The EU Falsified Medicines Directive (FMD) (2011/62/EU) was adopted in 2011 and introduced new harmonised measures to ensure that medicines in the EU are safe, and that trade in medicines is properly controlled.
Elements of the Directive, including a common logo to identify legal online pharmacies, and tougher rules on the control and inspection of producers of active pharmaceutical ingredients have already been implemented.
Member States have until February 2019 to implement the final part of the Directive, the ‘safety features’ regulation. The Commission published the adopted Delegated Regulation on the safety features policy (EU 2016/161) on 9 February 2016 following scrutiny by the European Parliament and Council. This provides more detail on how the measures set out initially in the Directive should be implemented.
The Delegated Regulation provides the detail of an end-to-end verification system where medicinal products bearing the safety features can be identified and authenticated.
The Delegated Regulation requires manufacturers to introduce new tamper-evident packaging on medicines and to include a unique identifier for each pack encoded within a 2D data matrix code. All manufacturers will upload the data embedded in the 2D barcode into the repositories system prior to placing the product on the market. The 2D barcode will be able: to be scanned at various points of the supply chain to confirm that it is an ‘authentic’ medicine. On supply of the product to the patient the unique identifier must be ‘decommissioned’ from the repository systems. The national repository is designed to link to a central repository to allow for the authenticity of the product to be verified across Europe.
Verification: Verification can take place at any time during the movement of the medicine through the supply chain. It is a check within the repository (IT database) of the data held which ensures that the product is authentic and originates from a legitimate manufacturer.
Decommissioning: Decommissioning takes places at the end of the supply chain when the product is being supplied to the patient and changes the status of the unique identifier in the repository to indicate that the pack has been supplied– so that any other pack bearing the same unique identifier cannot successfully be verified/or decommissioned.
The medicine supply chain is very complex and various entities throughout the supply chain have different legal responsibilities. Biocair is aware that we play a critical role within the supply chain and work closely with our customers to ensure that expectations and responsibilities are met. At present, as Biocair at no point in the supply chain take title to stock, we currently do not provide verification and decommissioning services.
Biocair will ensure that our customers are aware of this position and update the Quality Technical Agreements where applicable to clearly delimit the responsibilities which may include the below sub-sections:
a. Apply the safety features; namely Unique Identifier (UI) and Anti-Tamper Device (ATD), to medicinal products within the scope of the Falsified Medicines Directive.
b. Upload product master data into the European Medicines Verification System (EMVS).
c. Upload Unique Identifiers corresponding to physical shipment and intended market.
d. Update the EMVS to change the status of a Unique Identifier when a pack is/has:
Destroyed; Lost Unique Identifiers (as far as they are known); Identified and known packs that are suspected of theft; Exported; Other reasons as may be necessary (e.g. batch under investigation).
e. Change the status of a Unique Identifier to “dispensed” in accordance with Article 22 of Delegated Regulation 2016/161/EU when medicinal product bearing the safety features is supplied to customers not operating within a healthcare institute as defined in Article 23 of Deegated Regulation 2016/161/EU.
f. Withdraw product from EMVS and / or NMVS.
For further guidance or advice about FMD, please contact your local Biocair office.