Article 13e: Measures to close the procedures of Articles 13a to 13c

Location:
Chapter IIA
Source:
Eur-Lex

Where reference is made to this Article, the competent authority shall take the following measures:

(a) it shall inform the holder as to whether the variation is accepted or rejected;
(b) where the variation is rejected, it shall inform the holder of the grounds for the rejection;
(c) where necessary, it shall amend the decision granting the marketing authorisation in accordance with the accepted variation within the time limit laid down in paragraph 1 of Article 23.