Good Distribution Practices News

The British Medicines and Healthcare Products Regulatory Agency (MHRA) has published a report summarising GDP inspection deficiency data from its 2016 inspections.

The European GDP Guideline which has been published in a revised version on 7 March 2013 has caused a lot of discussion since then. Many requirements leave room for interpretation. On the GDP Association Webpage a section has been set up with frequently asked questions (FAQs). Please read more about the new Questions and Answers on GDP

A new Non-Compliance Report for parallel import, repacking and distribution of pharmaceutical products was published on the EudraGMDP site.

GDP Guidelines are certainly a hot topic in the EU and in WHO states. In the US, things are still developing but are getting more and more important, as the excerpts from recent Warning Letters addressing GDP isssues show.

The European GDP Association has been growing steadily since its foundation as Good Distribution Practice Interest Group in 2013. Now it represents close to 1.900 professionals from all over the world. Recently the Association announced that two new members joined the Advisory Board.

The European Institute for Pharma Logistics (EIPL) conducted a field study on drug deliveries by online pharmacies - with some alarmingly results. Find out more about the EIPL field study.

Marketing Authorisation Holder (MAH) might require Pharmacovigilance Agreements with Wholesale Distributors according to the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).