1.6. 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, p. 1.

As regards Directive 2001/82/EC, the Commission should be empowered in particular to adapt certain provisions and annexes, and to lay down specific conditions of application. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2001/82/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. Accordingly, Directive 2001/82/EC is hereby amended as follows: Article 10(3) shall be replaced by the following: ‘3. By way of derogation from Article 11, the Commission shall establish a list of substances essential for the treatment of equidae and for which the withdrawal period shall be not less than six months according to the control mechanisms laid down in Decisions 93/623/EEC and 2000/68/EC. That 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).’; in Article 11(2), the third subparagraph shall be replaced by the following: ‘However, the Commission may modify those specific withdrawal periods. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).’; in Article 13(1), the fourth subparagraph shall be replaced by the following: ‘However, the 10-year period provided for in the second subparagraph shall be extended to 13 years in the case of veterinary medicinal products for fish or bees or other species designated by the Commission. That 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).’; in Article 17(1), the second subparagraph shall be replaced by the following: ‘If it appears justified in the light of new scientific evidence, the Commission may adapt points (b) and (c) of the first subparagraph. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).’; in Article 39(1), the third subparagraph shall be replaced by the following: ‘The Commission shall adopt those arrangements in the form of an implementing regulation. That 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).’; Article 50a(2) shall be replaced by the following: ‘2. The Commission shall adopt any amendments which may be necessary in order to adapt the provisions of paragraph 1 to take account of scientific and technical progress. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).’; in Article 51, the first paragraph shall be replaced by the following: ‘The principles and guidelines of good manufacturing practice for veterinary medicinal products referred to in Article 50(f) shall be adopted by the Commission in the form of a Directive addressed to the Member States. Those measures, 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).’; in Article 67, point (aa) shall be replaced by the following: ‘(aa) veterinary 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: (i) the date of application of the decision adopted in accordance with the first subparagraph; or (ii) 1 January 2007, if no such decision has been adopted by 31 December 2006;’; Article 68(3) shall be replaced by the following: ‘3. The Commission shall adopt any amendments to the list of substances referred to in paragraph 1. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).’; Article 75(6) shall be replaced by the following: ‘6. The Commission may amend paragraph 5 in the light of the experience gained from its operation. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).’; Article 79 shall be replaced by the following: ‘Article 79 The Commission shall adopt any amendments which may be necessary to update Articles 72 to 78 to take account of scientific and technical progress. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).’; Article 88 shall be replaced by the following: ‘Article 88 The Commission shall adopt any changes which are necessary in order to adapt Annex I to take account of technical progress. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).’; Article 89 shall be amended as follows: the following paragraph shall be inserted: ‘2a. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’; paragraph 4 shall be replaced by the following: ‘4. The rules of procedure of the Standing Committee shall be made public.’.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-21 · Text as adopted (Official Journal); later amendments are not incorporated in this text.