Kategorie: Pharmaceutical Law
What 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 …
Read moreIntroduction of the emergent system of the availability of medicinal products
At the end of August, the Government submitted to the Chamber of Deputies a draft of amendment to the Act No. 378/2007 Coll., on pharmaceuticals and and on amendments to certain related acts (Act on Pharmaceuticals), as amendedon and the Act No. 48/1997 Coll., on public health insurance and on amendments and supplements to certain …
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