2021/0653/CZ
EC/EFTA
CZ République Tchèque
  • C00P - PRODUITS PHARMACEUTIQUES ET COSMETIQUES
2022-01-12
2021-10-26

- registration dossier

- technical legislative amendments ensuring compliance of the Decree with Act No 378/2007 on pharmaceuticals and on amendments to certain related acts, which is its implementing legislation.

Draft implementing decree amending Implementing Decree No 228/2008 on the marketing authorisation of medicinal products, as amended.

It finalises the adaptation of Regulation (EU) 2017/745 of the European Parliament and of the Council in the field of registration dossier requirements applicable to medicinal products for human use, including medical devices. There are also technical legislative adaptations of the text to ensure compliance of the text with Act No 378/2007 on pharmaceuticals and amending certain related acts, following the adaptation of Regulation 2016/161 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features on the packaging of medicinal products for human use, and the introduction

of a system of measures against falsification of medicinal products according to the EMA guidelines.
Keywords: marketing authorisation for medicinal products, medical devices, protective elements on packaging, counterfeit products
Reference to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC and 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