What do you want to do?


Do you want to register with us, inform us of changes, or tell us about an alert? Please select one of the four options below, or type key words into the 'What do you want to do?' search box, select the relevant category and end user type and press the search icon. If you are looking for information, please go to our How can we help? page.

How do MAHs onboard to the FMD?

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.

How do I progress the analysis of Alerts?

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).

Useful Links

Useful Links

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).

How does my company apply for the ‘micro MAH’ Fee Waiver?

Fill out an MAH Registration Form and return to SecurMed.  
Complete a SecurMed MAH Agreement and return to SecurMed.

What do I do when the NMVS returns an Alert?

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.

I am a Manufacturer – where can I find more information?

More information is available from the British Generic Manufacturers Association (BGMA).  

‘Product Not Found’ alerts

‘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.

What is the EMVO and how can I contact them?

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.

Should we contact SecurMed to infiliate to GS1?

No. Please contact GS1 directly.

Does Article 37(d) require that a National Medicine Verification Organisation (NMVO) directly alerts the relevant national competent authorities, the EMA and the Commission about a falsification? Is there is a time limit for such alerting?

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.

Where can I find a copy of the Delegated Regulation?

You can find the Delegated Regulation here.

Does the WDA holder need to connect to the EMVS?

No. Unless the WDA holder is also an MAH or a Parallel Distributor, there is no need to connect to the EMVS.

Do MAHs interact with the UK national hub for downloading pack data?

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.

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