Marketing authorisation for veterinary medicinal products: general conditions

1) OBJECTIVE

To pursue the approximation begun by Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products with a view to achieving completely free movement of veterinary medicinal products within the European Community.

2) COMMUNITY MEASURES

Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products.

Amended by the following measures:

Council Directive 90/676/EEC of 13 December 1990;

Council Directive 90/677/EEC of 13 December 1990;

Council Directive 92/74/EEC of 22 September 1992;

Council Directive 93/40/EEC of 14 June 1993.

This Directive was repealed by the Community code relating to veterinary medicinal products

3) CONTENTS

The following text contains a consolidation of existing Directives in the field of veterinary medicinal products.

The provisions of those Directives apply to:

• veterinary medicinal products offered for sale, inter alia, in the form of proprietary medicinal products, ready-made veterinary medicinal products or premixes for medicated feeding-stuffs;
• veterinary medicinal products used in order to produce active or passive immunity;
• immunological veterinary medicinal products;
• homeopathic veterinary medicinal products.

They do not apply to:

• medicated feeding-stuffs;
• veterinary medicinal products based on radioactive isotopes.

No veterinary medicinal product may be placed on the market of a Member State without prior authorisation from the competent authority of that Member State or without a marketing authorisation having been issued in accordance with Council Regulation (EEC) No 2309/93. Applications for authorisation must be accompanied by various documents and particulars, including the manufacturer's control methods (sterility tests, stability tests, etc.) and the results of physico-chemical, biological or microbiological, pharmacological and toxicological tests and clinical trials. Member States must make sure that this information is compiled by experts with the necessary technical or professional qualifications before it is submitted to the competent authorities.

Competent authorities will not authorise the marketing of a veterinary medicinal product intended to be administered to animals whose flesh or products are intended for human consumption unless the maximum residue limits for the active principle contained in the medicinal product have been set in accordance with Council Regulation (EEC) No 2377/90.

When the competent authority of a Member State issues a marketing authorisation, it will send a copy of the same to the European Medicines Agency. It will also draw up an evaluation report on the case dealing with the results of the analytical, pharmaco-toxicological and clinical tests carried out on the veterinary medicinal product in question. This report will be regularly updated.

Authorisations must, in principle, be granted within 210 days from the date of presentation.

If a Member State ascertains that an authorisation application made after 1 January 1995 is being actively examined by another Member State, it will await the result of this examination and the evaluation report. It will then recognise the decision of the other Member State within 90 days of receipt of the evaluation report unless it believes that authorisation of the medicinal product in question could pose a risk to human or animal health.

As of 1 January 1998, if a Member State is informed that another Member State has authorised the marketing of a veterinary medicinal product, it shall request from it the evaluation report and shall within 90 days either extend its recognition to or withhold it from the authorisation decision of the other Member State.

Marketing authorisation will be refused and veterinary medicinal products withdrawn if it becomes apparent that:

• the medicinal product is harmful under the conditions of use stated at the time of application;
• the medicinal product does not have any therapeutic effect or has insufficient effect on the species of animal for which the treatment was intended;
• the withdrawal period recommended by the applicant is inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer;
• the information requested is incomplete or missing.

Authorisation is valid for five years and renewable for five-year periods.

A Committee for Veterinary Medicinal Products has been set up in order to facilitate the adoption of a common position by the Member States with regard to marketing authorisations and to promote thereby the free movement of veterinary medicinal products.

The Committee acts:

• to make it easier to obtain product authorisation in other Member States when authorisation has already been obtained for the same product in one Member State;
• where a Member State considers that it is unable to grant a marketing authorisation;
• where one or more Member States have granted authorisation while one or more other Member States have refused it;
• to give its opinion before a Member State takes a decision to grant, suspend or revoke an authorisation.

Medicinal products may not be manufactured without authorisation, even if they are intended for export. Authorisation is also required for imports from non-member countries into a Member State.

The competent authority of the Member State concerned ensures, through repeated inspections, that the legal prescriptions regarding the medicinal products are being complied with.

The Directives lay down in detail the information which must be given on the packaging and leaflets of medicinal products.

Last updated: 13.03.2001