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Active Substance Registration



  • Jon
    23/09/2019 10:48
    “Active substance” means any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis;” Question 1 - API or Active Substance - Does the definition of “active substance” also include vials of product supplied from a ‘Third Country’ which are received in bulk by a Manufacturing Authorisation holder which then conducts secondary packaging, QC Testing, QP Batch certification and release to market for use in patients? Question 2 - Requirement to register “Active Substance” importation – Is a Manufacturing Authorisation holder also required to register “active substance” importation when it receives vials of product supplied in bulk from a ‘Third Country’ and subsequently conducts secondary packaging, QC Testing, QP batch certification and release to market for use in patients as per their Manufacturing Authorisation?
  • GMP Committee response
    15/11/2019 13:52
    The filled vials in this context sound like intermediate product, rather than active substance, even if the content is API without any excipients – it would be expected that the vials had been filled according to Part I GMP. The importer would need an MIA, not registration as an importer of active substances. To add a Biologics perspective to this answer, the imported batch as described would be described as the “final lot” with reference to the Ph Eur monograph for monoclonal antibodies. The words may be different but the outcome is the same. The batch should be regarded as a Drug Product and the requirements of Part 1 of the EU GMPs applied. The product must be handled under an MIA (IMP).
  • Jon
    15/11/2019 14:35
    The party responsible for physical importation for use in manufacturing would clearly need to be covered by an MIA. Would an MIA be required for a party which financially owns the intermediate / drug substance during importation but which subcontracts physical importation and final assembly activities to a manufacturing site?
  • GMP Committee response
    16/12/2019 17:53
    The legislation around IMP Import and MIA licensing and Inspection is not directly impacted by ownership. Many Manufacturing Organisations with an IMP MIA import for their clients without having ownership. There are other implications in other parts of legislation, e.g. over VAT, but specifically for GMP aspects financial ownership does not require MIA. Note that this response is specific to IMPs. There are currently different approaches taken by some EU regulators in relation to marketed products and if in doubt it is advisable to check with the regulatory agencies of the country in which the party with financial ownership is registered.
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