EU rules on the authorisation, import and production of veterinary medicines

 

SUMMARY OF:

Directive 2001/82/EC — the EU’s code relating to veterinary medicinal products

WHAT IS THE AIM OF THE DIRECTIVE?

It sets out EU rules on the authorisation, manufacturing, supervision, sale, distribution and use of veterinary medicinal products*.

It will be repealed and replaced by Regulation (EU) 2019/6 as of 28 January 2022.

KEY POINTS

Repeal

Directive 2001/82/EC will be repealed and replaced by Regulation (EU) 2019/6 as of 28 January 2022.

FROM WHEN DOES THE DIRECTIVE APPLY?

It has applied since 18 December 2001.

BACKGROUND

For more information, see:

KEY TERMS

Veterinary medicinal product: Any substance or combination of substances to treat or prevent disease in animals.

MAIN DOCUMENT

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 (OJ L 311, 28.11.2001, pp. 1-66)

Successive amendments to Directive 2001/82/EC have been incorporated in the original text. This consolidated version is of documentary value only.

RELATED DOCUMENT

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 (OJ L 4, 7.1.2019, pp. 43-167)

last update 07.07.2016