14 May The first DCP with RMS Bulgaria is now completed
Posted at 16:34h in Regulatory Affairs
The Bulgarian Drug Agency (BDA) announced that on May 10th, 2016 they completed the first decentralised procedure for authorising medicinal product where the reference member state (RMS) is Bulgaria. The procedure has been accepted by all six concerned member states.
Gaining experience to act as RMS is an important step for the BDA. The lack of RMS capacity has been affecting mainly the local drug manufacturers who have the majority of their products first authorised under national procedure in Bulgaria. Increasing the capacity of the BDA to effectively act as RMS could provide the local industry easier access to the other regulated markets in the EEA.