Article 18

1. Where the supervisory authorities or the competent authorities of any other Member State are of the opinion that the manufacturer or importer from third countries is no longer fulfilling the obligations laid down in Chapter IV of Directive 75/319/EEC, they shall forthwith inform the Committee and the Commission, stating their reasons in detail and indicating the course of action proposed. The same shall apply where a Member State or the Commission considers that one of the measures envisaged in Chapter V or Va of Directive 75/319/EEC should be applied in respect of the medicinal product concerned or where the Committee for Proprietary Medicinal Products has delivered an opinion to that effect in accordance with Article 20. 2. The Commission shall in consultation with the Agency forthwith examine the reasons advanced by the Member State concerned. It shall request the opinion of the Committee within a time limit which it shall determine having regard to the urgency of the matter. Whenever practicable, the person responsible for placing the medicinal product on the market shall be invited to provide oral or written explanations. 3. The Commission shall prepare a draft of the Decision to be taken which shall be adopted in accordance with Article 10. However, where a Member State has invoked the provisions of paragraph 4, the time limit provided for in Article 73 shall be reduced to 15 calendar days. 4. Where urgent action is essential to protect human or animal health or the environment, a Member State may suspend the use on its territory of a medicinal product which has been authorized in accordance with this Regulation. It shall inform the Commission and the other Member States no later than the following working day of the reasons for its action. The Commission shall immediately consider the reasons given by the Member State in accordance with paragraph 2 and shall initiate the procedure provided for in paragraph 3. 5. A Member State which has adopted the suspensive measures referred to in paragraph 4 may maintain them in force until such time as a definitive decision has been reached in accordance with the procedure laid down in paragraph 3. 6. The Agency shall, upon request, inform any person concerned of the final decision. CHAPTER 3 Pharmacovigilance

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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.