The European Union has marked the year 2012 in its agenda as the year in which several legal amendments in particular in the pharmacovigilance field are to be implemented by July 2012 as mandated by the new European requirements on drug safety. The new legislation including the regulation 1235/2010/EU and the directive 2010/84/EU will become applicable in July 2012.

This requires important changes to existing processes in within the Member States, the European Medicines Agency and Marketing Authorisation Holders and also creates completely new processes. Alongside significant changes in the national drug laws concerning pharmacovigilance, these changes also impact on a whole raft of other laws and provisions such as the GCP guidelines.

As your consultant in the pharmacovigilance and drug regulatory affairs field, we keep continual track of the latest regulatory requirements set by the relevant authorities on national and international levels. 

The proposed amendments will have practical implications not only for you as a pharmaceutical company but also for us as your service provider and therefore for our joint projects. In regulatory terms, there are e.g. changes in the mandatory reporting of adverse event cases, changes in writing periodic safety update reports as well as to the standard establishment of risk-management systems for all types of new marketing authorisations. 

As soon as a definite concept for the above-mentioned requirements is available, we will inform you in detail about the actions necessary to ensure that both you as a pharmaceutical company and we as your service provider continue to meet legal requirements to the full. 

Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)

The requirements for submitting product data to populate the EMA's Medicinal Product Dictionary will pose a special challenge to pharmaceutical companies during the course of the year. A Guidance on the implementation of Article 57(2), of Regulation (EC) No. 726/2004 published by the EMA in September 2011 has already roughly defined the enormous scope of the information to be supplied for all products registered within the EU, which are to be submitted to the EMA via the XEVMPD by the authorisation holders by July 2012 . 

At present we are working on several approaches to resolve this challenge. We expect the final definition of the technical specifications and content requirements from the EMA within the next three months. On receipt of this information, we will inform you further on our collaboration options in this area. 

Naturally, we would also be pleased to answer any questions you may have.