Article 20

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

1. The Member States shall take all appropriate measures to ensure that the time taken for the procedure for granting the authorization referred to in Article 16 does not exceed 90 days from the day on which the competent authority receives the application. 2. If the holder of the authorization requests a change in any of the particulars referred to in Article 17 (a) and (b), the time taken for the procedure relating to this request shall not exceed 30 days. In exceptional cases this period of time may be extended to 90 days. 3. Member States may require from the applicant further information concerning the particulars supplied pursuant to Article 17 and concerning the qualified person referred to in Article 21 ; where the competent authority concerned exercises this right, application of the time limits referred to in paragraphs 1 and 2 shall be suspended until the additional data required have been supplied.

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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.