Kategorie: Pharmaceutical Law
One step closer to the amendment of the Act on Pharmaceuticals
On Friday, 21 June 2019, within the third reading at the 30th meeting of the Chamber of Deputies of the Parliament of the Czech Republic, the draft amendment to Act No. 378/2007 Coll., Act on Pharmaceuticals, as amended (hereinafter referred to as “Act on Pharmaceuticals”) and some other acts, was approved. The amendment to the …
Read moreMedical 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 …
Read moreAnti-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 …
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