The decision as to whether an exemption from sunset clause should be requested or not depends on the MA holder. If the MA holder is interested in not having the marketing authorisation of the medicinal product became invalid, they may apply for the exemption. Pursuant to the provisions of Section 113, paragraph 5 of the Act on Pharmaceuticals, in the case of medicinal products authorised prior to the coming into force of the Act on Pharmaceuticals the 3-year period referred to in Section 34, paragraph 3 is calculated from the date of coming into force of the Act on Pharmaceuticals.
26. The medicinal product has been placed onto the market before the date of coming into force of the Act. Currently, this product is present on the market in the quantity of 9.5 thous. DDDs and consumption will not be increased by the end of the year.
Is it necessary to apply for an exemption in this case?
cz