by In2Pharma | Oct 17, 2025 | News
Luxembourg As part of the pharmacovigilance system, the marketing authorization holder has at its disposal, on a permanent and continuous basis, an appropriately qualified person responsible for pharmacovigilance. The person responsible for pharmacovigilance resides...
by In2Pharma | Oct 17, 2025 | News
Europe The European Commission (EC) has adopted Implementing Regulation (EU) 2025/1466, introducing important amendments to the EU pharmacovigilance framework.The regulation will enter into force 20 days after publication and will apply from 12 February 2026....
by In2Pharma | Oct 16, 2025 | News
Europe The European Medicines Agency (EMA) has recently published several important updates to Good Pharmacovigilance Practices (GVP) guidance: GVP Module VI – Addendum II introduces new guidance on the masking of personal data in Individual Case Safety Reports...
by In2Pharma | Jun 3, 2025 | News
Luxembourg As part of our ongoing regulatory intelligence monitoring, we identified a key update on the santesecu.public.lu website: the first edition of the Pharmacovigilance (PV) Bulletin was published by Santé publique Luxembourg on 26 March 2025. This bulletin was...
by In2Pharma | Apr 4, 2025 | News
Europe In December 2024, a draft version of an amendment to the European legislation for pharmacovigilance activities (Implementing Regulation EU No. 520/2012) has been published by the European Commission. Public feedback was collected until the 15th of January 2025....
