Good Distribution Practices News

According to the GDP guidelines, regular self-inspections should be performed. But what is considered as an appropriate regular interval?

The U.S. Food and Drug Administration (FDA) has announced the availability of the proposed rule National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs). According to the agency, the proposed rule, when finalized, would provide greater assurance that supply chain participants are sufficiently vetted and qualified to distribute prescription drugs, further strengthening the supply chain.

The European GDP Association, representing more than 4.000 professionals from across the globe, offers a Discussion Forum free of charge for its members. It gives you the opportunity to address your GDP-related questions to a large audience. To get an idea, take a look here.

A regulation strengthening the role of the EMA in crisis preparedness and management has been published in the Official Journal of the EU. The document also assigns several new tasks to the EMA.

Wholesale trading of medicinal products in Germany requires an authorisation according to Section 52a of the Medicinal Products Act (Arzneimittelgesetz – AMG). The holder of the authorisation must notify the competent authority in advance of any fundamental changes. A wholesaler from Brandenburg, Germany, did not comply with this notification requirement, as a GDP Non-Compliance Report published in October 2021 shows.

The European GDP Association has recently announced a change in the Board. Emil Schwan moves from the Board to the Authority Advisory Board.

The competent authority of Germany (Bezirksregierung Köln) has entered a new GPD Non-Compliance Report dated 03 December 2021 into the EudraGMDP database. Due to the seriousness of the violations, the Wholesale Distributor Authorisation was revoked.