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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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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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GDP Non-Compliance Report for Czech Wholesale Distributor

The competent authority of Czechia (State Institute for Drug Control) has issued a new GPD Non-Compliance Report - the first report published in the EudraGMDP database in 2024.

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Templates for Shortage Prevention and Mitigation Plans issued by EMA

On 18th of June 2024, the EMA has issued templates for Shortage Prevention Plans (SPPs) and Shortage Mitigation Plans (SMPs). Marketing authorization holders in the European Union/European Economic Area are encouraged to create Shortage Prevention Plans to minimize the risk of medicinal shortages.

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Checklist for Implementation of GDP Principles - Part 9: Transportation

According to Chapter 9 of the EU GDP Guidelines, it is the responsibility of the supplying wholesale distributor to protect medicinal products during transport. Regardless of the mode of transport, it should be possible to demonstrate that the medicines have not been exposed to conditions that may compromise their quality and integrity. In this article, you will find a checklist to verify the minimum implementation.

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EU adopts Supply Chain Law - Implications for pharmaceutical Companies

On 24th of May 2024, the EU member states adopted the European Supply Chain Law which requires companies of a certain size to monitor and prevent negative impacts on human rights and the environment from their supply chain activities.

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