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Regulation (EU) No 536/2014 of the European Parliament and of the CouncilShow full title

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance)

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Article 17Validation of an application for the authorisation of a substantial modification of an aspect covered by Part I of the assessment report

1.The reporting Member State for the authorisation of a substantial modification shall be the reporting Member State for the initial authorisation procedure.

Member States concerned may communicate to the reporting Member State any considerations relevant to the validation of the application of a substantial modification within five days from the submission of the application dossier.

2.Within six days from the submission of the application dossier, the reporting Member State shall validate the application taking into account considerations expressed by the other Member States concerned and notify the sponsor through the EU portal as to whether:

(a)the substantial modification concerns an aspect covered by Part I of the assessment report; and

(b)the application dossier is complete in accordance with Annex II.

3.Where the reporting Member State has not notified the sponsor within the period referred to in paragraph 2, the substantial modification applied for shall be deemed to concern an aspect covered by Part I of the assessment report and the application dossier shall be deemed to be complete.

4.Where the reporting Member State, taking into account considerations expressed by the other Member States concerned, finds that the application does not concern an aspect covered by Part I of the assessment report or that the application dossier is not complete, it shall inform the sponsor thereof through the EU portal and shall set a maximum of 10 days for the sponsor to comment on the application or to complete the application dossier through the EU portal.

Within five days from receipt of the comments or the completed application dossier, the reporting Member State shall notify the sponsor as to whether or not the application complies with the requirements set out in points (a) and (b) of paragraph 2.

Where the reporting Member State has not notified the sponsor within the period referred to in the second subparagraph, the substantial modification applied for shall be deemed to concern an aspect covered by Part I of the assessment report and the application dossier shall be deemed to be complete.

Where the sponsor has not provided comments or completed the application dossier within the period referred to in the first subparagraph, the application shall be deemed to have lapsed in all Member States concerned.

5.For the purposes of Articles 18, 19 and 22, the date on which the sponsor is notified in accordance with paragraph 2 or 4 shall be the validation date of the application. Where the sponsor is not notified, the validation date shall be the last day of the respective periods referred to in paragraphs 2 and 4.

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