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    Ao 99 S 1990

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    taengoo218
    This administrative order from the Philippines Department of Health outlines new labeling requirements for pharmaceutical products containing 4 or more active ingredients. It requires the generic name of each active ingredient and its strength to be printed in a box on the principal display panel, with the brand or trade name printed below in smaller letters. It provides examples of the new labeling format. It also establishes a process for drug companies to change over to the new labels, including deadlines to submit proposed labels for approval and to complete transitioning existing product labels.

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    Ao 99 S 1990

    Uploaded by

    taengoo218
    1K views2 pages
    This administrative order from the Philippines Department of Health outlines new labeling requirements for pharmaceutical products containing 4 or more active ingredients. It requires the generic name of each active ingredient and its strength to be printed in a box on the principal display panel, with the brand or trade name printed below in smaller letters. It provides examples of the new labeling format. It also establishes a process for drug companies to change over to the new labels, including deadlines to submit proposed labels for approval and to complete transitioning existing product labels.

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    ao-99-s-1990

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    This administrative order from the Philippines Department of Health outlines new labeling requirements for pharmaceutical products containing 4 or more active ingredients. It requires the generic name of each active ingredient and its strength to be printed in a box on the principal display panel, with the brand or trade name printed below in smaller letters. It provides examples of the new labeling format. It also establishes a process for drug companies to change over to the new labels, including deadlines to submit proposed labels for approval and to complete transitioning existing product labels.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    1K views2 pages

    Ao 99 S 1990

    Uploaded by

    taengoo218
    This administrative order from the Philippines Department of Health outlines new labeling requirements for pharmaceutical products containing 4 or more active ingredients. It requires the generic name of each active ingredient and its strength to be printed in a box on the principal display panel, with the brand or trade name printed below in smaller letters. It provides examples of the new labeling format. It also establishes a process for drug companies to change over to the new labels, including deadlines to submit proposed labels for approval and to complete transitioning existing product labels.

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    Republic of the Philippines

    Department of Health
    OFFICE OF THE SECRETARY

    SAN LAZARO COMPOUND


    RIZAL AVENUE, STA. CRUZ
    MANILA, PHILIPPINES
    TEL. NO. 711-4080

    December 03, 1990


    ADMINISTRATIVE ORDER
    NO.99 S. 1990
    SUBJECT : REQUIREMENTS FOR LABELLING MATERIALS OF CATEGORIES OF
    PHARMACEUTICAL PRODUCTS CONTAINING FOUR OR MORE
    ACTIVE INGREDIENTS OUTSIDE THE COVERAGE OF A.O. 85 s. 1990.
    Section 1 : Applicability of the provision of A.O. 55 s. 1990
    All pertinent provisions of A.O. 55 s. 1990 on general and specific requirements for
    labelling materials of pharmaceutical products shall apply to products containing four or
    more active ingredients covered by this A.O.
    Section 2 : Coverage
    All multiactive-ingredient pharmaceutical products containing four or more active
    ingredients not covered by A.O. 85 s. 1990, are covered by this A.O.
    Section 3 : Generic Labelling
    For these multiactive-ingredient products, covered by this A.O., The Generic Name for
    each active ingredient with the corresponding strength or concentration shall be printed
    within the outline box on the principal display panel with the Trade or Brand Name of the
    product printed in smaller letters than each generic name immediately below the box as
    shown in the example below:
    3.1. Example 1
    ORAL REHYDRATION SALT - 90
    Per Liter
    Sodium
    90 mEg
    Potassium
    20 mEg
    Chloride
    80 mEg
    Citrate
    30 mEg
    Dextrose
    25 mEg
    PEDIALYTE-90
    Example 2
    DTP + IPV INJ.
    Per 5 mL Vial
    Diphtheria Toxoid
    1 vac dose
    Tetanus Toxoid
    1 vac dose
    Bordetella Pertussis min Int 1 IU
    Inactivated Polio Myolitin
    Type I
    1 vac dose
    Type 2
    1 vac dose
    Type 3
    1 vac dose
    TETRACOQ

    Section 4 : Procedure for Changing Over to New Labels


    4.1 All drug establishments that own registered drug products covered under this A.O
    shall present their proposed generic labels in compliance with the above for review
    and approval by BFAD not later than March 31, 1991.
    4.2 All satisfactory applications for new generic labels covered by this A.O. submitted
    within March 31, 1991 deadline shall be approved by BFAD no later than May 31, 1991.
    4.3 Starting sixty (60) days after approval but not later than August 1, 1991, only such
    approved generic labels shall be used for these products in new production. The drug
    establishment is required to submit the last batch number bearing the old label and the
    first batch number bearing the new generic label before the start of actual production with
    the new label.
    4.4 After October 31, 1991, all covered products with the old label shall be deemed
    misbranded and subject to seizure by BFAD.
    4.5 It shall be the responsibility of the drug establishment to ascertain the coverage of this
    A.O. on its products.'
    4.6 Remedial generic labelling according to the provisions of A.O. 79 s. 1989 is available
    to products covered by this A.O.
    4.7 Approval of the new label under this new A.O. should not be taken to mean that the
    present formula for the FDC is acceptable. This formula will still be subject to review per
    A.O. 96 s.1990.

    Section 5 : Separability Clause


    In any case provision of the A.O is declared contrary to law or unconstitutional,
    other provisions which are not affected thereby shall continue to be in force and in effect.
    Section 6 : Effectivity
    This A.O. s., Rules and Regulations, and other Administrative issuance or parts thereof,
    inconsistent with the provisions of the A.O. are thereby repealed and modified
    accordingly.
    Section 7 : Effectivity
    This A.O. s, shall take effect fifteen (15) days after its publication in two newspapers
    of general circulation.

    (Sgd) ALFREDO R.A. BENGZON


    Secretary

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