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    khara teano
    1. The re-formulation of Nunormol 40 mg Tablet requires a major variation change application in the Philippines. 2. The application requires a letter of request indicating the type of major variation change and affected product, along with a notarized notification form and declaration letter. 3. I will review the relevant ACTRs to determine the timeline and ensure the variation change receives approval before regional implementation.

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    Domain 5-4

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    1. The re-formulation of Nunormol 40 mg Tablet requires a major variation change application in the Philippines. 2. The application requires a letter of request indicating the type of major variation change and affected product, along with a notarized notification form and declaration letter. 3. I will review the relevant ACTRs to determine the timeline and ensure the variation change receives approval before regional implementation.

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    1. The re-formulation of Nunormol 40 mg Tablet requires a major variation change application in the Philippines. 2. The application requires a letter of request indicating the type of major variation change and affected product, along with a notarized notification form and declaration letter. 3. I will review the relevant ACTRs to determine the timeline and ensure the variation change receives approval before regional implementation.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
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    35 views4 pages

    Domain 5-4

    Uploaded by

    khara teano
    1. The re-formulation of Nunormol 40 mg Tablet requires a major variation change application in the Philippines. 2. The application requires a letter of request indicating the type of major variation change and affected product, along with a notarized notification form and declaration letter. 3. I will review the relevant ACTRs to determine the timeline and ensure the variation change receives approval before regional implementation.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 4

    MiV-PA24

    MiV-PA2/MaV-2
    MiV-PH03
    MiV-PA25
    1. Addition of subcutaneous route of administration to current approved intravenous route
    MAV-PH01
    2. Change of test procedure of the drug product MIV-PA27
    3. Quantitative change of excipients already registered MIV-PA15
    4. Addition of markings to the tablets
    5. Change of specifications of the drug product (non-compendial)
    6. Change of specifications of the drug product (non-compendial)
    7. Extension of shelf-life of the drug product from 24 months to 36 months MAV15
    8. Change in the product label information to comply with the Administrative Order 2016-
    0008 “Revised Rules and Regulations Governing the Generic Labeling Requirements of
    Drug Products for Human Use”
    9. Change of storage condition from refrigerated (2-8 oC) to “not exceeding 25 oC). MIV-
    PA35
    10. Replacement of manufacturing site of the drug product MAV4

    B&C

    Fda circular 2014-008


    Minor variation requiring prior approval

    Brand name 180 working days


    Manuf site -180 working days
    Storage- 180 working days
    Marketing authorization – 1
    working day
    Shelf life- 1 working day
    shelf life- 1010
    replacement manuf site- initial reg
    fee
    brand name: 525

    You
    received

    information from your global regulatory office that the Nunormol 40 mg Tablet product, which is
    currently registered in the Philippines and other APAC affiliates, is planned for a re-formulation.
    As a regulatory affairs officer, you first compared the currently registered formulation to the new
    product formulation. As per the assessment, the re-formulation passes all conditions to be
    applied as a post-approval change and will not require a new registration. The change can be
    implemented as soon as all the regional affiliate countries receive a go signal from the
    respective affiliate country’s drug regulatory authority in the form of change approval. As the
    representative of your Philippines affiliate regulatory office, what information do you think you
    have to share during the meeting to communicate the regulatory requirements in the
    Philippines?
    1. What change/s (variation classification) must be applied for?
    a. Major variation change

    2. What are the requirements

    a. Letter of Request
    i. Indicate the type of request
    ii. indicate affected product
    b. notification form notarized
    c. declaration letter
    3. What ACTRs should you review

    4. Discuss
    timelines 

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