Manufacture of veterinary medicinal products (VMP), manufacture of active substances (API) for VMP, good manufacturing practice (GMP)
Manufacturers of veterinary medicinal products (VMPs) and manufacturers of active substances (APIs) for VMPs are obliged to comply with the relevant provisions of Regulation (EU) 2019/6 on veterinary medicinal products, Act No 378/2007 on medicinal products, as amended, Decree No 229/2008 on the manufacture and distribution of medicinal products, as amended, and the guidelines of the European Commission and the European Medicines Agency (EMA). The ÚSKVBL publishes more detailed guidelines, procedures and information to facilitate the orientation of manufacturers in this issue and publishes in Czech the European Commission's Guidelines for GMP (Volume IV of The Rules Governing Medicinal Products in the European Union - guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use) - the original version is available on the European Commission's website EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines. In case of doubt about the substantive content in the Czech translation, it is necessary to follow the original English version).
The ÚSKVBL also issues more detailed guidelines for GMP, procedures and information intended for manufacturers of GMPs, including control laboratories, new applicants for authorisation to manufacture GMPs, applicants for the issue of API certificates for GMPs, and provides more detailed information on the procedures for approving individual activities, including the approval of changes and extensions to the authorisation of such activities, and further describes some legal regulations and requirements in the field of GMPs for veterinary medicinal products.
You will also find here the information on the production and prescription of veterinary autogenous vaccines (VAV), veterinary autochthonous convalescent sera (ARS) and autologous stem cells.
In 2025, the European Commission will newly issue GMP requirements for the production of VMP, GMP requirements for the production of API for VMP and GMP requirements for the production of veterinary autogenous vaccines (VAV) in the form of implementing acts for Regulation (EU) 2019/6 on veterinary medicinal products.
On 27 October 2025, the European Commission officially issued (by publication in the Official Journal of the European Union) new implementing regulations for Regulation (EU) 2019/6 on veterinary medicinal products:
COMMISSION IMPLEMENTING REGULATION(EU) 2025/2091 of 17 October 2025 laying down good manufacturing practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
(text of the implementing regulation in EN and CZ versions available here: http://data.europa.eu/eli/reg_impl/2025/2091/oj)
and
COMMISSION IMPLEMENTING REGULATION(EU) 2025/2154 of 17 October 2025 laying down good manufacturing practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
(text of the implementing regulation in EN and CZ versions available here: http://data.europa.eu/eli/reg_impl/2025/2154/oj)
The implementing regulations shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union and shall apply from 16 July 2026.
After 16 July 2026, these implementing regulations shall replace the existing GMP guidelines contained in EudraLex - Volume 4 - Good Manufacturing Practice guidelines, which shall no longer be applied to the area of GMP for VMP and GMP for API used as starting materials in VMP.
In this section, you will find overview tables showing the links between the individual texts of the implementing regulations and the existing GMP guidelines.
In 2026, the European Commission will also issue, in the form of a separate implementing regulation to Regulation (EU) 2019/6 on veterinary medicinal products, GMP requirements for the production of veterinary autogenous vaccines (VAV).
Main legislation:
Regulation (EU) 2019/6 on veterinary medicinal products
Act No 378/2007 on pharmaceuticals, as amended
Decree No. 229/2008 Coll., on the production and distribution of pharmaceuticals, as amended
(after 16.07.2026 Commission Implementing Regulation (EU) 2025/2091 laying down good manufacturing practice for veterinary medicinal products)
(after 16.07.2026 Commission Implementing Regulation (EU) 2025/2154, laying down good manufacturing practice for active substances used as starting materials in veterinary medicinal products)
Documents which are available only in Czech are at this link.