S.L. 458.35 Art. 33Authorisations granted before the 21st July 2012.

(1) Holders of marketing authorisations which were granted before the 21st July, 2012, and for which the frequency and dates of submission of the periodic safety update reports are not laid down as a condition to the marketing authorisation, shall submit the periodic safety update reports in accordance with sub-regulation (2) until another frequency or other dates of submission of the reports are laid down in the marketing authorisation or determined in accordance with regulations 35, 36 or 37.

(2) Periodic safety update reports shall be submitted to the Authority immediately upon request or in accordance with the following:

(a) where a medicinal product has not yet been placed on the market, at least every six months following authorisation and until the placing on the market;

(b) where a medicinal product has been placed on the market, at least every six months during the first two years following the initial placing on the market, once a year for the following two years and at three-yearly intervals thereafter.