Pharmaceutical companies manufacturing or supplying prescription only dental pharmaceuticals will need to comply with the FMD regulatory requirements. Dental pharmaceutical wholesalers will need to comply with the FMD regulation where they also supply human medicines as those medicines may be returned from dental practitioners.
Yes. Multi-market packs can be supplied to the UKNI, Ireland and Malta. The EMVS will know when multi-market packs are uploaded, which systems to send the pack data to, and will also manage the decommissioning activity between them.
More information is available from the British Generic Manufacturers Association (BGMA).
No. The MAH should upload the pack data to the EU Hub, which will determine which packs need to be sent to the UKNI national hub. The EU Hub is the master system of record for MAH pack data.
The initial Software (TAN) Code and Password are only valid for 60 days.
For more information, please visit the NHS Digital FMD Toolkit for Community Pharmacy. FMD Source, the website of the UK FMD Working Group for Community Pharmacy, is also a useful guide. Community Pharmacy Northern Ireland (CPNI) also have some useful information.
Each Manufacturer who also holds a WDA needs to review their business operations and wholesaling processes and, where applicable, connect to SecurMed for medicines verification and decommissioning as a Wholesaler.
It is up to each MAH or Manufacturer to perform this assessment.
Each GP Practice (with one or more GP partners) is a separate legal entity. SecurMed registers Locations, not people. The location is processed as per the registered body information provided.
The UKNI MVS Certificate is only available for download for 60 days. Please store a local copy with the Passphrase provided with the Certificate.
For more information, please visit the NHS Digital FMD Toolkit for Secondary Care. The NI Department of Health provides information and related articles for Hospital Pharmacists
Your UKNI MVS account will be automatically locked if you try to access the system using an incorrect Password three times.
The safety features legislation sits within Article 54 of Council Directive 2001/83/EC.
The G195 – Mixed Bulk process is used to submit a cache of individual transactions that have buffered while connection to the NMVS has been interrupted.
Where stakeholders are unclear on the proposed legislation, for example – packaging and labelling changes, please contact DHSC/MHRA at FMD. safetyfeatures@mhra. gov. uk
Please refer to the Pack Coding Guidelines issued by EMVS
No. 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, the medicine should be labelled with safety features.
