News

EU Commission amends Delegated Regulation on Safety Features again

In order to ensure that medicinal products continue to be marketed with a unique identifier (UI) in Northern Ireland, Cyprus, Ireland and Malta, the Commission further extends the temporary derogation from the requirement to decommission UIs of products exported to UK.

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Change in the Board of the European GDP Association

The European GDP Association has recently announced a change in the Board. Emil Schwan moves from the Board to the Authority Advisory Board.

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Revised IPEC GDP Audit Guide for Pharmaceutical Excipients Available to the General Public

In September 2021, the International Pharmaceutical Excipients Council Federation (IPEC Federation) announced the availability of the revised IPEC Good Distribution Practices Audit Guide for Pharmaceutical Excipients (Version 3, 2021). After the guide was initially only accessible exclusively to IPEC members for three months, the document was now made available to the general public.

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GDP Non-Compliance Report for German Wholesale Distributor: No GDP Conform Quality System and No Suitable and Adequate Premises

The competent authority of Germany (Bezirksregierung Köln) has entered a new GPD Non-Compliance Report dated 03 December 2021 into the EudraGMDP database. Due to the seriousness of the violations, the Wholesale Distributor Authorisation was revoked.

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GDP for Veterinary Medicinal Products: Implementing Regulation (EU) 2021/1248 of 29 July 2021

In August 2021, the new Commission Implementing Regulation (EU) 2021/1248 on measures on good distribution practice for veterinary medicinal products entered into force. Read more in the summary of the most important aspects of the new document.

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Q&As from the EMA Webinar for Industry on Integration of EudraGMDP and OMS

At the beginning of October, we reported on important changes for entries in the EudraGMDP Database. To inform about the new developments, the EMA had organized a webinar for industry on the integration of EudraGMDP and OMS. The EMA has now published a 13-page Q&A document with 87 questions raised during that webinar.

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GDP for APIs used as Starting Materials in Veterinary Medicinal Products: Implementing Regulation (EU) 2021/1280 of 2 August 2021

The Commission Implementing Regulation (EU) 2021/1280 lays down the good distribution practices for active substances used as starting materials in veterinary medicinal products. It applies to importers, distributors, and manufacturers. The Regulation has been binding since August 2021 and is directly applicable in all Member States. We have summarised the most important requirements of the new Regulation.

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GDP Certificates and Wholesale Authorisations Automatically Extended until the End of 2022

In light of ongoing difficulties to conduct on-site GDP inspections due to restrictions arising from the COVID-19 pandemic, GDP certificates and time-limited wholesale authorisations for sites in the European Economic Area (EEA) are automatically extended until the end of 2022.

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Documents Accessible Free of Charge in the Member's Area of the European GDP Association

Do you know that many supporting documents are available free of charge in the member's area of the European GDP Association? To get an idea, take a look here.

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Recording of MHRA Supply Chain Webinar Available

On 13 August 2021, the Medicines & Healthcare products Regulatory Agency (MHRA) held a webinar "Protecting the medicines supply chain from falsified medicines". A link to the recording and updated information addressing some key questions received during this webinar have now been published on the MHRA Inspectorate blog.

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