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GMP

The European Medicines Agency (EMA) has updated Brexit-related guidance documents. These documents are supporting pharmaceutical companies in preparing for the United Kingdom's (UK) withdrawal from the European Union (EU). Now, the "Questions and Answers" document has been updated (Rev 04, published on 1 February 2019).

All medicinal products manufactured or imported into the Union (EEA) got to be manufactured in accordance with the EU GMP (see also Commission Directive 2003/94/EC, Recital (1) and Commission Directive 1991/412/EEC). After a successful inspection by the competent authority or inspectorate, a Certificate of Good Manufacturing Practice (the "GMP Certificate") is issued. GMP Certificates issued by a competent authority within the EU/EEA are recognised and accepted by other EU/EEA authorities no additional (EU) inspections occur.

When it involves products imported from the third countries into the EU/EEA, the supervisory authorities are the competent authorities of the Member State (or Member States) that granted the import authorisation.

So, will EU-based pharmaceutical companies still be ready to use a producing site for which the GMP Certificate has been issued by a UK Authority?

Yes, they're going to be. But only those certificates issued before the Brexit date are going to be acceptable: "GMP certificates issued by the United Kingdom’s competent authority before March 30, 2019 should therefore be considered intrinsically informative on GMP compliance."

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