Falsified Medicines Directive hub page


Since 2011, the European Commission and Parliament have been updating legislation to reduce the potential for counterfeit medicines to enter the legitimate medicines supply chain. The legislation is due to take effect on February 9th 2019 and will affect every pharmacist who dispenses or handles medicines.

The Directive proposes to create a system that insists upon a more rigorous quality assurance programme to be undertaken by everyone involved in the medicines supply chain, from the origin of raw ingredients through to the point of dispensing. This will include new security features on individual packs and a new electronic scanning authentication process to be undertaken at the point of dispensing.

Given the UK’s intention to rescind its membership of the European Union, pharmacists may wonder why this legislation is so important, but it is highly likely that the UK will still need to be fully engaged with the Europe-wide system if it wishes to move medicines efficiently into or out of Europe.

Manufacturers are required to ensure the quality of all providers of raw ingredients, including possible inspection of premises. They must also print a barcode containing a unique identifier on every pack that leaves the production line.

Wholesalers are required to verify packs as they pass through from manufacturer to destination.

Pharmacists are required to identify every pack as it enters the pharmacy, and authenticate the pack’s validity before it is dispensed.This is done by scanning the barcode on the pack and receiving a message back from the UK database confirming the authenticity of the pack.

There is a requirement for anyone working in the medicines supply chain to report any packs that do not receive a positive response following scanning with the new electronic security system.

The MHRA is the competent authority for the UK and is in the process of engaging with all stakeholders, working through all the issues to ensure a complete process for all sections of the medicines supply chain.

USEFUL RESOURCES

The competent authority for the UK is the MHRA . They will oversee the governance and implementation of the directive. 

For questions and unresolved issues contact the MHRA [email protected] or sign up for their email updates.

 

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