In May 2017 the EU Commission and EMA made a clear statement: after 30 March 2019 the Unit Kingdom will become a ‘third country’.
In a common Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use, the Commission and the Agency get the point strait that “all Union primary and secondary law ceases to apply to the United Kingdom from 30 March 2019, 00:00h (CET). That means that the U.K. will “become a ‘third country'”.
Generally, after the withdrawal of the UK from the European Union (EU), “medicinal products manufactured in the UK will be considered imported medicinal products”. That means:
- The Marketing Authorisation Holder (MAH) must be established in the EU (or EEA states Norway, Iceland and Liechtenstein). This will be also the case for centrally authorised medicinal products.
- The sponsor of an orphan medicinal product designation must be established in the EU (or EEA).
- The Qualified Person for Pharmacovigilance (QPPV) must reside and carry out his/her tasks in a Member State of the EU/EEA. Also the Pharmacovigilance System Master (PSMF) must be located in the EU/EEA.
- All production batches imported into the EU/EAA must be analysed/ controlled (again) at a site located in the EU/EEA.
- Batch release has to be performed in the EU/EAA. As a consequence, a UK based site for batch release has to transfer this activity “to a location established in the Union (EEA) and submit the corresponding variation”.
Now, the United Kingdom’s (UK) government has published a position paper on the possible future trade of goods between the UK and the EU (“Continuity in the availability of goods for the EU and the UK“). This paper sounds different from statements on European level so far. For example, the British government is looking for a free movement of goods and services, including – amongst other things – the continuous recognition of marketing authorisations, registrations and certifications of goods (including medicinal products). Also, inspections (of companies) should be recognised after the withdrawal and double structures for authorities and companies should be avoided. Here, the Qualified Person (QP) is mentioned explicitly. The United Kingdom aims to “avoid the unnecessary disruptive transfer of activities between the EU and the United Kingdom”, especially if such activities have to be duplicated for both markets.
Also the exchange between authorities, including matters in regards to medicinal products, should be maintained and promoted. A welcome proposal, since this is also a matter of consumer safety.