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Assessment of the causal relationship between the use of the medicinal product and the development of an adverse reaction Criteria for assessment Levels of the causal relationships
Certain Probable Possible Unlikely
Time Relationship Yes Possible Possible Possible
Explanation of a concomitant pathology Yes Yes Possible Possible
Positive results of withdrawal (improvement of the patient's condition after the drug discontinuation) No No Yes Yes
Positive results of re-administration (resumption of an adverse reaction after re-administration) Possible Possible No No

Pharmacovigilance system is a system used by the marketing authorisation holders and competent bodies to carry out tasks and responsibilities for pharmacovigilance, and intended to control the safety of medicines, to detect timely all changes in the assessment of the "benefit-risk" ratio of medicines, to develop and implement measures when the benefits exceed the risk.

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