19/20 May 2020
The European Medicines Agency (EMA) has updated the agency's 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) need to be manufactured in accordance with 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 comes to products imported from third countries into the EU/EEA, the supervisory authorities are the competent authorites of the Member State (or Member States) that granted the import authorisation. And they need to inspect.
So will EU-based pharmaceutical companies still be able to use a manufacturing site for which the GMP Certificate has been issued by a UK authority?
Yes, they will be. But only those certificates issued before the Brexit date will be acceptable: "GMP certificates issued by the UK competent authority before 30 March 2019 should therefore be considered as such information on GMP compliance ..."
After Brexit, UK authorities will no longer act as a supervisory authority for the EU/EEA. Therefore, EU/EEA supervisory authorites "responsible for supervision of manufacturing sites located in UK and third country sites previously inspected by UK 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". So they might need to perform inspections in the UK.