Section 34, paragraph 3 of Act No 378/2007 Coll., on pharmaceuticals, states, inter alia, the following: “The marketing authorisation became invalid, if the medicinal product is not placed onto the market in the Czech Republic within three years of the date of coming legally into force of the marketing authorisation (note: see answer to Question no. 7)…. If an authorised medicinal product placed on the market in the Czech Republic is not present on the market in the Czech Republic in the course of three years (note: see answer to Question no. 8), the marketing authorisation for this medicinal product became invalid.” For the purposes of sunset clause, the legislation does not take into account those packages of medicinal products which have been exported to other countries.
Exemptions from sunset clause may be granted under exceptional circumstances and with a view to public health protection. Export to third countries may, under certain circumstances, comply with the requirements governing the granting of an exemption pursuant to the provisions of Section 34, paragraph 4 of the Act on Pharmaceuticals, whereas the following must be evidenced:
- Name of the country of import;
- Information evidencing that the medicinal product has significant impact upon public health in the country of import;
- Information sales volume;
- A written proof that the authority in the country of import requires a valid marketing authorisation from the Czech Republic.
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