News

Questions & Answers on Good Distribution Practices (GDP) - Part 2

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 2 deals with questions related to the role of the Responsible Person for GDP.

More
Insufficient Quality System leads to GDP Non-Compliance Report

Wholesalers must ensure that their Quality Management Systems (QMS) is aligned with the GDP requirements. Otherwise, this can lead to a GDP Non-Compliance Report, as a recent example entered into the EudraGMDP database by the Romanian authority shows.

More
Questions & Answers on Good Distribution Practices (GDP) - Part 1

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 1 deals with questions related to GDP training.

More
Not Approved Storage Facilities lead to GDP Non-Compliance Report for Czech Wholesale Distributor

The competent authority of Czechia has entered a new GPD Non-Compliance Report into the EudraGMDP database due to the fact that a Czech wholesale distributor does not provide approved storage facilities.

 

More
Track & Trace: Do Medicinal Products have to be Decommissioned when Distributed to the UK?

Due to the Brexit, the question arises whether medicinal products have to be decommissioned in advance when distributed to the UK. Now, the European Commission has decided on a transition period for decommission with regard to exports to the UK.

More
Distribution of Temperature-Sensitive Pharmaceuticals: Requirements according to the EU GDP-Guidelines

With the approvals of various COVID-19 vaccines in many countries, the question arises how to safely transport the serum from the production sites to the storage and distribution centres and then on to the local vaccination centres. However, this question does not only arise for COVID-19 vaccines, but also any other temperature-sensitive product in general. The EU GDP-Guidelines contain some specific requirements for temperature-sensitive products in this regard.

More
New MHRA Inspectorate Blog GDP Post: Be aware of Fake Websites when Qualifying New Customers and Suppliers Using Online Resources

Qualification and re-qualification of suppliers and customers are a fundamental part of Good Distribution Practice (GDP). Using online resources and publicly available databases is established as a standard requirement during this process. But relying (only) on information that is easily available to everyone may involve a high risk. In this context, a new post, entitled “Qualifications of suppliers and customers online: reliable or fake news?” has been published in the MHRA Inspectorate blog.

More
Non-Compliance Report for German Wholesale Distributor Published

The competent authority of Germany has entered a new GPD Non-Compliance Report into the EudraGMDP database due to the discovery of serious GDP non-compliance at a German wholesale distributor.

More
Brexit: Phased Process for implementing Medicines Regulation in Northern Ireland

An agreed approach had been reached on a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021.

More
Labelling and Packaging Flexibilities for Covid-19 Vaccines

To facilitate the rapid deployment of the vaccine the European Commission (EC) recently published a document regarding labelling and packaging flexibilities for COVID-19 vaccines.

More
x
Search