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Counterfeit medicines

Hub on EU falsified medicines directive developed for UK pharmacists

UK FMD source website


The website says that it is likely that the EU’s Falsified Medicines Directive will come into effect before the UK leaves the EU

A website containing information to help community pharmacists prepare for the introduction of the EU Falsified Medicines Directive (FMD) has been launched by the UK FMD working group for community pharmacy, which includes representatives of all the main bodies in community pharmacy.

The website’s aim is to help UK pharmacies prepare for whatever new authentication systems are developed and introduced, and has been tailored to reflect the way UK pharmacies operate, rather than a theoretical ‘European’ model.

Under the FMD, all new packets of prescription medicines placed on the market in Europe from February 2019 onwards will have to bear two safety features: a unique barcode and an anti-tamper device. 

The website says that it is likely that FMD scanning will come into effect before the UK leaves the EU. Any changes made to the 2012 UK Human Medicines Regulations to implement FMD would remain in place until the UK government decides to change them.

At present, the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA), have stated that they are continuing with work to implement FMD in the UK and this is “business as usual” for them.

The UK database will be developed by SecurMed UK, a new organisation representing all the main supply-chain bodies for manufacturers, wholesalers and pharmacies. SecurMed UK represents pharmacy jointly with the National Pharmacy Association and the Company Chemists’ Association.

Raj Patel, a member of the National Pharmacy Association board, who is also chair of the UK FMD working group for community pharmacy as well as the dispensing entities director of SecurMed UK, comments: “Falsification of medicines is a major threat to patient safety and cases of falsification continue to be discovered by authorities. FMD aims to reduce this by allowing pharmacists to verify the authenticity of prescription medicines during the dispensing process.

“We recognise that this will be a big change for everyone in the medicines supply chain, especially community pharmacists. That’s why we’ve been working closely with the Department of Health and the MHRA to ensure that this is implemented in a proportionate way that fully reflects the UK’s unique dispensing models.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202322

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  • UK FMD source website

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