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• The marketing authorisation holder shall select a qualified person with an appropriate qualification, responsible for vigilance of the medicinal safety. • The person under Para. 1 shall be established on the territory of a Member State and shall be permanently at disposal of the marketing authorisation holder. The UK Marketing Authorisation Holders question is perhaps the most frequently asked question that we have fielded in our Brexit work. The agency says: According to Article 2 of Regulation (EC) No 726/2004 the marketing authorisation holder must be established in the Union. Through the EEA Agreement this is extended to include also Norway.

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