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.

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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.

‘Product Not Found’ alert

‘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 the UK GTIN product code require 13 or 14 characters?

GTIN product codes require 14 characters. For more information, please refer to the EMVS Pack Coding Guidelines.

FAQs on Alerts Portal for MAHs

As an MAH I do not have a recent alert ID to submit. Would it be possible to register?You can register using an alert on one of your GTINs / products from the past six weeks. The alert can be any type.