by In2Pharma | Jan 7, 2021 | News
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...
by In2Pharma | Jan 7, 2021 | News
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
by In2Pharma | Dec 15, 2020 | News
Belgium On December 11, 2020, a list of questions and answers was published on the FAMHP website to answer the most important questions about the COVID-19 vaccines. The questions and their answers can be found via this link, however, they are only in Dutch and French...
by In2Pharma | Dec 8, 2020 | News
Europe Appendix V of the QRD template has been updated. This appendix lists the details of the national reporting systems for communicating adverse reactions, which must be stated in the SmPC and the package leaflet. In the most recently updated version of Appendix V...
by In2Pharma | Nov 26, 2020 | News
Europe As of 1st December 2020, the actor registration module will be available in EUDAMED for manufacturers, authorised representatives, system/procedure pack producers and importers. It is the first of six EUDAMED modules that comes into force. The European...
