Do you know your directive 2001/83/EC from your regulation EC 726/2004? For an update on the European regulations that apply to medical information or pharmacovigilance, call in Genevieve Le Visage from the EMEA! Although some of us heard her at DIA last October, regulations, directives and legislation don’t stand still so we had an interim update.
Genevieve started off by summarising the key regulations we need to know (if you are a PIPA member, the presentation withe links is on the members section of the website).
Since 2007, the EU commission have summarised the consultation on information for patients & will strengthen legislation on pharmacovigilance and counterfeit medicines. To find the documents check out
The pharmacovigilance review aims to focus resource on public health improvements, rather than inefficiences in AE rteporting across the member states. It includes information on patient reporting of AEs, Risk Management Plans & PV committees.
Also worth a look is the EU Health Portal with healthcare information for patients & links to key European documents
As usual, Genevieve gave a clear run through the relevant legislation & developments now unfolding. She’s also presenting at the DIA Medical Information & Communications meeting this October – hopefully we’ll have more news on these 3 developments.