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

Changes concerning the submission of applications for renewal of the marketing authorisation pursuant to Section 34 paragraph 1 of the amended Act on Pharmaceuticals are described at  

http://www.sukl.eu/medicines/when-is-it-necessary-to-submit-an-application-for-renewal-of

 

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 at http://www.sukl.cz/seznam-lecivych-pripravku-u-nichz-skonci-platnost-rozhodnuti-4.