The European Medicine Agency launched an infringement action against a multinational company for serious violation of the pharmacovigilance obligations on twenty products authorized through CP.
The action follows an inspection carried out by the British regulatory authority (MHRA), which detected serious faults in the company pharmacovigilance procedures.
The infringement action was started based on art. 5 of Regulation EC no. 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004.
EMA will report on the investigation outcome to the European Commission which may impose fines or periodic penalty payments if the violation is confirmed. EMA will proceed with an assessment of the general impact of the violation on public health.
Pharmacovigilance is more and more preponderant among pharmaceutical companies’ activities and requires a remarkable organization and great responsibilities.
Born out of the increasing need to continuously control the efficacy of medicinal product in their post-marketing phase, its aim is to collect information on medicinal products, as well as on their efficacy and in particular on their adverse reactions.
Di Renzo Regulatory Affairs is able to offer a wide range of pharmacovigilance services in compliance with current European and National regulations and legislations:
- Control of National network of pharmacovigilance for possible adverse reactions related to the products
- Request of follow-up information to the local pharmacovigialnce responsible person
- Preparations of forms
- Transmission of ICRS and information on pharmaceuticals through the Eudravigilance network
- Search and evaluation of literary cases, and of safety and efficacy studies
- Preparation and submission of PSUR to the Competent Authorities
- Local contact and Qualified Person for the Pharmacovigilance
