Kategorie: Pharmaceutical Law

27. 05. 2019

Medical devices in the light of the new legislation – last year for preparation

Similarly as recently in the case of medical products, when on 9 February 2019 came into effect 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 …

15. 02. 2019

Anti-falsification regulation of medicinal products and changes it brings

A major breakthrough in the context of the newly introduced anti-falsification regulation in the field of pharmaceuticals has already taken place. On 9 February 2019, 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 …