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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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FIFO, FEFO, LIFO: What is the meaning?

FIFO, FEFO and LIFO are the three main strategies for warehouse management. But what do the three abbreviations actually stand for and what exactly do they mean?

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Questions & Answers on Good Distribution Practices (GDP) - Part 4

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 4 deals with questions related to documentation.

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GDP Non-Compliance Report for Romanian Wholesale Distributor

The competent authority of Romania (National Agency for Medicines and Medical Devices of Romania) has entered a new GPD Non-Compliance Report dated 15 April 2021 into the EudraGMDP database.

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GDP-Non-Compliance-Report for German Wholesale Distributor

The Competent Authority of Germany (Bezirksregierung Düsseldorf) has entered a new GPD Non-Compliance Report dated into the EudraGMDP database due to serious GDP violations at a German wholesaler. The case involves trading of falsified medicinal products and storage of expired medicinal products in regular stock. Furthermore, there are doubts on the reliability of the Reponsible Person and the CEO due to an ongoing criminal procedure.

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