Need more info?
If you can't find what you're looking for, please use the link below to get in touch.
The EU Commission Q&A on FMD can be found on the European Commission site.
Yes, this service is available. Useful resources:
Technical Bulletin: Certificate and Password Management Issues
Your UKNI MVS account will be automatically locked if you try to access the system using an incorrect Password three times.
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.
Bulk Registrations are suitable for multiple organisations/companies within the same legal entity at the same time. Each organisation/company will be an individual End User Location and will therefore have its own Username and UKNI MVS Certificate.
No. Unless the WDA holder is also an MAH or a Parallel Distributor, there is no need to connect to the EMVS.
The Northern Ireland pack labelling requirements are: – Product code in GTIN format – Batch Number – Expiry Date – Unique serialisation number – 2D matrix.
If the medicine associated with a device has an MA and is included in the list or products within scope (virtually all POMs) then under the FMD, it should be labelled with safety features.
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.
Contact the GS1 organisation in your respective country or at www. gs1. org/contact
Refer to your SOP and/or guidance on FMD Source or RPS. To progress the investigation of an Alert with SecurMed UK please click here.
We expect Wholesaler solutions to include bulk transactions and the baseline testing process includes single and bulk transactions. If you feel that your use case does not warrant bulk transactions contact tech@securmed. org. uk to confirm.
Yes. SecurMed UK has configured UKNI MVS passwords to expire 365 days after a change.
The MHRA does not allow direct decommissioning by manufacturers in the NMVS or EMVS for Article 23 customers.
Product, Batch and Pack data started being transmitted to the UKNI MVS when SecurMed UK was connected to the European Hub (EMVS) on 31st October 2018. Data for millions of packs is already downloaded.
Pan-European Public Procurement OnLine (PEPPOL) enables government organisations such as the NHS, and private companies, to exchange electronic trading documents over an interoperable, European-wide network. It offers a standardised network connection for electronic ordering, invoicing and shipping. For more information, please visit NHS Scan4Safety.
If you can't find what you're looking for, please use the link below to get in touch.