Will UK accept EU QP Certification after a "hard" Brexit?

Recommendation

20/21 November 2019
Barcelona, Spain

Quality Risk Management - An ICH Q9 Training Course

Although all parties involved are looking for a positive outcome of the current negotiations, a so called "hard Brexit" - a scenario in which the UK leaves the EU without a full agreement - is possible. This will cause problems in many areas and preparations started to deal with it.

The UK Department of Health & Social Care has now published a notice entitled "Batch testing medicines if there’s no Brexit deal" discussing the consequences for batch testing, Qualified Person (QP) certification and release. It sets out kind of a contingency plan for the case of a potential negative outcome from the EU exit negotiations.

Before 29 March 2019, nothing will change and manufacturers can test batches of medicines anywhere in the EU, EEA or a third country if covered by a 'Mutual Recognition Agreement' (MRA). A UK-based QP can certify a batch also for the EU or EEA market and vice versa.

If there is no deal after 29 March 2019, the UK will be a "third country" for the EU and no longer be part of the European Medicines Agency, EMA. However, in order to ensure continuity of supply, "the UK will continue to accept batch testing of human medicines carried out in countries named on a list set out by the MHRA". This list "would include EU countries, other EEA countries and those third countries with which the EU has an MRA". The same procedure will apply for Investigational Medicinal Products (IMPs).