The Falsified Medicines Directive (2011/62/EU)
Nowadays falsified medicines are one of the biggest threats to the public health and safety. Due to the ever-growing sophistication of falsifications, the threat of falsified medicines reaching patients in the EU increases year by year. Falsified medicines are severely threatening global health, therefore a need has arisen for a comprehensive strategy both at European and international level.
The Falsified Medicines Directive (Directive 2011/62/EU) appeared on 1st July 2011, in the Official Journal of the European Union and its member states were mandated to apply its measures starting with 2nd January 2013. Directive 2011/62/EU institutes mandatory safety features, namely a unique identifier and an anti-tampering device, which will allow the verification of the authenticity of medicinal products subject to prescription, thereby protecting both patients and businesses from the dangers of falsified medicines. The Falsified Medicines Directive instituted harsher rules to solidify the protection of public health, to ensure the safety of medicines and rigorous control of the medicine trade.
A delegated act was adopted on the 2nd October 2015, and published by the European Parliament and the Council on 9th February 2016. This act details the characteristics of the safety features, how and by whom should the authenticity of the medicine be verified.
The new ordinance applies ONLY to medicinal products for human use. Research and development trial products and those not yet authorized for the market are excluded from the Directive rule. The safety features are NOT required where the medicinal product is manufactured in the EU, but is destined for exportation only.
The safety features consist of two elements placed on the packaging of a medicinal product:
1 – a unique identifier, meaning a unique sequence carried by a two-dimensional barcode allowing the identification and authentication of the individual pack on which it is printed;
2 – a device allowing the verification of whether the packaging of the medicinal product has been tampered with (anti-tampering device);
A new kind of seal was developed at ELTRONIS, with exactly this Falsified Medicines Directive (2011/62/EU) in mind. enseal™, our patent-pending tamper-evident seal is the perfect tool to achieve the required goals and more. Designed with user-friendliness in mind, the non-adhesive tab for easy removal gives our enseal™ a revolutionary intuitive use, offers brand protection and its full transparency doesn’t interfere with the design of the package. It can contain a wide variety of features and safety elements (e.g. product authentication, tactile signs for the visually impaired end users, adjustable size to include more information, track and trace with hidden code and customized application). It’s all up to the customer and his needs. We officially launched this product during Pharmapack Europe 2016. (read more about it here).
It can be supplied with engage™, our cloud-based security and brand engagement software solution to verify the unique codes and serial numbers printed on the security seals. However engage™ is not exclusively part of enseal™. This application is offered as part of our large variety of labels and seals. (read more about engage™ here)
The safety features must be placed on the packaging of most prescription medicines and certain non-prescription medicines no later than 9th February 2019. These safety features 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, pharmacies and hospitals.