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Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use article 17 CELEX: 02001L0083-20250101 1. Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 210 days after the submission of a valid application.
Applications for marketing authorisations in two or more Member States in respect of the same medicinal product shall be submitted in accordance with Articles 28 ◄ to 39. 2. Where a Member State notes that another marketing authorisation application for the same medicinal product is being examined in another Member State, the Member State concerned shall decline to assess the application and shall advise the applicant that Articles 28 ◄ to 39 apply. |