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Thread: MHRA produced FAQs for Investigational Medicinal Product (IMP)

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    MHRA produced FAQs for Investigational Medicinal Product (IMP)

    1. Where can I find further information on this subject?

    The following FAQs are presented below:
    2. What is an investigational medicinal product (IMP)?
    3. Who is permitted to manufacture an IMP?
    4. What is meant by the terms Qualified Person (QP) release and Qualified Person certification?
    5. What documentation needs to be maintained relating to IMP manufacture and shipment?
    6. Do records of accountability need to be maintained?
    7. Do staff preparing the product need to be trained in the protocol?
    8. Do staff administering the product need to be trained in the protocol?
    9. What records should be maintained if the product is a refrigerated product or requires frozen storage?
    10. When does the Regulation 37 (Exemption for hospitals and health centres) apply?
    11. When does Paragraph 26 (Annex 13 IMP Labelling Requirements) apply?
    12. Is it necessary for a pharmacy to obtain QP certification documents when receiving clinical trial stock?
    13. Where can I find guidance on the manufacturing requirements for non-investigational products (NIMPs)?
    14. Do pharmacies always have to be involved in the receipt and storage of investigational medicinal product (IMPs)?
    15. Is there any legislation which states how and where the code breaks for clinical trials should be stored?

    Further frequently asked questions about IMPs can be found on the GMP area of the MHRA website: click here.
    Last edited by MHRA Super Moderator; 25th Oct 2011 at 10:46 AM.

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