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It will be repealed and replaced by Regulation (EU) 2019/6 as of 28 January 2022.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

National authorities must do the following:
- Authorise veterinary medicines before they can be sold and used.
- Establish a simplified registration procedure for homeopathic veterinary medicines.
- Ensure manufacturers and distributors of veterinary medicines within their jurisdiction have the necessary authorisation. The former must also have the services of a suitably qualified expert.
- Take appropriate measures to encourage the reporting of any adverse reactions to veterinary medicines.
- Carry out regular inspections and tests to ensure manufacturers comply with the legislation.
- Issue a certificate of good manufacturing practice if inspectors are satisfied standards are being respected. This is lodged in an EU database and must be done within 90 days.
- Suspend, revoke or withdraw the marketing authorisation of a product considered dangerous or of no therapeutic benefit.
National authorities may, if there is a serious outbreak of disease, allow the use of products that have not received their authorisation. They must first inform the European Commission.
Market authorisation:
- is only granted to an applicant based in the EU;
- is initially valid for 5 years;
- may be renewed — either for a further 5 years or for an unlimited period of time.
The procedure for taking an authorisation decision must be completed within 210 days of the marketing authorisation holder’s request being received.
The applicant must provide all the administrative information and scientific documentation to prove the product’s quality, safety and efficacy.
The marketing authorisation holder must take account of any scientific and technical progress made after receiving an authorisation and make the necessary changes in their manufacturing and control systems.
A coordination group examines the application if it is lodged in 2 or more EU countries.
Packages of veterinary medicines must contain detailed information, such as the manufacturer’s name and address, the strength of the product and its expiry date.
Imports and exports of veterinary medicines also require the necessary authorisations.
The legislation does not apply to certain items such as medicinal products used in research and development trials or prepared by a pharmacist for one or a small group of animals.
National authorities may exempt medicinal products from the need for marketing authorisation for small pets, such as fish, birds, homing pigeons, terrarium animals (like lizards and crickets), small rodents, ferrets and rabbits.

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:

Veterinary Medicines and Medicated Feed (European Commission).

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.