Consulting services in the field of obtaining the necessary permits for the release of new products
The registration service that we offer to our partners is based on the continuous monitoring of legislation, good knowledge of the regulatory process, years of experience and high quality communication with regulatory authorities.
Registration service/ renewal /approval of a drug variation in accordance with the requirements of the Medicines and Medical Devices Agency of Serbia includes the following:
- preparation of a registration file in accordance with local requirements and it’s submition;
- preparation of the Summary of Product Characteristics (SPC), the Patient Information Leaflet (PIL) and labelling drafts;
- registration/renewal process monitoring untill Marketing Authorization (MA) is obtained;
- preparation, submission and monitoring of the variations approval request.
- preparation and submission of the request for the approval of a maximum wholesale price to the relevant ministries (for Rx drugs);
- preparation and submission of the application to Reimbursement list of the National Health Insurance Fund.
Entry into Register of Medical Devices / renewal / approval of a medical device MA variation in accordance with local requirements.
Entry into Ministry of Health database / renewal of dietary products MA in accordance with local requirements.
MPharm Radmila Stojanović
Head of Development department