Bioequivalence and Bioavailability Forum

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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• 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.

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Edit: No document history as usual…

• Original version (2 May 2017).
  
• Rev 01 not in the webarchive, gone with the wind.
  
• Rev 02 (29 January 2018)
  
• Rev 03 (19 June 2018)