13. In what form should the safety features appear on the packaging of a medicinal product imported as a foreign-language batch?

The Institute allows for the placement of individual batches of a medicinal product onto the market in the Czech Republic, if the data on the labelling are in a language other than the Czech pursuant to Section 38 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended, and Section 3, paragraph 6(b) of Decree No 228/2008 Coll., on the marketing authorisation of medicinal products, as amended; for more information please our website.

In case of placement onto the market of a foreign-language batch of a medicinal product manufactured without safety features prior to 9 February 2019, or a medicinal product listed under Annex I to Commission Delegated Regulation (EU) 2016/161 (so called white list), the packaging of such a product does not have to bear the safety features.   

In case of placement onto the market of a foreign-language batch of a medicinal product manufactured after 9 February 2019, if the product is subjected to the obligation to incorporate safety features in the packaging, the safety features (UI and ATD) on the packaging of such product in the form present on the foreign-language packaging shall be acceptable, nevertheless, a sticker or Czech package leaflet attached to the packaging externally, e.g. with a rubber band/tape must not conceal the safety features. In case the Czech package leaflet is placed inside the outer packaging, which means the integrity of the ATD had to be broken, the outer packaging of the product shall bear a new adequate ATD, which shall conceal the original broken ATD. In case the outer packaging was subject to re-packaging (replacement of the outer packaging), it is necessary to remove the original UI from the repository system and to place new safety features (both UI and ATD) on the product packaging and upload the new UI to the repository system.