17. Does this mean that SUKL will monitor which medicinal products are jeopardized by the sunset clause and will inform companies?
SUKL does not decide upon expiration of marketing authorisation. The marketing authorisation ceases to be valid directly by law. It is not SUKL which handles marketing authorisations of medicinal products, but the marketing authorisation holder. Monitoring of validity of marketing authorisation of individual medicinal products is primarily up to the marketing authorisation holder and it is also in their interest. SUKL has taken steps to ensure that holders are informed. However, the actual steps to maintain validity of marketing authorisation are up to holders.
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