Falsified Medicines Directive (FMD)
Falsified Medicines Directive (FMD)
Falsified medicines are fake medicines that pass themselves off as real, authorised medicines. Falsified medicines might contain ingredients, including active ingredients, which are of bad quality or in the wrong dose – either too high or too low. As they have not been properly evaluated to check their quality, safety and efficacy – as required by strict EU authorisation procedures – this could be detrimental to patients’ health.
On 02 January 2013, in order to combat the ever increasing risk that falsified medicines reach patients, the “Falsified Medicines Directive” – Directive 2011/62/EC which aims to prevent the entry into the legal supply chain of falsified medicinal products came into force.
On 02 October 2015, the Commission Delegated Regulation (EU) 2016/161 supplemented Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for new safety features to appear on the packaging of medicinal products intended for human use.
The UK’s database will be developed by a new organisation, SecurMed UK, which comprises of all the main supply chain bodies representing manufacturers, wholesalers and pharmacies. Pharmacy is represented jointly by the NPA and CCA and Raj Patel of the NPA is currently the “dispensing entities” Director of SecurMed UK.
From 9 February 2019, the Regulation will apply to England.
Click on a heading below for more information.
EU common logo
Community pharmacy will already be familiar with another aspect of the Falsified Medicines Directive in terms of the EU common logo.
From 1 July 2015, everyone (including traditional “bricks and mortar” pharmacies with an online presence) authorised by the Medicines and Healthcare Products Regulatory Agency (MHRA) to sell human medicines online in the UK must display the EU common logo on every page of their website offering to sell human medicines. Pharmacy contractors with an online presence also must be registered with and be on MHRA’s list of UK registered online sellers available here. Patients will be able to verify your entry on MHRA’s register of authorised online sellers of medicines as the EU common logo will contain a hyperlink to the seller’s entry on the register.
Persons selling human medicines online without MHRA registration and / or not displaying the EU common logo can be sentenced to up to two years in prison, or fined, or both.
In the UK, the General Pharmaceutical Council (GPhC) already operates a different (voluntary) pharmacy logo scheme for pharmacies registered with it. Further information is available here. Note: This voluntary scheme is not a substitute for the EU common logo.
New safety features
From 9 February 2019, market authorisation holders are required to place two new safety features on all new packs of prescription medicines placed on the market in Europe from February 2019 onwards intended for human use. These include a unique identifier (UI) in the form of a 2D data matrix (barcode) which can be scanned at various points along the supply chain to determine its authenticity and an anti-tamper device (ATD).
It is hoped that these safety features will help in ensuring that medicines are genuine and that the security and integrity of the medicine supply chain can be maintained.
There will be significant changes required for pharmacy practice to comply with the Regulation. This page will be updated whenever further information is available.
Community Pharmacy FMD Working Group's (FMDWG) guidance and website
The UK FMDWG issued guidance to help community pharmacy teams understand and implement the EU Falsified Medicines Directive (FMD). The Way Forward for FMD in Community Pharmacy covers key assumptions about FMD, high level processes for incorporating authentication in to existing dispensing workflows, handing stock transition after 2019, what IT systems will need to deliver and implications for patient safety. A key assumption concerning Brexit is that the UK will be considered, for the purposes of the FMD Delegated Regulation, still to be ‘inside the EU’ now and in the future, mirroring the UK Government’s stated aim of “high regulatory alignment” with EU medicines legislation.
The website FMD Source also provides UK community pharmacists and their teams with detailed information to help them prepare for the start of FMD.
The UK FMDWG brings together all the main pharmacy bodies representing community pharmacy to influence and inform the implementation of FMD in the UK. The group comprises expert representatives from PSNC, NPA, AIM, CCA, CPW, CPS and CPNI. It meets regularly with DH and MHRA to discuss how FMD will operate in UK pharmacies and to seek a practical and pragmatic solution for its implementation.
Guidance from the MHRA
On 20 April 2016, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its’ guidance regarding packaging, labelling and patient information leaflets (PILs). The unique identifier and anti-tamper security features are included in a new section to the guidance which is available here.
Frequently asked questions
Who will be paying for FMD?
A. The costs of establishing each database is to be borne by manufacturers of branded and generic medicines and parallel distributors though additional licensing fees. Pharmacies and wholesalers will be responsible for making their connections to the database, as well as for software upgrades.
The pharmacy negotiating bodies are represented on the UK FMD Working Group and are working hard to ensure there is a pragmatic solution that recognises the additional costs and impacts that FMD could have on community pharmacies and their suppliers.
Q. What about Brexit?
A. Although the result of the referendum in 2016 has started the UK on a path towards leaving the European Union, it is unlikely that this will have taken place before FMD scanning and authentication comes in to effect from 9th February 2019. Other EEA countries and Switzerland are also participating in FMD. The full implementation of FMD may depend on the UK’s future relationship with the EU.
Pack serialisation is now a global approach to tackling falsification and similar systems are being developed in many markets, including India and China. As a result, serialised packs are already appearing in UK pharmacies.
The website FMD Source provides UK community pharmacists and their teams with detailed information to help them prepare for the start of FMD.
FMD Source has been developed by the UK FMD Working Group for Community Pharmacy which brings together all the main bodies representing community pharmacy to influence and inform the implementation of FMD in the UK. It is designed to help UK pharmacies prepare for whatever new authentication systems are developed and introduced.