S.L. 458.35 Art. 35Harmonised frequency for submission of reports.

(1) Where medicinal products that are subject to different marketing authorisations contain the same active substance or the same combination of active substances, the frequency and dates of submission of the periodic safety update reports resulting from the application of regulations 32 and 33 may be amended and harmonised to enable a single assessment to be made in the context of a periodic safety update report work-sharing procedure and to set a Community reference date from which the submission dates are calculated.

(2) This harmonised frequency for the submission of the reports and the Community reference date may be determined, after consultation of the Agency’s Pharmacovigilance Risk Assessment Committee, by one of the following:

(a) the Committee for Medicinal Products for Human Use, where at least one of the marketing authorisations for the medicinal products containing the active substance concerned has been granted in accordance with the centralised procedure provided for in Chapter 1 of