On June 2, the Ministry of Health and Social Protection (Ministerio de Salud y Protección Social - "Minsalud") issued Decree 601 of 2021, which develops the surveillance of adverse events following vaccination against Covid-19 and regulates the Council for the Evaluation of Adverse Reactions to Covid-19 Vaccine.

The Council for the Evaluation of Adverse Reactions to the Covid-19 Vaccine will issue technical concepts on the relationship between the application of the vaccine and an adverse event, considering that this event corresponds to an abnormal laboratory finding, symptom or unfavorable disease subsequent to vaccination. 

Therefore, in case a concept is required, the following must be submitted: (i) copy of the clinical history, (ii) copy of the treating physician's diagnosis or copy of the autopsy or the equivalent document in fatal events, (iii) completed and signed form in a standard format, so that the Board may issue the concept within a term of 30 working days.

This decree is effective as of June 2, 2021.