Draft European Falsified Medicine Regulation Issued

Details published of the requirements for a unique identifier and anti-tampering safety features to prevent the entry of falsified medicines and pharmaceuticals into the legal supply chain.

12 August 2015 - the European Commission has issued notification of the availability of the draft regulation. The final date for comments is 11th October 2015.

Pharmacist ScanningA draft of the EU delegated act on safety features - a key part of the Falsified Medicines Directive - has now been published. This means that the comment period will close in two months’ time and it is expected that the final delegated acts will be published end of the year.  The legislation will take effect three years after publication of the delegated acts for countries without pre-existing measures (six years for countries with pre-existing measures).

The regulation supplements Directive 2001/83/EC of the European Parliament and of the Council and lays down the detailed rules for the safety features appearing on the outer packaging of medicinal and pharmaceutical products for human use.

Regulation of prescription drugs

Counterfeit drugs have become an increasing global threat over the last few decades and more and more regulatory authorities, including Argentina, Brazil, India, South Korea, Saudi Arabia and the EU, have adopted or will adopt requirements for the use of globally unique drug identifiers and serialisation in order to protect the supply chain.

EU Falsified Medicines Directive

The regulation outlines requirements for a unique identifier and a safety feature to prevent or highlight tampering. The purpose of the regulation is to prevent entry into the legal supply chain of falsified medicinal products and to ensure product integrity and authentication of medicines (ie. safety features and product serialisation). It will encompass a harmonised unique identifier across Europe.

The newley published 34-page document details the technical specifications for the unique identifiers added to packs, the way these should be verified, and the data repository that will be used to store them.

The delegated act provides for:

The harmonised structure and content of the unique identifier as well as its carrier, across the EU. The setting up of an “end-to-end” system for the verification of the authenticity of the safety features complemented by risk-based checks at wholesaler level.In practice, the safety features placed on a medicine pack by the manufacturer are systematically verified for authenticity at the end of the supply chain, before that pack is dispensed to a patient (e.g.: by pharmacies or hospitals). The authenticity of medicines at higher risk of falsification is additionally verified in the middle of the supply chain by wholesalers. The setting up, management and supervision of a repositories system where legitimate unique identifiers are stored. The repositories system is to be set up and managed by stakeholders, under the supervision of Member States competent authorities. The repositories system is queried in order to verify the authenticity of the medicinal product. Additional reading:

Access a copy of the draft on ec.europa.eu.
Read a commentry and update from 3CIntegrity
Read news story on Securing Industry - Pharma