Commission Directive 2006/130/ECShow full title

Commission Directive 2006/130/EC

of 11 December 2006

implementing Directive 2001/82/EC of the European Parliament and of the Council as regards the establishment of criteria for exempting certain veterinary medicinal products for food-producing animals from the requirement of a veterinary prescription

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to 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(1), and in particular point (aa) of the first paragraph of Article 67 thereof,

Whereas:

(1) Pursuant to Article 67 of Directive 2001/82/EC, in the cases covered by the first and third paragraphs thereof, veterinary medicinal products may be dispensed to the public only against prescription. However, as certain substances, contained in veterinary medicinal products for food-producing animals, do not present a risk to human or animal health or to the environment, exemptions from that general requirement may be granted in accordance with point (aa) of the first paragraph of Article 67. Such exemptions are without prejudice to the application of any other provision of the first and third paragraphs of that Article.

(2) Consequently it is appropriate to establish criteria on the basis of which Member States may grant exemptions from the general rule, provided for in point (aa) of the first paragraph of Article 67 of Directive 2001/82/EC, requiring a prescription for dispensing to the public veterinary medicinal products for food producing animals.

(3) Where the veterinary medicinal products concerned are easy to administer and, even if administered incorrectly, do not present a risk either to the animal being treated or to the person administering the product, it should be possible for those products to be made available without the need for a veterinary prescription. On the other hand, it should not be possible to grant an exemption for products that feature an unfavourable pharmacovigilance profile or harm the environment.

(4) Inappropriate storage conditions may seriously affect the quality, safety and efficacy of veterinary medicinal products. Therefore, products whose quality, safety and efficacy can be guaranteed only when stored under special conditions should not be granted an exemption.

(5) Exempted veterinary medicinal products should furthermore contain only active substances that do not cause a risk for consumer safety as regards residues in food obtained from treated animals and they should have no potential for causing a risk to human or animal health by developing resistance to antimicrobials or anthelmintics, if used incorrectly.

(6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

HAS ADOPTED THIS DIRECTIVE:

(1)

OJ L 311, 28.11.2001, p. 1. Directive as amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58).