S.L. 458.35 ст. 37Marketing authorisation holders may submit requests.

(1) Marketing authorisation holders shall be allowed to submit requests to the Agency’s Committee for Medicinal Products for Human Use or the coordination group, as appropriate, to determine the Community reference dates or to change the frequency of submission of periodic safety update reports on one of the following grounds:

(a) for reasons relating to public health;

(b) in order to avoid a duplication of the assessment;

(c) in order to achieve international harmonisation.

(2) Such requests shall be submitted in writing and shall be duly justified. The Committee for Medicinal Products for Human Use or the coordination group shall, following the consultation with the Agency’s Pharmacovigilance Risk Assessment Committee, either approve or deny such requests. Any change in the dates or the frequency of submission of periodic safety update reports shall be made public by the Agency. The marketing authorisation holders shall accordingly submit an application for a variation of the marketing authorisation.