Legislation, especially pharmaceutical legislation, can be pretty tough to work through. For example: according to Directive 2011/62/EU of the European Parliament and of the Council, commonly referred to as the ‘Falsified Medicine Directive’, the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging should have “safety features enabling […]
Legislation, especially pharmaceutical legislation, can be pretty tough to work through. For example: according to Directive 2011/62/EU of the European Parliament and of the Council, commonly referred to as the ‘Falsified Medicine Directive’, the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging should have “safety features enabling wholesale distributors and persons authorised or entitled to supply medicinal products to the public to verify the authenticity of the medicinal product, and identify individual packs, as well as a device allowing verification of whether the outer packaging has been tampered with.”
If you read through the Falsified Medicine Directive, it is difficult to understand because you lack the directive it is based on. The Falsified Medicine Directive amends ‘Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products’. If you want to comprehend what is written in the Falsified Medicine Directive it is easier to read the latest consolidated version of Directive 2001/83/EC. This is the original directive, including all the changes according to the amendments, which gives a better overview than just reading separate amendments.
So what is this Falsified Medicine Directive about? The main point is to prevent falsified medicine from entering the legitimate supply chain by adding features to the packaging that allow pharmacists and supply chain professionals to verify the authenticity of each individual pack. It is also meant to harmonise safety features for medicinal products within the Union. But these are just a few of the main points: the legislation doesn’t provide us with practical guidelines or specifications to help us comply with the Falsified Medicine Directive.
CEN, the European Committee for Standardization, has almost completed the work on a document that does provide these practical guidelines and specifications. The document is called ‘FprEN 16679:2014 Packaging – Tamper verification features for medicinal product packaging’. This document “specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.” But, more importantly, it is recognised as a way to make sure your products comply with the legislation. It specifically states: “The packaging of medicinal products placed on the market and incorporating tamper verification features in accordance with this European Standard meets the requirements of Directive 2001/83/EC as amended by Directive 2011/62/EU.”
If all goes well, the final draft proposal will be accepted before the end of the year and we can expect the real standard to be available from the national standards bodies in 2016. From that time on, complying with the Falsified Medicine Directive will be a whole lot easier.