3.

In the event of an opinion in favour of granting the relevant authorization to place the medicinal product concerned on the market, the following documents shall be annexed to the opinion: a draft summary of the product characteristics, as referred to in Article 4a of Directive 65/65/EEC; details of any conditions or restrictions which should be imposed on the supply or use of the medicinal product concerned, including the conditions under which the medicinal product may be made available to patients, having regard to the criteria laid down in Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use (12), without prejudice to the provisions in Article 3 (4) of that Directive; the draft text of the labelling and package leaflet proposed by the applicant, presented in accordance with Directive 92/27/EEC, without prejudice to the provisions of Article 7 (2) of that Directive; the assessment report.

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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.