A discussion we have again and again inseminars is the question of planned deviations. To make it short: in GMP, nothing should be declared as a deviation that was planned

EudraGMDP is a GMP and GDP related database of the European Community containing manufacturing and wholesale authorisations, GMP certificates and non-Compliance Reports published in the EudraGMDP database. These reports are generated by the competent authorities,

It has recently been increasingly reported in the international press that there was a mix-up in the manufacturing of the Covid-19 vaccine by Johnson & Johnson (J&J). At the site

The EU-UK Trade and Cooperation Agreement (TCA) mentions medicinal products only briefly, but has a dedicated Annex on medicinal products and related GMP requirements; albeit not in great detail. These

In the course of the Brexit negotiations, the role of Northern Ireland was always in focus. The aim of the EU in particular was to avoid a hard border on