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.
Industry stakeholders have worked together and there is a 2-stage process. Upon initial receipt of an alert, SecurMed UK will work with the ‘pack in hand’ organisation and the Marketing Authorisation Holder to identify if there has been a technical or procedural error. Once confirmed that this is not the case, a submission is made to MHRA via the Yellow Card website by the organisation who first raised the 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.
Please refer to the European Pack Coding Guidelines from EFPIA.
GTIN product codes require 14 characters. For more information, please refer to the EMVS Pack Coding Guidelines.
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.
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.