CHAPTER IIIPROCEDURES FOR MARKETING AUTHORISATIONS

Section 1 Marketing authorisations valid throughout the Union (‘centralised marketing authorisations’)

Article 45Re-examination of the opinion of the Agency

1.

Where the applicant requests a re-examination of the opinion of the Agency in accordance with Article 44(4), that applicant shall forward to the Agency detailed grounds for such request within 60 days of receipt of the opinion.

2.

Within 90 days of receipt of the detailed grounds for the request, the Agency shall re-examine its opinion. The conclusions reached and the reasons for those conclusions shall be annexed to its opinion and shall form an integral part thereof.

3.

Within 15 days of the re-examination of its opinion, the Agency shall forward its opinion to the Commission and the applicant.

4.

Subsequent to the procedure set out in paragraph 3 of this Article, Article 44(6) to (10) shall apply.