The European Medicines Agency and the European Commission last week announced a plan to prevent falsified medicines from entering the market.
The European Medicines Agency (EMA) defines falsified medicines as “fake medicines that pass themselves off as real, authorized medicines.” In July 2011, the EU strengthened the protection of patients and consumers by adopting the Falsified Medicines Directive (Directive 2011/62/EU), whose purpose is to not only prevent falsified medicines from entering the supply chain, but also to allow EU citizens to buy high-quality medicines online through verified sources. It introduces harmonized safety and strengthened control measures across Europe by applying new safety measures.
The delegated regulation implementing the Directive, published Feb. 9 in the Official Journal of the European Union, introduces two safety features: a unique identifier (a two-dimension barcode) and an anti-tampering device to be placed on the packaging of most drugs for human use. “The safety features will help protect European citizens against the threat of falsified medicines, which may contain ingredients, including active ingredients, which are of low quality or in the wrong dosage and could potentially put patients’ health at risk,” EMA stated.
The unique identifier and the anti-tampering device placed on the packaging of the medicines will guarantee medicine authenticity for the benefit of patients and businesses and will strengthen the security of the medicine supply chain—from manufacturers to distributors to pharmacies and hospitals, EMA said.
Marketing-authorization holders are required to place the safety features on the packaging of most prescription drugs and certain non-prescription drugs in Europe no later than Feb. 9, 2019.
To enable implementation of the new rules, EMA and the Quality Review of Documents (QRD) Group have revised the product information templates for human medicines. The revised QRD template should be used for new marketing applications submitted from April 2016. Details on the regulatory requirements and timelines are available in the implementation plan.
The European Generic and Biosimilar Medicines Association (EGA), the official representative body of the European generic and biosimilar pharmaceutical industries, said it welcomed the publication of the regulation. Together with stakeholders, EGA said it will work to ensure the national implementation of an interoperable, pan-European repositories system, called the European Medicines Verification Blueprint System.
“We are confident that the implementation of the European Medicines Verification Blueprint System will be a major step forward for the fight against counterfeit medicines,” Adrian van den Hoven, Director General of the EGA said in a statement. “To ensure that our industries continue to deliver access to high-quality medicines and to improve patient safety, we plan to work closely with member states to allow the industries to apply voluntarily the safety features when needed to increase patient safety even more.”