Safety Features

Falsified medicinal products pose a serious threat to public health. On February 9, 2019, Commission Delegated Regulation (EU) 161/2016 (hereinafter referred to as the “Regulation”) entered into force, supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features (SF) appearing on the packaging of medicinal products for human use. The aim was to prevent the entry into the legal supply chain of falsified medicinal products. According to the Regulation, a list of deviations (only in czech language) from the obligation to provide or not to provide the medicinal product to the SF has been issued.

The safety features are:

• Unique identifier (UI) that identifies of an individual pack of a medicinal product and enables verify their authenticity
• Anti-tampering device (ATD) allowing the verification of whether the packaging of a medicinal product has been tampered with

The verification of both safety features is necessary to ensure the authenticity of a medicinal product in an end-to end verification system. The Regulation considers a situation where the UI cannot be successfully verified as a potential incident of falsification, and is flagged as such in the system except where the product is indicated in the system as recalled, withdrawn or intended for destruction. The investigation of these cases is provided by the Národní organizace pro ověřování pravosti léčiv (hereinafter “NOOL”). If the suspicion of falsified is confirmed, NOOL informs SÚKL, the European Medicines Agency and the European Commission about this fact. If it was not possible to successfully verify the UI or if it is obvious that the packaging of the medicinal product has been tampered with or there is a suspicion of such (damaged of ATD), it is necessary to notify SÚKL immediately via the web interface (API) or using the electronic form (only in czech language).

In accordance with the provision 11 (r) of the Act on Pharmaceuticals the Ministry of Health of the Czech Republic may in the situation when a verification of safety features appearing on the packaging of the medicinal product is not possible exceptionally temporarily allow distribution and dispensing of such medicinal product by the decision issued at the request of the marketing authorisation holder due to the fact that this medicinal product does not comply with the requirements of this Regulation after completion of the production of the medicinal product. In order to speed up the administrative procedure, a web application was created for submitting request, more information can be found on the website of the Ministry of Health of the Czech Republic.

In accordance with the provision 11 (r) of the Act on Pharmaceuticals SÚKL publishes a list of medicinal products which, at the request of the marketing authorization holders, have been temporarily allowed to be distributed and dispensed in the Czech Republic by issuing a decision of the Ministry of Health of the Czech Republic.

More information on safety features can be found at the following links: