We are a Marketing Authorisation Holder who have an active MAH for UK but we do not market any medicines here at the moment. Are we required to contract with SecurMed UK and pay fees for the UK system?
The MHRA position on this is that as you have an active MAH for the UK market you may decide at any point to start marketing and distributing medicines so you should contract with SecurMed UK.
SecurMed UK has decided that if an MAH is not actively marketing a medicine in the UK you do not need to contract/ pay fees. However, if at any point in the future you decide to start marketing or distributing medicines you are obliged under the Article 31(5) Delegated Regulation to apply the FMD safety features to your packs, onboard to EMVO to upload pack data and contract with SecurMed UK to pay fees for the UK MVS.