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Webinar: The new Annex 21

Tuesday, 21 April 2020
14.30 - 16.00 h

Webinar: The new EMA Reflection Paper on GMP and Marketing Authorisation Holders

Thursday, 23 April 2020
14.00 - 15.30 h


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Brexit: the British comment

30/08/2017

After the European Medicines Agency EMA in particular spoke out on the possible future of the trade with medicinal products on a European Union (EU) level, the British now provide some input.

The proclamations of the EMA so far have in parts sounded harsh and resolute: "The UK will become a third country" or "APIs manufactured in the UK will need Written Confirmation" are powerful words.

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.

The involved parties have made their positions clear now. The solution will probably lie somewhere in the middle; the suspense continues.


 

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