Function and activities

Function

The Agency shall be in charge of:

  • 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;

Activities

Activities performed in the ALIMS refer to the issues before issuing permits for the drug or medical device registration in the Register of medical devices and activities that are performed after the marketing of drugs and medical devices.

Activities performed in the ALIMS

Activities performed in the ALIMS

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.