(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,

(a)

the administration of veterinary medicinal products is restricted to formulations requiring no particular knowledge or skill in using the products;

(b)

the veterinary medicinal product does not present a direct or indirect risk, even if administered incorrectly, to the animal or animals treated, to the person administering the product or to the environment;

(c)

the summary of product characteristics of the veterinary medicinal product does not contain any warnings of potential serious side effects deriving from its correct use;

(d)

neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent serious adverse reaction reporting;

(e)

the summary of product characteristics does not refer to contraindications related to other veterinary medicinal products commonly used without prescription;

(f)

the veterinary medicinal product is not subject to special storage conditions;

(g)

there is no risk for consumer safety as regards residues in food obtained from treated animals even where the veterinary medicinal products are used incorrectly;

(h)

there is no risk to human or animal health as regards the development of resistance to antimicrobials or anthelmintic substances even where the veterinary medicinal products containing those substances are used incorrectly.