Amendments to the Pharmacovigilance System (Regulation/Directive)
The Commission wishes to improve the pharmacovigilance rules of 2010 by amending the pharmacovigilance system. New transparency and information obligations for authorisation holders are to be introduced. The initiation of the urgent union procedure is to be automatised and the list of drugs for additional surveillance is to be extended.
The new transparency and information obligations for authorisation holders and the automatic initiation of the urgent union procedure improve patient protection. Extending the catalogue of medicinal products to be automatically included in the list of medicinal products subjected to “strengthened” surveillance facilitates surveillance and thus also improves patient protection.