News

A new article titled “A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors” has been published on the MHRA Inspectorate blog. In this post, the Medicines and Healthcare products Regulatory Agency (MHRA) outlines key regulatory expectations, licensing requirements, delivery procedures, and specific considerations for recalls and repackaging when supplying medicines to the aviation and marine sectors – two environments that present unique logistical and compliance challenges.

Swissmedic has published Version 3.0 of its Technical Interpretation "Notifications according to Article 41, MPLO". The document outlines which major changes must be reported to Swissmedic and provides additional clarification on the notification process. While the guidance primarily addresses manufacturers, it also includes several important points relevant to companies operating in the GDP environment.

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.