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Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products and repealing Directive 2001/82/EC.

Type of law
Date of original text

This Regulation lays down rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of veterinary medicinal products. Its scope includes veterinary medicinal products prepared industrially or by a method involving an industrial process and intended to be placed on the market. Active substances used as starting materials in veterinary medicinal products are subject to these provisions too.
The Regulation is composed of the following Chapters: I) Subject matter, scope and definitions; II) Marketing authorizations General provisions and rules on applications; III) Procedures for marketing authorizations; IV) Post-marketing authorization measures; V) Homeopathic veterinary medicinal products; VI) Manufacturing, import and export; VII) Supply and use; VIII) Inspections and controls; IX) Restrictions and penalties; X) Regulatory network; XI) Common and procedural provisions; XII) Transitional and final provisions.
As a general rule, a veterinary medicinal product shall be placed on the market only when a competent authority or the Commission, as applicable, has granted a marketing authorization for that product in accordance with the procedure regulated under Chapters II and III. There will be centralised marketing authorizations that shall be valid throughout the European Union. On the other hand, authorizations shall also be required for manufacturing, importing and exporting veterinary medicinal products (see Chapter VI). Furthermore, the wholesale distribution of veterinary medicinal products shall be subject to the holding of a wholesale distribution authorization. Wholesale distribution authorisations shall be valid throughout the Union (see Chapter VII).
A European Union database on veterinary medicinal products shall be established, as set out under Chapter IV. The competent authorities, the Agency and the Commission shall have full access to the information in the product database. Moreover, marketing authorization holders shall have full access to the information in the product database as regards their authorizations.
Provisions on potential emergence of resistant bacteria of relevance for human and animal health are laid down.
Date of consolidation/reprint
An unofficial consolidated version of the present Regulation as amended last by Commission Delegated Regulation (EU) 2023/183 of 23 November 2022 is attached.
Serial Imprint
Official Journal of the European Union L 4, 7 January 2019, pp. 43-167.
Source language


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