Legislation of the Czech Republic

Acts and their implementing regulations governing the powers of SÚKL.     

Last update: 2013

 

Implementing regulations:

  • Decree No 229/2008 Coll., on the manufacture and distribution of pharmaceuticals, as amended;

  • Decree No 228/2008 Coll., on the marketing authorisation of medicinal products, as amended;

  • Decree No 106/2008 Coll., on good practice of vendors of selected pharmaceuticals and a professional training for vendors of selected pharmaceuticals  

  • Decree No 226/2008 Coll., on good clinical practice and detailed conditions of clinical trials on medicinal products, as amended; Decree on good clinical practice and detailed conditions of clinical trials on medicinal products.pdf Decree on good clinical practice and detailed conditions of clinical trials on medicinal products.pdf (229.29 KB)

  • Decree No 54/2008 Coll., on the method of prescribing medicinal products, particulars to appear on medical prescriptions, and rules governing the use of medical prescriptions, as amended;

  • Decree No 84/2008 Coll., on good pharmaceutical practice, detailed conditions of handling pharmaceuticals in pharmacies, healthcare facilities and other operators and facilities supplying medicinal products, as amended;

  • Decree No 85/2008 Coll., which lays down a list of active substances and excipients which may be used in the preparation of medicinal products, as amended;

  • Decree No 86/2008 Coll., on the principles of good laboratory practice in the area of pharmaceuticals, as amended;

  • Decree No 143/ 2008 Coll.,  on defining detailed conditions to assure the quality and safety of human blood and its components (Decree on Human Blood), as amended;

Act No 167/1998 Coll, on addictive substances and amending certain other acts, as amended

Implementing regulations:

  • Decree No 243/2009 Coll., on establishing a list of persons indicating their workplaces for their work is not required permit to treatment of addictive substances and preparations containing them
  • Decree No 125/2006 Coll., establishing printed forms pursuant to the Act No. 167/1998 Coll. of addictive substances and amending certain other Acts, as amended
  • Decree No 123/2006 Coll., on evidence and documentation of addictive substances and preparations, as amended
  • Decree No 83/2002 Coll., establishing list of legal and physical persons with their departments for the work where is not required permit to treatment of addictive substances, preparations containing them and precursors, as amended

Act No 160/1992 Coll., on health care in private health facilities, as amended

Implementing regulation:

  • Decree No 221/2010 Coll., on requirements for material and technical equipment of health facilities and amending Decree of the Ministry of Health No. 51/1995 Coll. amending and supplementing Decree of the Ministry of Health Czech Republic No. 49/1993 Coll. on the technical and material requirements for healthcare facilities, and amending the Decree of the Ministry of Health Czech Republic No. 434/1992 Coll. on health emergency service (Decree on the requirements for material and technical equipment of health facilities), as amended