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3rd Country Manufacturer

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Wholesale Distributor Authorisation

Wholesale distributors of medicinal products must possess an authorisation to engage in activity as a wholesaler in medicinal products.

Member States shall enter the information relating to the authorisations referred to article 77(4) of the Directive 2001/83/EC as amended, and article 99 of Regulation (EC) 2019/6 into EudraGMDP as referred to in article 111(6) of the Directive 2001/83/EC as amended, and article 100 (5c) of Regulation (EC) 2019/6 respectively.

The Union format for the Wholesale Distribution Authorisations document is published in the Compilation of Union Procedures, which can be found at the following location:

Compilation of Union Procedures on Inspections and Exchange of Information revision 19.1 (europa.eu)

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