Q3 2013 New EU GDP Directive

This quarter the long awaited, new, EU Good Distribution Practice (GDP) Guideline came into force and one of the major new aspects of this guideline refers to the transportation of medicinal products. While previously such transportation was not on the radar of pharmaceutical inspectorates, it now certainly is. This has triggered transport temperature service providers to offer new services to their dealers and clients including a GDP-compliance program. We will participate in such a program of the world leading transport temperature control system provider which will be launched in early 2014.

Occasionally, we run into “vintage marketing authorizations” dating back to the eighties of the last century and which were never updated since then. The particular one we were asked to upgrade this quarter is now facing serious problems as the manufacturer who produced this medicine for decades, now terminates his production system. So, the upgrade of this registration file is not only about “technology transfer” from one company to another but also from one century to another. Those were the days when the validation concept still had to be invented, when API – manufacturers were irrelevant as long as they could produce a DAB IX or BP quality grade (Ph. Eur. wasn’t around yet) and Good Clinical Practice was still in its infancy. Nevertheless such an upgrade presents an interesting challenge including fascinating journeys back in time.

On the pharmacovigilance frontier we have extended our services towards the Belgian market by establishing a cooperation with our Belgian colleagues from FarmaConsult (www.farmaconsult.be). This extension is relevant as, during the last decades, we have seen the rise of Benelux-organisations servicing both the Dutch and the Belgian market. Not quite a “piece of cake” this Belgian market, not only due to the different languages in Flanders, Wallonia and the German region, but also due to the cultural differences related to this trilingual market. Together we now can support such Benelux organisations while paying due respect to these lingual and cultural differences.