Regulatory affairs

Our job at the Regulatory Affairs Department is to obtain and maintain marketing authorisations on Croatian territory for your human and veterinary medicinal products through national and common EU procedures. We also provide regulatory support for medical device distributors and manufacturers with our expertise and experience in regulatory assessments and national specifics. The scope of our business activities includes regulatory support of placing food supplements and food for particular nutritional uses on the Croatian market, as well. We are proud of our longstanding successful cooperation with Croatian competent authorities i.e. Agency for Medicinal Products and Medical Devices, Ministry of Health, Ministry of Agriculture and Croatian National Institute of Public Health.