Anvisa approved on Wednesday, 10, a resolution that formalizes rules so that states, the Federal District, municipalities and the private sector can import medicines and vaccines against Covid-19.
The release by the National Health Surveillance Agency also includes drugs that have not been approved for use in Brazil.
In practice, Anvisa's decision is to enforce the effects of Provisional Measure (MP) 1,026 / 21, known as MP for Vaccines, which was sanctioned this week by President Jair Bolsonaro.
Imported drugs and vaccines must have specific indication for treatment or prevention of Covid-19 approved by the foreign health authority and must have at least phase 3 clinical studies completed or with provisional results.
The new law also establishes a period of seven days for Anvisa to evaluate the request for temporary authorization for emergency use whenever the vaccine has been approved by at least one foreign health authority among those listed in the law.
The text also increases the number of foreign health authorities that serve as a basis for the temporary authorization of vaccines in the country.
In addition to agencies in the United States, the European Union, Japan, China, the United Kingdom, Canada, South Korea, Russia and Argentina, the text includes agencies Australia, India and other recognized foreign health authorities. and certified by the World Health Organization - WHO.
Importer will be responsible
According to Anvisa, the importer will be responsible for the quality, efficacy and safety of the medicine or vaccine to be imported, as well as for monitoring transport conditions, to guarantee the general conditions and the maintenance of the quality of the imported products, in addition to their adequate storage. .
It is also up to the importer to provide guidance to health services on the use and conservation of imported products, as well as to patients, on how to notify technical complaints and adverse events related to them.
The creation of mechanisms for monitoring, post-distribution and post-use of imported products is also the responsibility of the importer.