medicinal products for human use

Act amending Act No 167/1998 Coll., on addictive substances and on amendments to certain other acts, as amended, Act No 378/2007 Coll., on pharmaceuticals and on amendments to certain related acts (Pharmaceuticals Act), as amended, and Act No 634/2004 Coll., on administrative fees, as amended

The proposed amendment to Act No 167/1998 Coll., on addictive substances and on amendments to certain other acts, as amended, and Act No 378/2007 Coll., on pharmaceuticals and on amendments to certain related acts (Pharmaceuticals Act):

- adapts these acts to the conditions for implementation of the second phase of introducing electronic prescriptions.
In essence, it concerns the introduction of new electronic prescription functionalities on the basis of Act No 378/2007 Coll., on pharmaceuticals and on amendments to certain related acts (Pharmaceuticals Act), as amended, as a result of which electronic prescriptions should be used, as a matter of priority, for prescribing medicinal products containing addictive substances included in Annex 1 or Annex 5 of Government Regulation No 463/2013 Coll., on the schedules of addictive substances, as amended.
- ensures better availability of the active substance referred to as ‘cannabis for medical use’ produced in the territory of the Czech Republic.
The system for granting licences for the cultivation of cannabis plants for medical use will be modified, thanks to which the number of growers of cannabis plants for medical use should increase, thereby improving the availability of cannabis for medical use to Czech patients and, at the same time, its affordability due to a reduction in the price of cannabis for medical use in the context of competition.
The amendment should enable businesses to cultivate cannabis plants for medical use under the conditions laid down by law in order to produce the substance referred to as ‘cannabis for medical use’, which they can then distribute within the Czech Republic or export.

Keywords: medicinal products containing addictive substances, cannabis for medical use, addictive substances, electronic prescription