Article 7

1. Paragraphs 2 to 6 shall apply in respect of pharmacologically active substances which are authorized for use in veterinary medicinal products on the date of entry into force of this Regulation. 2. After consulting the Committee on Veterinary Medicinal Products, the Commission shall publish a timetable for the consideration of these substances, including time limits for submission of the information referred to in Annex V. The persons responsible for marketing the veterinary medicinal products concerned shall ensure that all relevant information is submitted to the Commission in accordance with the requirements of Annex V and in conformity with the principles laid down in Directive 81/852/EEC before expiry of the relevant time limits. The competent authorities of the Member States shall bring any other relevant information to the attention of the Commission. 3. After verifying within 30 days that the information is submitted in correct form, the Commission shall forthwith submit the information for examination to the Committee for Veterinary Medicinal Products, which shall deliver its opinion within a renewable period of 120 days. That Committee shall appoint one of its members to act as rapporteur and to undertake an evaluation of the information. 4. Having regard to the observations formulated by the members of the Committee for Veterinary Medicinal Products, the Commission shall prepare, within a maximum period of 30 days, a draft of the measures to be taken. If the information submitted by the person responsible for marketing is insufficient to enable such a draft to be prepared, that person will be requested to provide additional information, within a specified period, for examination by the Committee. The rapporteur shall update the evaluation report to take account of the additional information received. 5. The draft of the measures to be taken shall be communicated forthwith by the Commission to the Member States and those persons responsible for marketing who have submitted information to the Commission before expiry of the time limit established in accordance with paragraph 2. These persons may, at their request, provide oral or written explanations to the Committee for Veterinary Medicinal Products. 6. The Commission shall forthwith submit the draft measures to the Committee for Adaptation to Technical Progress of the Directives on Veterinary Medicinal Products for the application of the procedure laid down in Article 8.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-04 · Text as adopted (Official Journal); later amendments are not incorporated in this text.