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Abbreviations used in the GDP Environment

During several GDP events organized by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. The overview, initially published a few months ago, has now been further expanded.

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Swissmedic updates Responsible Person Requirements

Swissmedic has published an updated version of the Technical Interpretation "Responsible Person: Requirements (I-SMI.TI.17e)", which includes numerous clarifications. Although compliance with the previous version typically remains sufficient, some situations may require immediate action from license holders. The new interpretation is effective immediately.

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PDA publishes Technical Report on Last Mile Distribution

The Parenteral Drug Association (PDA) has published a new document - Technical Report No. 46 (Revised 2024): Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users. It provides details on temperature control, monitoring and security, and data management, with a focus on supply chain management. Furthermore, the document covers supply chains in Europe, Africa, Brazil, U.S., Canada and China.

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German Authority issues new GDP Non-Compliance Report

The competent authority of Germany (Bezirksregierung Koeln) has issued a new GDP Non-Compliance Report in the EudraGMDP database. During a reinspection, it was found that the issues from the inspection in October 2023 had not been resolved. Furthermore, new critical and serious findings were identified.

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Checklist for Implementation of GDP Principles - Part 10: Specific Provisions for Brokers

Chapter 10 of the EU GDP Guidelines describes the requirements for brokers. In this article, you will find a checklist to verify the minimum implementation.

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Bezirksregierung Köln stellt neuen GDP-Non-Compliance-Report aus

Die zuständige deutsche Behörde, die Bezirksregierung Köln, hat einen neuen GDP-Non-Compliance-Report ausgestellt und in der EudraGMDP-Datenbank veröffentlicht. Bei einer Reinspektion eines Großhändlers wurde festgestellt, dass die bei der Inspektion im Oktober 2023 festgestellten Abweichungen nicht behoben worden waren. Außerdem wurden neue kritische und schwerwiegende Mängel aufgedeckt.

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GDP-Checkliste - Teil 10: Besondere Vorschriften für Vermittler

Kapitel 10 der EU GDP-Leitlinien regelt die Anforderungen an Vermittler. In diesem Artikel finden Sie eine Checkliste zur Überprüfung der Mindestumsetzung.

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EU Commission releases "Assessment of the Supply Chain Vulnerabilities for the first Tranche of the Union List of critical Medicines"

On 10 July 2024 the European Commission's Health Emergency Preparedness and Response Authority (HERA) published a technical report evaluating vulnerabilities in the supply chain for medicines listed in the Union list of critical medicines.

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Report on Trends in the Falsification of Medicines

The EU Commission published a report on the latest trends in the falsification of medicinal products. The report makes an attempt to include an assessment of whether the Falsified Medicines Directive is effective in preventing falsified medicines from entering the legal supply chain.

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New Measures to Report Medicine Disappearances

The Council of Europe has adopted a new recommendation to report the disappearance of medicines. The aim is to protect public health by promoting better cooperation and reporting between the relevant authorities.

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