Article 11: Measures to close the procedures of Articles 8 to 10

Location:
Chapter II
Source:
Eur-Lex

1.   Where reference is made to this Article, the competent authority of the reference Member State shall take the following measures:

(a) it shall inform the holder and the other relevant authorities as to whether the variation is accepted or rejected;
(b) where the variation is rejected, it shall inform the holder and the other relevant authorities of the grounds for the rejection;
(c) it shall inform the holder and the other relevant authorities as to whether the variation requires any amendment to the decision granting the marketing authorisation.
2.   Where reference is made to this Article, each relevant authority shall, where necessary and within the time limit laid down in paragraph 1 of Article 23, amend the decision granting the marketing authorisation in accordance with the accepted variation.