Covid-19: Healthcare impacts
Anvisa’s deadlines are suspended for 120 (one hundred and twenty) days. The deadlines to accomplish the requirements relate to the following petitions for registration and post-registration of input, drugs and biological products: certification of bioequivalence centers, qualification of pharmaceutical equivalence centers, and consent and modification in clinical trials of drugs and biological products. In such cases, if companies believe that there is a need for suspension, then they should submit a temporary filing request. The suspension does not apply in the case of deadlines for field actions in necessary situations. At the very least, this provision suspends the distribution of copies of processes; allows for electronic signatures on documents, including those for physical petitions; extends the deadline for submitting company size information; and suspends prescriptive deadlines for punitive actions.
Anvisa has allowed companies to manufacture and import surgical masks, particulate respirators or their equivalent, safety glasses, facial protectors, disposable hospital clothing, caps and props, valves, circuits and respiratory connections for use in health services, without the need for product authorization and notification.
It has also allowed the acquisition of personal protective equipment; pulmonary ventilators, circuits, connections and respiratory valves; and parametric monitors and other medical devices essential for the fight against COVID-19, new and not regulated by ANVISA. To this end, the products must be regularized and marketed in a member jurisdiction of the International Medical Device Regulators Forum (IMDRF), by public and private agencies and entities, as well as health services, and when similar devices regularized by Anvisa are available in the market. Despite the exemption from registration, the manufacturer and importer must comply with the other requirements applicable to the sanitary control of medical devices as well as applicable technical standards, and carry out post-market controls according to applicable regulations.
Anvisa has restricted, for a period of 30 (thirty) days, the entry of foreigners into the country by air from the following countries, regardless of their nationality: the People’s Republic of China, the European Union, the Republic of Iceland, Kingdom of Norway, the Swiss Confederation, the United Kingdom of Great Britain, Northern Ireland, the Commonwealth of Australia, the Islamic Republic of Iran, Japan, Malaysia and the Republic of Korea. Restrictions apply to passengers in transit to a country of destination who do not admit their tickets.
Anvisa has also simplified the rules for the production of 70% alcohol gel Now, the product and the company do not need registration and operating authorization, respectively. However, it is important to remember that local health surveillance has its own rules and, in theory, there is a need to obtain sanitary licenses. Companies producing these goods for donation to the government enjoy greater flexibility.
Anvisa published technical note No. 3/2020 to make itself available to discuss the impacts of COVID-19 on clinical research with the scientific community.
The Ministry of Health has temporarily authorized the practice of Telemedicine. The service should be performed directly between physicians and patients, through information and communication technology that ensures the integrity, security and confidentiality of information. The issuance of prescriptions and medical certificates by electronic means was allowed, but an electronic signature issued through certificates and keys issued by the Brazilian Public Keys Infrastructure (ICP-Brasil) is still required.
Finally, the Ministry of Health developed the Strategic Action “Brasil Conta Comigo – Profissionais da Saúde” seeking to train and register health professionals to confront COVID-19. This strategic action will occur through a joint action between the Ministry of Health and the Professional Councils, and such registry can be used by the public administration to request the services and cooperation of health professionals in case of emergencies.
