EMA Updates Brexit Guidance
The European Medicines Agency (EMA) and other EU bodies have updated technical and practical guidance, as well as a document describing the legal obligations for drug manufacturers under Brexit.The three documents include an updated Q&A and a 23-page practical guidance – both addressing a situation where the UK leaves the EU without a withdrawal agreement – and a document on legal rules that explains how EU rules in the field of medicinal products for human and veterinary use will no longer apply to the UK after 30 March.
The practical guidance deals with questions on variations, transfers of marketing authorization, transfers of orphan designation, the Qualified Person for Pharmacovigilance, ongoing initial marketing authorization procedures and GMP, GCP and GLP compliance, submission of information to EMA databases and more.
Meanwhile, the Q&A, drafted jointly by the Directorate-General for Health and Food Safety of the European Commission and EMA, features new questions such as: “Can I, as of the withdrawal date, import a medicinal product into the Union (EEA) on the basis of a certificate issued before the withdrawal date by the UK OMCL [Official Medicines Control Laboratory]?” (no), and “Who will take over supervision of the manufacturing sites of medicinal products in third countries (including UK after the Withdrawal date) previously supervised by UK authorities and when will the next GMP inspection be conducted?”
The answer for the second question noted how as of the withdrawal date, UK authorities will no longer be a supervisory authority on inspections. “The new Union supervisory authority 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,” the Q&A says.
The updated Q&A also features a series of questions on parallel distribution.
And the legal document lays out some of the basics for what happens once the UK departs from the EU, noting:
“EU law requires that marketing authorisation holders are established in the EU (or EEA); Some activities must be performed in the EU (or EEA), related for example to pharmacovigilance, batch release etc.”
In particular, the Commission and EMA said they “expect marketing authorisation holders to prepare and proactively screen authorisations they hold for the need for any changes. The necessary transfer or variation requests will need to be submitted in due time, considering the procedural timelines foreseen in the regulatory framework.”
EMA Brexit-related guidance for companies