Good Distribution Practices News

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.

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.

Chapter 2 of the EU GDP Guidelines requires a written training programme. But what exactly does this mean and how can it be put into practice?

The previously published Aide-Memoires for GDP and GMP Inspections regarding safety features are now accompanied by a third one: Aide-Memoire for Pharmacy Inspections. What are the obligations of persons authorized or entitled to supply medicinal products to the public?

During an action week coordinated by INTERPOL against illegal internet trade checks led to the discovery of very large numbers of fake and illicit drugs. Overall the operation resulted in the seizure of around 9 million medical devices and illicit pharmaceuticals.

The competent authority of Czechia has added a new GPD Non-Compliance Report into the EudraGMDP database. The report states that the company concerned does not provide approved storage facilities and the services of a qualified person are not ensured.

The competent authority of Germany has entered a new GPD Non-Compliance Report dated 21 July 2021 into the EudraGMDP database due to critical violations of GDP requirements. One of the reasons is that the Responsible Person (RP) does not fulfil the responsibilities personally and is not continuously contactable.