Falsified Medicines Directive

Falsified Medicines Directive

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.

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 most prescription medicine packaging intended for human use. These include a unique identifier in the form of a two-dimension barcode which can be scanned at various points along the supply chain to determine its authenticity and an anti-tampering device.

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.

Guidance

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.



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