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IPEC: Version 3 of GDP Guide available

In January 2025, version 3 of the IPEC Guide "Good Distribution Practices Guide for Pharmaceutical Excipients" was published on the IPEC website (International Pharmaceutical Excipients Council Europe (IPEC Europe) asbl).

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2nd Version of the Union list of Critical Medicines published

On 16 December 2024, the European Commission, the HMA  and the EMA, published an updated version of the Union list of critical medicines and the updated version of the corresponding Q&A document.

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Securing Europe's Drug Supply: How EDSForm is Addressing Medicine Shortages

The European Drug Shortages Formulary (EDSForm) project aims to tackle drug shortages across Europe.

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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 related to good manufacturing practice and good distribution practice. These are aimed specifically at wholesalers and brokers and provide information on how to recognise suspicious offers and take appropriate action.

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Swissmed informs about Control Campaign against illegal Trading in Medicinal Products

As part of an internationally coordinated operation, Swissmedic, the Federal Office for Customs and Border Security (FOCBS) and Swiss Sport Integrity (SSI) inspected over 1,000 suspicious postal shipments. Numerous counterfeit or non-authorised medicinal products were seized during the operation.

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Two new PICS Documents on Remote Assessments published

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two documents for inspectors related to remote assessments. Although the documents are primarily intended for GMP inspectors, they can also be useful for the GDP area (with appropriate modifications).

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The GDP Non-Compliance Reports of 2024 - An Overview

If the outcome of an inspection is that a wholesale distributor does not comply with Good Distribution Practice (GDP), a statement of non-compliance may be entered into the EudraGMDP database. As in previous years, we have prepared an overview of the GDP Non-Compliance Reports issued in 2024, including the corresponding reasons for their issuance.

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IPEC: Updated GDP Guide for Excipients

In October 2024, the IPEC (International Pharmaceutical Excipients Council Europe (IPEC Europe) asbl) announced on its website the new version 3 of its GDP guide 'Good Distribution Practices Guide for Pharmaceutical Excipients'.

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GDP in the US: Pre-posting of USP Chapter <1079.2> on MKT

The United States Pharmacopeia (USP) has issued a pre-posting notice to inform of the anticipated publication of General Chapter <1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products. This provides early access to the chapter due to strong regulatory interest in several Climatic Zone IVb countries.

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Romanian Authority Issues further GDP Non-Compliance Report

We recently reported on two GDP Non-Compliance Reports issued by the Romanian authorities. Now, an additional report concerning a Romanian wholesaler has been published in the EudraGMDP database.

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