Updated Frequently Asked Questions about Parallel Distribution

On 12 April 2022 the EMA updated the FAQ/General Question No. 22.

Article 76 of Directive 2001/83/EC and Article 102 (5) of Regulation (EU) 2019/6 imposes the individual obligation on the distributor who intends to import a medicinal product from another Member State to submit the notification to the marketing authorization holder and the Agency in case of medicinal products which have been granted an authorization pursuant to Regulation (EC) No 726/2004.

However, if as a result of a merger/acquisition the parallel distributor is dissolved or if it changes the legal form, there is an assumption of continuity of the legal entity. In these situations, a notification of a bulk change (‘Reassignment of notices for Parallel Distribution’) would need to be submitted.

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