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When is a WDA Required? - Discussion of the ECA GDP Survey Results

During the recent ECA GDP survey on the implementation of GDP across member countries, several interesting findings emerged. In the previous article, we discussed the current status of fiscal importation requirements within the EEA. In this second article, we now look at when a Wholesale Distribution Authorisation (WDA) is required in the member countries.

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How Valuable Are Commercial GDP Certificates?

Companies that specialise exclusively in the transport of medicinal products are generally not subject to direct regulatory supervision and therefore do not receive a GDP certificate (Wholesale Distribution Authorisation, WDA). Commercial GDP certificates promise standardised quality assurance, but their reliability and effectiveness are increasingly being questioned. The webinar “Commercial GDP Certificates” examines the various aspects and practical challenges of GDP certification.

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Questions and Answers on Transport and Vehicle Qualification (Part 2)

During the Live Online Training “Temperature-Sensitive Pharmaceuticals – Transport and Vehicle Qualification”, a number of interesting and practice-oriented questions were raised by the participants. These questions have been answered in writing after the event. To share some of the key insights with a broader audience, we have compiled a selection of these Q&As for general access. Read Part 2 here.

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Why correct GTIN and 2D Code Data are important

The Defective Medicines Report Centre (DMRC) of the MHRA recently reported an increase in artwork errors, specifically relating to the Global Trade Item Number (GTIN) and the 2D GSI DataMatrix code, which encodes the GTIN, batch number, and expiry date of a drug product. 

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Questions and Answers on Transport and Vehicle Qualification (Part 1)

During the Live Online Training “Temperature-Sensitive Pharmaceuticals – Transport and Vehicle Qualification”, a number of interesting and practice-oriented questions were raised by the participants. These questions have been answered in writing after the event. To share some of the key insights with a broader audience, we have compiled a selection of these Q&As for general access. Read Part 1 here.

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Supply Chains in 2035

A recent research initiative by Kühne Logistics University (KLU) and SAP Supply Chain Consulting examines how supply chains are likely to evolve over the next decade. The study involved around 660 supply chain experts. The findings show a clear shift: instead of broad experimentation with new technologies, companies are now focusing on data quality, scalable solutions and measurable value.

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Fiscal Importation within the EEA - Discussion of ECA GDP Survey Results

During the recent ECA GDP survey the implementation of GDP across members' countries, a number of interesting findings arose. Some of these will be discussed in upcoming issues of the ECA GDP Newsletter. The first topic in this series focuses on the current status of fiscal importation requirements within the EEA.

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MHRA Blog Post: GDP in the Aviation and Marine Sectors

The MHRA Inspectorate has informed readers that the blog post "A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors" is available on the MHRA website.

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Two new GDP Non-Compliance Reports from Romania

Two new Non-Compliance Reports issued by the National Authority of Medicines and Medical Devices of Romania (NAMMDR) are currently available in the EudraGMDP database. Both concern wholesale distributors whose activities were fully suspended due to violations of GDP requirements.

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Commercial GDP Certificates: Helpful Tool or Questionable Assurance?

Within the pharmaceutical supply chain, transport and logistics services are frequently outsourced to providers who, although not under direct regulatory oversight, must still comply with the EU GDP Guidelines. Commercial GDP certificates are one way of demonstrating such compliance. This article explores the role of commercial GDP certificates in pharmaceutical logistics.

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