Medicines

Vytvořeno: 11. 2. 2020 Poslední aktualizace: 5. 8. 2020

Based on the Withdrawal Agreement which entered into force on 1st February 2020 the future relationship with the United Kingdom is to be negotiated during the transition period ending on 31st December 2020, unless otherwise stated.

It is necessary to ensure availability of medicines after Brexit date – 31st January 2020 as well.

The issue of medicines is not dealt with in the Withdrawal Agreement. It is therefore not possible to guarantee zero restriction of availability, which will depend on the respective marketing authorisation holders. In the lifecycle of a medicine, the number of individual procedures and related inspections, which are currently handled by the United Kingdom and whose performance will require re-distribution between other Member States, including the Czech Republic, will increase. This concerns, for example, pharmacovigilance inspections, mutual recognition procedures for registering of medicines and inspection of goods manufacturing practices as well. After the Brexit date it is necessary that holder of the marketing authorisation be settled in the European Union/European Economic Area, therefore the registrations had to been re-distributed on another marketing authorisation holder. Moreover, batch release of medicines and batch control of medicines have to be settled in European Union/European Economic Area as well.

Before the first Brexit date (31st March 2019), State Institute for Drug Control already advised marketing authorisation holders to react in a timely fashion, before Brexit date, and proactively check whether changes of the current registrations were needed. Thanks to the postponement of the Brexit date many problems have been solved.

During future bilateral relations negotiations with the United Kingdom attention should be paid particularly to potential negotiation of Mutual Recognition Agreement on inspection of goods manufacturing practices and of Mutual Recognition Agreement on recognition of good laboratory and clinical practice certificates. Other unresolved questions relate to recognition of batch release certificates for immunobiological medicines and vaccines and blood derivatives, cooperation between the European Medicines Agency and National Agency of Medicines of the United Kingdom and also recognition of batch release and batch control of medicines of the United Kingdom concerning their registrations in the EU. European Commission still supports coordinated approach of the European Medicines Agency and the EU Member States during the negotiation process.

The impact of Brexit on medicines is also described in detail on the website of the State Institute for Drug Control.