The framework changes the procedure for submitting periodic benefit-risk assessment reports and the analysis by the Agency’s sector dealing with pharmacovigilance. The frequency of presentation of reports, for example, will be carried out by a list published here, on the portal, and which is based on the list proposed by the European Medicines Agency (European Medicines Agency – EMA). The presentation is no longer associated with the product registration date in Brazil and will be linked to the international registration date of a drug or combination of drugs. Philippe Calandra 21 August 2020 All news
