by In2Pharma | Oct 20, 2025 | News
The Netherlands Recent updates to the Dutch Medicines Act (Geneesmiddelenwet) of 8 February 2007 have been published. This Act defines the composition and responsibilities of the Medicines Evaluation Board (MEB) and regulates the licensing of manufacturers,...
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 | Oct 13, 2025 | News
The Netherlands GMH (Gedragscode Medische Hulpmiddelen) has published the maximum hourly fees for service contracts for 2026. These hourly fees are indexed every year and are subcategorized by the education level of the health care professional. You can find the...
by In2Pharma | Oct 13, 2025 | News
Europe Following the revision of the Variation Regulation effective as of 1 January 2025, the European Commission (EC) has adopted and published the final version of the guidelines concerning the classification of variations and the operation of the relevant...
