Wholesale distributors of medicinal products must possess an authorisation to engage in activity as a wholesaler in medicinal products. |
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Member States shall enter the information relating to the authorisations referred to article 77(4) in the Union Database(EudraGMDP) as referred to in article 111(6) of the Directive 2001/83/EC as amended. |
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The Community format for the Wholesale Distribution Authorisations document is published in the Compilation of Community Procedures, which can be found at the following location : |
Compilation of Community Procedures on Inspections and Exchange of Information |