Alims ALiMS Vlada Republike Srbije
ALiMS
ACTIVITY

Activities carried out in the Agency refer to the operations preceding the issuance of marketing authorizations and the activities carried out upon the marketing of medicinal products and medical devices.



Aktivnosti

Premarketing activities

Experts employed in the Agency, as well as the expert cooperators of the Agency participate in the evaluation of pharmaceutical, pharmacological-toxicological and clinical documentation on quality, safety and efficiency of medicinal products. Evaluation of documentation is performed in accordance with the Law on Medicinal Products and Medical Devices, and based on the insight into complete Common Technical Dossier – CTD or European Dossier, presented by the client during the submission of application.
In order to provide the citizens of Serbia and health-care workers with the best possible conditions for prevention, diagnostics, treatment and rehabilitation, it is necessary to make a wide range of high-quality, safe and efficient medicinal products and medical devices available on the Serbian market, which is the obligation of the Agency.

The Medicines and Medical Devices Agency of Serbia also receives applications from the manufacturers of innovative medicinal products that have their registered offices outside Serbia, for the performance of IIIa and b and IV phase of clinical trials of medicinal products, i.e. medicinal products in the phase of development and those already marketed. The applications are processed by the Agency experts in cooperation with the experts from the Commission for Clinical Trials of Medicinal Products. The consent is given in line with Directive 2001/20 EC, and the certificate on compliance with Good Clinical Practice in line with ICH guidelines (International Conference on Harmonization – ICH).
Pursuant to the Law on Medicinal Products and Medical Devices, the issuance of marketing authorizations, as well the renewals and amendments thereto, are carried out in the Medicines and Medical Devices Agency of Serbia. Procedures for the issuance of marketing authorizations for medical devices are harmonized with the guidelines on Good Regulatory Practice and the Law on Medicinal Products and Medical Devices.



Postmarketing activities

The Medicines and Medical Devices Agency of Serbia, performs the activities of organized and continual monitoring of adverse reactions to medicinal products, by applying the latest international standards:

  • spontaneous reports on adverse reactions to medicinal products
  • gathering and evaluating reports made by health-care workers on adverse reactions during the treatment of patients
  • reports on adverse reactions during clinical trials and
  • evaluation of periodic reports on adverse reactions to medicinal products in postmarketing period (Periodic Safety Update Reports – PSURs).

Due to the access to current data bases, the Agency experts provide reliable information on medicinal products and medical devices, as well as advices to patients and health-care professionals regarding the rational and economical use thereof. For the purpose of pharmacoepidemiologic and pharmacoeconomic researches, the Agency monitors the distribution and consumption of medicinal products and medical devices. Within the National Centre for Information on Medicines and Medical Devices there is the Library of the Agency with the current web-site presentation of the Agency performances and information on medicinal products and medical devices.
Web site of the Medicines and Medical Devices Agency of Serbia is: http://www.alims.gov.rs.