New subsection Sunset Clause launched within the section Distribution, Manufacturing and Inspection
Within the section Distribution, Manufacturing and Inspection of the website of the Agency for Medicinal Products and Medical Devices of Croatia (HALMED), in its segment Distribution, a new subsection titled Sunset Clause has been opened.
We remind that the sunset clause is applied under the provision of the Article 54 of the Medicinal Products Act (Official Gazette, No. 76/13 and 90/14), according to which, if a medicinal product has not been placed on the market in the Republic of Croatia for three years since the date of the granting of a marketing authorisation, HALMED will revoke its marketing authorisation. HALMED will also revoke the marketing authorisation of an authorised medicinal product that had previously been placed on the market in the Republic of Croatia but has not been on the market for three consecutive years.
The new subsection contains detailed information regarding the enforcement of sunset clause as well as regarding the possibility to request exemption from its enforcement.