The EU Falsified Medicines Directive (2011/62/EU) (FMD) aims to ensure that medicines in the European Union (EU) are safe and that trade in medicines is properly controlled.
The final part of the Directive, the ‘safety features’ Delegated Regulation (EU) 2016/161) comes into force on 9 February 2019.
These safety features are:
- a unique identifier (a 2D data matrix code and human readable information) which will be placed on prescription medicines and products that can be scanned at fixed points along the supply chain
- tamper evident features (anti-tampering devices) on the pack.
On supply to the patient, the unique identifier must be ‘decommissioned’ via a scan from the FMD system.
Any party that manufactures, operates as a wholesaler dealer or supplies medicines to the public must work towards compliance with the Falsified Medicines Directive (FMD) irrespective of any Brexit scenario.
This has limited implications for the social care sector in Scotland as most medicines are obtained on a named patient basis and will be decommission by the supplying pharmacy.
Further, Article 23 of the EU Delegated Regulation 2016/161 allows member states to ensure that wholesalers decommission medicines supplied to non–healthcare services that themselves supply stock medicines to patients.
It is expected that providers work with their wholesalers to ensure that both sides are clear on their obligations so that all medicines are correctly decommissioned.
For more information see link below:
https://www.gov.uk/guidance/implementing-the-falsified-medicines-directive-safety-features