Article 29

In order to prepare its opinion, the Committee: shall verify that the particulars and documents submitted in accordance with Article 28 comply with the requirements of Directives 81/851/EEC and 81/852/EEC and examine whether the conditions specified in this Regulation for issuing a marketing authorization are satisfied; may ask for a State laboratory or a laboratory designated for this purpose to test the veterinary medicinal product, its starting materials and, if need be, its intermediate products or other constituent materials in order to ensure that the control methods employed by the manufacturer and described in the application documents are satisfactory; may request a State laboratory or laboratory designated for this purpose to verify, using samples provided by the applicant, that the analytical detection method proposed by the applicant in accordance with point 8 of the second paragraph of Article 5 of Directive 81/851/EEC is suitable for use in routine checks to reveal the presence of residue levels above the maximum residue level accepted by the Community in accordance with the provisions of Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (13); may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specific time limit. Where the Committee avails itself of this option, the time limit laid down in Article 28 shall be suspended until such time as the supplementary information requested has been provided. Likewise, this time limit shall be suspended for the time allowed to the applicant to prepare oral or written explanations.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.