01 Dec Entry into force of Sunset clause in Estonia
Update of § 76 of section 6(1) of the Medicinal Products Act, according to which the Agency of Medicines may revoke a marketing authorization if the medicinal product has not been available on the market for three consecutive years in Estonia, unless it is necessary to maintain the marketing authorization in the interests of public health.
Upon issuance of the Marketing Authorization, it is expected that medicinal product will be launched and marketed in Estonia. The purpose of this update is to motivate MAH’s to market their registrered medicinal products in order to improve the availability of medicines. The State Agency of Medicines will contact the marketing authorization holders whose medicine has not been sold in Estonia for the last 3 years.
For more information, please contact local consultant in Estonia.