Brexit [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2017-12-12 12:50  – Posting: # 18059
Views: 3,066

Dear all,

the EC’s Directorate-General Health and Food Safety and the EMA published Rev 01 of

Questions and Answers related to the United Kingdom’s
withdrawal from the European Union with regard to the medicinal
products for human and veterinary use within the framework of
the Centralised Procedure

11. Can medicinal products used in bioequivalence studies be sourced in the UK?
[…] Bioequivalence studies that have been conducted with a medicinal product sourced in the UK can be used in generic/hybrid marketing authorisation applications only if the marketing authorisation for that application will be granted before 30 March 2019.*

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Edit: No document history as usual…

Cheers,
Helmut Schütz
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