Alims ALIMS Vlada Republike Srbije
ALIMS
clinical trials
Forms regarding clinical trials

Application for the authorization of clinical trials/clinical trial application

  Zahtev za odobrenje kliničkog ispitivanja leka/prijava kliničkog ispitivanja  Zahtev za odobrenje kliničkog ispitivanja leka/prijava kliničkog ispitivanja

 Application for the authorization of variations of and amendments to clinical trials

  Zahtev za odobrenje izmena i dopuna kliničkog ispitivanja   Zahtev za odobrenje izmena i dopuna kliničkog ispitivanja

 Notice on the completion of clinical trials

  Obaveštenje o završetku kliničkog ispitivanja  Obaveštenje o završetku kliničkog ispitivanja

 Authorization for the import of medicinal products for use in clinical trials

  Dozvola za uvoz leka za upotrebu u kliničkom ispitivanju  Dozvola za uvoz leka za upotrebu u kliničkom ispitivanju

ANNOUNCMENT FOR SPONSORS OF CLINICAL TRIALS AND CROs RELATED TO THE SUBMISSION OF SAFETY INFORMATION TO ALIMS

Since 1st November 2010, safety information from clinical trials including individual cases (SUSAR – Suspected Unexpected Serious Adverse Reaction) and annual safety reports, should be submitted to the Medical Department of ALIMS instead of so far reporting to the National Pharmacovigilance Centre. Data can either be e-mailed on the following address medicinski.sektor@alims.gov.rs or posted to the ALIMS postal address indicating “To the Medical Department”.

In respect of it, marketing authorization holders are expected to ensure separate submission of safety information from clinical trials to the Medical Department and  spontaneously reported adverse drug reactions to the National Pharmacovigilance Centre within the following month (as of 1st December 2010).