Change concerning the submitting of applications for renewal of marketing authorisation

The State Institute for Drug Control (SÚKL) hereby informs of a change concerning the submitting of applications for renewal of marketing authorisation introduced by the amended Act on Pharmaceuticals.  

Where the decision on marketing authorisation of a medicinal product ceases to be valid within 9 months following the effective date of the amended Act No. 378/2007 Coll. (Act on Pharmaceuticals), the application for renewal of marketing authorisation can be submitted within the time limit stipulated in Section 34 paragraph 1 of the Act on Pharmaceuticals as effective until the effective date of the amendment to this Act. This means that for medicinal products whose marketing authorisation expires by 2 January 2014 inclusive, the application for marketing authorisation renewal may be submitted according to the existing rules. The State Institute for Drug Control has published a list of medicinal products to which the current rules for lodging of applications for renewal apply.

For medicinal products whose marketing authorisation expires on 3 January 2014 or later, the application for renewal must be submitted no later than 9 months prior to the expiration of marketing authorisation, i.e. for medicinal products whose marketing authorisation expires on 3 January 2014 the application for renewal must be submitted by 3 April 2013. The Institute therefore publishes a list of medicinal products whose marketing authorisation expires in the period from 3 January 2014 to 31 March 2014 and for which the application for renewal must be submitted 9 months prior to the expiration of the marketing authorisation. The Institute shall suspend any application for renewal of the marketing authorisation of a product whose marketing authorisation expires on 3 January 2014 that has been filed later than 9 months before this date.

The Institute will not publish information on further marketing authorisations that are about to expire.

Marketing Authorisation Branch
21 March 2013