Falsified Medicines and Serialisation

Falsified medicines (so-called 'counterfeits') have been a growing major threat to public health and safety. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year. As a response, the European Commission Delegated Act Regulation 2016.161 (also called the Falsified Medicine Directive or FMD) was published on the 9th of February 2016.


The Falsified Medicines Directive

According to the FMD, each pack of medicine must be sealed and identified by a data matrix barcode containing at minimum the article code, the batch, the expiry date and the unique serial number, in order to facilitate batch tracing, traceability down to the individual pack, pharmaceutical product identification, and pharmacovigilance. This is called serialisation.  


Movianto's Pharmaceutical Serialisation Services

Movianto has been working with clients regarding European FMD serialisation systems since 2015. Working closely with some of our key clients, we successfully launched serialisation services in 2019 for more than 250 clients across Europe. Our direct connection to 10 National Medicines Verification Systems (NMVS) has enabled us to optimise the response time and reliability of the proposed serialisation solutions.  

During the first year after launch, we operated millions of scans (authenticity checks, pack tracing, decommission and/or reactivation) of data matrices on behalf of our clients. In addition, in certain locations where we offer manufacturing and rework services in compliance with GMP, we propose serialisation production services.

Learn more about Repacking & Labelling

Consolidation and Aggregation

Months before the go live of the new FMD requirements, hospitals in several countries were raising concerns about the significant volume of scans that this new activity would represent for themFollowing the outcome of a European workgroup, the European Medicines Verification Organisation (EMVO) authorised healthcare and pharmaceutical supply chain actors (distributors, wholesalers, etc.) such as Movianto to provide aggregation and consolidation services to support the hospitals.   


What are Consolidation and Aggregation Services in the context of FMD?

The Consolidation service consists of providing hospitals with a file per logistic unit per order. Each file lists the serial numbers of the serialised products included in the corresponding unit. A unique aggregated barcode is printed on each logistic unit of the consolidated order to guarantee traceability.   

The Aggregation service, which is complementary to the Consolidation one, enables us to use the aggregation data already available at the manufacturer to optimise the consolidation process of full cartons and pallets.  

In 2018, we started to develop Aggregation and Consolidation solutions to support hospitals with the FMD requirements. Our 2 first pilot clients went live with these additional functionalities a few months after the launch of the new regulation in 2019. Movianto was one of the first players on the market to put consolidation and aggregation services at our clients’ disposal.   

Currently, we have Consolidation and Aggregation solutions in operation in France, the Benelux region, and Germany. The expertise and experience gained through this journey enable us to successfully support you with the implementation of similar solutions in other countries.