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GDP for Active Substances used as Starting Materials in Veterinary Medicinal Products: Obligation to Perform Audits

The European Medicines Agency (EMA) has updated its list of questions and answers on the GMP/GDP guidelines. The newly added chapter deals with the requirements for active substances used as starting materials in veterinary medicinal products. Among other things, it is clarified that the Veterinary Medicines Regulation requires manufacturers and importers of veterinary medicinal products to perform audits based on a risk-assessment on the manufacturers, distributors and importers from whom they source the active substances.

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How often should GDP Self-Inspections be performed?

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

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Proposed Rule for the Licensure of WDDs and 3PLs published

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.

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GDP Non-Compliance Report due to GDP Violations concerning RP, Supplier Qualification, Operations and Trading

The competent authority of Germany (Bezirksregierung Köln) has entered a new GPD Non-Compliance Report dated 18 January 2022 into the EudraGMDP database.

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Active and Passive Shipping Systems and Transport Equipment

In this article, we will provide some information and examples of active and passive shipping systems and equipment used for the transport of time and temperature sensitive pharma products.

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The GDP Discussion Forum

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.

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EU: Strengthening the EMA

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.

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Großhandel mit Arzneimitteln: Anzeigepflicht bei Änderungen

Für den Großhandel mit Arzneimitteln bedarf es gemäß § 52a Arzneimittelgesetz (AMG) einer Erlaubnis. Der Inhaber der Erlaubnis hat wesentliche Änderung der Großhandelstätigkeit der Nachweise der zuständigen Behörde vorher anzuzeigen. Ein Großhändler aus Brandenburg kam dieser Anzeigepflicht nicht nach, wie ein bereits im Oktober 2021 veröffentlichter GDP-Non-Compliance-Report zeigt.

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Wholesale Distribution of Medicinal Products - Obligation to Notify Changes

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.

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The GDP Non-Compliance Reports of 2021 - An Overview

Wholesale trade in medicinal products requires a wholesale authorisation. A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor by the national competent authority. If the outcome of an inspection is that the wholesale Distributor does not comply with Good Distribution Practice, a statement of non-compliance may be entered into EudraGMDP. For your information please see the comprehensive overview of the GDP non-compliance reports entered in 2021 and the respective reasons for issuing them.

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