Non-interventional studyNon-interventional study

Non-interventional study

Non-interventional study – a study in which the following conditions are met:

  • the medicinal product is prescribed in accordance with the summary of product characteristics;
  • the decision to prescribe a specific treatment to a patient is not made in advance according to a study protocol, but in accordance with routine clinical practice, and the prescription of the medicinal product is clearly separated from the decision to include the patient in the study;
  • no additional diagnostic or monitoring procedures are applied to patients, and epidemiological methods are used to analyse the data obtained.*

*Decision No. 87 of the Council of the Eurasian Economic Commission dated November 3, 2016 “On Approval of the Good Pharmacovigilance Practice Rules of the Eurasian Economic Union” (as amended by Decision No. 81 of the Council of the Eurasian Economic Commission dated May 19, 2022). Effective date — December 6, 2022.