Follow-up notice to marketing authorisation holders regarding the enforcement of the provision of the Article 54 of the Medicinal Products Act (Official Gazette, No. 76/13 and 90/14)
30.06.2016
As a follow-up to the earlier notice to marketing authorisation holders regarding the enforcement of the provision of the Article 54 of the Medicinal Products Act (Official Gazette, No. 76/13 and 90/14), the so-called "sunset clause", we inform marketing authorisation holders on the way of requesting exemption from the enforcement of this provision from the Agency of Medicinal Products and Medical Devices of Croatia (HALMED).
Namely, according to the Paragraph 3 of the Article 54 of the Medicinal Products Act, if a medicinal product has not been placed on the market for three years since the granting of a marketing authorisation or has not been on the market for three consecutive years, HALMED will exceptionally not revoke the marketing authorisation due to protection of public health, in case a marketing authorisation which is valid in the Republic of Croatia is a condition for granting and/or renewal of marketing authorisations in other countries as well as in other exceptional circumstances, based on a written justification by the marketing authorisation holder.
Marketing authorisation holders can submit their justifications for requesting exemption from revocation of marketing authorisation based on the provision prescribed in the Article 54 of the Medicinal Products Act to HALMED by delivering the completed and signed form printed on a memorandum personally to HALMED's Registry Office or by sending it per post to: Agency for Medicinal Products and Medical Devices of Croatia, Ksaverska cesta 4, 10 000 Zagreb, Republic of Croatia, separately for every pharmaceutical form and strength of a medicinal product for which exemption from revocation of marketing authorisation is requested.
HALMED will consider the justifiability of all explained requests and will deliver the decision on the acceptance of reasons to the marketing authorisation holder in writing.
Marketing authorisation holders can send all additional questions related to the enforcement of the sunset clause provision and the possibility of requesting exemption to HALMED via the e-mail address sunsetclause@halmed.hr.
