Submission of notification on placing the medicinal product on the market
16.08.2013
According to the Art. 55 of the Medicines Act (Official Gazette, No 76/13), the marketing authorisation holder is required to notify the Agency in written form about the day of the first placing of the medicinal product on the market, without delay and no later than 15 days from the day of placing the product on the market for every pharmaceutical form and strength.
The day of placing the product on the market is the day of batch release in Croatia one of the presentations or dosage form and strength packaging. The information about the placing on the market is important to the Agency in order to comply with the Art. 54 of the Medicines Act, according to which the Agency revokes the marketing authorisation for the medicinal product not placed on the market in Croatia within three consecutive years after granting the marketing authorisation. This provision known as Sunset Cause applies in cases where the medicinal product that was previously on the market, has not been on the market for the three consecutive years. Therefore, marketing authorisation holders are requested to inform the Agency on the day of the last placing on the market in the current year for all their medicinal products via table that should be fulfilled and submitted electronically to stavljanjeupromet@halmed.hr, no later than 1st October 2013.
Notifications for medicinal products that are placed on the market after 1st July 2013 are submitted at the same address via fulfilled form.
*For the medicinal product having marketing authorisation, whose reference medicinal products has a valid market protection period according to the Art 29, § 2 and 3 of the Medicines Act or the adequate period of intellectual property rights protection, the beginning of the three years period from the Art. 54, § 1 of the Medicines Act begins with the expiration of the corresponding protection period.
