S.L. 458.35 Art. 29Periodic safety update reports.

(1) Marketing authorisation holders shall submit to the Agency periodic safety update reports containing:

(a) summaries of data relevant to the benefits and risks of the medicinal product, including results of all studies with a consideration of their potential impact on the marketing authorisation;

(b) a scientific evaluation of the risk-benefit balance of the medicinal product;

(c) all data relating to the volume of sales of the medicinal product and any data in possession of the marketing authorisation holder relating to the volume of prescriptions, including an estimate of the population exposed to the medicinal product.

(2) The evaluation referred to in sub-regulation (1)(b) shall be based on all available data, including data from clinical trials in unauthorised indications and populations.

(3) The periodic safety update reports shall be submitted electronically.