VII.C.2. Standard submission schedule of PSURs

Marketing authorisation holders for products authorised before 02 July 2012 (centrally authorised products) and 21 July 2012 (nationally authorised products) and for which the frequency and dates of submission of PSURs are not laid down as a condition to the marketing authorisation or determined otherwise in the list of Union reference dates, shall submit PSURs according to the following submission schedule [REG 28(2), DIR Art 107c(2)].

• at 6 months intervals once the product is authorised, even if it is not marketed;
• once a product is marketed, 6 monthly PSUR submission should be continued following initial placing on the market in the EU for 2 years, then once a year for the following 2 years and thereafter at 3-yearly intervals.