Kategorie: Pharmaceutical Law
The rule of precedence in EU law and the boundary between medicinal products and foods considering the judgment of the Court of Justice of the European Union in Case C 451/24
The European market is increasingly confronted with products whose nature lies at the boundary between medicinal products, food supplements, and foods for special medical purposes, thereby creating significant regulatory uncertainty for both businesses and national authorities. In this context, the judgment of the Court of Justice of the European Union in Case C‑451/24 of 4 …
Read moreWhat will the uniform monthly employers’ report bring?
In the area of labour law and payroll administration, one of the most important administrative obligations for employers is the regular reporting of data on employees and their wages to a wide range of institutions. Under the current system, employers must submit more than twenty reports and forms at various deadlines each month to institutions …
Read moreMDR postponed for one year
As we informed you earlier in our article, new EU legislation fundamentally regulating the field of medical devices was to enter into force on 26 May 2020, namely 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 …
Read moreTransformation of the Czech medical devices laws
With regard to the adoption and forthcoming application of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (“MDR”) and Regulation (EU) 2017/746 of the European Parliament and of the Council on diagnostic medical devices in vitro (“IVDR”), the Czech legislation in the field of medical devices is likely to …
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