In 2012, the Government of the CR approved an amendment to the Act on pharmaceuticals concerning the field of labeling and packaging of medicinal products, among others. The transposition of Directive 2011/62/EU as regards the prevention of the entry into the legal supply chain of falsified medicinal products was one of the reasons for the approval of an all-embracing act. In terms of packaging technologies and automatic identification issues, a crucial part concerns the so-called safety features. These must be applied on medicinal products for human use subject to prescription or to prescription with restrictions unless they have been listed on the list of medicinal products that shall not bear the safety features as adopted by the European Commission.
Authorization