News

February 2016 (not added on our website yet) : EU Module 1 eCTD specifications changed to version 3.0.1, and are in force since July 1st, 2016. eCTD validation criteria also changed to version 6.1, to be in line with the updated EU M1. Medipha Santé will be attending the CPhI congress 2016, which will take place in Barcelona from October 4th...

The new decree (210/1016) on fees chargeable by Fimea entered into force on 1 April 2016. Most notably, there are no increases in fees.  In addition, the pharmacy dispensary licence fee and the following type IB variation application fees have decreased. Human medicines, type IB variations National type IB variation fee decreased from EUR 500 to EUR 450. Finland, CMS...

EuDRAcon is pleased to announce the launch of its new and improved website. Covering 28 Member States, EuDRAcon is a network of highly professional and experienced regulatory affairs specialists, with experience in all aspects of drug development, from cradle to grave.  We can advise you on those tricky national issues as well as all aspects of drug quality, safety and efficacy...