21 Feb News from Croatia – Sunset Clause
Legal basis in HR
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) in HR. According to this Act, 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, or if an authorised medicinal product that had previously been placed on the market in the Republic of Croatia has not been on the market for three consecutive years, HALMED will revoke the marketing authorisation.
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 in the Republic of Croatia is considered the date of placing of the medicinal product on the market.
Marketing authorisation holders are obliged to confirm the date of the first placing of a medicinal product on the market to HALMED in writing about. In addition, MAHs must notify HALMED in writing about any temporary or permanent discontinuation of supply of the Croatian market for any medicinal product.
Starting dates for Sunset Clause
- For any MAs granted before 1 July 2013, the starting date is 1 July 2013.
- For new MAs 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.
What exceptions are allowed?
- 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 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 or
- in other exceptional circumstances, based on a written justification by the marketing authorisation holder.