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    Annexure-B-List of Clinical Technical Documents

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    faisal abbas
    The document outlines 12 criteria that must be met for new drugs to be considered for inclusion in the formulary of The Aga Khan University Hospital in Karachi, Pakistan. The criteria include requirements such as registration with the country's drug regulatory authority, GMP certification, API source and certification, clinical trial data, quality control procedures, marketing authorization in other countries, cost structure, and safety features. Meeting these criteria ensures medications considered for the formulary align with patient needs, safety standards, and the hospital's mission of providing high quality care. Applicants must provide documentation addressing all 12 criteria and sign the application.

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    Annexure-B-List of Clinical Technical Documents

    Uploaded by

    faisal abbas
    6 views1 page
    The document outlines 12 criteria that must be met for new drugs to be considered for inclusion in the formulary of The Aga Khan University Hospital in Karachi, Pakistan. The criteria include requirements such as registration with the country's drug regulatory authority, GMP certification, API source and certification, clinical trial data, quality control procedures, marketing authorization in other countries, cost structure, and safety features. Meeting these criteria ensures medications considered for the formulary align with patient needs, safety standards, and the hospital's mission of providing high quality care. Applicants must provide documentation addressing all 12 criteria and sign the application.

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    The document outlines 12 criteria that must be met for new drugs to be considered for inclusion in the formulary of The Aga Khan University Hospital in Karachi, Pakistan. The criteria include requirements such as registration with the country's drug regulatory authority, GMP certification, API source and certification, clinical trial data, quality control procedures, marketing authorization in other countries, cost structure, and safety features. Meeting these criteria ensures medications considered for the formulary align with patient needs, safety standards, and the hospital's mission of providing high quality care. Applicants must provide documentation addressing all 12 criteria and sign the application.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    6 views1 page

    Annexure-B-List of Clinical Technical Documents

    Uploaded by

    faisal abbas
    The document outlines 12 criteria that must be met for new drugs to be considered for inclusion in the formulary of The Aga Khan University Hospital in Karachi, Pakistan. The criteria include requirements such as registration with the country's drug regulatory authority, GMP certification, API source and certification, clinical trial data, quality control procedures, marketing authorization in other countries, cost structure, and safety features. Meeting these criteria ensures medications considered for the formulary align with patient needs, safety standards, and the hospital's mission of providing high quality care. Applicants must provide documentation addressing all 12 criteria and sign the application.

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    of 1

    Annexure 7.

    The Aga Khan University Hospital, Karachi

    Pharmacy Services

    To: All Pharmaceutical Suppliers

    Date:

    Subject:Application for New Drugs

    Medications are a critical component of the care provided to patients and are used for diagnostic, symptomatic,
    preventive, curative, and palliative treatment and management of diseases and conditions. The following criteria must be
    met before new product will be considered for inclusion in the Hospital Formulary:

    1" Registration Certificate for the product from the Drug Regulatory Authority of Pakistan (DRAP) o
    2. Copy of GMP certificate / last inspection from DRAP n
    3. Source of Active Pharmaceutical lngredients (APl) and its plant GMP certificate n
    4. Copies of API accreditation e.g. USFDA, EDQM, and WHO etc. n
    5. Certificate of Analysis of API and finished pharmaceutical product with following data
    - Sterility testing data n
    - Bioavailability data n
    - Bioequivalence data I
    - Comparative dissolution n
    - Pharmacovigilance data tr
    - Thermolabile products temperature and humidity logs tr
    6. Quality structure at manufacturing sites (technical staffs) n
    7. Marketing authorization of product in any exporting country r:
    8. HistoricalTrust and National Presence:
    - IMS Ranking, and Market Share n
    - Number of units sold in last 12 months n
    - Launch Date in Pakistan tr
    9. lndependent studies on safety, efficacy will be an advantage tr (

    10. Cost Structure must be made available (TP/MRP) n


    11^ At least one (01) samples for each formulations and strength of the drug tr
    12. ls your product having safety features e.g. Look-alike and Sound-alike (LASA) Barcode (GS1) etc. D
    Footnote: '
    ,'

    This decision of addition into formulary is based on the hospital's mission, patient needs, and types of services provided.
    Medication selection at AKUH is a collaborative process that includes patient need and safety as well as economics.

    Applicant's Name, Position and signature:

    Company Name and Stamp:

    Hospital Formulary Management Revision Date: Z-Aug-L9 PageT

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