LEGISLATION
FMD: WHERE ARE WE NOW?
the medicinal product and to identify individual packs, but also to verify, by means of a device, whether the outer packaging has been tampered with.
In February, details of the safety features, which set out obligations on all of those in the supply chain were published, and the UK now has three years to implement them.
These safety features include a 2D bar code with a unique identifi er and tamper evident packaging: measures which will affect all prescription medicines (unless they’re exempted).
The unique identifi er features:
• a sequence of alpha-numeric or numeric characters given to the individual pack
• a code allowing identifi cation of the name
• common name, pharmaceutical form and strength as a minimum
• reimbursement information if required by MS,
S
ince the Brexit result in June, there has been considerable confusion over the progress and potential impact of European legislation that is still in the pipeline. One element of that legislation has been the Falsifi ed Medicines Directive (FMD), which was published in February of this year, and which is due to be fully implemented in 2019.
In a bid to dispel some of the confusion surrounding the subject, the Chief Pharmaceutical Offi cer, Dr Mark Timoney, recently chaired a progress update by the Medicines and Healthcare products Regulatory Agency (MHRA) in a bid to update NI stakeholders on the FMD safety features, which are to be introduced.
The FMD followed on from an EU Council Directive from 2011 and is intended to reduce the occasions on which falsifi ed medicines enter the legitimate supply chain.
12 - PHARMACY IN FOCUS
The directive defi nes a falsifi ed medicine as one where there is a false representation of any of the following:
• its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients
• its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder, or
• its history, including the records and documents relating to the distribution channels used
As a result, amongst other things already in place, safety features are to be introduced to enable manufacturers, wholesale distributors and those who supply to patients to not only verify the authenticity of
• batch number, and • expiry date
Portadown pharmacist, and UCA Executive member, Turlough Hamill, who attended the MHRA meeting, felt that the update was both necessary and proved, ultimately, very benefi cial to stakeholders.
‘Following Brexit,’ Turlough told PiF, ‘there has obviously been a great deal of confusion over what’s going to happen in the future with regard to European legislation that’s currently in the pipeline, and the FMD falls into this category.
‘As pharmacists, we’re well aware of the need to protect the public against falsifi cation of some drugs, particularly biological drugs or higher-risk drugs, so it’s vital that steps are taken not only to avoid falsifi ed medicines entering the supply chain, but also to be able to identify the point of entry of
those that do manage to enter the chain at some point.
‘What came out of the MHRA presentation was that everything hinges on the point at which the product code is decommissioned. For most stakeholders the code will be decommissioned at the point of dispensing, but what became clear during the course of MHRA’s presentation, was that different procedures may apply in different pharmacy settings - in hospitals or in family planning clinics, for example.
‘The full implications of FMD haven’t been fully ironed out yet - particularly for pharmacy in the hospital setting. The delegated regulation allows those in the hospital setting to decommission the unique identifi er at any point when the medicine is within their control which is different from the provisions for community pharmacy.
‘From a purely community pharmacy point of view, however, there will defi nitely be a requirement for an additional software upgrade and I would imagine that the cost of that upgrade will fall on the contractor. Such issues will, I imagine, come down to the ‘fi ner detail’ that will need to be ironed out at a much later date. The fact that we’re still three years away from implementation of this directive means that there’s plenty of time for the minutiae of FMD to be sorted. I don’t believe that the UK voting to leave the European Union will have any impact on FMD. It’s vitally important that the risk of falsifi ed medicines entering the supply chain is reduced by whatever means possible and this risk remains whether we are still part of the European Union or not. In today’s world of online purchasing and parallel imports, controls are even more vital, and FMD, when it’s fully implemented, will play an important role in reducing the risk to the public.’ •
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