Medicines and Medical Devices Agency of Serbia (ALIMS)

28/01/2025
28/01/2025
Institution
Regulatory Authority
Institution identification

Institution ID

1000000459

Institution full name and acronym

Medicines and Medical Devices Agency of Serbia (ALIMS)

Institution countries

Serbia

Type of institution

Regulatory Authority

Institution role

Other

Institution website

ENCePP partner

Yes
Institution description
ALIMS is responsible for following activities:
- issuing marketing authorizations for medicinal products and medical devices;
- performing laboratory quality control of medicinal products and medical devices;
- issuing authorizations for clinical trials of medicinal products and medical devices and controlling the conduct of clinical trials;
- monitoring adverse reactions of medicinal products and medical devices;
- issuing certificates on compliance with guidelines on Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice in clinical trials of medicinal products and medical devices;
- authorizing the import of non-registered medicinal products and medical devices for the treatment of a particular patient or group of patients and medicinal products and medical devices for scientific research;
- classification of medicinal products and medical devices;
- collecting and processing statistical data on trade and consumption of medicinal products and medical devices;
- providing information and promotion of rational use of medicinal products and medical devices;
- integration into international networks of information on medicinal products and medical devices and integration into international agencies associations;
- other tasks in accordance with this Law
Institution details
Experience with collecting data directly from individual patients or respondents:
Yes
Interest in carrying out research that is funded by pharmaceutical companies:
No

Contact details