Placing Medicinal Products on the Market
Only medicinal products authorised by the Agency for Medicinal Products and Medical Devices (HALMED) or European Commission and medicinal products authorised for parallel import or parallel distribution may be distributed in Croatia.
Notification of placing medicinal product on the market
Under Paragraph 1, Article 55 of the Medicinal Product Act (Official Gazette, No. 76/13), the marketing authorisation holder is obliged to notify HALMED in a written form about the date of first placing of medicinal product on the market, no later than within 15 days from the placing on the market for every pharmaceutical form and strength. The notification should be sent to HALMED by e-mail: stavljanjeupromet@halmed.hr by completing the Application form for placing on the market, where applicable. The date when one type or size of pharmaceutical form pack size or strength is released for distribution in the Republic of Croatia, or the batch release date is considered the date for placing the medicinal product on the market.
Important notice: Before placing the medicinal product from human blood or plasma and vaccines, the marketing authorisation holder is obliged to ensure the special quality control of every product batch.
HALMED is responsible for carrying out the special quality control of every batch from human blood or plasma and vaccines, except for batches manufactured in other EU Member States, or countries participating in the mutual recognition procedure (MRP) for granting marketing authorisation, for which the competent authorities have completed the official control authority batch release and granted the OCABR certificate. If the special quality control of products from human blood or plasma or vaccines , or starting material has been carried out by an official authority control laboratory elsewhere in the EU, EEA, or Switzerland, HALMED will accept the results of the special quality control for the Republic of Croatia and in this case carry out only an administrative check of the following submitted administrative-scientific data:
- the OCABR certificate
- the date of placing the product on the market in the Republic of Croatia with marketing information form (MIF). The form is accessible on the webpages of the European Directorate for the Quality of Medicines & Health Care (EDQM), or here.
HALMED carries out the administrative check of the administrative-scientific data within 7 days from the receipt of a dully completed application and in case of non-compliance informs the marketing authorisation/wholesaler.
The list of batches of medicinal products from human blood or plasma or vaccines undergone the administrative check of administrative-scientific data is available here.
