Measures to help protect patients from falsified medicines

9 February 2016

New regulation introduces 'safety features' on the packaging of medicines for human use

The European Medicines Agency (EMA) and the European Commission (EC) have prepared an Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use for centrally authorised medicines to guide applicants and marketing-authorisation holders in meeting the requirements of a new regulation of the Falsified Medicines Directive. The delegated regulation introduces two safety features, a unique identifier (a 2-dimension barcode) and an anti-tampering device, to be placed on the packaging of most medicines for human use.

The regulation has been published today in the Official Journal of the European Union. 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. 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.

Marketing-authorisation holders are required to place the safety features on the packaging of most prescription medicines and certain non-prescription medicines no later than 9 February 2019.

EMA has revised the product information templates for human medicines to enable the implementation of the new rules. Details on the regulatory requirements and timelines are available in the implementation plan published today.

Falsified medicines are fake medicines that pass themselves off as real, authorised medicines. In July 2011, the EU strengthened the protection of patients and consumers by adopting a new Directive on falsified medicines for human use. This Directive not only aims to prevent falsified medicines entering the legal supply chain and reaching patients, but also to allow EU citizens to buy high quality medicines online through verified sources. It introduces harmonised safety and strengthened control measures across Europe by applying new safety measures.