Article 6

1. In order to obtain the inclusion in Annex I, II, or III of a new pharmacologically active substance which is: intended for use in veterinary medicinal products for administration to food-producing animals, and intended to be placed on the market of one or more Member States which have not previously authorized the use of the substance concerned in food-producing animals, the person responsible for marketing shall submit an application to the Commission. The application shall contain the information and particulars referred to in Annex V and shall comply with the principles laid down in Directive 81/852/EEC. 2. After verifying within a period of 30 days that the application is submitted in correct form, the Commission shall forthwith submit the application for examination by the Committee for Veterinary Medicinal Products set up under Article 16 of Directive 81/851/EEC. The Committee shall appoint one of its members to act as rapporteur and to undertake an initial evaluation of the application. 3. Within 120 days of referral of the application to the Committee for Veterinary Medicinal Products, and having regard to the observations formulated by the members of the Committee, the Commission shall prepare 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 the Committee with additional information for examination. The rapporteur shall update the evaluation report to take account of the additional information received. 4. Within 90 days of receipt of the additional information referred to in paragraph 3, the Commission shall prepare a draft of the measures to be taken, which shall forthwith be communicated to the Member States and the person responsible for marketing. Within a further 60 days, the person responsible for marketing may, at his request, provide oral or written explanations for consideration by the Committee for Veterinary Medicinal Products. The Commission may, at the request of the applicant, extend this time limit. 5. Within a further 60 days the Commission shall submit the draft measures to the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products Sector, set up under Article 2b of Directive 81/852/EEC, 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.