Article 17: Measures to close the procedures of Articles 14 to 16

Location:

Chapter III

Source:

1. Where reference is made to this Article, the Agency shall take the following measures:

(a) it shall inform the holder of the outcome of the assessment;

(b) where the variation is rejected, it shall inform the holder of the grounds for the rejection;

(c) where the outcome of the assessment is favourable and the variation affects the terms of the Commission decision granting the marketing authorisation, the Agency shall transmit to the Commission its opinion and the grounds for its opinion as well as the revised versions of the documents set out in Article 9(4) of Regulation (EC) No 726/2004.

2. In the cases identified under paragraph 1, point (c), the Commission, having regard to the opinion from the Agency and within the time limit provided for in Article 23(1a), shall amend where necessary the decision granting the marketing authorisation. The Union Register of Medicinal Products provided for in Article 13(1) of Regulation (EC) No 726/2004 shall be updated accordingly.