Pharmacovigilance Implementing measures - Consultation

BEUC strongly welcomed the adoption of the new pharmacovigilance legislation as an important step to strengthen the EU pharmacovigilance system and to increase consumers’ trust in the safety of medicines.

For a proper implementation of the legislation it is necessary to guarantee that the European Medicines Agency and the national competent authorities have adequate resources to perform their tasks and are in the position to have a complete oversight on the safety profile of all medicines on the market.

In implementing the legislation it is important to bear in mind the new definition of adverse reaction that now includes also misuse, abuse and medication errors.

The technical requirements for the pharmacovigilance master file, the quality systems, the collection, processing and assessment of data, the formats and protocols should be designed as to ensure an efficient detection of signals and a proper management of risks.