Article 31

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

All decisions taken pursuant to Articles 18, 28 and 29 and all negative decisions taken pursuant to Articles 5 (b) and 11 (3) shall state in detail the reasons on which they are based. Such decisions shall be notified to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force and of the time limit allowed for applying for such remedies.

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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.