The CMED Resolution No. 6/2020, published on December 23, 2020, established procedures for the analysis of price information documents regarding requests for pricing of COVID-19 vaccines.
The analysis and approval of the price will be the responsibility of the Technical Executive Committee of the Brazilian Drug Market Regulation Chamber (CMED), within 90 days from the receipt of all necessary documents.
It is noteworthy that the vaccine prices with temporary emergency use authorization will not be analyzed by CMED due to its experimental nature.
Finally, it was established that the vaccines designated to the National Operationalization Plan of Vaccination against COVID-19, of the Ministry of Health, or for sale to Federal agencies, or any of the sub-national entities, may be commercialized for the price presented by the pharmaceutical company that files the Informative Price Document, until a final decision of CMED is made.
From our point of view, the regulation provides for immediate access to the vaccine and gives reasonable legal certainty as to the price practiced during emergency use and during the evaluation by CMED.
The Resolution is already in force.