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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.

The European Commission published a new version of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. The new version contains four new Q&As compared to the previous version, which mainly cover the tasks of parallel traders when dealing with safety features during repackaging. 

The European Medicines Agency (EMA) has published a new Q&A document on Remote RP activities. Remote activities by the Responsible Person may be permitted, but should occur within the EU/EEA or Northern Ireland in all cases.

According to Chapter 7 of the EU GDP Guidelines, any activity covered by the GDP guide that is outsourced should be correctly defined, agreed and controlled in order to avoid misunderstandings which could affect the integrity of the product. In this article, you will find a checklist to verify the minimum implementation.