Article 7

According to their particular qualifications, the role of the experts shall be: 1. to carry out such work as falls within their particular discipline (analysis, pharmacology and similar experimental sciences, clinical trials) and to describe objectively the results obtained in both quantitative and qualitative terms; 2. to describe their findings in accordance with Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicologial and clinical standards and protocols in respect of the testing of veterinary medicinal products (1), and in particular to state: (a) in the case of analysts, whether the product conforms with the stated composition, providing any reasons for the control testing methods which the manufacturer is to use; in the case of pharmacologists and appropriately qualified specialists: - the toxicity of the product and the pharmacological properties observed, whether, after administration of the veterinary medicinal product under normal conditions of use and observance of the recommended withdrawal period, foodstuffs obtained from the treated animals contain residues which might constitute a health hazard to the consumer; in the case of clinicians, whether they have found in animals treated with the product effects corresponding to the information furnished by the manufacturer pursuant to Article 5, whether the product is well tolerated, what dosage they recommend and what are the contra-indications and side-effects, if any; 3. to give reasons for the use of the references to published data referred to in point 10 (a) and (b) of the second paragraph of Article 5, according to the conditions laid down by Council Directive 81/852/EEC. The experts' detailed reports shall form part of the documentation which the applicant shall lodge with the competent authorities. CHAPTER III Examination of applications for authorization - Authorization - Renewal of authorization

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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.