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.

UK MVS end user

Software suppliers

Marketing Authorisation Holders

Report Alerts

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).

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.

‘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.

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.

Need more info?

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