Chief Pharmaceutical Inspectorate

9 February 2019 – from this day on, companies have been required to place a unique identifier and an anti-tampering device on the packaging of medicinal products.
The new requirements, together with the system of databases gathering information on medicinal products from the European Union, are aimed at preventing falsified medicinal products from entering the legal chain of distribution.

„Safety features,” as the new anti-tampering devices for medicinal products are referred to, are introduced in accordance with Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use.

Article 54(o) of Directive 83/2001/EC stipulates that the packages of medicinal products should contain safety features allowing wholesale distributors and persons authorised or entitled to supply medicinal products to the patients to verify the authenticity of the medicinal product and identify individual packs. The Directive also stipulates that the packaging of a medicinal product should also contain an element (Anti Tempering Device, ATD) making it possible to verify whether the package has been opened or not.

Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use specifies the rules governing the protection of medicinal products against falsification.

The Regulation has introduced two safety features – unique identifier (UI) and anti-tampering device (ATD). The identifier, in the form of a 2D code and accompanying information, contains basic data on a particular package of a medicinal product, such as medicinal product lot number, serial number of the particular package, expiry date, and product code. With a special scanner, the 2D code can be read and, using a computer system, information whether the product has been positively verified, i.e. whether it comes from a legal source, can be displayed at subsequent stages of the distribution chain. ATD, on the other hand, allows verification whether the individual pack of a product was tampered with or not at subsequent stages of the distribution chain.

The obligation to use safety features applies to medicinal products subject to medical prescription, except  products listed in Appendix 1 to the Commission Delegated Regulation, as well as to OTC products listed in Appendix 2.
Furthermore, pursuant to Article 54a(5) of Directive 2001/83/EC on the Community code relating to medicinal products for human use, each Member State may specify a group of medicinal products with extended scope of application of the safety features.