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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.
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).
National Competent Authorities
GOV. UK guidance on:
FMD Safety Features
FMD Errors or Alerts
To register for the FMD Safety Features newsletter, or for any queries about the FMD, please contact the Medicines and Healthcare products Regulatory Agency (MHRA).
Fill out an MAH Registration Form and return to SecurMed.
Complete a SecurMed MAH Agreement and return to SecurMed.
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.
More information is available from the British Generic Manufacturers Association (BGMA).
‘Product Not Found’ alerts amount to more than 30% of the total alerts generated when scanning medicines under FMD. Often, this is due to packs which are not part of FMD or are from batches generated prior to FMD coming into effect.
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.
No. Please contact GS1 directly.
The use of the term “provide for” in Article 37(d) of Commission Delegated Regulation (EU) 2016/161 means that an NMVO has to ensure that the National Competent Authorities (NCA), the EMA and the Commission are informed.
Please consult the UK government website.
You can find the Delegated Regulation here.
No. Unless the WDA holder is also an MAH or a Parallel Distributor, there is no need to connect to the EMVS.
No. The MAH should upload the pack data to the EMVS, which will determine which packs need to be sent to the UK national hub. The EMVS is the master system of record for MAH pack data.