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

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  1. #11
    11. When does Paragraph 26 (Annex 13 IMP Labelling Requirements) apply?

    All IMP for use within a clinical trial must be labelled in accordance with paragraph 26 of annex 13. This applies to not only the investigational product but also to any comparators and placebos used.

    In some cases, however, abridged labelling is permitted. Paragraph 26 lists the information which should appear on labels, but does allow some flexibility if the absence can be justified. This is often referred to as abridged labelling and is agreed on a trial-specific basis. The cases where this form of labelling is permitted are as follows:
    1. For marketed product used within its marketing authorisation, the product can be labelled according to dispensed medicine requirements if this was approved as part of the CTA. However, sponsors may wish their products be labelled following the guidance in Paragraph 32 of Annex 13
    2. if the IMP being used is a drug product in a vial which needs to be reconstituted aseptically for the purposes of administration, then the vial would need Annex 13 labelling.

    For further information please see Annex 13 (external link)
    Last edited by MHRA Super Moderator; 25th Oct 2011 at 06:49 PM.

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