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18. If it for instance occurs that the 3 year period is about to expire shortly, while the medicinal product was not introduced to the Czech market, but there are valid grounds why this did not happen, may an exemption for the MP be applied for?

Pursuant to Section 34 a (3) of the Act on Pharmaceuticals, SUKL may under exceptional circumstances and in view of public health protection or due to rights of third parties decide that the marketing authorisation of medicinal product shall not cease to be valid. Such decision shall be made in an administrative procedure which may be started upon its own initiative or based on a justified request of a marketing authorisation holder. The Act on Pharmaceuticals stipulates that the request be submitted 6 months prior to the day on which the 3 year period expires at the earliest and 3 moths at the latest. This means in practice that an exemption may thus be submitted to SUKL always from 1 July to 1 October of the particular year. If the marketing authorisation holder claims that there are grounds which comply with requirements set out by the Act on Pharmaceuticals, these grounds shall be listed and documented in the request. SUKL will issue a decision in a subsequent administrative procedure pursuant to the valid Administrative Code, e.g. before expiration of the statutory 3 year period. As soon as this decision becomes effective, SUKL will publish the information on whether the marketing authorisation ceased to be valid or not together with a rationale on its website.