Activities
The Agency's remit in the field of medicinal products and medical devices is regulated under the Medicinal Products Act (Official Gazette No. 76/13, 90/14).
Under Article 212 of the above mentioned Act, the Agency engages in the following activities:
- granting of marketing authorisations for medicinal products and homeopathic medicinal products
- carrying out registration procedures for traditional herbal medicinal products and homeopathic medicinal products
- granting of authorisations for parallel imports of medicinal products
- making expert assessments of quality, efficacy and safety of medicinal products
- performing laboratory analyses of medical devices
- performing tasks of the official laboratory for quality control for the Republic of Croatia
- performing quality control of medicinal products and homeopathic medicinal products, and issue certificates of quality control
- analysing and assessing adverse reactions and safety of subjects in clinical trials
- preparing the Croatian Pharmacopoeia
- issuing the Croatian Pharmacopoeia and other expert publications from its scope of work
- performing pharmacovigilance tasks
- granting manufacturing authorisations to manufacturers and importers of medicinal products and investigational medicinal products
- keeping the register of manufacturers, importers and wholesale distributors of active substances and excipients
- granting of authorisations for wholesale distribution of medicinal products
- granting of authorisations for retail sale of medicinal products in specialized retail sale outlets
- granting of authorisations for brokering of medicinal products
- giving approval for entry and importation of medicinal products
- giving approval for emergency entry and importation of medicinal products
- monitoring adverse reactions and defects of medicinal products
- initiating procedures for the suspension marketing medicinal products and make product recalls
- monitoring the supply of medicinal products
- monitoring the consumption of medicinal products and promote their rational use
- proposing measures to the Minister to supervise the consumption of medicinal products
- engaging in waste management activities (for its own needs)
- ensuring education and providing information on medicinal products
- providing expert advice from its scope of activities
- providing expert guidelines from its scope of activities
- proposing harmonisation of regulations on medicinal products with those of the European Union as well as with the regulations and guidelines of international institutions
- establishing international cooperation in the field of medicinal products
- carrying out inspection of the production of medicinal products, investigational medicinal products, active substances or excipients and the inspection of pharmacovigilance
- keeping the register of manufacturers of medical devices, the register of medical devices and the register of the wholesale distributors of medical devices
- analysing and evaluating adverse events in clinical trials of medical devices
- granting of authorisation for the retail sale of medical devices in specialized retail sale outlets -keeping the register of medical devices marketed in the Republic of Croatia
- operating a vigilance system for medical devices, and monitor safety of medical devices
- carrying out the procedure for emergency recall of medical devices
- carrying out the procedure for classification of medical devices
- issuing certificates of free sale of medical devices
- ensuring education and provide information about medical devices
- establishing international cooperation in the field of medical devices
- determines the maximum permitted wholesale price of a medicinal product and exceptionally higher than the maximum permitted wholesale price, carries out the annual calculation of the price of a medicinal product
- proposing harmonisation of regulations on medical devices with those of the European Union as well as with the regulations and guidelines of international institutions
- performing other tasks in the field of medicinal products in line with this Act and the ensuing regulations and in the field of medical devices in accordance with the Medical Devices Act and the ensuing regulations.
