Products and batches not in scope of the Falsified Medicines Directive (FMD)

There are some products and batches in the Finnish supply chain having a 2D matrix printed on packs even though not falling under the scope of the Falsified Medicines Directive (FMD), e.g. non-EU batches and medical devices. Scanning these packs causes unnecessary errors in the National Medicines Verification System (NMVS).

There is a functionality in the NMVS that allows the creation and maintenance of a list of products and batches not in scope of FMD (so called non-FMD list). To minimize the number of unnecessary errors, a product and batch may be added to the list based on a case-by-case risk assessment.

Finnish Medicines Verification Organisation FiMVO maintains the content of this list in the Finnish Medicines Verification System (FiMVS) under the supervision of the Finnish Medicines Agency Fimea. This non-FMD list functionality can only be used for single market batches with Finland as the target market and for batches the data of which has not been uploaded in the European Medicines Verification System (EMVS) at all.

When a user attempts to verify or change the state of a pack(s), and the specified product code and batch number are included in the non-FMD list, FiMVS returns the following operation code and response: A74: ’The batch is exempted from FMD requirements.’ (41020006).

The pack returning the above mentioned response may be dispensed or taken into saleable stock if there are no quality concerns or suspicion of a falsification due to other reasons.
Please also note that when an end user in Finland tries to verify or decommission a pack belonging to a non-EU batch and the batch in question is not included in the non-FMD exemption list, FiMVS raises an exception due to an unknown product code A1: ‘The product code is unknown.’ (41020000). If not known, the reason for the missing data should be clarified.

We would kindly like to remind MAHs to keep FiMVO informed of all information letters sent to the Finnish distribution chain, e.g. information regarding batch recalls, product withdrawals and batches distributed in Finland under an exemption granted by Fimea.
Please send information letters and any additional support queries to nmvs@fimvo.fi.