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Medicines

Published: 7. 1. 2021 Last update: 12. 1. 2021

It is essential to ensure availability of medicines after the Brexit date and the end of the transition period (31st December 2020) as well. The area of medicines has been adapted in accordance with the Withdrawal Agreement and Trade and Cooperation Agreement between the United Kingdom and the EU which came into force on 1st January 2021.

The Czech Republic has been getting ready to handle the consequences of Brexit for a long period of time and cooperating intensively with all stakeholders. Already before March 2019, The State Institute for Drug Control, advised the marketing authorisation holders to react prior to the Brexit date and control proactively whether changes in current registrations of medicines were necessary. In the Czech Republic, obligations for marketing authorisation holders and applicants for clinical trials concerning consequences of Brexit are fulfilled in the majority of cases. In this context, there are not further consequences of Brexit on availability of medicines relating to provision of healthcare in the Czech Republic.

From 1st January 2021, the EU and the United Kingdom are separate regulatory and legislative areas. All goods exported from the EU to the United Kingdom have to fulfil rules and norms of the United Kingdom, therefore they are subject to checks in order to verify compliance with legal regulations of the United Kingdom. Similarly, it is necessary to ensure that all goods exported from the United Kingdom to the EU fulfil requirements and norms of the EU, therefore they are subject to checks in order to verify compliance with EU legal regulations in areas such as safety, health etc.

In the Czech Republic, in healthcare settings, it is possible to use only registered medicines (except extraordinary situations listed in section 8 paragraph 3 of Act No. 378/2007 Coll., on medicines). Access of medicines to the EU market is conditional upon receiving marketing authorisation.

The objective of the Trade and Cooperation Agreement in the area of medicines is to promote availability of medicines in the territory of both parties, stipulate conditions for recognition of GMP inspections results and share official documents between both parties. Last but not least, the purpose of that agreement is to support public health, consumer protection and environment through implementation of regulatory approach in compliance with particular international norms and norms of World Health Organization, The Organisation for Economic Cooperation and Development or International Council for Harmonisation on Technical Requirements for Pharmaceuticals for Human Use.

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

 


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