The National Health Surveillance Agency (Anvisa) decided today (12) to extend the validity of authorizations for the emergency use of medicines and vaccines against covid-19 for 1 year. Within this period, companies will have to request the definitive sanitary registration.
With the resolution approved today, Anvisa intends to maintain the current standard in the supply of vaccines and medicines against covid-19. The authorization for emergency use of vaccines was due to the need for a quick response to the contagion of covid-19 and the increase in the number of cases and deaths in the country.
The agency’s decision was necessary, since emergency use authorizations lost their validity with the end of the Public Health Emergency of National Importance (Espin), declared by the Ministry of Health in April. The vaccines from Pfizer, Johnson & Johnson (Janssen) and AstraZeneca have already had their definitive registrations approved by the agency.
The resolution approved today by the Collegiate Board also brought some changes to the new emergency use authorization requests. Among the main points is the need for manufacturers of medicines or vaccines to have a Good Manufacturing Practices Certificate (CBPF) issued by Anvisa, in addition to the obligation of companies holding authorization to notify serious adverse events within 72 hours of the occurrence. .
