Manufacturing and Importation of Finished Products and Active Pharmaceutical Ingredients

As of the end of the transition period, UK authorities will no longer undertake the role of a supervisory authority. The new EU supervisory authority responsible for supervision of manufacturing sites located in the United Kingdom and third country sites previously inspected by the United Kingdom will decide, using a risk-based approach, when an inspection of the site(s) concerned will be required, in order to confirm or re-confirm GMP compliance.

As of the end of the transition period, these requirements apply to medicinal products imported from the United Kingdom to the EU. Member States may require the marketing authorisation holder of a human immunological medicinal product or a medicinal product derived from human blood or plasma or immunological veterinary medicinal product to submit samples from each batch of the bulk and/or the medicinal product for examination by an Official Medicines Control Laboratory (OMCL) or a laboratory that a Member State has designated for that purpose before the release on the market.

A list of the OMCLs that may be in a position to provide EU OCABR certificates for different products is available to manufacturers from the European Directorate for the Quality of Medicines & Healthcare (EDQM) of the Council of Europe on request at batchrelease@edqm.eu.

According to Article 46b(2) of Directive 2001/83/EC, active substances for medicinal products for human use are to only be imported in the EU if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing that exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the EU.

Source: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-stakeholders-withdrawal-united-kingdom-eu-rules-medicinal-products-human-use-veterinary_en

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