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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
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[F1Without prejudice to stricter Community or national rules relating to dispensing veterinary medicinal products and serving to protect human and animal health, a veterinary prescription shall be required for dispensing to the public the following veterinary medicinal products:]
those products subject to official restrictions on supply or use, such as:
the restrictions resulting from the implementation of the relevant United Nations conventions on narcotic and psychotropic substances,
the restrictions on the use of veterinary medicinal products resulting from Community law;
[F2veterinary medicinal products for food-producing animals.
However, Member States may grant exemptions from this requirement according to criteria established by the Commission. The establishment of those criteria, being a measure designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).
Member States may continue to apply national provisions until either:
the date of application of the decision adopted in accordance with the first subparagraph; or
1 January 2007 , if no such decision has been adopted by 31 December 2006 ;]
those products in respect of which special precautions must be taken by the veterinarian in order to avoid any unnecessary risk to:
the target species,
the person administering the products to the animal,
[F3. . . . .]
the environment;
those products intended for treatments or pathological processes which require a precise prior diagnosis or the use of which may cause effects which impede or interfere with subsequent diagnostic or therapeutic measures;
[F1official formula, within the meaning of Article 3(2)(b), intended for food-producing animals.]
[F1Member States shall take all necessary measures to ensure that, in the case of medicinal products supplied only on prescription, the quantity prescribed and supplied shall be restricted to the minimum amount required for the treatment or therapy concerned.
In addition, a prescription shall be required for new veterinary medicinal products containing an active substance that has been authorised for use in a veterinary medicinal product for fewer than five years.]
Textual Amendments
F1 Substituted by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.
F2 Substituted by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Four.
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