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)
13.06.2016
According to the provision of the Article 54 of the Medicinal Products Act (Official Gazette, No. 76/13 and 90/14), the so-called "sunset clause", 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, the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) will revoke the marketing authorisation for this medicinal product. Additionally, HALMED will revoke the marketing authorisation for 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.
For the purpose of the enforcement of this provision, the date when one pack type or pack size of a pharmaceutical form and strength of a medicinal product is released on the market for the Republic of Croatia is considered the date of placing of the medicinal product on the market.
In order for the provision of this article of the Medicinal Products Act to be enforced, in accordance with the Article 55 of the Act, marketing authorisation holders are obliged to notify HALMED in writing about the date of the first placing of a medicinal product on the market, as well as about the decision concerning temporary or permanent discontinuation of supply of the Croatian market with a particular medicinal product.
The starting date for the monitoring of the three-year period is 1 July 2013 for marketing authorisations granted before this date, whereas for new authorisations granted after 1 July 2013 the starting date of the three-year period is the date of the granting of a marketing authorisation. If the respective market protection period or the respective period of protection of intellectual property rights for its reference medicinal product are still ongoing, the three-year period for a medicinal product with a marketing authorisation begins with the day of expiry of the protection period.
In a case in which 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 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 will submit their justified requests for exemption from revocation of marketing authorisation due to the provision of the Art. 54 of the Medicinal Products Act, for every pharmaceutical form and strength, to HALMED by delivering the completed form, which will be published on HALMED's website until the end of June 2016, 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. HALMED will consider all the received requests and will also deliver the decision on the acceptance of reasons for exemption 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.
