Sunset Clause Application to Generic Medicinal Products

Notification of marketing authorisation holders regarding the calculation of the 3-year period for placement on the market of a generic medicinal product only as of 1 January of the year following the expiry of the reference medicinal product market protection and the necessity of notification to SÚKL of what medicinal products it applies to.  

The provision of Section 34a, paragraph 1 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended (hereinafter referred to as the “Act on Pharmaceuticals”) stipulates that marketing authorisation expires if, within the timeline of 3 years of its coming into force, the medicinal product is not placed on the market in the Czech Republic; in respect of generic products, this timeline begins to run only on the day when the period for which it must not be placed on the market pursuant to Section 27, paragraph 1 expires. The provision of Section 27, paragraph 1 of the Act on Pharmaceuticals then stipulates that a generic product must not be placed on the market before the expiry of 10 years of the first marketing authorisation of the reference product in any of the Member States or in the EU.

The aforementioned implies that the timeline of 3 years for the placement on the market of a generic medicinal product commences on 1 January of the year following the expiry of the reference product market protection, i.e. only on 1 January of the year following the expiry of 10 years of the first marketing authorisation of the reference product of the concerned marketing authorisation holder in any Member State or in the EU.

SÚKL cannot reflect this shift in the 3-year period for the placement on the market of a generic product when compiling the list of medicinal products jeopardised by the sunset clause application, and it is therefore fully up to the marketing authorisation holder to notify SÚKL of what medicinal products (with reference to the specific reference product) this clause is to be applied to, and do so using e-mail address sunset@sukl_cz. Following verification of the information provided, SÚKL shall subsequently not place this generic product on the list of medicinal products expired through the application of the sunset clause.

A list of medicinal products jeopardised by the application of the sunset clause is available always as of 1 June and 1 October of the given year at: http://www.sukl.cz/leciva/prehled-lecivych-pripravku-k-sunset-clause.

This shift in the 3-year period for the placement on the market of a generic medicinal product does not constitute a reason for granting of an exemption referred to under Section 34a, paragraph 3 of the Act on Pharmaceuticals, but constitutes a reason for “postponement” of the sunset clause application.

Queries for lists of medicinal products expired due to or jeopardised by the sunset clause and notifications that the 3-year period for the placement on the market of the generic product begins to run from 1 January of the year following the expiry of the reference product market protection (i.e. on 1 January of the year following the expiry of 10 years of the first marketing authorisation of the reference product in any Member State or in the EU) are to be sent to: sunset@sukl_cz.

Marketing Authorisation Branch

3. 7. 2018