Posted Wed, 19 May 2021 07:51:28 GMT by Mikael Zad Head of Regulatory Affairs
Dears,

Are parallell distributors obliged to not cover the original batch and expiry of the source product? Where can more information about this be found on the EMA website?

Kind regards,
Mikael
Posted Wed, 26 May 2021 09:15:24 GMT by Anna Fiodorova

For the requirements on the batch numbers for the parallel-traded products, please refer to Chapter 5 Question 5 ‘What are the requirements for batch numbers appearing on the packaging of medicinal products subject to parallel trade?’ of the Guidance on good manufacturing practice and good distribution practice: questions and answers.
 

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