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    Regulation for releasing biological products by the technical in-charge

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    Last update dateSunday 03 January 2016

    Ministry of Health and Medical Education

    Deputy of Food and Drug

    Supreme Supervising Department of Drug and Narcotics

    Document Number

    BP-RU-100-01

    Document Title

    Regulation for releasing biological products by the technical in-charge

    Regulation for releasing biological products by the technical in-charge

    Reference: this document has been compiled according to the agreement number d19247/102/5/ dated 2006/10/07 in the supreme supervising department of drugs and narcotics of the deputy of food and drug.

     

    To speed up availability of drugs and grouped releasing of biological products including products derived from urine or tissue like HMG, HGC, low molecular weight heparin and also different forms of insulin and somatropin and glucagon from new drugs will be trusted to the technical in-charge of the importing company, while conforming to the following conditions:

    1. investigating the release of the first three imported or produced batches will be done by this supreme department.
    2. If derivatives of plasma like albumen have been used in the formulation on the above products, their release will be done by this supreme department.
    3. If there are any changes in the production file of the product including changes in the place of production, formulation, packaging, source of the active ingredient and similar cases, these changes must first be reported and approved by the supreme department of drugs according to the guide for change (B-MA-G-09). Mean while the release will be done by the supreme department.
    4. Needed documents for release include the active ingredient analysis papers and the final product and the certificate for release from the manufacturer and the certificate of  completeness in the original forms and their contents must be checked by the technical in-charge according to the reference.
    5. Must not have any record complaint in the drug market or being disqualified in the control laboratory. In these cases, decision about the release of the drug will lie with the supreme department of drugs.
    6. The Farsi guide and bilingual packaging and inscribing IRC on the box must be checked by the technical in-charge.
    7. A sample must be taken from the first importing shipment of each year and after informing the supreme department of drugs, be sent for the laboratory checks and be presented alongside copies of the control documents in the release file.

    The investigation report along with the release file, include:

    The completed form with the signature and stamp of the importing company.

    The original analysis papers and release certificate of the producer.

    The original approval certificate for the state of transportation according to the attached plan with the signature of the technical in-charge and the stamp of the company,

    Copy of the stamped receipt from the supreme supervising department of drugs and narcotics

    Must be presented to this office within 3 days.

    In case the above conditions are not met, the following legal actions will be taken:

    Written warning and registration in the company and the technical in-charge’s file.

    Voiding permissions given to the company

    Re evaluating the qualification of the technical in-charge

    “Information regarding shipments of imported biologic products”

     

    Name of the importing company:

    Name of the product:

    Generic name:

    Name of the manufacturer and the originating country:

    Name the MA holder:

    Form of drug:

    Batch number

    Amount of import:

    Date of production:

    Expiry date:

    Details of the accompanied solvent:

    Number of imported shipments in the current year:

    Date of last sampling and the result:

    Name of distributing company:

    Accompanying documents:

    Sampling:

    State of the shipment (can be released/ cannot be released):

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