art_40__para
All decisions taken pursuant to Articles 11, 36, 37 and 38, all negative decisions taken pursuant to Article 10 point 2 and Article 19 (3) of this Directive and all decisions to withhold authorization to manufacture or to import from third countries or to suspend or withdraw manufacturing authorization 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 current legislation and the time allowed for seeking such remedies. Marketing authorizations and revocations of such authorizations shall be published by each Member State in its official gazette.
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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.