Falsified medicines may contain ingredients of bad or toxic quality, or in the wrong ingredient or the wrong dosage. They represent a serious risk to public health that is the reason why the European Union (EU) put in place a comprehensive strategy to fight against it.
The Falsified Medicines Directive (Directive 2011/62/EU), amended directive 2001/83/EC and is in force since 21 July 2011. Member states had to start applying its measures in January 2013. It introduced harmonised European measures to fight against medicine falsifications
and ensure that medicines are safe and that their trade is rigorously controlled.
- Obligatory safety features on the outer packaging of medicines: a unique identifier (UI) and an anti-tampering device (ATD);
- A common, EU-wide logo to identify legal online pharmacies;
- Tougher rules on import of active pharmaceutical ingredients;
- Strengthened record-keeping requirements for wholesale distributors.
The Commission Delegated Regulation (EU) 2016/161 details the technical characteristics of the safety features, how medicine authenticity should be verified and by whom.
The scope of the legislation is mainly with prescription medicines but the Delegated Regulation specifies some exceptions.
Which medicinal products have to bear the safety features?
- Medicinal products subject to prescription (unless included in Annex I to the Regulation);
- Medicinal products not subject to prescription which are included in Annex II to the Regulation;
- Medicinal products to which Member States have extended the scope of application of the UI or of the ATD.
For instance, France has extended the scope of application of the:
- UI to all reimbursed medicines
- ATD to all medicines
Timetable for setting up the system
The Commission Delegated Regulation will apply as of 9th February 2019 in all EU Member States.
To comply with the Falsified Medicines Directive (FMD) and "the Delegated Regulation" manufacturers should implement the following safety features:
- Attribution of an unique Identifier to each individual pack of a medicinal product (unique serial number);
- Implement an Anti-tampering Device to each individual pack of a medicinal product allowing the verification of whether a pack has been opened/tampered with.
Manufacturers shall encode the unique identifier in a two-dimensional barcode. The bar code shall be a machine-readable Data matrix and have error detection and correction equivalent to or higher than those of the Data Matrix ECC200.
The choice of the most appropriate device allowing the verification of whether a pack has been opened/tampered with is left to the manufacturer.
The unique identifier of each medicinal product shall consist of the following data elements:
- A code allowing the identification of at least the name, the common name, the pharmaceutical form, the strength, the pack size and the pack type of the medicinal product bearing the unique identifier (product code);
- A numeric or alphanumeric sequence of maximum 20 characters, generated by a deterministic or a non-deterministic randomisation algorithm (serial number);
- A national reimbursement number or other national number identifying the medicinal product, if required by the Member State where
the product is intended to be placed on the market.
The European Medicines Verification System (EMVS)
In order to record the unique identifiers each EU member state and each EEA country must establish National Medicines Verification Systems (national repositories). All National Medicines Verification Systems (NMVS) will be connected to an European central repository the European Hub to ensure the verification of individual medicinal product packs also throughout Europe.
The marketing authorisation holder (MAH) or the person responsible for placing the medicinal product on the market, shall ensure that the serialisation data is uploaded to the repositories system via the European Hub before the medicinal product is released for sale or distribution by the manufacturer, and that it is kept up to date thereafter. Data in the system belongs only to him and different parties cannot access each other's data. The European Hub will therefore be the European Medicines Verification Organisation (EMVO) and will feed information to national repositories.
Corporations/group of companies have to decide which legal entity will act as their On-boarding Partner (OBP). All relevant data of the Marketing Authorisation Holders (MAH) of the corporation/group of companies will be transferred via the OBP to the EU hub (EMVO).
Verification of medicines will take place in the National Medicines Verification Systems. The national systems are used by local actors in the pharmaceutical supply chain, i.e. wholesalers, pharmacies and hospital pharmacies. Before a medicine is handed out by a pharmacy, a hospital pharmacy or a dispensing physician, the serial number of the medicinal product will be scanned, checked and verified for authenticity against a data repository. If the unique identifier on the pack matches the information in the repository, the medicinal product is decommissioned and supplied to the patient. Should any inconsistencies appear during the verification process the medicine must not be handed out.
The repository systems are located in the EU and consists of:
- a central information and data router (hub)
- national or supranational repositories connected to the hub
The effectiveness of an end-to-end verification system in preventing falsified medicinal products from reaching the public depends upon the systematic verification of the authenticity of the safety features and the subsequent decommissioning of the UI of every supplied pack, so that that unique identifier cannot be re-used.
Décret n° 2018-291 du 20 avril 2018 (Law decree regarding serialization in France)
European Medicines Verification Organisation (EMVO). EMVO's members are organisations representing the pharmaceutical industry, pharmacies, wholesalers and hospital pharmacies.
FRANCE MVO (CIP official site for serialisation)