S.L. 458.35 Art. 31When reports are to be submitted.

(1) By way of derogation from regulation 29, the holders of marketing authorisations for medicinal products referred to in Directive 2001/83/EC, Article 10(1), or Directive 2001/83/EC, Article 10a, and the holders of registrations for medicinal products referred to in Directive 2001/83/EC, Article 14, or Directive 2001/ 83/EC, Article 16a, shall submit periodic safety update reports for such medicinal products in the following cases:

(a) where such obligation has been laid down as a condition in the marketing authorisation; or

(b) when requested by a competent authority on the basis of concerns relating to pharmacovigilance data or due to the lack of periodic safety update reports relating to an active substance after the marketing authorisation has been granted.

(2) The assessment reports of the requested periodic safety update reports shall be communicated to the Agency’s Pharmacovigilance Risk Assessment Committee, which shall consider whether there is a need for a single assessment report for all marketing authorisations for medicinal products containing the same active substance and inform the coordination group or the Committee for Medicinal Products for Human Use accordingly, in order to apply the procedures laid down in Article 107c(4) and Article 107e of Directive 2001/83/EC.