When is it necessary to submit an application for renewal of the marketing authorisation of a medicinal product?

According to Section 34(1) of the Medicinal Products Act, the extension must be submitted at least 9 months before the expiry of the marketing authorisation.

The list of medicinal products whose marketing authorisation expires by 2 January 2014 (which are subject to the existing rules for submission of applications for marketing authorisation renewal), and the list of medicinal products whose marketing authorisation will cease to be valid in the period from  3 January 2014 to 31 March 2014 (first products for which the period for submission of the application for renewal is 9 months before the expiration of the marketing authorisation), is available here.