14. In what form should the safety features appear on the packaging of a medicinal product which is subject to an approved specific therapeutic programme?

In case a specific therapeutic programme has been approved for a medicinal product the packaging of which bears safety features, it is necessary to place a sticker as well as the Czech package leaflet, if applicable, (which should be attached externally with a rubber band/tape) in a manner which will not conceal the safety features (UI and 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; the new product packaging does not have to bear new safety features.

In case of approval of a specific therapeutic programme for a medicinal product the packaging of which does not bear safety features, the safety features (IU and ATD) shall not be added to the product packaging.