Update Adverse Drug Reaction reporting details

Update Adverse Drug Reaction reporting details

Belgium On February 29th, EMA published the newest version (v29) of QRD Appendix V. In this version, the contact details for reporting adverse drug reactions in Belgium has been changed, since the authority has decided to abandon the use of a postal address and go...
Update Adverse drug reaction reporting details

Update Adverse drug reaction reporting details

Luxembourg On January 17th, EMA published the newest version (v28) of QRD Appendix V. In this version, the contact details for reporting adverse drug reactions in Luxemburg has been changed, to include the German version of the address. Luxembourg/Luxemburg [French]...
Adjusted fees for applications to EMA

Adjusted fees for applications to EMA

Europe Every year, the European Commission adopts a regulation adjusting the fees payable to the Agency with reference to the inflation rate in the European Union for the previous year. The 2022 inflation rate was 10.4%. The adjusted fees for all...
News on the various Mutual Recognition Agreements (MRAs)

News on the various Mutual Recognition Agreements (MRAs)

Europe On 19 April, the “Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2021” was published. This annual report of the GMP/GDP Inspectors Working Group (GMP/GDP IWG) gives a short but good overview of what was...