art_7__para

Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products · European Union

Member States shall take all appropriate measures to ensure that the procedure for granting an authorisation to place a proprietary medicinal product on the market is completed within 120 days of the date of submitting the application. In exceptional cases this time limit may be extended for a further ninety days. The applicant shall be notified of such extension before the expiry of the initial time limit.

National law under this provision

2 national measures recorded under this provision, in 1 form — sign in to view the analysis.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.