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No. Unless the WDA holder is also an MAH or a Parallel Distributor, there is no need to connect to the EMVS.
Aggregation data is not available in the NMVS/EMVS. Off-system solutions may be available dependent on the particular supply chain system. Further guidance is expected from the UK NCAs (DHSC/MHRA) who can be contacted at fmd. safetyfeatures@mhra. gov. uk.
Guidance has been issued about how to manage alerts on the Community Pharmacy FMDsource website and on the NHS Digital FMD site.
The European Medicines Verfication Organsiation (EMVO) is a Belgian non-profit organisation representing stakeholders united in securing the legal supply chain from falsified medicines. For more details go to their website.
More information is available from the British Generic Manufacturers Association (BGMA).
Your UK MVS account will be automatically locked if you try to access the system using an incorrect Password three times.
Fill out an MAH Registration Form and return to SecurMed.
Complete a SecurMed MAH Agreement and return to SecurMed.
Authorisation is required from each legal entity, for all its Locations. If you submit a Bulk Registration for multiple legal entities, the EULA can only be accepted once for each entity, so please ensure you have permission from each of them before submission.
Please refer to the European Pack Coding Guidelines at the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The EU Commission Q&A on FMD can be found on the European Commission site.
To register one or more Locations from one or more legal entities, select the Bulk Registration process when you have logged onto our Portal.
There are two processes MAHs must complete to onboard for FMD:
1. Onboard to the European Medicines Verification Organisation(EMVO)
All MAHs must onboard to the EMVO to be able to upload pack information to the UK MVS.
It is not recommended. It is necessary for the person registering to accept the terms and conditions of the EULA, which could not be justified without an agreement in place.
The UK pack labelling requirements are: – Product code in GTIN format – Batch Number – Expiry Date – Unique serialisation number – 2D matrix.
Request from a Pack-In-Hand actor
In order for us to proceed with the analysis please download and complete the PiH_Alert data request form and return it along with photos of the pack (if you still have it).
The renewal email is sent automatically by the UK MVS to the End User Location Contact email address provided at the time of registration, unless this has since been changed.