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Serbia: ALIMS Released New eServices and Guidelines Related to Applying for Clinical Studies

Tuesday, February 13, 2018: The Medicines and Medical Devices Agency of Serbia (ALIMS) has released new eServices and guidelines related to submission of requests for clinical studies. In the functional area Euslugs and Euphrates, new instructions have been published:

"Instructions for Applicants for Clinical Trials" and "Ethical Committee Contact Point", intended for applicants for clinical trials. ALIMS inform applicants of the clinical trial requests that new e-services have been published related to submitting requests for clinical studies:

  • e-submission of APPROACH / APPLICATION for clinical trial for HUMANS
  • e-submission of request for approval CHANGES AND ADDITIONS of clinical trial for HUMANS
  • e-submission of a request for notifications of CLINICAL TRIAL for HUMANS
  • e-submission of a request for APPROVAL / REGISTRATION of the clinical trial for the MEDICINAL PRODUCT
  • e-submission of the request for approval AMENDMENT AND EXTENSION of the clinical trial for the MEDICINAL PRODUCT
  • e-submission of a request for notifications on the CLOSURE of the clinical trial for the MEDICINAL PRODUCT

In order to submit eServices for published services related to clinical trials, it is necessary to authorize the eGovernment portal to submit it.

In the document "Industry Guide V 2.0. - e-Claiming clients and checking the status of the submitted request "in the section" User Administration and Authorization "section, there is a detailed instruction regarding the administration and assignment of authority.

 
 
 
 
 
 
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