Organization and resources
In order to perform the related, mutually connected tasks, the Medicines and Medical Devices Agency of Serbia consists of the following:
• Director’s Office
• Quality Management
• Regulatory Affairs Group
• eDevelopment and IT Management
• National Control Laboratory
– Physical and Chemical Laboratory
– Instrumental Laboratory
– Microbiological Laboratory – Batch release
– Pharmacological Laboratory – Vivarium
• Department of Quality Management and Support
• Veterinary Sector
• National Center for Information on Medicines and Medical Devices
• Center for Human Medicines
– Licensing Sector
– Medicine Effectiveness and Safety Evaluation Sector
– Pharmaceutical Sector
– Department for Clinical Trials
– National Center for Pharmacovigilance
• Backoffice Center
– Financial Sector
o Department for Accounting Affairs
o Department of Commercial Affairs and Public Procurement
– Administrative Sector
o Department of Legal and General Affairs
o Department for receiving requests for the control of human and veterinary drugs and medical devices, other requests and clerical work
• Medical Devices Sector
There was appointed a Managing Board:
| PRESIDENT | Spec. dr. med. Šepetkovski Aleksandar KCS, Belgrade |
| MEMBERS | Prof. dr Ninković Dragan Faculty of Special Education and Rehabilitation “FASPER”, Belgrade |
| Prof. dr. Maksimović V. Živan Belgrade |
|
| Prof. dr. Dragaš Marko KCS, Belgrade |
|
| Spec. dr. med. Čebedžić Rajko Medicines and Medical Devices Agency of Serbia |
- Committee for Marketing Authorisation of Human Medicinal Products,
- Committee for Marketing Authorisation of Veterinary Medicinal Products
- Committee for Marketing Authorisation of Medical Devices,
- Committee for Human Medicinal Products Clinical Trials Assessment,
- Committee for Medicinal Products and Medical Devices Safety Assessment
- Committee for Homeopathic Medicinal Products
- Committee for Veterinary Medicinal Products Pharmacovigilance
- Committee for Veterinary Medicinal Products Clinical Trials Assessment
- Committee for Marketing Authorisation of Traditional Medicinal Products
- Committee for Marketing Authorisation of Radiopharmaceuticals
Highly responsible, complex and variable activities in the Agency are carried out by educated, qualified, professional and experienced staff. When it comes to the age structure of personnel, the Medicines and Medical Devices Agency of Serbia has endeavored in its Personnel Policy to comprise all three age categories: the wisdom of experienced professionals, innovative youth and the power of maturity.
In 2019 , the Agency for Medicines and Medical Devices Agency of Serbia has 173 employees.
All the laboratories within the National Control Laboratory of the Agency have been renovated so as to comply with the strictest world demands in the domain of quality control, particularly the Microbiological Laboratory, i.e. its sterile block.
The Agency disposes with the latest equipment necessary for the quality control of medicinal products and medical devices, as well as for the informatic support for all processes conducted in the Agency. Necessary equipment qualification and calibration, as well as computer data protection processes are performed on a regular basis, according to the plans defined.