What is the process for onboarding to FMD?
There are two processes Marketing Authorisation Holders (MAHs) need to perform to onboard for FMD:
- Onboarding to EMVO – all MAHs must onboard to EMVO to be able to upload pack information into the EMVS/ NMVS repositories system. EMVO will perform a detailed set of assessments, contract with the MAH and require payment of a fee before granting access to EMVS. You can onboard to EMVO at https://emvo-medicines.eu/pharmaceutical-companies.
- Contracting with SecurMed UK and paying fees to fund the EMVS/NMVS repositories system. All MAHs are required under Article 31 (5) of the Delegated Regulation to bear the costs of the EMVS/NMVS repositories system. This means contracting with and paying fees for access to the SecurMed UK Medicines Verification System. SecurMed UK have a published contracting and fee payment model (available upon request). All MAHs are requested to register with SecurMed UK providing company and address details, listing of all MAHs (both EMA and MHRA) and the name and contact details of the Responsible Person for your respective MAHs. Click here for details of the SecurMed UK MAH onboarding procedure.