EMA: Updated guidance documents on parallel distribution
The European Medicines Agency, EMA, has updated its regulatory and procedural guidance documents on parallel distribution as of 9 June 2021.
The 30-page Q&A document on parallel distribution has been extensively revised. From general explanations to the notification procedure of the EMA, it provides all important information on the process for the distribution of medicinal products from one European Member State to another.
- Frequently asked quesitions about parallel distribution
- List of centrally authorised products requiring a notification of a change for update of annexes
- Checklist for initial notifications for parallel distribution: guidance for industry
- Checklist for annual updates for parallel distribution: guidance for industry
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