UKMVS Operationally Live
The UK MVS is operationally live within the wider European system. Marketing Authorisation Holders which have successfully onboarded (contracted and paid fees) with SecurMed UK can commence loading data into the production UK MVS.
The Falsified Medicines Directive (2011/62/EU) and associated Delegated Regulation (EU 2016/161) shall apply in the UK on, and after, 09 February 2019.
Entities that market medicines in the UK with at least one valid and active marketing authorisation or parallel import licence to which the Delegated Regulation applies are required under the Regulation to bear the costs of establishing and managing the UK repository system.
MAHs are required to register with SecurMed UK and to pay a Set-Up Fee per MAH and an annual operational fee.
Without timely payment of fees, medicines will not be able to be verified, or authenticated at the time of supply to patients in the UK and MAHs may therefore be in breach of their legal obligations.
Further details about the MAH onboarding procedure can be found at: www.securmed.org.uk/mah-onboarding