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Article 9

1. Where a Member State, as a result of new information or a reassessment of existing information, considers that the urgent amendment of a provision contained in Annexes I to IV is necessary in order to protect human or animal health, and therefore requires swift action to be taken, that Member State may temporarily suspend the operation of the provision concerned in its own territory. In that case, it shall immediately notify the other Member States and the Commission of the measures, attaching a statement of the reasons therefor. 2. The Commission shall as soon as possible examine the grounds given by the Member State concerned and, after consulting the Member States within the Committee for Veterinary Medicinal Products, it shall then deliver its opinion forthwith and take appropriate measures; the person responsible for marketing may be requested to provide the Committee with oral or written explanations. The Commission shall immediately notify the Council and the Member States of any measures taken. Any Member State may refer the Commission's measures to the Council within 15 days of such notification. The Council, acting by a qualified majority, may take a different decision within 30 days of the date on which the matter was referred to it. 3. If the Commission considers that it is necessary to amend the provision of Annex I to IV concerned in order to resolve the difficulties referred to in paragraph 1 and to ensure the protection of human health, it shall initiate the procedure laid down in Article 10 with a view to adopting those amendments; the Member State which has taken measures under paragraph 1 may maintain them until the Council or the Commission has taken a decision in accordance with the abovementioned procedure.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-04 · Text as adopted (Official Journal); later amendments are not incorporated in this text.