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Re: CaptBeer post# 350990

Tuesday, 08/17/2021 1:22:25 PM

Tuesday, August 17, 2021 1:22:25 PM

Post# of 426486
The period of market exclusivity should be counted as starting from the date of notification of the marketing authorisation decision to the MAH, which can be found in the Official Journal of the European Union as well as in the Union register of medicinal products for human use on the European
Commission website.

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-procedural-advice-users-centralised-procedure-generic/hybrid-applications_en.pdf


3/26/21

https://www.ema.europa.eu/en/medicines/human/EPAR/vazkepa
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