Article 2

The duties of the experts according to their respective qualifications shall be: (a) to perform tasks falling within their respective disciplines (analysis, pharmacology and similar experimental sciences, clinical trials) and to describe objectively the results obtained (qualitatively and quantitatively); to describe their observations in accordance with Council Directive 75/318/EEC (1) of 20 May 1975, on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products, and to state, in particular: - in the case of the analyst, whether the product is consistent with the declared composition, giving any substantiation of the control methods employed by the manufacturer; in the case of the pharmacologist or the specialist with similar experimental competence, the toxicity of the product and the pharmacological properties observed; in the case of the clinician, whether he has been able to ascertain effects on persons treated with the product which correspond to the particulars given by the applicant in accordance with Article 4 of Directive 65/65/EEC, whether the patient tolerates the product well, the posology the clinician advises and any contra-indications and side-effects; where applicable, to state the grounds for using the published references mentioned in point 8 (a) and (b) of Article 4, second paragraph, of Directive 65/65/EEC under the conditions set out in Directive 75/318/EEC. Detailed reports by the experts shall form part of the particulars accompanying the application which the applicant submits to the competent authorities.

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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.