Veterinary medicinal products, medicated feed, veterinary care, monitoring activities, sanctions

Draft Act amending Act No 378/2007 on pharmaceuticals and amending certain related acts (the

Pharmaceuticals Act), as amended, and other related acts

The draft Act amending Act No 378/2007 on pharmaceuticals and amending certain related acts (the Pharmaceuticals Act), as amended, and other related acts adapts into the national legislation of the Czech Republic new directly applicable EU legislation in the field of veterinary medicinal products and medicated feed

– Regulation (EU) 2019/6, on veterinary medicinal preparations and repealing Directive 2001/82/EC and Regulation (EU) 2019/4, on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC.
The main areas covered by the draft are the use of medicinal products in the provision of veterinary care, the specific conditions for the use of antimicrobial medicinal products, the competence of the competent authorities in the regulation of veterinary medicinal products, the authorisation of veterinary medicinal products, in particular with regard to products not subject to Regulation (EU) 2019/6, the conditions for the manufacture, prescription and running of veterinary transfusion products and biological veterinary medicinal products based on autologous or allogeneic cells, the availability of veterinary medicinal products for rare therapeutic indications. conditions for placing into circulation for veterinary medicinal products not authorised in the Czech Republic ('cascade'), clinical trials, putting into circulation, manufacture, distribution, pharmacovigilance, monitoring activities and sanctions in the field of veterinary medicinal products. Conditions for manufacture and placing into circulation of medicated feed. Regulation of advertising of veterinary medicinal products and medicated feed.
The draft contains a reference to the following European legislation and international guidelines:
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC.
Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC.
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, as amended.
Commission Implementing Regulation (EU) 2019/1793 of 22 October 2019 on the temporary increase of official controls and emergency measures governing the entry into the Union of certain goods from certain third countries, implementing Regulations (EU) 2017/625 and (EC) No 178/2002 of the European Parliament and of the Council and repealing Commission Regulations (EC) No 669/2009, (EU) No 884/2014, (EU) 2015/175, (EU) 2017/186 and (EU) 2018/1660, as amended.
Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the field of animal health (‘Animal Health Law’), as amended.
Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors, as amended.
Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, as amended.
Regulation (EC) No 183/2005 of the European Parliament and of the Council.
Regulation (EC) No 999/2001 of the European Parliament and of the Council, as amended.
International Guidelines for Good Clinical Practice on Cooperation for Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).
The draft does not refer to national technical standards, technical documents or company standards, European standards and harmonised standards.
The regulations amended by the draft refer to the following national technical standards, European standards, harmonised standards or international standards containing a national annex or a national note:
Act No 378/2007 on pharmaceuticals and on amendments to certain related acts, as amended.
Convention for the elaboration of the European Pharmacopoeia and the Protocol to the Convention for the drawing up of a European Pharmacopoeia, promulgated under No 255/1998.
Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia (OJ L 229, 17. 8. 1998, p. 3), Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand (OJ L 229, 17. 8. 1998, p. 62), Agreement on mutual recognition between the European Community and Canada (OJ L 280, 16. 10. 1998, p.
3), Agreement on mutual recognition between the European Community and Japan (OJ L 284, 29. 10. 2001, p.
3), Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (OJ L 114, 30. 4. 2002, p. 369).
WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce) in the latest version published by the World Health Organisation.
Act No 40/1995 on the regulation of advertising and on amendments to Act No 468/1991 on the operation of radio and television broadcasting, as amended.
The legislation does not contain any of the above references.
Act No 91/1996 on animal feed, as amended.
The legislation does not contain any of the above references.
Act No 634/2004 on administrative fees, as amended.
Communication 69/2002 on the adoption of the Convention on the Grant of European Patents (European Patent Convention), Article 136(2). § 35b of Act No 527/1990 on inventions and improvement proposals, as amended.

Keywords: Veterinary medicinal products, medicated feed, veterinary care, monitoring activities, sanctions