Organization and resources

Organization

In the Medicines and Medical Devices Agency of Serbia, due to performing related and interacted tasks there are formed the organizational units as follows: p>

  • National Control Laboratory
  • National Pharmacovigilance Centre
  • National Centre for Information on Medicines and Medical Devices
  • Human Medicines Centre
  • Centre for Support
  • Pharmaceutical Department
  • Medical Department
  • Veterinary Medicines Department
  • Medical Devices Department
  • Licencing Department
  • Assessment Department
  • Administrative Department
  • Financial Department
  • eDevelopment and IT
  • Physico-Chemical Laboratory
  • Biological Laboratory
  • Quality Control and Support

as well as the Quality Control Management and Managing Director Office.


Rules on internal organization


Managing Board of ALIMS

There was appointed a Managing Board:

PREDSEDNIK Spec. dr. med. Šepetkovski Aleksandar
KCS, Beograd
ČLANOVI Prof. dr Ninković Dragan
Fakultet za specijalnu edukaciju i rehabilitaciju “FASPER”, Beograd
Prof. dr. Maksimović V. Živan
Beograd
Doc. dr. Dragaš Marko
KCS, Beograd
Spec. dr. med. Čebedžić Rajko
Agencija za lekove i medicinska sredstva Srbije

The Commities

The Committees were formed as follows:

  • 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

Internal organization chart of ALIMS

Human Resourses

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 2016 , the Agency for Medicines and Medical Devices Agency of Serbia has 173 employees.

Facility capacities

Activities in the Medicines and Medical Devices Agency of Serbia are carried out in two objects – the old building, which belonged to the Pharmacy Institute of Serbia and the new facility the construction of which was financed from the project of the European Agency for Reconstruction.

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.

Equipment

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.