
ingredients, active psychotropic ingredients or drug precursors comprises:
(a) One (1) copy of the purchase order for such drug raw materials on standard form 19 in the
Appendix;
3. An application for permission to sell drug raw materials comprises:
(b) One (1) copy of the sale order for such drug raw materials on standard form 19 in the
Appendix;".
34. Article 54.1 [Procedures for granting permission to purchase the group of addictive drugs, or for
permission to sell drug raw materials which have active addictive/narcotic ingredients, active
psychotropic ingredients or drug precursors] is amended as follows:
"1. The applicant submits an application file to:
(b) The Department of Health in the province where the applicant has its trading/business location
in the case of a wholesale or retail establishment, private hospital, research or testing institute,
training establishment, compulsory rehabilitation centre, or establishment providing opioid
substitution treatment or other establishment operating for non-commercial purposes;
(c) To the Ministry of Defence in the case of an establishment managed by such ministry".
35. Article 65 [Application for permit to import drugs containing active ingredients without a registration
certificate or drugs containing herbal ingredients used in Vietnam for the first time]
"1. The following conditions must be satisfied for permission to import:
(a) The drug is licenced for circulation in one of the following countries: the manufacturing country,
a member country of the International Council for Harmonization of Technical Requirements for
Pharmaceuticals for Human Use (ICH), or Australia.
(b) The drug is used in one of the following cases:
- It is mentioned in guidelines issued or approved by MoH on disease diagnosis,
prevention or treatment;
- It is used for emergency or preventive purposes;
- It is used in diagnosis, prevention or treatment of group A infectious diseases,
cancer, HIV/AIDS, viral hepatitis, tuberculosis, malaria or other diseases as decided by
the Minster of Health;
2. The application file for the import licence comprises:
(d) Original set of samples of the label and guidelines on use of the drug of the manufacturing or
exporting country, unless such data or a summary of the special characteristics of the product
are attached to the certificate of pharmaceutical product;
(e) Clinical data about the safety and efficacy of the drug in accordance with regulations on drug
registration issued by MoH.
The data prescribed in this sub-clause need not be lodged if the drug has already been issued
with an import permit pursuant to this article and there is no change in the information relevant
to indications, dosage and eligible users".
36. Sub-clauses (c), (d) and (e) of article 66.2 [Requirements and application file for a permit to import
drugs containing substances with a drug registration certificate but not satisfying [insufficient
quantities for] treatment needs, and drugs containing substances which have been used in Vietnam
but which are insufficient for treatment needs] are amended as follows:
"2. The application file for the import licence comprises:

(c) Quality file pursuant to regulations of MoH regarding application of ASEAN technical files
(ACTD) during drug registration or the equivalent standards on quality and research results as
prescribed in article 76.7 of this Decree;
(d) Original set of samples of the label and guidelines on use of the drug of the country of
manufacture or export, unless such samples and use guidelines or a summary of the special
characteristics of the product are already attached to the pharmaceutical product certificate;
(e) Clinical data if required by regulations of MoH on drug registration.
The data specified in the above sub-clause is exempt if an import licence has already been
issued pursuant to this article and there is no change of information about indications, dosage
and eligible users."
37. Article 67.2(c) [Requirements and application file for a permit to import drugs to meet urgent needs of
national defence and security, epidemic control or disaster or fire relief]
(c) Original copy or copy sealed by the competent agency of the written request or approval
issued by any of the competent agencies prescribed in sub-clauses (a), (b) or (c) of clause 1
above, specifying the following: name of the active ingredients in the case of a pharmaceutical
or biological drug or name of the herbal substance in the case of a pharmaceutical product or
traditional drug, the formulation and concentration of substances in the case of pharmaceutical
or biological products and the volume of substances in the case of herbal drugs and traditional
medicines; the packaging specifications, and the manufacturer and country of manufacture of
the drug".
38. Article 68 [Requirements and application file for an import permit for drugs for special treatment
purposes] is amended as follows:
(a) Clause 1(b) of article 68 is amended as follows:
"(b) The drug does not meet all treatment requirements and falls into one of the following
categories:
- The drug is used for emergency, anti-toxic or anti-rejection purposes;
- The drug is on the list of rare drugs;
- The drug is within the guidelines issued or approved by MoH on anti-shock
and shock treatment;
- The drug is used for specific patients currently being treated at clinics
(including diagnosis, prevention or treatment) of group A infectious diseases,
cancer, HIV/AIDS, tuberculosis, malaria or other serious diseases as decided by
the Minster of Health;"
(b) Clause 3(c) of article 68 is amended as follows:
3. The application file for the import licence of a drug prescribed in clause 1(b) or (c) of this
article comprises:
"(c) The original document from the medical examination and treatment establishment
["clinic"] specifying the reason for importing the drug, the number of patients expected to
use it, the corresponding drug demand, and an undertaking to be wholly liable for the
use of the drug proposed to be imported. There must also be an original or copy sealed
by the hospital of the minutes of the Council for Drugs and Treatment regarding the
requirement to import the drug. Minutes are not required in the case of a vaccination
establishment which does not have such a Council or if the drug is to be used for
emergency or anti-toxic purposes and the document from the clinic has also set out a list
of patients requiring the drug".
"(c) Clause 3(g) of article 68 is amended as follows:
A drug supplier need not implement the provisions of article 91.15 of this Decree if it has a
copy of its pharmaceutical business licence issued by its home country and certified
consularized in accordance with regulations".

39. Article 69.2(d) [Requirements and application file for a permit to import rare drugs] is amended as
follows:
"(d) Original set of samples of the label and guidelines on use of the drug of the manufacturing or
exporting country, unless such data is attached to the certificate of pharmaceutical product;"
40. Article 71 [Requirements and application file for a permit to import drugs serving a State medical
program] is amended as follows:
(a) Clause 1(b) of article 71 is amended as follows:
"1. Import shall only be licensed when the following requirements are satisfied:
(b) The drug has been licensed for circulation in one of the following countries namely the
exporting country, an ICH member country, or Australia".
(b) Clauses (c), (d) and (dd) of clause 2 of article 71 are amended as follows:
"(c) Technical file pursuant to regulations of MoH regarding application of ASEAN technical
files (ACTD) during drug registration or the equivalent standards on quality and research
results as prescribed in article 76.7 of this Decree;
(d) Clinical data if required by regulations of MoH on drug registration.
The data specified in the above sub-clause is exempt if an import licence has already
been issued pursuant to this article and there is no change of information about
indications, dosage and eligible users;
(dd) Original set of samples of the label and guidelines on use of the drug of the country of
manufacture or export, unless such samples and use guidelines are already attached to
the pharmaceutical product certificate".
41. Article 72 [Requirements and application file for a permit to import drugs as emergency or
humanitarian aid] is amended as follows:
(a) Clause 1 of article 72 is amended as follows:
"1. A permit to import shall only be issued if the drug is licensed for circulation in the
exporting country or in a member country of ICH or in Australia, and the drug falls within
one of the following categories:
(a) The humanitarian aid drug is brought by a foreign medical examination and treatment
team for the work of humanitarian medical examination and treatment;
(b) The drug provided as aid is for use for specific patients treated at a clinic as requested
by such clinic;
(c) The drug is for use in a State medical program or project;
(d) The drug provided as aid does not fall into the categories prescribed in sub-clauses (a),
(b) or (c) of this clause and is not an addictive drug, radioactive drug or vaccine.
(b) Sub-clauses (a), (c), (dd), (e), (g), (h), (k) of clause 2 of article 72 are amended as follows:
(a) Import order on standard form 24, 25 or 26 in Appendix 3 with this Decree;
(c) Copy or certified copy of a document from the authorized State agency approving use of
the drug in a State medical program or project in the case of humanitarian aid via a
program or project; or original approval document from the authorized agency on
humanitarian examination or treatment in the case of import pursuant to clause 1(a);
(dd) Quality file pursuant to regulations of MoH regarding application of ASEAN technical
files (ACTD) during drug registration or the equivalent standards on quality and research
results as prescribed in article 76.7 of this Decree;
(e) Clinical data if required by regulations of MoH on drug registration;

The data specified in the above sub-clause is exempt if an import licence has already
been issued pursuant to this article and there is no change of information about
indications, dosage and eligible users;
(g) Original set of samples of the label and guidelines on use of the drug of the
manufacturing or exporting country, unless such data or a summary of the special
characteristics of the product are attached to the certificate of pharmaceutical product;
(h) Two (2) sets of samples of the label and guidelines on use in Vietnamese as sealed by
the importer;
(k) The data prescribed in sub-clauses (d), (dd), (e), (g), (h), and (i) is exempt in a case of
import pursuant to sub-clauses (a) or (b) of clause 1 above, but there must be a written
undertaking that the drug is permitted for circulation in the manufacturing country or in a
member country of ICH or in Australia and a document from the aid recipient must list
clearly the list of patients requiring to use the drug in the case prescribed in clause 1(b)
above;".
42. Article 76 [Requirements regarding documents in an application file for a permit to import drugs] is
amended as follows:
(a) Clause 3(d) of article 76 is amended is as follows:
"3. The following documents must be consularized except where that is exempted by
[Vietnamese] law:
(d) The use guidelines on the drug of the manufacturing or exporting country, except in the
cases prescribed in articles 66.2(d), 69.2(d), 71.2(dd) and 72.2(g) of this Decree".
(b) The heading of article 5 and sub-clauses (b) and (c) of clause 5 of article 76 are amended as
follows:
"5. Requirements regarding certification of samples of the label and guidelines on use of the
drug of the manufacturing or exporting country unless the drug has the same trade
name, active ingredients, content or concentration, and form of preparation as the brand
name drug with a registration certificate in Vietnam, manufactured by the same
manufacturer as that of the brand name drug or by a manufacturer authorized by the
manufacturer of the brand name drug, and with a lower price than that of the brand
name drug sold in Vietnam as prescribed in article 70:
(b) The use guidelines on the drug of the manufacturing or exporting country, except in the
cases prescribed in articles 66.2(d), 69.2(d), 71.2(dd) and 72.2(g) of this Decree;
(c) The use guidelines for the purpose of the consularization process must be an original".
(c) Sub-clause (d) is added to article 76.5 as follows:
"The sample of the label prescribed in article 65.2(d); and the sample of the label and
guidelines on use prescribed in article 66.2(d), 69.2(d), 71.2(dd) and 72.2(g) of this Decree
must be sealed by the manufacturer or owner of the product or owner of the product licence
(recorded on the pharmaceutical product certificate) and by the importer;"
(d) Clause 7 is added to article 76 as follows:
"7. Provision on quality standards and biological equivalence study results:
(a) They must be a copy sealed by the manufacturer or by the product owner or by the
owner of the product licence (as recorded in the pharmaceutical product certificate) and
by the importer;
(b) The biological equivalence study results are only required if it is necessary to report the
data on such results pursuant to regulations of MoH on registration of drugs.
The above data is exempt if the drug was manufactured and is licenced for circulation (as
expressed on the pharmaceutical product certificate) in a country which is a standing or
founding member of ICH, or Australia.

43. Article 77 [Procedures for licencing import of drugs without a certificate of drug registration in
Vietnam]
(a) The heading of clause 1 and sub-clause (g) of clause 1 of article 77 is amended as follows:
"In the case of import of drugs as prescribed in articles 65, 66, 69, 71, and sub-clauses (c) and
(d) of article 72.1:
(g) In a case of importing drugs for provision of humanitarian medical prevention and
treatment services as approved by the competent agency but the data prescribed in
sub-clauses (d), (dd), (e), (g), (h) and (i) of article 72.2 is not submitted but the drugs are
essential for disease treatment, then MoH shall consider and make a decision on the
basis of advice from the Advisory Council on issuance of certificates of drug circulation
[i.e. free sale]".
(b) The heading of article 77.3 is amended as follows:
"3. In the cases of import of drugs prescribed in sub-clauses (b) and (c) of article 68.1,
article 70, sub-clauses (a) and (b) of 72.1, article 73, and article 74.1 of this Decree".
(c) Clause 4(e) of article 77 is amended as follows:
"4. In the cases of import of drugs prescribed in article 75:
(e) Within three (3) months after the date on which the Department of Health requests
additional documents, the applicant must submit such documents as requested and if on
expiry of the above time-limit the applicant fails to amend or supplement its request for
an import permit or if the matter is not resolved within four (4) months from the date of
lodging the initial file, then the application file shall no longer be valid."
44. Article 78.3 [Management of import of drugs without a certificate of drug registration in Vietnam] is
amended as follows:
(a) The heading of clause 3 of article 78 is amended as follows:
"3. In the case of drugs used for emergency purposes, poison control or as vaccines for a
number of special cases with a restriction on the amount to be used and in the case of
other drugs permitted for import pursuant to sub-clauses (b) and (c) of article 68.1 of this
Decree:".
(b) Sub-clause (c) is added to article 78.3 as follows:
"(c) It is not necessary to implement the provision in article 103.4 of the Law on Pharmacy
[requiring testing of a number of drugs before they are put into circulation]. In the case of
drugs requiring to be preserved/stored in cold conditions or at very low temperatures,
the importer must monitor the storage conditions (cold chain) during the process of
transporting the import consignment (sealed with confirmation by the importer) from the
automatically recording temperature/freezer equipment".
45. Article 79.3 [Application file for a permit to import controlled drugs with a certificate of drug
registration in Vietnam] is amended as follows:
"3. In the case of drugs on the list of drugs and drug ingredients prohibited from use in certain
industries and trades and where the total number of such drugs requested to be imported, the
total number still available as at the time of formulation of the order, and the total number
which will continue to be imported pursuant to the issued import permit exceed 150% of the
actual trading requirements in the one year prior to formulation of the order, there must be an
explanatory document attached to the evidence provided."
46. Sub-clauses (a), (d), (dd) and (e) of article 80.1 [Application file for a permit to import controlled drug
ingredients] are amended as follows:
"1. An application filed for an import permit comprises:
(a) Original of the purchase order for the imports on standard forms 35, 36 or 41 in Appendix 3
issued with this Decree;

(d) Report on use of drug raw materials on standard form 37 in Appendix 3 issued with this
Decree, except where the import is of toxic drug raw materials, and a report on the business
results of trading the final product manufactured from the raw materials on standard form 38 in
Appendix 3 issued with this Decree, except where the import is of toxic raw materials for
producing drugs.
Lodging the business results report is exempt if the raw materials and standard substances are
imported for drug testing or drug research purposes, or as raw materials for the production of
drugs;
(dd) The report on production, use and trading of the raw materials and standard substances
proposed to be imported and the proposed business plan regarding the finished products
manufactured from the raw materials requested to be imported, except where the raw
materials are imported to be drugs; the proposed business plan on the finished products need
not be lodged if the raw materials and standard substances are imported for drug testing or
drug research purposes, or as raw materials for the production of drugs;
In the case of drugs on the list of drugs and drug ingredients prohibited from use in certain
industries and trades and where the total number of such drugs requested to be imported, the
total number still available as at the time of formulation of the order, and the total number
which will continue to be imported pursuant to the issued import permit exceed 150% of the
actual trading requirements in the one year prior to formulation of the order, there must be an
explanatory document attached to the evidence provided.
(e) In the case of raw materials and standard substances imported for drug testing or research
purposes or as raw materials for the production of drugs; and in the case of toxic materials to
be made into drugs or other substances on the list of drugs and substances prohibited from
use in a number of industries and sectors imported in order to produce drugs for export; and in
the case of drug ingredients/raw materials with a certificate of free sale in Vietnam or on the list
of adjuvants and semi-finished products for manufacture of drugs pursuant to an application
file for registration of the drugs which already have a certificate of registration of circulation in
Vietnam, it is not necessary to file the data prescribed in sub-clauses (b) and (c) above."
(a) The name of article 87 is amended as follows:
"Article 87 Application file for a permit to import herbal ingredients/substances not in the cases
prescribed in articles 82 to 86 inclusive"
(b) Sub-clauses (b) and (dd) of article 87.1 are amended as follows:
"1. An application file for an import licence comprises:
(d) A drug supplier need not implement the provisions of article 91.15 of this Decree if it has a
copy of its pharmaceutical business licence issued by its home country and certified and
consularized in accordance with regulations;
(dd) Certified copy of the GMP certificate of the manufacture issued by the competency agency of
the home country."
48. Article 91 [Import of drugs and herbal/drug ingredients] is amended as follows:
(a) Clause 5 of article 91 is amended as follows:
"Representative offices in Vietnam of manufacturers, of holders of registrations [establishments
named in the registrations], of holders of certificates of free sale of drugs undergoing clinical trial,
bio-availability study or bio-equivalence study; of providers of clinical trials and of bio-availability
studies or bio-equivalence studies are permitted to import drugs, drug ingredients/raw materials,
primary packages and standard substances to serve such clinical trials, bio-availability or bio-
equivalence studies, and to serve registration for circulation, and research and testing of drugs and of
drug raw materials."
(b) Clause 5a is added to clause 5 of article 91 as follows:
"5a The following agencies and organizations satisfy the conditions prescribed in article 35 of the
Law on Pharmacy [so as not to be required to have an SC Certificate for pharmacy business]:

(a) Importers of drugs as prescribed in article 67 of this decree when the Ministry of Defence, the
Ministry of Public Security, the Ministry of Health appoints such import;
(b) Importers of drugs for aid or humanitarian aid when the competency State agency approves
receipt of such aid."
(c) Clause 8(a) of article 91 is amended as follows:
"8. MoH decides the quantity of drugs or herbal ingredients for which import is restricted as
follows:
(a) The number or permitted drugs containing substances without a drug registration certificate or
of drugs containing substances used in Vietnam for the first time as prescribed in article 65,
shall depend on the business requirements of the importer;"
(d) Clause 15 of article 91 is amended as follows:
"15. Suppliers of drugs and raw materials for drug manufacture means a foreign establishment
which signs a purchase and sale agreement with the importer. Such suppliers must fall in one
of the following categories:
(a) An establishment manufacturing imported drugs and pharmaceuticals [raw materials];
(b) The owner of products or the owner of circulation licences [certificates of free sale] of imported
drugs and/or pharmaceuticals as recorded in the pharmaceutical product certificates in the
case of drugs which have been granted with a certificate of registration of circulation in
accordance with the Law on Pharmacy and drugs which have a certificate of registration for
circulation in Vietnam;
(c) A foreign establishment which has registered drugs or drug raw materials with certificates of
registration for circulation in Vietnam which are still effective at the time of customs clearance
but not being an establishment prescribed in sub-clause (a) or (b) above;
(d) An establishment which has been issued with an operational licence by a foreign enterprise for
drugs and drug raw materials in Vietnam [or] an operational licence of a foreign company in
vaccines, medical bio-products and raw materials for the production of vaccines and medical
bio-products in Vietnam;
(dd) If the supplier is an establishment prescribed in sub-clauses (c) or (d) or (h) of this clause, then
it must be authorized in writing by an establishment prescribed in either sub-clause (a) or (b)
above to supply drugs to Vietnam, except where the establishment prescribed in either sub-
clause (d) or (h) is in fact the same establishment as that prescribed in sub-clause (a) or (b).
Authorization document includes a power of attorney or a seller's permit or a partnership
certificate. Authorization documents must be in Vietnamese or English with at least the
following information: name and address of the authorized establishment and of the
establishment providing the authorization; the scope of authorization including supply of drugs
and drug raw materials in Vietnam; the term of the authorization or the time-limit for sale of
goods; responsibilities of the parties in ensuring quality and origin of the drugs and raw
materials supplied into Vietnam; and the signatures of the parties.
(e) Suppliers of imported drugs as prescribed in article 67, 73 and 74.1 of this Decree are not
required to implement the provisions in this clause;
(g) Suppliers of imported drugs as prescribed in articles 68 and 70 of this Decree are not required
to implement the provisions in this sub-clause (dd) above;
(h) Establishments shall be announced in accordance with clause 22 of this article."
(dd) Clause 16 of article 91 is amended as follows:
"16. Suppliers of adjuvants, softgel shells and primary packages of controlled drugs, standard
substances and drug raw materials are permitted to import same for testing, research or for
producing export drugs as stipulated in article 80; and drug raw materials pursuant to
articles 82 to 85 of this Decree; and drugs as humanitarian aid without implementing the
provisions in clause 15 above".
(e) Clauses 22, 23 and 24 are added to article 91 as follows:
"22. If MoH receives a letter from a competent agency of an exporting country requesting
announcement of a list of manufacturers and traders of drugs and drug raw materials

registering to supply same to Vietnam, MoH shall:
(a) Within thirty (30) days after receipt of such request, announce on its website a list of such
manufacturers and traders registering to supply drugs and drug raw materials to Vietnam;
(b) If MoH receives a letter from such foreign agency requesting a change to the information about
the foreign suppliers the Ministry has announced, then the Ministry shall again implement the
provisions in sub-clause (a) above.
23. Competent agencies of exporting countries as prescribed in this clause shall provide written
notices to MoH as follows:
(a) If there is a change of the registered supplier of drugs and drug raw materials as announced
by MoH regarding name, business location or operational scope, then such foreign agency
should notify such change within one (1) month after the date of its letter of approval to the
changes;
(b) If the supplier notifies that it has stopped or terminated its activities of manufacturing or trading
drugs and drug raw materials within the exporting country, then the foreign agency should
notify such change within fifteen (15) days after the date of the letter from such foreign agency
confirming that the activity of the supplier has been stopped or terminated.
24. Documents from competent agencies of exporting countries referred to in clauses 23 and 24
above should:
(a) Record the name, address and contact information about the competent agency of the
exporting country; information about the country or territory registered to supply drugs or drug
raw materials to Vietnam; and the name of each supplier, its business location, business scope
and contact information about such manufacturer or trader of drugs and drug raw materials
registered to supply same to Vietnam;
(b) Original documents should be provided in English or Vietnamese, or otherwise the original
documents need to be translated into English or Vietnamese and the translations need to be
certified in accordance with regulations."
49. Article 93 [Documents to be produced and submitted upon customs clearance of drugs and drug raw
materials] is amended as follows:
(a) Clause 2(dd) of article 92 is amended as follows:
"(dd) In the case of import of drugs and drug raw materials as prescribed in article 59.1(dd) of the
Law on Pharmacy [Imports delivered at the port of departure of the exporting country before
their certificates of free sale expire and which are permitted to be circulated until such expiry
date] and an import permit/licence is not required, the importer must present the bill of lading
for such consignment showing that the goods were exported from the port of the exporting
country prior to the certificate of free sale expiring, in order to obtain customs clearance".
(b) Sub-clauses (e), (g) and (h) are added to article 92.2 as follows:
"(e) In the case of import of drugs and drug raw materials as prescribed in article 59.1(dd) of the
Law on Pharmacy [Imports delivered at the port of departure of the exporting country before
their certificates of free sale expire and which are permitted to be circulated until such expiry
date] and an import permit/licence is required, the importer must present the bill of lading for
such consignment showing that the goods were exported from the port of the exporting country
prior to the certificate of free sale expiring and also the expired import permit/licence, in order
to obtain customs clearance.
(g) In the case of import of drug raw materials on the list of substances, adjuvants and semi-
finished products for manufacture of drugs pursuant to an application file for registration of
drugs which already have a certificate of registration of circulation in Vietnam, and an import
permit/licence is not required, then the importer shall present the bill of lading for the
consignment of raw materials showing that the goods were exported from a port of the
exporting country prior to expiry of validity of the registration certificate for circulation of the
drugs used to announce the raw materials, in order to obtain customs clearance (in a case
where the certificate of free sale used to announce the raw materials has expired as at the
time of obtaining customs clearance);
(h) In the case of import of drug raw materials on the list of substances, adjuvants and semi-
finished products for manufacture of drugs pursuant to an application file for registration of
drugs which already have a certificate of registration of circulation in Vietnam and an import
permit/licence is required, then the importer shall present the bill of lading for the consignment

of raw materials showing that the goods were exported from a port of the exporting country
prior to expiry of validity of the registration certificate for circulation of the drugs used to
announce the raw materials, in order to obtain customs clearance (in a case where the
certificate of free sale used to announce the raw materials or the import permit/licence has
expired as at the time of obtaining customs clearance)."
(c) Clause 3(e) of article 92 is amended as follows:
"3. Regarding import of drug raw materials and semi-finished raw materials, regardless of
availability of a certificate of free sale in Vietnam:
(e) If herbal substances and semi-finished pharmaceutical products as prescribed in
article 59.1(dd) of the Law on Pharmacy are imported and are not in the category requiring an
import permit, then the importer shall submit the bill of lading for the consignment showing that
the goods were exported from a port of the exporting country prior to expiry of the certificate of
free sale, in order to obtain customs clearance;"
(d) Sub-clauses (h) and (i) are added to article 92.3 as follows:
"(h) If herbal substances and semi-finished pharmaceutical products as prescribed in
article 59.1(dd) of the Law on Pharmacy are imported and are in the category requiring an
import permit, then the importer shall submit the bill of lading for the consignment showing that
the goods were exported from a port of the exporting country prior to expiry of both the
certificate of free sale and import permit/licence, in order to obtain customs clearance;
(i) In a case of import of herbal substances and semi-finished pharmaceutical products in the
form of an import permit but without a certificate of free sale in Vietnam and at the time of
customs clearance the import permit has expired, then the importer shall present the bill of
lading of the consignment showing that the goods were exported from a port of the exporting
country prior to such import permit expiring, in order to obtain customs clearance."
(dd) Sub-clause (e) is added to article 92.4 as follows:
"4. Customs clearance of imported drugs and drug raw materials:
(e) In a case of import of herbal substances and semi-finished pharmaceutical products in the
form of an import permit but without a certificate of free sale in Vietnam and at the time of
customs clearance the import permit has expired, then the importer shall present the bill of
lading of the consignment showing that the goods were exported from a port of the exporting
country prior to such import permit expiring, in order to obtain customs clearance."
50. Article 93.1(dd) [Herbal substances for which registration is compulsory, and registration conditions]
is amended as follows:
"1. A herbal substance must be registered before being sold in Vietnam if:
(dd) The herbal substance is on the list of herbal substances/ingredients that are able to be
domestically grown or harvested and satisfy the conditions on treatment and ability to be
supplied at a reasonable price".
51. Article 98.5(b) [Application file for assessment of satisfaction of GMP standards] is amended as
follows:
"5. An application for GMP inspection/assessment comprises:
(b) GMP certificate and report on GMP inspection/assessment as prescribed in clauses 1 to 4
above, and the manufacturing licence prescribed in clauses 1 to 3 above which must be
originals or certified copies and which must still be valid as at the time of lodging the file. If the
expiry term is not specified, then such documents must have been issued or promulgated
within the period of three (3) years as from the date of their issuance3.
The GMP certificate and manufacturing licence are exempt from being lodged if they have
already been announced on the website of the competent pharmacy administrative agency."
3 Allens footnote: This is the literal translation here.

52. Sub-clauses (a) and (b) of article 99.1 [Receipt of application files and time-limits on inspection] are
amended as follows:
"1. MoH receives application files for GMP assessment, carries out the assessment and prepares
the GMP assessment report and notifies the results as follows:
(a) Within twenty (20) days [formerly 30] from the date of receipt of a complete application file by
the State agency for pharmacy regarding their requirement to satisfy GMP conditions, in the
case of mutual assessment and acceptance of inspection results;
(b) Within forty (40) days [formerly 60] after the date of receipt of a complete application file in the
case of assessment being made in the form of a document inspection [namely an inspection of
the file in relation to production conditions];"
53. Clauses 2(a), 3(c) and 4 of article 100 [Responsibilities of applicants for registration of drugs and
drug raw materials of foreign manufacturers during GMP inspection, and cases in which applications
for registration are rejected] are amended as follows:
(a) Clause 2(a) of article 100 is amended as follows:
"2. An application for a certificate of drug or drug raw material registration shall be rejected if the
applicant or manufacturer commits any of the following breaches:
(a) A breach resulting in revocation of the certificate of free sale of the drug or drug raw materials
as prescribed in sub-clauses (a), (d) and (dd) of article 51 of the Law on Pharmacy".
(b) Clause 3(c) of article 100 is amended as follows:
"3. As from the day on which a breach is notified by a competent agency, the applicant is
suspended from submitting an application for issuance of a certificate of drug or drug raw
material registration for the following periods:
(c) From six (6) months up to one (1) year [formerly from 3 to 5 years] in the cases prescribed in
clause 1(b) of article 58 of the Law on Pharmacy and in clause (g) of this article."
(c) Clause 4 of article 100 is amended as follows:
"4. Application files for issuance or extension of certificates of free sale of drugs or drug raw
materials where the applicants have breached the provisions prescribed in sub-clauses (a),
(b), (d), (dd) or (e) of clause 2 above which are lodged prior to the date the breach is dealt with
shall no longer be valid. On expiry of the term of suspension of receipt of the application file as
prescribed in clause 3 above, an applicant wishing to register drugs or drug raw materials must
lodge a file in accordance with the provisions in the Law on Pharmacy."
54. Article 105 [Methods of provision of drug information] is amended as follows:
"Article 105 Methods of provision of drug information
Drug information shall be provided to medical and pharmaceutical practitioners by the following
methods:
1. Providing information via people introducing drugs.
2. Publishing documents containing drug information.
3. Holding seminars to introduce drugs.
55. The title of article 107 is amended as follows:
"Article 107 Cases in which certificates of confirmation of information contents about drugs
(confirmation certificates) are issued
56. Clauses 1(e) and 2(e) of article 108 [Application file for a certificate of confirmation of information
contents about a drug] as issued as follows:
"(e) Licence for establishment of the rep office of the foreign company in Vietnam if the foreign
establishment is the named applicant requesting confirmation of the information contents, or
SC certificate for pharmacy business if a Vietnamese trader makes the application in its name

for confirmation of the information contents. In the case of a Vietnamese trader making the
application, the SC certificate for pharmacy business issued by MoH is exempt".
(a) The name of the article is amended as follows:
"Article 111 Requirements regarding the data in an application file for a confirmation certificate
(b) Clauses 2, 5 and 6 of article 111 are amended as follows:
"2. Data prescribed in clause 1(d) and in sub-clauses (d) and (e) of clause 2 of article 108 means
a copy sealed by the applicant in the case of data issued by MoH or a certified copy in the
case of data which MoH did not issue.
5. Data prescribed in clauses 1(b) and 2(b) of article 108 mean two original copies.
6. Each application file for issuance of a certificate of confirmation of information contents about a
drug is regulated as follows:"
58. Article 113.2 [Procedures for issuance of a confirmation certificate] is amended as follows:
"2. Within ten (10) days [formerly 15] after receipt of a complete file, the file-receiving agency
issues a certificate on standard form 5 or 6 in Appendix 4, and if the application is refused,
then such agency responds in writing specifying its reasons".
"3 If the application file needs to be amended or supplemented, then within ten (10) business
days after receipt, the file-receiving agency provides a written request for amendment or
addition as follows:
(a) The written request must specifically set out the items and contents which need to be
amended or supplemented;
(b) Within ten (10) days [formerly 15] after receipt of the amended or supplemented file, the
agency issues a confirmation certificate on standard form 5 or 6 in Appendix 4, or provides a
written response setting out the reasons for refusal;
(c) Within ninety (90) days after receipt of the request from the file-receiving agency, the applicant
must amend or supplement its file, otherwise on expiry of this time-limit the application file shall
no longer be valid".
"Article 116 Authority to issue confirmation certificates
1. MoH issues confirmation certificates in the case of information by the method prescribed in
article 105.2.
2. The Department of Health issues confirmation certificates in the case of information in the form
prescribed in article 105.3."
61. The title of article 120 is amended as follows:
"Article 120 Circumstances in which a certificate of contents of a drug advertisement is issued"
62. Clauses 1(e) and 2(e) of article 121 [Application file for issuance of a certificate confirming contents
of a drug advertisement] are amended as follows:
"(e) Licence for establishment of the rep office of the foreign company in Vietnam if the foreign
establishment is the named applicant requesting confirmation of the advertisement contents, or
SC certificate for pharmacy business if a Vietnamese trader makes the application in its name
for confirmation of the advertisement contents. In the case of a Vietnamese trader making the
application in its name, the SC certificate for pharmacy business issued by MoH is exempt."

(a) The title of article 124 is amended as follows:
"Article 124 Requirements for an application file for a certificate of drug advertisement contents"
(b) Clauses 2, 5 and 6 of article 124 are amended as follows:
"2. The documents prescribed in sub-clauses (d) and (e) of clause 1 and in sub-clauses (d) and
(e) of clause 2 of article 121 means copies sealed by the applicant in the case of data issued
by MoH, or certified copies in the case of data other than that issued by MoH;
5. The data prescribed in clauses 1(b) and 2(b) of article 121 must be two originals;
6. Each application file requesting issuance of a certificate of drug advertisement contents is
regulated as follows:"
"Article 127 Sequence and procedures for issuance of a certificate of drug advertisement contents
1. An applicant for a certificate lodges an application file with MoH.
2. The sequence and procedures for issuance of a certificate of drug advertisement contents is
implemented in accordance with article 113 of this Decree".
"Article 128 Authority to issue certificates of drug advertisement contents
MoH issues certificates of drug advertisement contents".
66. Article 129(a) is added after article 129 as follows:
"Article 129(a) Provisions on amending items or contents for which a confirmation certificate has
been issued
1. If any information contents or items recorded in a certificate confirming advertisement
information or advertisement contents are incorrect due to a fault of the certificate-issuing
agency, then the applicant shall send a request to such agency and specify the contents which
need to be rectified. On receipt of an application, the agency shall provide a receipt on
standard form 7 in Appendix 4, and the establishment [applicant] is entitled to conduct the
advertising or implement the information contents in accordance with such amended or
corrected items and is liable for such corrected or amended items.
2. If advertisement information or advertisement content for which a certificate has been issued is
changed but does not fall within the cases prescribed in articles 107.1(b) or 120.1(b) of [this]
Decree 54, then the applicant for such certificate shall notify the certificate-issuing agency
about the items which need to be amended, and such establishment [applicant] is entitled to
implement the amended items and is responsible for such amended information or
advertisement contents."
67. Clause 3 of article 130 [File for declaration of drug prices] is amended as follows:
"3. A file declaring a drug price in the case of a change of the certificate of free sale as prescribed
in article 55.2(b) of the Law on Pharmacy [drugs which already have certificates of free sale
but then there are changes in their ingredients etc.] shall be implemented as prescribed in
clause 1 above".
68. Article 131.1(c) [Receipt of declarations of drug prices and amendments to same] is amended as
follows:
"(c) When there is a change in the certificate of free sale in a case prescribed in article 55.2(b) of
the Law on Pharmacy or there is a change in the drug import licence, then before putting the
initial drug consignment onto the Vietnamese market, the establishment concerned must lodge
a drug price declaration file.
If there is a change in the certificate of free sale otherwise than as prescribed in article 55.2(b)
of the Law on Pharmacy or a change of import licence but the drug price has not been

changed as compared to the proposed wholesale or retail price of such drug for which a
declaration has been made, then the establishment which made the declaration need not
lodge a drug price declaration file but need only lodge the file prescribed in article 130.4
[documents which are submitted when there is a change to information but the drug price itself
is not changed]."
"(c) [Regarding domestic drugs] when there is a change to the certificate of free sale in a case
prescribed in article 55.2(b) of the Law on Pharmacy and before commissioning the first drug
consignment onto the Vietnamese market, the enterprise concerned must submit a drug price
declaration file.
If there is a change in the certificate of free sale otherwise than as prescribed in article 55.2(b)
of the Law on Pharmacy but the drug price has not been changed as compared to the
proposed wholesale or retail price of such drug for which a declaration has been made, then
the establishment concerned need not lodge a drug price declaration file but need only lodge
the file prescribed in article 130.4 [documents which are submitted when there is a change to
information but the drug price itself is not changed]."
70. Sub-clauses (b), (c) and (d) of article 131.4 [Receipt of declarations of drug prices and amendments
to same] are amended as follows:
"(b) The staff receiving a file shall check its composition and the number of documents in the file,
and if they are adequate shall seal the application with the date of receipt and hand one
(1) copy to the applicant in a case of personal lodgement or send one (1) copy in the post,
such receipt to be on standard form 6 in Appendix 7 if MoH received the file or standard form 7
in Appendix 7 if the provincial people's committee received the file, and at the same time
transfer the other original to the competent State staff to process.
If the file is inadequate, then staff must specify what items need to be amended or
supplemented and immediately hand same to the applicant in person or send same in the post
to the applicant no more than two (2) working days after receipt of the file;
(c) Within seven (7) days after receipt of an adequate file declaring or redeclaring a drug price or
declaring a change of information about a drug for which the price has already been declared,
MoH shall publish such information on its website.
(d) In the case of an application file for declaration of the price of a drug manufactured
domestically:
- Within three (3) business days after receipt of the file, the provincial people's committee must
report to MoH drugs for which prices have been redeclared on standard form 8 in Appendix 7;
- Within four (4) business days [formerly 5] after receipt of such report, MoH collates same and
announces the information on its website;
- If a provincial people's committee after conducting a check sends a letter to the declarant
enterprise requiring it to declare whether its price is consistent with market changes, such
provincial people's committee must send a copy of the letter to MoH".
71. Article 132.1 [Responsibilities of State drug pricing authorities] is amended as follows:
"1. During circulation of a drug, the competent State agency shall rely on the principles in
article 134 [Principles for reviewing and announcing the declared prices of drugs] to check a
file of declared or redeclared drug prices including checking whether such price levels were in
fact implemented, checking that information in the file was accurate, and requiring an
enterprise to explain price components or to redeclare for compliance with market factors in
necessary cases, in order to serve the work of price stabilization, State management of prices,
and checks and inspections in accordance with law".
72. Article 132.2(b) is amended as follows:
"2. The State agency, during drug price inspection, shall take action for a breach of law in the
following cases:

(b) Failure to adjust or amend a drug price without reporting in writing to the State pricing agency
or making an inaccurate report on price components";
73. Clauses 2, 3 and 4 of article 133 [Responsibilities of pharmacy traders to implement the regulations
on price declaration] are amended as follows:
"2. A pharmacy trading establishment is permitted to sell drugs as from the date the manufacturer
or establishment placing the order or importer of such drugs lodges the drug price declaration
file.
3. A pharmacy business establishment is not permitted to wholesale or retail drugs at a higher
price than that declared by the manufacturer or establishment placing the drug order or
importer.
4. If the competent State administrative agency provides a written request to a pharmacy trader
to report on the price of drugs which it has declared, then within sixty (60) days as from the
date of such request, the establishment concerned must provide a response reporting on the
level of the price declared including the price components or amendments made as required
by such State agency. If the trader fails to respond in writing by expiry of this term, then the
price declaration or redeclaration file shall no longer be valid".
74. Article 134.1 [Principles for reviewing and announcing the declared prices of drugs] is amended as
follows:
"1. Prices declared by drug traders shall be checked in accordance with the following principles:
(a) The price is not higher than the drug selling price in ASEAN countries;
(b) Accuracy of the components of the drug selling price of the importer, manufacturer or
establishment placing the order as the latter establishments have declared;
(c) Compliance with changes in the costs of ingredients making up the product such as
ingredients/raw materials, cost of fuel, wages and other relevant costs where there has been
increase in the price of the drug".
75. Clauses 5 and 6 of article 134 are amended as follows:
"5. State drug pricing authorities may establish expert groups to check the accuracy of files of
declared prices.
6. The Minister of Health shall establish an inter-branch pricing council to comprise
representatives from MoH, the Ministry of Finance, Vietnam Social Insurance and other
relevant agencies to advise the Minister on price review in the following cases:
(a) The declared drug in fact has a content or concentration which is different from that announced
on the Ministry's website;
(b) The form of preparation of the drug is in fact different from that announced on the Ministry's
website;
(c) The drug is a new drug;
(d) The drug is on the list of drugs undergoing price negotiation, the drug is a proprietary drug, a
drug manufactured according to EU-GMP or PIC/S-GMP standards by a manufacturer which is
a member State of ICH or Australia, or the drug was manufactured according to WHO-GMP
standards for which MoH has issued a certificate and the national pricing agency has licenced
circulation in a member country of ISH or Australia with the following redeclared increase rates:
- Over 10% of the price (calculated on the smallest pack) of 5,000 VND up to 100,000 VND;
- Over 7% of the drug price (calculated on the smallest pack) above 100,000 and up to
1,000,000 VND;
- Over 5% of the price of the drug (calculated on the smallest pack) exceeding 1,000,000 VND."
76. Article 136.2 [Retail margins applicable to retailers in health facilities] is amended as follows:

"2. The drug retailer within the premises of a public clinic may only buy drugs for which contracts
have been won by suppliers to such clinic with a decision awarding them a contract at health
facilities at the provincial and central level within the last twelve (12) months [before the
purchase]; and drugs for which there is a decision awarding the supplier its procurement bid at
the local or national level within the term of the frame contract or agreement for concentrated
procurement calculated up until the time of purchase of the drug and with the price level as
follows:
(a) For drugs on the list of winning bids [for supply to] the same clinic, the purchase price by the
retailer must not be higher than the successful bid of the same time;
(b) In the case of drugs not on the list of winning bids [for supply to] the same clinic, the purchase
price must not be higher than a successful bid during the last twelve (12) months for the same
drug at a provincial or central health facility; [or] the successful bid for concentrated
procurement at the local or national level within the term of the framework contract or
agreement on concentrated procurement calculated up until the time of purchase of the drug.
This provision does not apply in the case of drugs for which import is licenced as prescribed in
articles 67 or 68 [Licensing import to serve the requirements of national defence and security,
epidemic control or disaster or fire relief, or for special treatment]; or to addictive drugs,
psychotropic drugs, precursors and new drugs prescribed in article 2.14 of the Law on
Pharmacy for which there has not yet been a successful bid at a medical health
establishment".
77. Article 140.2 [Deadline for obtaining pharmacy practising certificates]
"2. By 1 January 2021 [formerly 1 July 2018] the person in charge of quality assurance of a
manufacturer of drugs or drug raw materials must have a pharmacy practising certificate".
78. Article 143 [Transitional provision] is amended as follows:
(a) Clause 3 is amended as follows:
"3. Import and export licences for drugs and drug raw materials, orders for such exports and
related administrative procedures implemented [issued] in accordance with the Law on
Pharmacy of year 2005 and its implementing guidelines shall continue to be implemented until
the expiry of the terms of such licences.
Drugs and drug raw materials prescribed in this clause which are imported into or exported out
of Vietnam shall be granted customs clearance if they satisfy the provisions in the Law on
Pharmacy of year 2005 and its implementing guidelines or if they comply with the provisions of
this Decree as from its effective date".
(b) Clause 5(a) is amended as follows:
"5. Traders in controlled drugs shall comply with the following:
(a) Establishments currently trading in controlled drugs prescribed in sub-clauses (a) and (b) of
article 2.26 of the Law on Pharmacy are permitted to continue operating until the end of
30 June 2019. After that date, establishments wishing to continue operation must have an
SC Certificate for pharmacy business for controlled drugs consistent with the operational
scope of the enterprise as prescribed in Section IV of Chapter 3 of this Decree;"
(c) Clause 7 is amended as follows:
"7. From 1 January 2021 at the latest, herbal substances, prior to circulation in Vietnam, must
have a certificate of registration of circulation or their standards must have been announced as
prescribed in clauses 1 and 2 of article 93 [herbal substances for which registration is
compulsory] of this Decree."
(d) Clause 11 is amended as follows:
"11. Operational licences of foreign enterprises regarding drugs and drug raw materials in Vietnam,
operational licences of foreign enterprises regarding vaccines, medical bio-products and raw
materials for the production of vaccines and medical bio-products in Vietnam which were
issued prior to the effective date of Decree 54 [1 July 2017] are effective for use until the expiry
date of such licences."

79. The phrase "Department of Health in the location [province] where an establishment has its
headquarters" is replaced by "Department of Health in the place where such establishment has a
business location" in articles 33.1(b), 34.1(b), 50.1(b), 51.1(b) and 55.2(b).
80-86. Changes to Appendices [not translated].
CHAPTER 3
Sector being Tissue Banks and Human Organ Transplantation
Article 1 To repeal a number of provisions of Decree 118 dated 22 July 2016 amending Decree 56
ordination Centre for human organ transplantation
1. The fourth item in article 3(a).2(b) [Regarding material facilities of a tissue bank].
2. The fourth item in article 3a.2(c) [Regarding requirements on personnel of a tissue bank].
3. Item 4 in article 4.1(d) [Application file for an operational licence for a tissue bank].
Article 2 To amend a number of provisions of Decree 118 dated 22 July 2016 amending Decree 56
ordination Centre for human organ transplantation
1. Article 3a is amended as follows:
"Article 3a Conditions for operation and grant of an operational licence for a tissue bank
1. Tissue banks may only operate after they have a tissue bank operational licence issued by the
Ministry of Health [MoH].
2. Conditions for the grant of a licence are:
(a) Having a decision on establishment of the tissue bank or being a tissue bank named in a
document from the competent agency regulating the organizational structure of medical
establishments for the State tissue bank or having an enterprise certificate as a private tissue
bank;
(b) Appropriate material facilities comprise:
- Technical room for receipt, processing, preservation and supply of tissue;
- A laboratory. In the case of a tissue bank belonging to a medical establishment, testing may be
conducted in the same testing section as that of the medical establishment;
- A general administrative area for managing files and for consultancy.
(c) Minimum requirements on personnel:
- The professional manager of the tissue bank must satisfy all the conditions prescribed in
article 35.4 of the Law on Donation, Removal and Transplantation of Human Tissue and
Organs;
- One general practitioner with a laboratory practising certificate (biochemistry and haematology
or microbiology) or one laboratory assistant with a medical examination and treatment
practising certificate;
- One medical technician or nurse with an intermediate level or higher degree in medicine and a
medical examination and treatment practising certificate.
In the case of a tissue bank belonging to a medical establishment, personnel may be
concurrent employees but the medical technician or nurse must work full-time;
(d) Having all the equipment and facilities listed in Appendix 1 issued with this Decree. A tissue
bank belonging to a medical establishment may share such equipment and facilities with the
medical establishment.
- If the tissue bank has a corneal operation, the conditions in clause 3 must be satisfied.

- Rules on management/administration.
- Technical rules on collection, preservation and distribution of each type of tissue for which the
bank has registration.
3. Conditions for grant of an operational licence for a corneal bank (namely a tissue bank only
conducting activities on cornea):
(a) The material facilities must satisfy the conditions prescribed in article 2(b) above;
(b) They must have the equipment and facilities prescribed in Appendix 1 issued with this Decree;
(c) Personnel:
- They must sufficient personnel as prescribed in article 2(c) above;
- The person taking grafts must have graduated at the high school level and must be trained in
taking, preserving and transporting cornea".
"Article 4 Application file and procedures for grant of an operational licence for a tissue bank
1. The application file comprises:
(a) Request for a licence on the standard form in Appendix 2 issued with this Decree;
(b) Copy establishment decision of the tissue bank or photocopy together with the original for
comparison purposes, or enterprise certificate in the case of a private tissue bank;
(c) Declaration of the material facilities and medical equipment as evidence of satisfaction of the
conditions in article 3a above;
(d) In the case of an independent tissue bank, declaration of the personnel of the tissue bank to
prove satisfaction of conditions in article 3a above, and copy degree and practising certificate
of the manager; and in the case of a tissue bank belonging to a medical establishment, there
need only be the practising certificate.
2. Sequence and procedures for grant of an operational licence for a tissue bank:
(a) The agency, organization or individual concerned (applicant) submits one set of an application
file in compliance with clause 1 above to MoH via administrative channels or in person;
(b) Three (3) business days after receipt, MoH considers the validity of the file, and if it is invalid,
provides a written notice to the applicant guiding it on how to complete the file;
(c) Within five (5) business days after receipt of a complete and valid file, MoH issues a decision
establishing an Evaluation Council on licensing of tissue banks, the composition of such
council to be at least five (5) members being representatives of relevant units under MoH, and
medical and legal experts;
(d) Within seventeen (17) business days after its establishment decision, the Council conducts an
evaluation at the tissue bank, prepares evaluation minutes and reports the result to the MoH;
and based on such report from the Council, the Minister grants an operational licence to the
tissue bank on the standard form in Appendix 3 issued with this Decree;
The time-limit for resolution is thirty (30) days as from the date of receipt of a valid application
file from the entity concerned
CHAPTER 4
Insecticidal Chemicals and Germicidal [Anti-Bacteria] Chemicals in both the Domestic and Medical
Sectors
Article 1 To repeal a number of provisions of Decree 91 dated 1 July 2016 regulating management of
insecticidal and germicidal chemicals in both the domestic and medical sectors
1. Article 4.1.

2. Clauses 1(c) and 2 of article 5.
3. Sub-clauses (c), (e) and (g) of clause 1 and clause 2(c) of article 7.
4. Requirements on evidence to proof compliance with the technical regulations of the Ministry of
Industry and Trade on safe distance in article 7.1(d).
5. Article 10.1.
6. Clause 2(b) and sub-clauses (b), (d), (dd) and (e) of article 14.3.
7. Article 15.5.
8. Article 40.1(b).
9. Clauses 1 and 3 of article 41.
10. Article 42.3.
Article 2 To amend a number of provisions of Decree 91 dated 1 July 2016 regulating management of
insecticidal and germicidal chemicals in both the domestic and medical sectors
1. Article 6.1 [Conditions regarding material facilities and equipment] is amended as follows:
"Satisfying the conditions stipulated in section 1 of Chapter 2 of Decree 113 dated 9 October 2017
with regulations implementing the Law on Chemicals".
2. Article 7.2(d) [File announcing satisfaction of conditions for manufacturing products] is amended as
follows:
"(d) The documents prescribed in sub-clauses (d) and (dd) of clause 1 of this article must be
certified by the manufacturing establishment".
3. Article 8.4 [Announcement of satisfaction of conditions in order to manufacture products] is amended
as follows:
"4. Within three (3) business days after the date recorded in the receipt for an application file, the
Department of Health makes a public announcement on its website of the name, address and
contact telephone number of the manufacturing establishment".
4. Clause 5(a) of article 8 is amended as follows:
"Change of personnel: a document requesting that information be updated namely announcement of
satisfaction of conditions enclosing data prescribed in article 7.1(b) above".
5. Article 10.2 [Conditions applicable to a testing establishment] is amended as follows:
"2. Satisfying ISO 17025:2005 or updated versions as certified by a registered certification agency
in accordance with the law on business conditions for providing conformity assessment
services."
"Article 12 Announcement of satisfaction of conditions for conducting testing
1. Before conducting initial testing, a testing establishment must send a notice to MoH including
the data prescribed in article 11 above, and if the Ministry has an online system then this data
may be sent online.
2. Within three (3) business days after receipt of the notice from the testing establishment, MoH
makes a public announcement on its website of the following information: name, address and
contact telephone number of the testing establishment or unit, and a list of the chemicals which
it is able to test.
3. If a testing establishment changes any of the testing conditions as compared to those it has
already notified to MoH, then within five (5) business days after such change, the
establishment must send the Ministry the data prescribed in article 11 above.

4. If it is discovered that the testing establishment fails to in fact satisfy some of the conditions it
has already notified to MoH and fails to remedy such defect within the time-limit requested by
the Ministry, then MoH shall terminate publication of the information relevant to the
establishment and provide a written notice to the establishment of such termination. The
testing establishment is then not permitted to conduct tests as from the date on which MoH
issues such written notice of termination."
7. Article 14.2(a) [Conditions applicable to establishments conducting verifications] is amended as
follows:
"2. Regarding personnel:
(a) The person in charge of the verification section must have at least three (3) years' experience
working in the sector of production verification".
8. Clause 3(a) of article 14 is amended as follows:
"(a) Having a laboratory that is managed and operated in accordance with ISO 17025:2005 or ISO
15189:2012 or an updated version of either. If testing services are provided, then such
services must be registered pursuant to the law on business conditions for providing
conformity assessment services;"
"Article 16 Announcement of satisfaction of conditions for conducting verifications
1. Before conducting the initial verification activities, the verification establishment must send a
notice to MoH with the data prescribed in article 15 above, and if the Ministry has an online
system then this data may be sent online.
2. Within three (3) business days after receipt of the notice from a verification establishment,
MoH makes a public announcement on its website of the following information: name, address
and contact telephone number of the verification establishment or unit, and a list of the
verification procedures announced by the establishment as satisfying conditions.
3. If a verification establishment changes any of the conditions as compared to those it has
already notified to MoH, then within fifteen (15) business days after such change, the
establishment must send the Ministry the data prescribed in article 15 above.
4. Within three (3) business days after receipt of the notice from the verification establishment as
prescribed in clause 3 above, MoH is responsible to update information on its website.
5. If it is discovered that the verification establishment fails to in fact satisfy some of the
conditions it has already notified to MoH and fails to remedy the defect within the time-limit
required by the Ministry, then MoH shall terminate registration of the information relevant to the
establishment and provide a written notice to the establishment of such termination. The
verification establishment is then not permitted to conduct tests as from the date on which MoH
issues such written notice of termination due to the establishment's failure to satisfy the
conditions."
10. Clause 4(d) of article 26 [Requirements regarding an application file to register circulation] is
amended as follows:
"(d) Original or valid copy of the results of component testing and active ingredients of the product.
The test results must be made by an establishment which satisfies the conditions on testing
prescribed in article 10. If testing establishments in Vietnam do not have the capacity for
testing, a registration establishment may use the testing results of production units or of an
independent testing laboratory satisfying ISO 17025:2005 or ISO 15189:2012 or updated
versions and such registration unit shall be liable for the lawfulness of the test results it
provides";
11. Clause 3 of article 40 [Conditions applicable to traders of products] is amended as follows:
"3. Traders of insecticidal and germicidal chemicals comprising incenses and mosquito spray;
mosquito repellents for domestic and medical use; anti-insect spray cans; anti-insect cream,
stickers and rings for humans; evaporation liquids; anti-mosquito curtains and papers; and

disinfectants used in the domestic sector are not required to meet the requirements in
clauses 1 and 2(c) of this article".
12. Clause 2 of article 41 [Conditions applicable to insecticidal and germicidal chemical service
providers] is amended as follows:
"2. The person directly performing insect control treatment must have training in the following
items of knowledge and must have certification from the establishment of such training,
namely:
(a) How to read information on product labels;
(b) Insecticide and bactericidal techniques appropriate for the services provided by the
establishment;
(c) Safe use and safe disposal of insecticidal and germicidal preparations/products."
13. Clause 2 of article 42 [File on declaration of satisfaction of conditions for provision of services] is
amended as follows:
"2. List of people who have received training in items of knowledge as certified by the owner of the
establishment."
14. Clause 1(a) is added before clause 1 of article 63 [Responsibilities of establishments providing
insecticidal and germicidal products] as follows:
"1(a) To organize training courses for persons in their establishment directly performing insecticidal
and germicidal activities. If the establishment does not itself organize such training, then it
must nominate the people directly performing these activities to study at another establishment
providing training programs with the contents prescribed in article 41.2 of this Decree".
15. Amendments are made to standard forms 1, 3, 4, 5, 6 and 8 in Appendices 1, 4, 7 and 9 of this
Decree.
CHAPTER 5
Medical Examination and Treatment Sector
Article 1 To repeal a number of provisions of Decree 109 dated 1 July 2016 regulating grant of
practising certificates and operational licences for medical examination and treatment
establishments ["healthcare facilities"]
1. Article 7(d).
2. Clauses 17, 18 and 19 of article 22.
3. Clause 3(a) of article 23.
4. Sub-clauses (b), (c) and (k) of article 23.5.
5. Sub-clauses (b) and (c) of article 24.2.
6. Clauses 3 and 5 of article 24.
7. Sub-clauses (a), (c) and (d) of article 25.2.
8. Article 25.3(a).
9. Clauses 4(b) and 5 of article 25.
10. Sub-clauses (a), (d), (dd) and (e) of article 26.1.
11. Item 9 in article 26.1(c).
12. Article 26.2(a).
13. Sub-clauses (a), (d) and (dd) of article 27.1.
14. Second item in clauses 2(a) and 3(a) of article 27.

15. Items 10 and 11 in sub-clauses (a), (b) and (c) of article 28.1.
16. Clause 3(a) and item 3 in clause 3(b) of article 28.
17. Sub-clauses (b) and (c) of article 29.1.
18. Article 29.2.
19. Sub-clauses (a) and (b) of article 29.3.
20. Sub-clauses (a), (d) and (dd) of article 30.1.
23. Items 2 and 3 of article 30.3(b).
25. Article 31.5.
26. Clauses 2(b), 3(b) and 4(a) of article 32.
27. Articles 33 to 38 inclusive.
28. Sub-clauses (b) and (c) of clause 1 and clause 2(a) of article 39.
Article 2 To amend a number of provisions of Decree 109 dated 1 July 2016 regulating grant of
practising certificates and licences for medical examination and treatment establishments
["healthcare facilities"]
1. Clause 1(b) of article 4 [Cases in which amended practising certificates are issued] is amended as
follows:
"(b) An amended practising certificate is issued when there are any of the following changes in the
[initial] such certificate:
- An additional specialized operational scope when the practitioner requests the addition of a
speciality other than those already recorded in the certificate;
For a specialized technique other than the practitioner's specialities recorded in the practising
certificate, the practitioner is permitted to practise such specialized technique after having a
qualification or certificate of training in such speciality issued by a lawful technical training
establishment and with written permission from the person in charge of technical expertise at
the establishment, without having to make an addition to the professional activities prescribed
in the practising certificate.
- When there is a change of the scope of professional activities in the practising certificate and
the practitioner requests such change, namely specialities different from those already
specified in the practising certificate;"
"Article 7 Application file for issuance of an amended practising certificate
1. The application file comprises:
(a) Request for an additional professional activity to be listed in the practising certificate, on
standard form 5 in Appendix 1 issued with this Decree;
(b) Valid copy of the issued practising certificate;
(c) Valid copies of the qualifications or certificate of training from the lawful training establishment
where training occurred no more than six (6) months earlier than the request for addition".

"Article 22 Form of organization of medical examination and treatment establishments ["healthcare
facilities"]
Healthcare facilities must be established in accordance with law in one of the following organizational
forms:
1. Hospital, comprising a general hospital and specialized hospital.
2. Infirmary belonging to the people's public security [police] force.
3. General clinic [polyclinic].
4. Specialized clinic comprising:
(a) General internal medical clinic;
(b) Specialized clinic for internal medicine: cardiology, respiratory medicine, gastroenterology,
paediatrics and other internal medicine specialities;
(c) Healthcare consultancy clinic or a clinic providing healthcare consultancy via IT and telecom
media;
(d) General surgery clinic;
(dd) Obstetrics clinics;
(e) Andrology [healthcare for males] clinic;
(g) Clinic of odonto-stomatology (teeth, jaw and face);
(h) Ear, nose and throat clinic;
(i) Ophthalmology [eye] clinic;
(k) Cosmetology [cosmetic surgery] clinic;
(l) Rehabilitation clinic;
(m) Psychiatry clinic;
(n) Oncology clinic;
(o) Dermatology clinic;
(p) Traditional medicine facility; traditional medicine healing clinic;
(q) Dietetics [specialized nutrition} clinic;
(r) Drug treatment and rehabilitation clinic;
(s) HIV/AIDS examination and treatment clinic;
(t) Laboratory;
(u) Diagnostic imaging and x-ray clinic;
(v) Opioid replacement clinic as regulated in Decree 90 dated 1 July 2016 regulating treatment of
addicts using opium substitutes;
(x) Preventive care clinic;
(y) Occupational disease clinic;
(z) Other specialized clinics.
5. Family healthcare facility (or healthcare facility following the principles of family medicine):
Engaged in pilot operation in accordance with MoH regulations.
6. Maternity ward.
7. Healthcare/medical service provider comprising:

(a) Inoculation/injection, pulse counting/temperature and blood pressure service provider;
(b) Home healthcare service provider;
(c) Emergency patient transport (both domestically and abroad) service provider;
(d) Optical glasses service provider;
(dd) Cosmetics service provider;
(e) Other healthcare service providers.
8. Health station at the commune level.
9. A medical evaluation or forensic establishment which provides healthcare must be organized in
the form prescribed in clause 3 above. A psychiatrist forensic clinic which provides healthcare
must be organized in one of the forms prescribed in clauses 1, 3 or 4(m) of this article, and
such clinic must satisfy all the conditions applicable to such form.
10. The medical clinic of any agency, unit or organization which provides healthcare must be
organized in one of the forms prescribed in clauses 3 or 4(a) of this article, and such clinic
must satisfy all the conditions applicable to such form.
11. A medical centre with the function of conducting medical examination and treatment shall be
granted an operational licence in the form of a general hospital or polyclinic and must satisfy all
the conditions applicable to such form. Classification is based on the principle that if granted
with an operational licence as a polyclinic then the clinic shall be ranked Grade 4, and if
granted an operational licence as a hospital then it shall be ranked in accordance with the
hospital ranking for the scale of such establishment.
12. A healthcare facility which satisfies the conditions applicable to a healthcare/medical service
provider as prescribed in this Decree is entitled to add the relevant specialties to its
professional activities.
4. Article 23a is added as follows:
"Article 23a General conditions for grant of operational licences to medical examination and
treatment establishments ["healthcare facilities"]
1. Material facilities/infrastructure:
(a) Having a fixed location (except for a mobile establishment);
(b) Ensuring the conditions on radiation safety, and fire prevention and fighting stipulated by law;
(c) Having a sterilization area to treat medical devices for reuse, except where the facility does not
have devices which need to be re-sterilized or it has a contract with some other clinic to
sterilize its instruments.
2. Equipment and instruments:
(a) Having adequate medical equipment and instruments appropriate for the scope of professional
activities of the facility;
(b) An occupational disease clinic must have at least one section providing bio-chemical testing;
(c) An healthcare consultancy clinic or clinic providing healthcare consultancy via IT and telecom
media is not required to have the facilities and equipment prescribed in sub-clauses (a) and (b)
above, but must have sufficient IT and/or telecom media and equipment appropriate for the
scope of its registered activities.
3. Personnel:
(a) Each healthcare facility must have one (1) person in charge of technical expertise, and such
person/persons and heads of specialized departments of the facility must satisfy all of the
following conditions:

- Being a doctor with a practising certificate with the scope of professional activities appropriate
for the specialized operational scope of the establishment;
- If a healthcare facility has many specialities, then the practising certificate of the person in
charge of technical expertise must have specialized operational scope compliant with at least
one (1) of the clinical specialities for which the facility has registered operation.
- In respect of the clinics mentioned below, the person in charge of technical expertise must also
satisfy the following conditions:
+ For a rehabilitation clinic, being a doctor with a practising certificate in physiotherapy or
functional rehabilitation;
+ For a drug treatment and rehabilitation clinic: being a physician specializing in psychiatry
or a general practitioner with a training certificate in psychiatry or a traditional medicine
doctor with a training certificate in support of drug detoxification by traditional medicine
methods;
+ For an HIV/AIDS examination and treatment clinic: being a doctor specializing in
infectious diseases or a general practitioner with a training certificate in HIV/AIDS
examination and treatment;
+ For a traditional medicine examination clinic: being a traditional medicine doctor or
traditional medicine specialist;
+ For a traditional medicine healing clinic: being a medical practitioner or a person issued
with a certificate of herbal remedies handed down from ancestors traditional medicine
prescription certificate or a person issued with a certificate of healing methods handed
down from ancestors;
+ For a nutrition clinic: being a doctor specializing in nutrition or a general practitioner with
a certificate of training in the nutrition speciality or a preventive medical practitioner with
a certificate of training in the nutrition speciality or a degree in the nutrition speciality or a
traditional medicine doctor with a certificate of training in the nutrition speciality or a
bachelor of medicine with a certificate of training in nutritional medicine or a physician
with a certificate of training in nutritional medicine;
+ For a cosmetic surgery clinic: being a doctor specializing in plastic surgery or in
cosmetic plastic surgery;
+ For an andrology [healthcare for males] clinic: being a doctor specializing in medicine for
males or a general practitioner with a certificate of training in medical specialities for
males;
+ For a laboratory: being a doctor or technician in the field of testing, with a university or
higher degree and certificate of specialized laboratory practice or a bachelor of
chemistry or biology or a pharmacist at university level in the case of a person recruited
to act as laboratory specialist prior to the effective date of this Decree and issued with a
specialized practising certificate as a technician;
+ For a diagnostic imaging and x-ray clinic: being a doctor specializing in imaging or a
bachelor of radiology with a university or higher degree and a practising certificate;
- Having worked in the medical examination and treatment sector for at least thirty six (36)
months after being granted a practising certificate, or having been directly involved in medical
examination and treatment work for at least fifty four (54) months. The assignment and
appointment of the person in charge of technical expertise at a healthcare facility must be
made in writing;
- Being a full-time practitioner at the healthcare establishment.
(b) Apart from the person responsible for technical expertise at a medical examination and
treatment establishment ["healthcare facility"], other people working at the healthcare facility, if
conducting medical examination and treatment, must have practising certificates and may only
conduct such work within the scope assigned. Based on the scope of specialized operation,
and on the degrees, training certificates and capability of practitioners, the person responsible

for technical expertise at a healthcare facility shall assign such practitioners to undertake
technical specialties in writing;
(c) Laboratory technicians with university qualifications shall read and sign test results. If a
healthcare facility does not have a specialized laboratory doctor or technician with a university
degree, then the doctor who ordered such tests to be conducted shall to read and sign test
results;
(d) A radiologist with radiology qualifications at the university level shall read and explain
diagnostic images. If a healthcare facility does not have a specialized radiology doctor or x-ray
doctor, then the physician shall appoint an imaging diagnostic technician to read and sign the
final diagnostic images;
(dd) Other people participating in the process of medical examination and treatment but not
required by the law on medical examination and treatment to have practising certificates, are
permitted to conduct activities as delegated by the person in charge of technical expertise of
the healthcare facility (medical physics engineer, radiotherapy engineer, speech therapist,
psychotherapist and other personnel), and the assignment must be consistent with the
specialized certificates of the person appointed.
4. A healthcare facility must satisfy the following conditions:
(a) Being a medical examination and treatment establishment which has been licensed for
operation in accordance with law;
(b) There must be sufficient sections conducting clinical and sub-clinical examination and
sufficient personnel and medical equipment for such examination and detection of a person's
health condition in accordance with health standards and medical examination forms issued
together with guidelines on health examination as stipulated by law.
5. Any cosmetic services facility not in the form requiring an operational licence must sent written
notice of its satisfaction of conditions to provide cosmetic services on the standard form in
Appendix 8 issued with this Decree to the Department of Health in the province or city of its
headquarters, at least ten (10) days prior to commencing operation.
Cosmetic services which use drugs, substances or equipment to intervene in the human body
(surgery, operations, injections, extraction\s, inflation, radiation, buring or other invasive
procedures) which change skin colour, shape, weight, and defects of body parts (skin, nose,
eyes, lips, face, chest, abdomen, buttocks and other parts of the body); or which tattoo, spray
or embroider the skin by using injecting anaesthetics may only be conducted at a hospital with
a specialized cosmetic section or at a specialized cosmetics clinic or at a medical examination
and treatment establishment [healthcare facility] with one of its specialized activities being
cosmetics and depending on the operational scope of such facility approved by the competent
agency."
"Article 23 Conditions for grant of an operational licence to a hospital
In addition to satisfying the conditions prescribed in article 23a of this Decree, the hospital must also
satisfy the following conditions:
1. Scale of the hospital:
(a) A general hospital must have at least thirty (30) patient beds;
(b) A specialized or traditional medicine hospital must have at least twenty (20) patient beds; and
an eye hospital or psychiatric hospital must have at least ten (10) patient beds.
2. Material facilities:
In addition to satisfying the conditions prescribed in article 23a, depending on the scale of the general
or specialized hospital, it must be designed and built in satisfaction of the following conditions:

(a) Departments, rooms and corridors must be conveniently arranged for the technical activities to
be conducted on a centralized, inter-connected [inter-locked] and closed model within the
hospital's premises;
(b) Both a general and specialized hospital must have a minimum construction floor area of 50m 2
or more per patient bed; and the front width of the hospital must be at least 10 metres;
(c) It must have a back-up power supply;
(d) It must satisfy the conditions on treatment of medical waste as prescribed in the law on the
environment.
3. Medical equipment: There must be sufficient vehicles for both internal and external emergency
transportation. If the hospital does not have emergency vehicles for external transportation, it
must sign a contract with a healthcare facility with an operational licence which includes within
the scope of its professional activities the provision of emergency patient transportation
services.
4. Organization:
(a) Departments:
- Having at least two of the following four departments namely internal medicine, surgery,
obstetrics and paediatrics in the case of a general hospital and at least one suitable clinical
department in the case of a specialized hospital;
- The medical examination department must have a place for patient reception, an emergency
room and a patient ward, consulting rooms and minor surgery rooms (if any minor surgery is
carried out);
- A sub-clinical department must have at least one room/unit for testing and one unit for image
diagnosis. An eye hospital without an image diagnosis unit must have signed a contract for
professional assistance with a healthcare facility which has an operational licence permitting
image diagnosis;
- A pharmacy;
- Other specialized departments and sections within the hospital must be appropriate for the
scale, functions and tasks of the hospital.
(b) Other rooms and sections to perform the functions of integrated planning, organizing
personnel, quality control, nursing, financial accounting and other necessary functions.
5. Personnel:
(a) The number of full-time (tenured) practitioners in each department must account for at least
fifty per cent (50%) of the total number of practitioners in such department;
(b) The heads/deans of specialized departments in the hospital must have practising certificates
appropriate for their specialty and must be full-time practitioners at the hospital;
(c) The heads/deans of other departments not requiring a practising certificate must have
university qualifications in the faculty suitable to their assigned jobs and must be full -time
practitioners at the hospital."
"Article 24 Conditions applicable to grant of an operational licence for an infirmary belonging to the
people's public security force
In addition to satisfaction of the conditions prescribed in article 23a of this Decree, an infirmary
belonging to the people's public security force must also satisfy the following conditions:
1. Scale:
(a) The infirmary must have at least ten (10) patient beds;

(b) It must have at least two (2) departments being internal medicine and surgery including an
emergency section, a patient ward, and a sub-clinical department.
2. Material facilities: There must be consulting rooms, emergency rooms, patient wards and
laboratories with an area sufficient to use the facilities and instruments servicing medical
examination and treatment."
"Article 25 Conditions for grant of an operational licence to a general clinic [polyclinic]
In addition to satisfying the conditions prescribed in article 23a above, a polyclinic must also satisfy
the following conditions:
1. Scale of a polyclinic:
(a) It must have at least two (2) of the four (4) specialized departments being internal medicine,
surgery, obstetrics and paediatrics;
(b) Having a sub-clinical unit (for testing and image diagnosis).
2. Material facilities: There must be an emergency ward, a patient ward, a specialized clinic and a
minor surgery clinic (if minor surgery is carried out). Clinics within the general clinic must have
sufficient space for performance of their specialized techniques.
3. Medical equipment: Having anti-shock first aid kits and sufficient specialized emergency drugs.
4. Personnel: The number of practising full-time doctors must account for at least fifty per cent
(50%) of the total number of the doctors at the polyclinic who provide healthcare. People in
charge of specialized clinics and sub-clinical rooms (laboratories and diagnostic imaging) of
the polyclinic must work full-time at the clinic."
"Article 26 Conditions for issuance of an operational licence for a specialized clinic
In addition to satisfying the conditions prescribed in article 23a above, except for the conditions
applicable to the person in charge of technical expertise, a specialized clinic must satisfy the
following conditions:
1. Material facilities:
(a) If operations are performed including such things as implants, acupuncture, massage/
compression, then there must be a separate room or area for such operations and with an
area being adequate for performing these specialized techniques;
(b) If the specialized clinic performs both upper and lower gastro-intestinal [GI] endoscopy
techniques, then there must be separate rooms/wards for each procedure;
(c) If the clinic provides examination and treatment of occupational diseases, there must be a bio-
chemistry laboratory.
2. Medical equipment: There must be an anti-shock kit and sufficient specialized emergency
drugs."
"Article 30 Conditions for grant of an operational licence [to a maternity ward]
1. In addition to satisfying the conditions prescribed in article 23a above, a maternity ward must
also satisfy the following conditions:
(a) Material facilities:
- Functional rooms which are designed to be inter-connected and convenient for emergencies,
examination and treatment;

- Having an anti-natal clinic, gynaecological examination ward and a maternity clinic, each with
sufficient space to perform the specialized techniques.
(b) Medical equipment:
- Having sufficient vehicles for both internal and external emergency transportation. If the
maternity ward does not have a vehicle for emergency transportation externally, then it must
have a contract signed with a healthcare facility which has an operational licence and which is
permitted to provide services being emergency patient transport and assistance;
- Having an anti-shock first aid kit and sufficient specialized emergency drugs.
2. The person in charge of technical expertise at a maternity ward must satisfy the following
conditions:
(a) Being a specialist doctor in obstetrics and gynaecology or a house nurse with university or
higher qualifications and with a practising certificate;
- Having conducted examinations and treatment in gynaecology for at least thirty six (36)
months after issuance of his or her practising certificate or having worked directly in
examination and treatment in gynaecology for at least fifty four (54) months. Assignment and
allocation of duties by the person responsible for technical expertise in the maternity ward
must be made in writing.
3. Any maternity ward which satisfies the condition to provide paediatric services in accordance
with article 27 of this Decree or to provide vaccinations in accordance with the law on
vaccination is permitted to supplement its specialized scale and operational scope."
10. To add article 33a as follows:
"Article 33a Conditions for grant of an operational licence to a healthcare/medical service provider
1. Material facilities: They must satisfy the conditions prescribed in clause 1(a) of article 23a:
- A healthcare service provider providing optical glasses must have an establishment with an
area of at least 15m2 .
- The room for giving injections and for changing bandages must have an area of at least 10m 2.
2. Medical equipment:
In addition to satisfying the conditions prescribed in clause 2(a) of article 23a, the service provider, if
providing the following services:
(a) If it give injections, changes dressings/bandaging, or measures heartbeat, temperature and
blood pressure then it must have an anti-shock first aid kit;
(b) If it provides emergency transportation then it must have an ambulance; and it must have an
anti-shock medicine kit and sufficient emergency drugs. If it has registered to transport patients
overseas, then it must have an emergency transportation services contract signed with an
aviation services company.
3. Personnel:
In addition to satisfying the conditions prescribed in article 23a above, except for the conditions
applicable to the person responsible for technical expertise, if the service provider also provides the
following services:
(a) If it provides emergency transportation then the person responsible for technical expertise
must also satisfy the following conditions:
- Be a doctor with a practising certificate;
- Have a degree or a certificate of having studied the speciality of intensive care.
(b) If it gives injections, changes bandaging, measures blood pressure, heartbeat and
temperature, or provides home healthcare services, then the person in charge of technical
expertise must have graduated at the intermediate or higher level, must have a practising

certificate and must have worked for at least forty five (45) months in a medical examination
and treatment establishment which provides the above services;
(c) If it provides optical glasses services, then the person in charge of technical expertise must
have graduated at the intermediate or higher level, must have a practising certificate and have
certificates of training in the ophthalmic [eye] specialties or in testing and diagnosis of eye
refractive errors;
(d) If it provides cosmetic services, the person performing tattooing, spraying or embroidering the
skin without anaesthetics at the cosmetic services establishment must have a certificate of
training on tattooing, spraying or embroidering the skin issued by a lawful training
establishment;
(dd) If the home healthcare service provider also provides services of changing dressings, taking
out stitches, physiotherapy, functional rehabilitation, mother and baby care, taking blood tests
and returning the results, caring for cancer patients and other home nursing services, then the
person in charge of technical expertise at the homecare health facility must be a person who is
a medical graduate at the intermediate or higher level or must have a practising certificate, and
must have worked in the medical examination and treatment sector for at least forty five (45)
months."
11. Article 45b is added as follows:
"Article 45b Issuance, reissuance and revocation of a certificate of ownership of herbal remedies
and traditional healing methods handed down from ancestors
1 An application file requesting issuance or reissuance of a certificate of ownership of herbal
remedies and healing methods handed down from ancestors (hereinafter abbreviated as a
Certificate) comprises:
(a) A new application file:
- Request for grant of the Certificate on standard form 1 in the Appendix issued with this Decree;
- Explanatory statement of the herbal remedies and traditional healing methods on standard
form 2 in Appendix 15 issued with this Decree;
- Health certificate issued within the six (6) months preceding the date of lodging the file, on the
standard form as regulated;
- Two colour photos measuring 4 x 6cm on a white background, taken no more than six months
prior to the date of lodging the application.
(b) An application file requesting reissuance of a Certificate which has been lost, damaged or
withdrawn:
- Request for reissuance of the Certificate on standard form 4 in the Appendix issued with this
Decree;
- Health certificate issued within the six (6) months preceding the date of lodging the file, on the
standard form as regulated;
- Two colour photos measuring 4 x 6cm on a white background, taken no more than six months
prior to the date of lodging the application.
2 Procedures for issuance of a new certificate of ownership of prescription remedies and
traditional hearing methods:
(a) The applicant for the Certificate sends one set of the application file to the Department of
Health in the locality of his or her residence, and on receipt of the file the Department issues
the applicant a receipt on standard form 5 in Appendix 15;
(b) If the application file needs to be amended or supplemented, then within five (5) business days
after receipt of the file, the Department of Health sends a written notice to the applicant to
amend or supplement the file.

If the applicant fails to so amend or supplement the file within sixty (60) days after the date of
the request from the Department of Health, then the application file shall no longer be valid,
and the applicant must lodge a new application file in order to obtain a Certificate;
(c) If the file does not need to be amended or supplemented, then within ten (10) business days
after receipt of the file, the Department of Health in the province/city where the file was
received sends it to the Provincial Medical Council in the province where the applicant resides,
to obtain its opinion;
(c)[sic] Within thirty (30) days after receipt of the written request from the Department of Health, the
Provincial Medical Council sends its written response on standard form 3 in Appendix 15;
(d) After receiving the written response from the Provincial Medical Council, the Department of
Health organizes an Evaluation Council;
(dd) Within ten (10) business days after receipt of minutes from the Evaluation Council, the
Department of Health issues a Certificate on standard form 6 in Appendix 15, or provides a
written response to the applicant setting out its reasons for refusal.
3 The director of a provincial Department of Health has authority to issue, reissue and revoke
Certificates.
4 A Certificate shall be revoked in the following cases:
(a) It was issued contrary to authority;
(b) It contains illegal contents;
(c) There is a conclusion from a specialized council established by the Department of Health that
the person to whom the Certificate was issued committed a professional error with grave
consequences to the health and life of patients;
(d) The person granted the Certificate falls within the category prescribed in Article 18.4 of The
Law on Medical Examination and Treatment'.
12. Clause 5 is added to Article 50 as follows:
"Regional Treatment Clinics providing inpatient treatment are only applicable to regional
general clinics which provide inpatient treatment and which were established and operating
prior to the effective date of this Decree in mountainous and remote areas and which have
written permission from both the provincial people's committee and the Department of Health."
CHAPTER 6
Cosmetics Sector
Article 1 Repeal of some legal instruments in the cosmetic sector
1. To repeal the following provisions of Decree 93 dated 1 July 2016 regulating conditions for producing
cosmetics:
(a) Article 3.1 [Providing that the establishment producing cosmetics must be lawfully
established];
(b) Sub-clauses (c) and (e) of Article 4.3 [Conditions for issuance of an SC Certificate
to produce cosmetics, requiring that all types of semi-finished products brought into
production must have quality standards, and that there must be a production
process for each product];
(c) Clause 1(d) of Article 7 [Requiring that an application file for issuance of an SC
Certificate contains a list of current products being produced or products proposed
to be produced, and quality standards];
(d) Clause 2(b) of Article 7 [Requiring that an application file for reissuance of an SC
Certificate contain the original of the previously issued certificate].
2. To repeal the following provisions of Circular 06/2011/TT-BYT dated 25 January 2011 regulating
management of cosmetics:
(a) Article 4.2 [Requiring that a file for declaration of a cosmetic product comprises a
copy of the business registration certificate of the entity responsible to put products

onto the market];
(b) Sub-clauses (b), (d) and (g) of Article 34.1 [Regulating the application file of a
producer for a certificate of good practice of cosmetic production of the Asean
Association];
(c) Article 35.1 [Regulating import of cosmetics].
Article 2 Article 4.3(a) of Decree 93 dated 1 July 2016 regulating conditions for producing cosmetics is
amended as follows:
"Article 4 Conditions for issuance of an SC Certificate to produce cosmetics
3. Having a quality control system which satisfies the following requirements:
(a) Raw materials, supplies and add: semi-finished products used during the production of
cosmetics must satisfy the quality standards of the manufacturer".
CHAPTER 7
Sector of Prevention and Control of Infectious Diseases
Article 1 To repeal a number of provisions in the sector of prevention and control of infectious diseases
1. To repeal a number of provisions of Decree 103 dated 1 July 2016 on assurance of biosafety in
laboratories:
(a) Article 2;
(b) Article 4.1(d);
(c) Sub-clauses (a), (c), (d), (dd) and (e) of Article 5.1;
(d) Sub-clauses (b) and (c) of Article 5.2;
(dd) Sub-clauses (b) and (d) of Article 5.3;
(e) Sub-clauses (b), (c), (d), (dd), (e) and (g) of Article 5.4;
(g) Article 6.2(c);
(h) Article 6.4(b);
(i) Article 7.1(dd);
(k) Article 7.2(c);
(l) Article 8;
(m) Sub-clauses (d), (e) and (h) of Article 11.1;
(l) Article 11.4(b).
2. To repeal the following provisions of Decree 104 dated 1 July 2016 regulating vaccination activities:
(a) Article 8.1(c);
(b) Sub-clauses (each) (b), (c), (d), (dd) and (e) of Article 9.1;
(c) Sub-clauses (b) and (d) of Article 9.2;
(d) Clause (d) of Article 10.1(b).
3. The following is repealed: Circular 43/2011/TT-BYT of MoH dated 5 December 2011 regulating the
management regime for infectious disease specimens.
Article 2 To amend a number of provisions in the sector of prevention and control of infectious diseases
1. To amend a number of articles of Decree 103 dated 1 July 2016 on assurance of biosafety in
laboratories:
(a) Clause 1(d) of Article 4 [Classification of laboratories in accordance with their level
of biosafety] is amended as follows:
"1. Biosafety of laboratories is ranked in four levels as follows:
(d) The establishments prescribed in sub-clauses (a), (b) and (c) above are permitted to preserve,
store, use, study, exchange and destroy samples/specimens of blood, serum, plasma, urine,
faeces, human body fluids and other samples from humans containing or likely to contain
agents which are infectious for humans, microbial strains and samples containing
micro-organisms capable of causing human disease, if such establishments have the
necessary equipment to preserve such samples and relevant practise standards on storing,
using, researching, exchanging and destroying such specimens/samples."
(b) Clause 1(b) of Article 5 [Conditions applicable to level I biosafe laboratories]:

"(b) Having emergency eye washers and first aid kits."
(c) Clause 1 of Article 9 [Provision on practice within laboratories] is amended as
follows:
"1. Level I, II and III biosafe laboratories must comply with the conditions on facilities and
equipment, personnel and practice, and maintenance and calibration of testing equipment and
supervision of practice during testing."
(d) Clause 1 of Article 10 [Authority to issue, reissue, self-declaration of and recovery
of certificates confirming that laboratories satisfy conditions on biosafety]:
"1. The Minister of Health evaluates, issues, reissues and revokes certificates that a laboratory
satisfies biosafety criteria in the case of Level III establishments, but excluding establishments
within the managerial authority of the Ministry of Public Security."
(dd) Clause 1(b) of Article 11 [Application file for grant of a biosafety certificate] is amended as follows:
"(b) Declaration of personnel on standard form 3 in the Appendix issued with this Decree."
(e) Sub-clauses (c) and (dd) of Article 11.2 are amended as follows:
"2. File for reissuance comprises:
(c) A report on any changes relating to personnel;
(dd) A report on any changes relating to material facilities."
(g) Clause 1 of Article 17 [Responsibilities of health managing agencies] is amended as follows:
"1. MoH conducts periodical or one-off inspections of laboratories granted a Level III biosafety
certificate and of those laboratories which have self-declared their compliance with the
biosafety criteria namely Level I and II laboratories throughout the entire country."
(h) Clause 2 of Article 19 [Prevention of any biosafety incident/breakdown] is amended as follows:
"2. Each year, Level III biosafety laboratories must organize preventive and remedial exercises
regarding a biosafety incident in accordance with regulations of MoH."
(i) Clause 4 of Article 20 [Dealing with and remedying the consequences of a biosafety incident] is
amended as follows:
"4. If an incident occurs at a Level II or III biosafe laboratory with a significant impact on the
community or national security, then processing and remedying the incident must be
implemented in accordance with Section 2 of Chapter 4 of the Law on Prevention of Infectious
Diseases."
2. To amend Article 36 [Collecting information] of Decree 89 dated 25 June 2018 with regulations for
implementation of the law on prevention of infectious diseases, regarding border health quarantine.
"1. The health quarantine officer shall collect:
(a) The health quarantine declaration of micro-organism samples, biological products, tissues, and
human body organs which are to be imported for the purpose of prevention, research,
diagnosis and treatment;
(b) The medical certificates and import permits from MoH for blood, serum, plasma, urine, faeces,
and other samples from the human body which contain or are likely to contain agents which
could infect humans, micro-organisms or items containing micro-organisms capable of causing
diseases to importers, for the purpose of prevention, research, diagnosis and treatment.
2. An application file requesting import comprises:
(a) Request for an import permit on standard form 25 in the Appendix issued with this Decree;
(b) Copy of the approval decision from the competent agency permitting implementation of the
research subject or research project or copy of the approved research or project decision or
copy of the valid written agreement or other relevant data between the domestic establishment
and the foreign establishment regarding import of the specimens;
(c) For Level I and II biosafe laboratories, a copy of their self-declarations on satisfying biosafety
standards, or a certificate of biosafety in the case of a Level III biosafe laboratory.
3. Procedures for issuance of an import permit:

(a) The establishment lodges an application file for the import permit directly with MoH or sends it
in the post;
(b) If it is not necessary to amend or supplement the file, MoH issues an import permit within
fifteen (15) days after the date recorded on the receipt for the file;
(c) If the file needs to be amended or supplemented, MoH sends a letter notifying the applicant
within ten (10) days after the date recorded on the receipt for the file;
(d) Within thirty (30) days after the request from MoH, the applicant must amend or supplement its
file, and on failure to do so after the expiry of this time-limit, must recommence the procedures
for application for an import permit for the samples;
(dd) If the amended or supplemented file still fails to satisfy the requirements, MoH sends a further
letter to the applicant as prescribed in sub-clause (c) above; if the file is now complete, then
MoH issues an import permit in accordance with sub-clause (b) above."
3. To amend a number of articles of Decree 104 dated 1 July 2016 regulating vaccination activities.
(a) Clause 1(d) of Article 8 [Receipt, transport and preservation of vaccines] is
amended as follows:
"(d) There is a temperature monitor of the vaccines during their transportation, storage and use
and which fully records temperatures on transportation/shipping and delivery. At a vaccine
preservation establishment, temperature must be monitored at least twice each day."
(b) Clause 1(a) of Article 9 [Conditions applicable to a fixed vaccine establishment] is
amended as follows:
"(a) The vaccination area must be protected from the rain, sun and wind, have good ventilation and
be arranged on the principle of one way route from reception, guidance, counselling,
screening, vaccination, monitoring and treatment up until post-vaccination management."
(c) Clause 3(b) of Article 9 is amended as follows:
"(b) Health workers participating in vaccination activities must be trained in vaccination. Staff who
directly conduct screening, provide counselling, provide monitoring/follow-up and
post-vaccination management must have professional qualifications as a doctor or higher, and
staff providing the vaccinations must have intermediate level medical qualifications or
intermediate level nursing/midwife qualifications."
(d) Clause 1(c) of Article 10 [Conditions applicable to a mobile vaccination unit] is
amended as follows:
"(c) Having vaccine containers and an anti-shock kit in accordance with regulations of MoH."
(dd) Clause 2(b) of Article 10 is amended as follows:
"(b) Material facilities must be arranged on the principle of one way route from reception, guidance,
counselling, screening, the actual immunization, monitoring/follow-up and post-vaccination
management."
(e) Clause 2(c) of Article 10 is amended as follows:
"(c) Equipment: having vaccine containers or cold boxes and anti-shock kits in accordance with
regulations of MoH."
(g) Clause 2(d) of Article 10 is amended as follows:
"(d) Personnel: having at least two (2) medically qualified staff who satisfy the conditions
prescribed in clause 3(b) of article 9."
(h) Clause 2 of Article 11 [Announcement that an establishment satisfies the conditions for providing
vaccinations] is amended as follows:
"2. Within three (3) business days after receipt of a notice from an establishment announcing its
satisfaction of conditions for vaccination activities, the Department of Health registers
information about the name, address and head of the establishment as set out in such notice
on its website (the time for calculating the date of disclosure of information by the
establishment is as from the date sealed on the letter when received by the Department of
Health)."

CHAPTER 8
Sector being HIV/AIDS Prevention and Treatment
Article 1 To repeal a number of articles in the HIV/AIDS prevention and treatment sector
1. To repeal the following provisions of Decree 75 dated 1 July 2016 regulating conditions for HIV
testing:
(a) Article 3;
(b) Article 5.1(b);
(c) Article 5.2(b).
2. To repeal the following articles of Decree 90 dated 1 July 2016 regulating treatment of opioid
dependents with alternative medicine/replacement drugs:
(a) Sub-clauses (b), (c) and (d) of Article 12.1;
(b) Lines 6 and 7 of Article 12.2(a);
(c) The item in Article 12.3(h) reading "the number of full-time staff must be seventy
five per cent (75%) or more of the total number of staff of the replacement
treatment establishment;
(d) Article 13.1(b).
3. Circular 15 dated 24 May 2013 guiding quality assurance of HIV testing techniques is repealed.
Article 2 To amend a number of articles of Decree 75 dated 1 July 2016 regulating conditions for
conducting HIV testing
1. Article 4 [Conditions applicable to establishments conducting HIV screening tests] is amended as
follows:
"1. For HIV screening tests conducted by a health facility:
(a) Personnel: Having testing staff who satisfy the following conditions:
- Having a professional qualification from a secondary school or higher in one of the following
majors being medicine, pharmacy, biology or chemistry;
- Having been trained in HIV testing techniques;
(b) Having equipment for testing and for preserving biological products and specimens appropriate
for the HIV testing techniques which the establishment conducts;
(c) Regarding material facilities: having a fixed location.
2. For HIV screening tests in the community:
(a) The people taking tests must have knowledge on HIV counselling, knowledge about the actual
HIV tests and knowledge on conducting the testing pursuant to guidelines of the manufacturer;
(b) Having instruments for testing and for preserving biological products consistent with the type of
HIV testing products used."
"(a) Professional staff must have a university or higher degree in medicine, pharmacy, biology or
chemistry, and have six (6) months or more experience in HIV testing."
"The material facilities must satisfy at least the following conditions:
(a) Areas for conducting testing must use water proof materials, heat resistant materials and
non-corrosive chemicals; and must ensure adequate light, air and cleanliness, must be
dust-proof, moisture-proof and have clean water;
(b) Testing tables/benches must be easy to clean with conventional detergents, and must be
placed in a well-lit place and protected from draught;
(c) There must be a location for handwashing;

(d) There must be means for treating waste prior to it being transferred to the waste -containing
area."
"(c) Having accurate test results on the sample forms for tests held by HIV testing establishments
as recognized by MoH."
CHAPTER 9
Reproductive Health
Article 1 To repeal a number of provisions on reproductive health
1. The following is repealed: Article 7 [Medical file and procedures for requesting gender reassignment]
of Decree 88 dated 5 August 2008 on gender reassignment;
2. The following is repealed: Article 1.1 [Conditions regarding facilities, medical equipment, and staff
carrying out in-vitro fertilization] of Decree 98 dated 1 July 2016 amending Decree 10 dated
28 January 2015 regulating childbirth by in-vitro fertilization and conditions for surrogacy for
humanitarian reasons.
3. The following is also repealed: Circular 29/2010/TT-BYT of MoH dated 24 May 2010 with guidelines
for implementation of Decree 88 referred to above.
Article 2 To amend a number of provisions in the reproductive health sector
1. To amend a number of articles of Decree 88 dated 5 August 2008 regulating gender reassignment:
(a) Article 8 is amended as follows:
"Article 8 Conditions applicable to a medical examination and treatment establishment/health
facility permitted to conduct medical intervention in order to reassign gender/sex
A hospital must satisfy the following conditions in order to conduct the above-mentioned medical
intervention procedures:
1. Being a general or specialized public hospital, specializing in internal medicine or paediatrics
or obstetrics, being a provincial, central or being a private hospital with a specialized
department for internal medicine, obstetrics or paediatrics.
2. It must have approval from the competent agency to operate in the specialty of medical
interventions for the purpose of gender/sex reassignment."
(b) Article 10 is amended as follows:
"The health facility has conducted the medical intervention procedure to redetermine the gender of
the person on the medical certificate of such patient in accordance with the standard form prescribed
by such health facility."
2. To amend a number of articles of Decree 10 dated 21 January 2015 regulating in-vitro fertilization
and conditions for surrogacy for humanitarian purposes as follows:
(a) Clause 2 of Article 7 [Health facilities permitted to conduct in-vitro fertilization
procedures] is amended as follows:
"2. Having the material facilities, medical equipment and staff to perform the in-vitro fertilization
procedures as follows:
(a) Material facilities:
- Having an emergency recovery room;
- Conducting reproductive endocrine testing;
- Having a separate unit for conducting in-vitro fertilization techniques such as retrieving sperm,
lab culturing and screening sperm to the criteria recommended by WHO;
(b) Medical equipment: Having at least two (2) CO 2 incubators; two (2) warmers; one (1) sperm
storage container; one (1) centrifugal machine; one (1) container for storing frozen embryos;

one (1) ultrasound machine with vaginal probe; one (1) reversible microscope; two (2) stereo
microscopes; and one (1) set of operating cabinets.
(c) Personnel: Staff directly performing in-vitro fertilization techniques must satisfy the following
requirements:
- There must be at least two (2) doctors trained in in-vitro fertilization techniques and two (2)
medical and/or pharmaceutical university graduates who have been trained in clinical
embryology;
- There must be two (2) clinicians with practising certificates in accordance with the Law on
Medical Examination and Treatment;
- All staff must have diplomas, certificates or certificates of training in in-vitro fertilization
techniques provided by a domestic or foreign training institution;
- Staff must have a certificate that they have conducted/practised at least twenty (20) cycles of
infertility treatment by in-vitro fertilization techniques at an establishment certified by MoH as
satisfying the conditions for performance of such techniques."
(b) Standard form 2 is amended namely "Minutes of Appraisal of an Establishment
permitted to perform in-vitro fertilization, sperm retention and embryo preservation
enclosed with Decree 10 dated 28 January 2015 referred to above."
CHAPTER 10
Implementing Provisions
Article 1 Effectiveness
This Decree is of full force and effect as from the date of issuance [12 November 2018].
Article 2 Transitional Provision
1. Transitional provision for Decree 89 of year 2018:
(a) Any unit granted a licence/permit to import or export samples prior to the effective
date of this Decree may continue to import same in accordance with the items
recorded in such licence/permit;
(b) Any unit which requested grant of an import or export licence/permit for samples
and lodged same prior to the effective date of this Decree but has not yet received
such licence/permit, must conduct import of samples in accordance with the
provisions of this Decree.
2. Transitional provision for Decree 103 of 2016:
(a) Laboratories which have been issued with certificates must continue to maintain the
regulated conditions within the term of such certificates and must conduct
self-declaration or apply for reissuance of their certificates prior to their expiry in
accordance with Decree 103 and this Decree;
(b) Laboratories which have already self-declared that they satisfy the biosafety
standards must continue to maintain conditions in accordance with the provisions of
Decree 103 and this Decree;
(c) Any newly constructed or renovated laboratory, namely newly constructed or
renovated after the effective date of this Decree, must satisfy the conditions on
biosafety appropriate for each level in accordance with the provisions of
Decree 103 and this Decree.
3. Transitional provision for Decree 104:
(a) Vaccination establishments granted SC Certificates for vaccination activities must
continue to maintain the conditions prescribed for the effective term of such
SC Certificates and must complete self-declarations of satisfaction of conditions
prior to their SC Certificates expire, in accordance with the provisions of
Decree 104 and this Decree;
(b) Vaccination establishments which have announced satisfaction of conditions for
vaccination activities must maintain such conditions in accordance with the
provisions of Decree 104 and this Decree;
(c) Vaccination establishments operating after the effective date of this Decree must

satisfy the conditions prescribed in Decree 104 and this Decree.
(a) Any application file requesting a practising certificate or an SC Certificate for
conducting business or for an import or export licence/permit for drugs or drug raw
materials in accordance with the provisions of Decree 54 and which was lodged
prior to the effective date of this Decree, shall be processed in accordance with the
provisions of Decree 54;
(b) Raw materials used for the production of drugs in accordance with a registration file
for a drug which has registration for its circulation and which was announced prior
to the effective date of this Decree may continue to the imported up until expiry of
validity of the drug circulation registration;
(c) Drugs which a drug retailer within the premises of a health facility purchased prior
to the effective date of this Decree shall be implemented/subject to the provisions of
Decree 54.
Application files for practising certificates or operational licences prior to the effective date of this Decree
shall comply with the provisions of Decree 109.
Article 3 Effectiveness
Ministers, heads of ministerial equivalent and Government agencies, and chairpersons of provincial
people's committees are responsible to implement this Decree.
On behalf of the Government

Prime Minister
NGUYEN XUAN PHUC

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DECREE 155

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Pursuant to the Law on Organization of the Government dated 19 June 2015;

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3 Allens footnote: This is the literal translation here.

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On behalf of the Government

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