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Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products · European Union

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;

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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.