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    Compliance Circular

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    sadaf
    The Drug Regulatory Authority of Pakistan issued a circular regarding compliance with official pharmacopeial specifications. [1] The Registration Board extended the timeline for manufacturers and importers to implement following official pharmacopeial specifications to six months from July 26, 2021. [2] All registration holders must follow official pharmacopeial specifications for formulations where an official monograph is available in the most recent edition of the relevant pharmacopeia. Manufacturers can apply for approval to use equivalent specifications. [3] The circular was distributed to provincial quality control boards and pharmaceutical organizations for compliance.

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    Compliance Circular

    Uploaded by

    sadaf
    55 views1 page
    The Drug Regulatory Authority of Pakistan issued a circular regarding compliance with official pharmacopeial specifications. [1] The Registration Board extended the timeline for manufacturers and importers to implement following official pharmacopeial specifications to six months from July 26, 2021. [2] All registration holders must follow official pharmacopeial specifications for formulations where an official monograph is available in the most recent edition of the relevant pharmacopeia. Manufacturers can apply for approval to use equivalent specifications. [3] The circular was distributed to provincial quality control boards and pharmaceutical organizations for compliance.

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    ComplianceCircular

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    The Drug Regulatory Authority of Pakistan issued a circular regarding compliance with official pharmacopeial specifications. [1] The Registration Board extended the timeline for manufacturers and importers to implement following official pharmacopeial specifications to six months from July 26, 2021. [2] All registration holders must follow official pharmacopeial specifications for formulations where an official monograph is available in the most recent edition of the relevant pharmacopeia. Manufacturers can apply for approval to use equivalent specifications. [3] The circular was distributed to provincial quality control boards and pharmaceutical organizations for compliance.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    55 views1 page

    Compliance Circular

    Uploaded by

    sadaf
    The Drug Regulatory Authority of Pakistan issued a circular regarding compliance with official pharmacopeial specifications. [1] The Registration Board extended the timeline for manufacturers and importers to implement following official pharmacopeial specifications to six months from July 26, 2021. [2] All registration holders must follow official pharmacopeial specifications for formulations where an official monograph is available in the most recent edition of the relevant pharmacopeia. Manufacturers can apply for approval to use equivalent specifications. [3] The circular was distributed to provincial quality control boards and pharmaceutical organizations for compliance.

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    © All Rights Reserved
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    of 1

    Govemment of Pakistan

    Ministry ofNational Health Services, Regulation and Coordination


    Drug Regulatory Authority of pakistan
    (Pharmaceutical Evaluation & Registration Division)
    *******
    "SAY NOTO CORRUTTION"

    No. F.3 -512020-l &V II (M-297) Islamabad, the 26h July , 2O2l

    CIRCULAR

    Subject: CO ANCE WITHP CO PEIAL CIFICA TION.

    In continuation of this Authority's circular of even number dated 276 January,


    2021 on the subject captioned above. The subject matter was again discussed in
    307th & 309'h
    meetings of Registration Board; wherein, the Registration Board extended
    timelines and made
    minor amendment in its previous decision as follows: -

    i. All registration holders shall follow official Pharmacopeial specifications for all
    such formulations for which official monographs of drug product is available
    in
    the most recent edition of such pharmacopeia.

    ii. The manufactwervimporters having stringent/equivarent product specifications


    for all parameters than officiar pharmacopeial specifications, sha apply to
    Registration Board for its approval.

    iii. The Board allowed timeline of further six months (w.e.f. 27s
    Jury, 202r) to the
    manufacturer/importer for implementation of above decision.

    2' Accordingly, above decision of Registration Board is hereby circulated for


    compliance by all manufacturers/importers for all registered
    drug products.

    A onal r (PE R
    Secretary, Regi stration Board
    Distribution:-
    i. Secretary, provincial euality Control Boards_ of
    the punjab, Sindh, Khyber
    pakhtunkhw4 Balochistan
    ..
    ii.
    and Islamabad Capital Territory.
    All pharmaceutical ManufacturerVlmpo.tersl
    iii chairman, pakistan pharmaceutical Manufacturers
    Association, Isramabad.
    iv. Executive Director, pharma Bureau, faractri.
    v. Executive Director/chairman, pakistan chemist
    & Druggists Association, Karachi.
    /vi- Director (MIs), DRAp with tire reqr*i i"-rpr""a
    rhe same on DRAp,s website.
    Coov for information lo:-

    a. PS to Chief Executive Officer, DRAp,


    Islamabad.
    b. ApS to Director (pE&R)/Chairman. n.ei;tratio,
    soara.

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