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, Turkey 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.
The U.S. Drug Quality and Security Act (DQSA)
The Drug Quality and Security Act (DQSA) was signed into law on 27 November 2013. It outlines critical steps to build an electronic, interoperable system for identification and traceability of prescription drugs as they are distributed in the U.S.. The new law supersedes any states requirements. The requirements are phased in over a period of 10 years by providing a migratory path from lot traceability to serialisation to item-level traceability. The new system will enable verification of the legitimacy of the drug product identifier down to the package level, enhance detection and notification of illegitimate products in the drug supply chain and facilitate more efficient recalls.
EU Falsified Medicines Directive
One of the key objectives of the European Directive on the prevention of the entry into the legal supply chain of falsified medicinal products is to ensure product integrity and authentication of medicines (ie. safety features and product serialisation). It will encompass a harmonised unique identifier across Europe.
The Delegated Acts on safety features (Regulation 2016/161), were adopted on 2 February 2016, and published in the Official Journal of the EU on 9 February 2016. The regulation is explaining the technical details of the EU Falsified Medicines Directive (FMD), setting up the first "end-to-end verification system" for drugs across the world. The deadlines for implementation of the requirements across Europe is 9 February 2019, and in 2025 for Belgium, Italy and Greece. Implementation at national level can be completed before the end of these transition-periods.
For implementation guidelines, please see the Healthcare page.