§ 56 (4) (i) of the Act No. 362/2011 Coll. on medicinal products and medical devices as amended:
The State Institute shall cancel the marketing authorisation of a medicinal product for human use, if medicinal product for human use is not placed on the market in the Slovak Republic within three years of marketing authorisation of the medicinal product for human use.
§ 56 (4) (j) of the Act No. 362/2011 Coll. on medicinal products and medical devices as amended:
The State Institute shall cancel the marketing authorisation of a medicinal product for human use, if medicinal product for human use placed on the market in the Slovak Republic was not on the Slovak market for three consecutive years
The State Institute for Drug Control (SIDC) has set up the “Sunset clause database” for this purpose.
Based on data from this database SIDC notifies the holders individually about the fact that administrative proceedings have been initiated in the matter of revoking the decision on the marketing authorization of the medicinal product at half-yearly intervals (March, September). In case of discrepancy in this database - missing information about the import or sale of your medicine, ask your distributor to fulfill his obligations under the law (§18 (1) (i) and (h)).
The SIDC accepts global marketing authorisation which means the marketing authorisation will remain valid, if at least one pack-size of any strength/pharmaceutical form of the medicinal product is placed on the market in Slovak Republic. It applies to medicinal products with the same name.
https://ec.europa.eu/health/system/files/2019-07/vol2a_chap1_en_0.pdf
Contact person: Mgr. Andrea Krajčí, MPH (andrea.krajci@sukl.sk)
Request for a sunset clause exemption ref.: §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 from §56 (4) (i) and (j). Such exemptions must be duly justified.“
Request for a sunset clause exemption should be sent to the SIDC (Štátny ústav pre kontrolu liečiv, Kvetná 11, 825 08 Bratislava 26) by official letter (there is no special national form) in Slovak language and should contain also the following information:
- Justification for the need to have the medicinal product available on the market despite the fact that the medicinal product has not been placed on the market for three consecutive years
- Current therapies / options in the indication
- Estimated number of patients who the medicinal product is intended for
Request for the sunset clause exemption could be submitted anytime during valid marketing authorisation - submission one month before expiration of the marketing authorisation is recommended.
