AFFORDABLE MEDICINES

LICENSING UNIT
Guideline for the completion of the Application Form for:
 A Licence to Dispense Medicines (Authorised Prescribers)
 A Licence to Compound & Dispense (Homeopaths Only)

I: General Information
1. Dispensing Licence applications are made to the Director-General: Health, in terms
of Section 22C(1)a of the Medicines and Related Substances Act (Act 101 of
1965), as amended.
2. All applications must be completed in full, using black ink. Fields marked with * are
compulsory. Incomplete applications will not be processed.
3. Only original applications must be submitted to the Department. Applications may
be posted, couriered or hand delivered. NO FAXED OR EMAILED COPIES WILL
BE ACCEPTED.
4. Before submitting the application form, have the following documents on hand:
a. Certified copy of Identity Document
b. Certified copy of your registration card with Statutory Council
c. Certified copy of certificate of completion of the Dispensing Course with a
provider accredited by the South African Pharmacy Council (SAPC)
d. Proof of payment of the non-refundable application fee and annual fee
e. Nurses only:
i. Completed and signed Section H of application form
ii. Confirmation of employment on company letter head and signed by an
authorised manager
iii. Proof of areas of specialisation and protocol competencies (certified)
5. NOTE: Applications are processed within 90 days of receipt of all required
documents.
6. Application outcomes are posted to applicants via registered mail, to the postal
address supplied on the application form. They may also be collected from the
Department in person. Applicants may also send by courier (at own cost) to collect.

II: Completing the Application Form

SECTION A to C:
 Complete General Information, Residential Address & Business Address.
 Ensure that you include the Province at which the Dispensing Licence will be utilised.

Page 1 of 3
Review date: 19/06/2014
 AFFORDABLE MEDICINES
LICENSING UNIT
Guideline for the completion of the Application Form for:
 A Licence to Dispense Medicines (Authorised Prescribers)
 A Licence to Compound & Dispense (Homeopaths Only)

SECTION D:
 Indicate profession as well as qualification obtained.
 Ensure that the Statutory Council and Registration Number are supplied for each
qualification listed.

SECTION E
 This information refers to the requirements to comply with Good Pharmacy Practice
Requirements. This is to ensure that the norms and standards as required by the
South African Pharmacy Council are complied to. It is mandatory to answer all the
questions.

SECTION F:
 This section indicates documentation that must be submitted together with the
application form for the dispensing licence.

SECTION G:
 This section is a declaration by the applicant that the information furnished to the
Department is true and correct. It also ensures that the applicant is aware that
inspections may be done by the Department on the premises, and gives consent to
these.

SECTION H (Nurses ONLY):

 This section must be completed by nurses only. It covers authorisation in terms of
Section 56(6) of the Nursing Act, 2005 (Act 33 of 2005).
 This section must be accompanied by the required documents.

SECTION I & J:
 Section I is a declaration by the applicant that the information furnished to the
Department is true and correct. It also ensures that the applicant is aware that
inspections may be done by the Department on the premises, and gives consent to
these. This section must be signed in front of the Commissioner of Oaths, who will
then proceed to complete section J.

Page 2 of 3
Review date: 19/06/2014
 AFFORDABLE MEDICINES
LICENSING UNIT
Guideline for the completion of the Application Form for:
 A Licence to Dispense Medicines (Authorised Prescribers)
 A Licence to Compound & Dispense (Homeopaths Only)

III: Application & Annual Fees Payable

 A non-refundable application fee of R1000-00 (as published in the Government
Gazette is payable once off on application. No Cheque payments are accepted.
 An annual fee of R200-00 per year must be paid on application, and is payable yearly
after that on or before 28 February.
 Proof of payment of both amounts must be submitted to together with your application
form.
 Your Statutory Council Number (without the Prefix Letters) must be used as the
reference when making payments to the Department.
 Note: Where the Statutory Council Number is less than 8 (eight) numbers –
please add zero’s at the end to make up 8 (eight) numbers.
 Payments to the National Department of Health are payable to the following account:
Banking details:
Bank : ABSA
Account Holder : National Department of Health
Branch : Vermeulen Street
Branch code : 632005
Account No. : 405 364 3510
Account type : Cheque account
Beneficiary Ref. : Statutory Council Registration Number ONLY

IV: Delivery Address

POSTAL ADDRESS COURIER/HAND DELIVERY
National Department of Health National Department of Health
Affordable Medicines: Licensing Unit Affordable Medicines: Licensing Unit
Civitas Building, South Tower – 4th Floor Civitas Building, South Tower – 4th Floor
Private Bag x828 Cnr Thabo Sehume & Struben Streets
Pretoria Pretoria Central
0001 0001

V: Enquiries
EMAIL (preferred) : dispensepps@health.gov.za
Telephone : 012 395 8314/8315
Facsimile : 086 621 0829

Page 3 of 3
Review date: 19/06/2014
 DEPARTMENT OF HEALTH
DIRECTORATE: AFFORDABLE MEDICINES

PRIVATE BAG X828, PRETORIA 0001

EMAIL: dispensepps@health.gov.za
TELEPHONE : 012-395-8314/8315 FACSIMILE : 0866 210 829
APPLICATION FOR A LICENCE TO COMPOUND OR DISPENSE MEDICINES IN TERMS OF
SECTION 22C (1) (a) OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT 101 OF 1965),
AS AMENDED
SECTION A: GENERAL INFORMATION
1. Title*
2. Surname of Applicant*
3. Full names of Applicant*
4. Identity Number of Applicant*
SECTION B: RESIDENTIAL ADDRESS
1. Street Address of Applicant*

Code

2. Postal Address of Applicant*

Postal Code*
SECTION C: BUSINESS ADDRESS (where dispensing will take place)

1. Street Address of Premises*

Code Province*

2. Postal Address of Premises*

Postal Code*
Home Telephone Number - -
Business Phone Number* - -
Fax Number of Applicant - -
Cell Number of Applicant* - -
E-mail address

SECTION D: QUALIFICATIONS
Profession (specify)*
Qualification*
Name of Statutory Council*
Statutory Council Registration Number*
Qualification
Name of Statutory Council
Statutory Council Registration Number
Qualification
Name of Statutory Council
Statutory Council Registration Number
SECTION E: DISPENSING COURSE
Name of SAPC Accredited Provider*
Name of Course Completed*
Date of Completion*

Review Date: 19/06/2014

Page 1
 APPLICATION FORM FOR A LICENCE TO COMPOUND OR DISPENSE IN TERMS OF SECTION 22C(1)(a)
OF ACT 101 OF1965 - AUTHORISED PRESCRIBERS

*SECTION F: PARTICULARS OF THE PREMISES

I, _________________________________________________________ , as the applicant, declare that:
1. The size of the premises is m2
2. Key, key card or other device or the combination of any device, which allows access to the dispensary is
kept on the person of the authorized prescriber . Yes No
3. Only the authorized prescriber has keys to the pharmacy area where schedule 1 – 6 items are kept. Yes No
4. There is sufficient security to prevent unauthorised access to medicines. Yes No
5. The pharmacy will be suitably located in the consulting rooms. Yes No
6. The dispensary is suitably located in the pharmacy. Yes No
7. The pharmacy is accessible to persons with disabilities. Yes No
8.There is/ will be a separate facility for washing hands Yes No

9.There is/ will be a separate facility for cleaning of equipment Yes No

10.The premises will be kept clean, orderly and tidy. Yes No
11.The floor surface will be of impermeable material. Yes No
12.All working surfaces will be finished with a smooth impermeable and washable material Yes No
13. All countertops and shelves will be finished with a smooth, impermeable and washable material which is
easy to keep clean Yes No
14. Walls are finished with a smooth, impermeable and washable material, which is easy to keep clean Yes No
15. There will be sufficient and adequate lighting. Yes No

16. There is an air conditioner in the pharmacy which is in good working condition. Yes No

17. The temperature in the dispensary will be below 25 0 C. Yes No

18. There is at least one fire extinguisher or fire hose in the pharmacy. Yes No

19. There will be a suitable waiting area, in accordance with Good Pharmacy Practice (GPP) guidelines Yes No
20. There is a suitable private area for the provision of information and advice, in accordance with GPP
standards. Yes No
21. There is a suitable area for the screening and performing of tests. Yes No
22. The professional image of the dispensing area is not affected by the display of commercial material not
directly linked with health. Yes No
23. The pharmacy is designated as a non-smoking area. Yes No
24. The receiving area for deliveries will be clearly defined and separated from the rest of the pharmacy Yes No

25. A fridge for heat sensitive pharmaceuticals and vaccines will be available. Yes No
26. A nurse prescriber - only patient ready packs or original packings Yes No
27. No bulk stock is kept on premises Yes No

Review Date: 19/06/2014

Page 2
 APPLICATION FORM FOR A LICENCE TO COMPOUND OR DISPENSE IN TERMS OF SECTION 22C(1)(a) OF ACT 101
OF 1965 - AUTHORISED PRESCRIBERS

SECTION G: SUPPORTING DOCUMENTATION*

1. Certified copy of Certificate of successful completion of a course in dispensing, or compounding and dispensing.

2. Certified copy of Proof of current registration with the Statutory Council

3. Certified copy of Identity Document

4. Proof of payment of application and/or annual fees.

SECTION H: FOR NURSES ONLY (see page 4)*

1. Section 56(6) authorisation signed by authorising doctor*

2. Proof of Areas of Specialisation and Protocol Competencies (certified)*

3. Confirmation of employment on company letter head and signed by authorised manager*

SECTION I: DECLARATION BY THE APPLICANT*

1. I hereby give consent for an inspection of the premises in terms of the applicable legislation.
2. The information furnished herewith is true and correct.

APPLICANT'S SIGNATURE: …………………………………………………………………………………..

DATE: - -
D D M M Y Y Y Y

SECTION J: DECLARATION BY COMMISSIONER OF OATHS*

SIGNED and SWORN TO before me on this --------------- day of ----------------------------- in the year ---------------------
The deponent (applicant) having acknowledged that he/she understands the contents of this declaration.

SIGNATURE OF COMMISSIONER OF OATHS

----------------------------------------------------------

DATE: ------------------------------------------------------

STAMP

This form may be completed and submitted to the Director-General ONLY IF the applicant has completed the
supplementary course on dispensing and/or compounding.

Review date: 19/06/2014

Page 3
 APPLICATION FORM FOR A LICENCE TO COMPOUND OR DISPENSE IN TERMS OF SECTION 22 C(1)(A)
OF ACT 101 OF 1965 - AUTHORISED PRESCRIBERS

DEPARTMENT OF HEALTH
DIRECTORATE: AFFORDABLE MEDICINES

PRIVATE BAG X828, PRETORIA 0001

EMAIL: dispensepps@health.gov.za
TELEPHONE : 012-395-8314/8315 FACSIMILE : 0866 210 829

SECTION H: AUTHORITY UNDER SECTION 56(6) OF THE NURSING ACT, 2005 (ACT 33 OF 2005)

1. Name of Nurse
2. Name of Clinic/Facility

You are hereby authorised to diagnose prescribe and dispense medicines for the conditions listed in
the standing orders of the clinic according to the treatment protocols listed in the standing orders of the
clinic according to the treatment protocols listed below subject to the limitations imposed by the
Regulations to Section 38A of the Nursing Act.

You are to maintain legible, comprehensive clinical notes in the patient file and to complete the drug
register required under the licence issued in terms of section 22C (1) (a) of the Medicines and Related
Substances Act (Act 101 of 1965) as amended.

Name of Medical Practitioner in charge: …………………………………………………........

Signed at …………………………………........ on ………… day of ……………… 20………..

Signature: ………………………………… Qualification(s): ……………………………..........

HPCSA No: ………………………………

Address: …………………………………………………………………………………………

…………………………………………………………………………………………

…………………………………………………………………………………………

Tel: (………) ……………………….......

Note: Attach confirmation of employment on company letter head, signed by the authorised
manager.

Area of Specialisation Mark with Proof

(Attach proof of completion) X Attached
(state YES or NO)

Primary Health Care

Occupational Health
Other(specify)

Mark with Proof

Protocol Competencies Attached
X (state YES or NO)

STI
EPI
TB
Diabetes
Hypertension
Travel Medicines
Other(specify)
Other(specify)

Review date:19/06/2014

Page 4