The future of the Falsified Medicine Directive and serialisation in the UK may impact on us all. Without the Falsified Medicine Directive (FMD), medicines cannot be verified, and counterfeits will enter the supply chain.
It is with great sadness as a pharmacist and a responsible person (RP – MHRA) that I read that the Royal Pharmaceutical Society has only just requested, in a letter to Matt Hancock, that action is taken by the Government to prevent counterfeit medicines entering the medicines supply chain following the UKs exit from the European Union.
The UK has implemented several requirements of FMD over the last year.
Companies are required to register with the MHRA and comply with Good Distribution Practice (GDP) if they manufacture, import, sell, supply, or export Active Pharmaceutical Ingredients (APIs). Distance selling pharmacies have to put the EU logo on every page of their website, register with the MHRA and comply with a set of rules.
Serialisation became UK Law on the 9th of February 2019. The uptake across the supply chain has been varied.
UK manufacturers have made significant investments and complied. New batches of medicines cannot be QP certified and released into saleable stock unless the product is verified as “Active“. This meets the requirements of both FMD and EUGMP. Uptake by pharmacies and pharmacists has been poor. To comply, they are required to scan the “2D” code and check of tamper evident seals to verify the product, and then once supplied to a patient it is deactivated and removed from the database.
There are concerns that removal of FMD safeguards could leave the UK vulnerable to counterfeit medicines, which could impact on patient care in the UK.
The MHRA has announced the new role of Responsible Person for Imports (RPi) to help to prevent falsified medicines entering the supply chain. Without access to “EMVS” or participation of the whole supply chain (including hospital and retail pharmacies), connectivity between the UK and Europe may not be enough.
It may be that the UK is imbedded into the EMVS and that it would result in a massive cost to remove access to the data. Europe may not want to allow the UK access to the database in 2021. The whole supply chain may not comply, but the without FMD the risk of falsified medicines increasing in the UK will be higher.
Find out more about this and other current changes on our training courses.