News

The European GDP Association (GDPA) is conducting a survey to gather insights into the implementation of GDP requirements across different regions. We invite all stakeholders involved in GDP to take part in this initiative. Participation will take only about 10 to 15 minutes.

In April 2025, the Health Products Regulatory Authority (HPRA) released Version 8 of its Guide to Good Distribution Practice of Medicinal Products for Human Use. While primarily aimed at wholesalers and brokers based in Ireland, the updated guide provides insights into regulatory expectations that are relevant for all stakeholders involved in the distribution of medicines across the EU.

Around 60 participants attended the ECA Webinar "GDP Update 2025" in March. Many interesting aspects were discussed in the Q&A session. After the event, the speaker, Dr. Christian Grote-Westrick, answered the submitted questions in writing. We have compiled a selection of these questions and answers for you – read Part 2 here.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 medicines recall due to a critical labeling error in one batch of Paracetamol 500 mg tablets. The blister packs inside the affected cartons incorrectly state 'Aspirin 300 mg Dispersible Tablets' instead of 'Paracetamol 500 mg'. This incident reveals a failure in the Quality Management System (QMS) and a lapse in oversight by the Qualified Person (QP), while also highlighting the important role of wholesalers and pharmacies in promptly removing affected batches to prevent medication errors.