§ 56 (4) i) of the Act No. 362/2011 Coll. on medicinal products and medical devices as amended:
„The marketing authorisation shall be withdrawn by the State Institute for Drug Control if any authorisation which within three years of its granting is not followed by the actual placing on the market of the authorised product in Slovak Republic“
§ 56 (4) j) of the Act No. 362/2011 Coll. on medicinal products and medical devices as amended:
„The marketing authorisation shall be withdrawn by the State Institute for Drug Control when an authorised product previously placed on the market in Slovak Republic is no longer actually present on the market for a period of three consecutive years.“
The State Institute for Drug Control (SIDC) has set up for this purpose the “Sunset clause database”.
The SIDC accepts global marketing authorisation which means the marketing authorisation will remain valid at least one pack-size of any strength/pharmaceutical form of the medicinal product is placed on the market in Slovak Republic.
Request a sunset clause exemption
§ 56 (5) of the Act No. 362/2011 Coll. on medicinal products and medical devices as amended:
„The State Institute for Drug Control may, in exceptional circumstances and on public health grounds grant exemptions. Such exemptions must be duly justified.“
Request a sunset clause exemption should be send to the SIDC (Štátny ústav pre kontrolu liečiv, Kvetná 11, 825 08 Bratislava 26) by official letter (there is no special national form) and should contain also the following information:
- Reasonable needs of medicinal product availability in the market despite the fact that the medicinal product is not on the market three years
- Current therapies / options in the indication
- Estimated number of patients to whom the medicinal product is intended
Request for sunset clause exemption could be submitted anytime during valid marketing authorisation - submission one month before expiration of the marketing authorisation is recommended.
