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CHAPTER III U.K. PROCEDURES FOR MARKETING AUTHORISATIONS

Section 3 U.K. Marketing authorisations valid in several Member States (‘decentralised marketing authorisations’)

Article 50U.K.Request by the applicant for re-examination of the assessment report

1.Within 15 days of receipt of the assessment report referred to in Article 49(5), the applicant may provide written notice to the competent authority in the reference Member State requesting a re-examination of the assessment report. In that case, the applicant shall forward to the competent authority in the reference Member State detailed grounds for such a request within 60 days of receipt of that assessment report. The competent authority in the reference Member State shall without delay forward that request and the detailed grounds to the coordination group.

2.Within 60 days of receipt of the detailed grounds for the request for re-examination of the assessment report, the coordination group shall re-examine the assessment report. The conclusions reached by the coordination group and the reasons for those conclusions shall be annexed to the assessment report and shall form an integral part thereof.

3.Within 15 days of the re-examination of the assessment report, the competent authority in the reference Member State shall forward the assessment report to the applicant.

4.Subsequent to the procedure set out in paragraph 3 of this Article, Article 49(7), (8), (10) and (11) shall apply.