Multifaceted Falsified Medicines Directive Cleared in Europe; Implementation Will Pose Challenges for Industry and Regulators

Legislation adopted by the EU Council on May 27 will significantly strengthen the EU’s ability to detect falsified medicines and prevent their entry into the legitimate supply chain by adding new requirements in four main areas: ● safety features ● supply chain and good distribution practices (GDPs) ● active substances, and ● Internet sales.

The EU Council’s adoption followed on the heels of the passing of the “Falsified Medicines Directive” by the European Parliament (EP) in February. In its announcement, the Council stressed that the directive is aimed at “protecting patients against the rising threat of falsified medicines.”  The European Commission released a Q&A on the directive immediately following its passage [see link at the end of the story].

The new safety features contained in the legislation are designed to ensure the authenticity of prescription products, and will be required on the outer packaging.  The qualified person (QP) for the final dosage form manufacturer will be responsible to ensure as part of batch release that the safety features have been applied.

The supply chain security/GDP component of the directive provides increased quality management and documentation obligations for all the players involved including wholesalers, distributers and brokers. Among the key features is the requirement that wholesalers verify that their suppliers and customers comply with GDPs.

New registration requirements will also be placed on the manufacturers of active substances, and distributors of APIs will be required to register their activities.  In addition, manufacturers purchasing APIs from other firms will need to audit these suppliers.

The directive also provides a more coordinated foundation for the regulation of internet sales, which are currently being done differently within each of the member states. In addition to the member state requirements, a certification process will be put in place that will allow Internet sellers to display a logo on their website showing that they have been approved by the EU as a reputable seller.

The Falsified Medicines Directive is one of three prongs of a broad-based EU legislative effort known as the “Pharmaceutical Package.”  Also part of this package is legislation to: ● strengthen the EU’s pharmacovigilance effort, and ● better regulate the way health information is supplied to the general public.

The pharmacovigilance prong was the first to be adopted.  The directive was officially published at the end of 2010, beginning the implementation process, which will be completed July 2012. The third prong on patient information access is currently being redrafted.

[The story that follows for subscribers here encompasses the insights on the content, significance and implementation timelines and challenges of the Falsified Medicines Directive provided at the PDA/EMA conference in London in early May by a key EMA official involved in the legislation. Nonsubscribers can purchase the story for $195 by contacting Karen Bertani (  For subscription/license information, click here.]