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Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
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1.On receipt and after acknowledgement of the notification in accordance with Article 13(2), the competent authority shall examine it for compliance with this Directive.
2.Within 90 days after receipt of the notification the competent authority shall:
prepare an assessment report and send it to the notifier. A subsequent withdrawal by the notifier shall be without prejudice to any further submission of the notification to another competent authority;
in the case referred to in paragraph 3(a), send its report, together with the information referred to in paragraph 4 and any other information on which it has based its report, to the Commission which shall, within 30 days of its receipt, forward it to the competent authorities of the other Member States.
In the case referred to paragraph 3(b), the competent authority shall send its report, together with the information referred to in paragraph 4 and any other information on which it has based its report, to the Commission no earlier than 15 days after sending the assessment report to the notifier and no later than 105 days after receipt of the notification. The Commission shall, within 30 days of its receipt, forward the report to the competent authorities of the other Member States.
3.The assessment report shall indicate whether:
(a)the GMO(s) in question should be placed on the market and under which conditions; or
(b)the GMO(s) in question should not be placed on the market.
The assessment reports shall be established in accordance with the guidelines laid down in Annex VI.
4.For the purpose of calculating the 90 day period referred to in paragraph 2, any periods of time during which the competent authority is awaiting further information which it may have requested from the notifier shall not be taken into account. The competent authority shall state the reasons in any request for further information.
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