Notice to marketing authorization holders on the possibility of Croatia's participation as RMS in MRP and DCP procedures following Brexit
Following decision on the withdrawal of the United Kingdom (UK) from the European Union (EU), made at a Brexit referendum that took place in 2016, after the Article 50 of the Treaty on European Union was activated, UK should leave the EU on March 29, 2019. Consequently, marketing authorization holders of medicinal products authorized through the MRP and DCP procedures with UK as a Reference Member State (RMS) should determine a new RMS among EU member states.
The Agency for Medicinal Products and Medical Devices (HALMED) is willing to assume the role of Reference Member State for medicinal products already approved through MRP and DCP procedures with the UK as the RMS. Therefore, HALMED invites marketing authorisation holders to submit to HALMED a request for consideration of the possibility of taking over the role of the Reference Member State.
RMS change consideration requests should be sent to HALMED at: email@example.com.
No fees will be charged for changing the RMS.
Please note that the following standard criteria must be fulfilled in order to make the change of RMS from the UK to Croatia:
- Croatia must already be a Concerned Member State (CMS) in the respective procedure
- All ongoing regulatory procedures with the UK as the RMS (e.g. variations, applications for renewal of marketing authorisations) must be concluded before the switch can take place.
Detailed information on already approved medicinal products and changing the RMS with regard to Brexit is available on the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) website, or here.