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 and related implementing regulations (see below), Act No 378/2007 on medicinal products, as amended, Decree No 229/2008 on the manufacture and distribution of medicinal products, as amended.
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 replaced previous 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 previous 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). COMMISSION IMPLEMENTING REGULATION (EU) 2025/2091 laying down good manufacturing practice for veterinary medicinal products does not apply to the production of VAV.
On 17 April 2026, the European Commission officially issued (by publication in the Official Journal of the European Union) a new implementing regulation: COMMISSION IMPLEMENTING REGULATION (EU) 2026/857 of 16 April 2026 amending Implementing Regulation (EU) 2025/2091 as regards the retention of samples of veterinary medicinal products that are repackaged for the purpose of parallel trade
(text of the implementing regulation in EN and CZ versions available here: http://data.europa.eu/eli/reg_impl/2026/857/oj)
This is the first example of the procedure by which the European Commission will update the texts of the GMP VMP or GMP API implementing regulations in the future following changes in the GMP Guidelines texts. This was done based on a proposal to revise the text of Appendix 19 - Reference and retention samples by PIC/S and the EMA GMP/GDP Inspectors Working Group. It 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.
Main legislation:
Regulation (EU) 2019/6 on veterinary medicinal products
Commission Implementing Regulation (EU) 2025/2091 laying down good manufacturing practice for veterinary medicinal products
Commission Implementing Regulation (EU) 2025/2154, laying down good manufacturing practice for active substances used as starting materials in veterinary medicinal products
Commission Implementing Regulation (EU) 2026/857 amending Implementing Regulation (EU) 2025/2091 as regards the retention of samples of veterinary medicinal products that are repackaged for the purpose of parallel trade
Act No 378/2007 on pharmaceuticals, as amended
Decree No. 229/2008 Coll., on the production and distribution of pharmaceuticals, as amended
Documents which are available only in Czech are at this link.