Those involved in medicines/medicinal products and medical devices in Romania are expected to follow the guidelines on good pharmacovigilance practices (GVP).
Beyond the need to meet expected pharmacovigilance-related standards as stipulated by the EU, the MAH might be asked to undertake post-authorization studies related to the safety or efficacy of a particular product. Currently, all pharmacovigilance and medical device vigilance activities must be undertaken within the context of the Personal Data Processing Law which states that personal data related to health cannot be processed without the data subject’s specific consent.
The MAH may be asked by the National Agency for Medicines and Medical Devices to appoint a pharmacovigilance contact person in Romania, who would report to the EU-QPPV. NAMMD is the National Competent Authority (NCA) with regards to pharmacovigilance.
It is expected that where a local contact pharmacovigilance person is appointed, this person would be able to conduct local literature monitoring, take responsibility for case processing and distribute DHCPs, for example, in line with GVP guidelines.
With a comprehensive understanding of local pharmacovigilance processes and local pharmacovigilance contacts Grove provides a range of pharmacovigilance activities in Romania within a fully comprehensive outsourced local pharmacovigilance services solution.
For those involved in pharmaceuticals/medicines and medical devices, the pharmacovigilance service package comprises: