Frequently Asked Questions about Parallel Distribution

On 9 June 2021 the EMA published the Q&A guidance on parallel distribution.

Centrally authorised medicinal products (“CAPs”) put on the market of one Member State can be marketed in any other Member State by a distributor, independently of the marketing-authorisation holder (“parallel distribution”). Parallel distribution (hereinafter also “PD”) pertains to all centrally authorised products and is checked by the European Medicines Agency (hereinafter “the Agency”).

This guidance provides the answers to frequently asked questions about parallel distribution of all centrally authorised products. This Q&A includes general information, initial notification, parallel distribution notification check, post- parallel notice guidance, safety updates / bulk changes / annual updates and fees.

Read the pdf 
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