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Back to the forum  Query: 2018-01-22 21:24 CET (UTC+1h)
Vienna, Austria,
2017-12-12 12:50

Posting: # 18059
Views: 489

 Brexit [BE/BA News]

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.*

  • In exceptional cases where bioequivalence studies are intended for use in new applications which will be submitted before 30 March 2019 and if these bioequivalence studies have been already completed the applicants may consider contacting the competent authority to discuss the particular circumstances of their application in order to avoid unnecessary repetition of studies in humans or animals.

Helmut Schütz 

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes

2018-01-10 11:56

@ Helmut
Posting: # 18155
Views: 132


Dear Helmut,
My name is Christos. I am working for a generic company and i would like to rise a question on your post. According to this EMA publication and the Question and Answers, it is clear that you cannot use a reference for a bioequivalence study which is sourced from UK if the marketing authorization for the application is not possible to be granted before 30 March 2019. What is not clear, in my opinion, is the requirement the manufacturer site (or the responsible for the batch release site) not to be located in UK. In other words, could we use the same reference product sourced from France as an example, and the manufacturer/release site to be in UK??
Do you or someone else know anything about that?
And if it is a requirement how someone could face the issue that some references write on the PIL two or more manufacturing sites, one in UK and the others in the rest EU?? We faced this problem and the majority of the pharmaceutical warehouses could not provided us any further information.
Thank you very much in advance,

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
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but rather a convenient method of arranging the arithmetic.    R.A. Fisher

BEBAC Ing. Helmut Schütz