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Yes. SecurMed UK has configured UKNI MVS passwords to expire 365 days after a change.
Contact the GS1 organisation in your respective country or at www. gs1. org/contact
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.
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
The MHRA has confirmed that subject to the outcome of a public consultation anti-tamper devices may continue to be placed on out-of-scope products after 9th February 2019 if the relevant manufacturer considers that it is necessary to do so in the interests of patient safety.
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.
Where medicines are dispensed for a named patient as a homecare supplied drug, the medicine will be decommissioned by the homecare service provider ‘at the time of supply’ to that patient.
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.
Please refer to the European Pack Coding Guidelines from EFPIA.
The Northern Ireland pack labelling requirements are: – Product code in GTIN format – Batch Number – Expiry Date – Unique serialisation number – 2D matrix.
No, whether a pack is IMT or local does not affect the transaction that is submitted to the UKNI MVS nor the response, therefore IMT is not relevant for baseline testing.
Visit the MHRA FMD guidance. To sign up to the MHRA’s FMD Safety Features Newsletter, please contact the MHRA.
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.
For more information, please visit the NHS Digital GP FMD Toolkit. The BMA, DDA and MHRA websites also have useful resources for Doctors and GPs. If you can’t find what you’re looking for, please contact the BMA.
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.
The safety features legislation sits within Article 54 of Council Directive 2001/83/EC.