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GDP Non-Compliance Report for German Wholesale Distributor: RP is not Continuously Contactable

The competent authority of Germany has entered a new GPD Non-Compliance Report dated 21 July 2021 into the EudraGMDP database due to critical violations of GDP requirements. One of the reasons is that the Responsible Person (RP) does not fulfil the responsibilities personally and is not continuously contactable.

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New MHRA Inspectorate Blog GDP Post: Protecting the UK Medicines Supply Chain

One of the objectives of Good Distribution Practice (GDP) and an important aspect for distributors of medicinal products is preventing falsified medicines entering the legal supply chain. In this context, a new post, entitled "Too good to be true? How to play your part in protecting the UK medicines supply chain" has been published on the MHRA Inspectorate blog.

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European GDP Association publishes new Q&A Document

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The European GDP Association has answered these questions and combined them in a Q&A document.

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CJEU Judgement on OTC Medicines

In a recently published ruling, the Court of Justice of the European Union (CJEU) decided that a medicinal product not subject to medical prescription in one Member State may not automatically be placed on the market in another Member State. Rather, the medicinal product may only be placed on the market in a Member State if the competent authority of that Member State or the EU Commission has granted its marketing authorisation.

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Acting as a Responsible Person (import) (RPi): MHRA concretises Eligibility Criteria

Last year, the Medicines and Healthcare products Regulatory Agency (MHRA) published a guidance called "Acting as a Responsible Person (import) ". The guidance describes the role of the Responsible Person (import) (RPi) and how to become a RPi. This guidance was now updated, listing extensive qualification requirements for RPi's.

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European GDP Association nominates Alfred Hunt as new Advisory Board Member and Deputy Chair

The European GDP Association, representing about 3.500 professionals from across the globe, has extended its Board. Alfred Hunt was invited to join the Advisory Board and accepted to take over the role as a Deputy Chair.

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EMA publishes Q&A Document about Parallel Distribution

Parallel distribution is defined as the distribution of a centrally authorised medicinal product from one Member State to another by a pharmaceutical company independent of the marketing-authorisation holder. In this context, the European Medicines Agency (EMA) has recently published a new comprehensive Q&A document containing answers to the most common questions.

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Questions & Answers on Good Distribution Practices (GDP) - Part 5

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 5 deals with questions related to deviations.

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New Version of the Q&As on Safety Features for Track & Trace

The European Commission has published Version 18b of the "Questions & Answers" on safety features. In particular the update took into account the new ISO standard for Packaging Tamper verification features.

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Recall of Product Samples from U.S. Market Due to Improper Storage Temperature Conditions

A global healthcare company is voluntarily recalling 1,468 product samples from the U.S. market because they were stored at temperatures below storage requirements. The products affected are used to lower blood glucose levels in people with diabetes. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

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