EMA adds Considerations for Wholesale Distributors and Brokers on suspicious Offers

The European Medicines Agency (EMA) has published two new Q&As on its website in the section "Guidance on good manufacturing practice and good distribution practice: Questions and answers". These are aimed specifically at wholesalers and brokers and provide information on how to recognise suspicious offers and take appropriate action.

Recognising suspicious offers

The first question is about how suspicious offers can be recognised.

In this context, the EMA emphasises that wholesalers and other stakeholders who purchase or receive medicinal products should always bear in mind the risk that the products offered could be counterfeit, illegal, or in other ways not of full quality.

It also states that comprehensive due diligence checks should be carried out when concluding new contracts with unknown suppliers. In this context, it also refers to Article 5.2 of the European Union (EU) GDP guidelines for human medicinal products and Article 21 (2) of the European Union (EU) GDP regulation for veterinary medicinal products. In addition, the EudraGMDP database should be used to verify the identity of the wholesaler in question.

Measures in the event of suspicious offers

The second question addresses the measures to be taken if wholesalers or brokers become aware of a substantiated suspicious offer.

In this case, there is an obligation to immediately contact the national competent authority, as well as the marketing authorisation holder. This applies to suspected falsified products, whether offered to them or to other parties.

The complete information can be found in the Q&As on the EMA website.