REGISTRATION OF MEDICINES AND MEDICAL DEVICES

When you decide to sell your healthcare products to Serbian market, one of essential steps is Registration of drugs and medical devices at Medicines and Medical Devices Agency of Serbia. We can help you do this efficiently and build a foundation for further business development and enabling smooth further activities. Our regulatory affairs department is responsible for both obtaining and maintaining marketing authorisations. We are striving to provide high quality services, to meet requirements of both our partners and relevant local legislation.

Activities we perform in this field are:

Communication with producer to prepare registration package alligned with Law on Medicines and Medical Devices of Serbia and applicable rulebooks

submitting documentation for registration (CTD or other registration file format) to the Medicines and Medical Devices Agency Serbia and follow-up until obtaining Marketing Authorisation

labelling adjustments and implementation after completing registration (Summary of Product Characteristics, Patient Information Leaflet, Instructions For Use, Primary and Secondary package text)

maintatining valid marketing authorisations through submitting variations and renewal requests

obtaining expert's opinions

pharmacovigilance

vigilance of medical devices

obtaining insurance policies for registered medical devices

preparation of files and application submission for obtaining Maximized prices at Ministry of Health and Ministry of Trade

preparation of files and application submission for obtaining Reimbursement prices at National Health Insurance Fund (Reimbursement list)