Revision of the PIC/S GMP Guide: Annex 13 and Annex 16

Revision of the PIC/S GMP Guide: Annex 13 and Annex 16

Europe At the end of January, EU Regulation 536/014 “Clinical trials” went into force. The entry into force of this Regulation resulted in the parallel updating of some international guidelines. In particular, a new version of the GMP Guide PE016 was...
Update fees MEB

Update fees MEB

The Netherlands As of 1st January 2021, the Medicines Evaluation Board (MEB) will increase the fees for marketing authorization applications and changes the annual fee for medicines for human use and the fees for consultation procedures. The fees for veterinary...
Update of FAMHP fees for 2021

Update of FAMHP fees for 2021

Belgium The FAMHP’s fees have been updated and corrected for the indexation of January 2021. All concerned updated fees can be found here. Source: FAMHP