The National Health Surveillance Agency (Anvisa) has been publishing resolutions with the objective of adapting the health sector to the changes resulting from the covid-19 pandemic. Only in the month of March resolutions by the Board of Directors (RDCs) under numbers 348, 349, 350, and 356, were published in the Official Federal Gazette (DOU), all valid for 180 days. They provide for extraordinary and temporary measures concerning medicines, sanitizers, equipment, and medical devices.
RDC No. 348, of March 17, establishes extraordinary and temporary criteria and procedures for the treatment of applications for registration of drugs, biological products, and products for in vitro diagnosis, and post-registration changes for drugs and biological products. Through RDC 348, priority access to the registration of these products is possible, especially those for in vitro diagnosis. The purpose is not to assess and approve products automatically, but to provide dexterity to the regulatory agency's application review process.
RDC No. 349, of March 19, aims at regulating the criteria and procedures related to application for regularization of personal protective equipment, pulmonary ventilator-type medical equipment, and other devices recognized as strategic by Anvisa at this time. The measure speeds up the procedures for approval of medical equipment, such as substitution of the presentation of the Good Manufacturing Practices Certification by the Medical Device Single Audit Program (MDSAP) or Quality Management System Certification ISO 13485, among other simplified processes.
RDC No. 350, of March 19, determines the criteria and procedures for the manufacture and sale of antiseptic or sanitizing preparations, exceptionally without prior authorization from Anvisa. Provided that the technical quality criteria established in other Anvisa resolutions are followed, companies regularized may manufacture and sell products such as 70% ethyl alcohol, 80% glycerin ethyl alcohol, 75% glycerin isopropyl alcohol, and 0.5% chlorhexidine diglyconate.
The companies regularized must have an Operating Permit (AFE) issued by Anvisa and a health license or permit issued by the competent health agency from the states, Federal District, and municipalities, as well as other operating permits, including for manufacturing and storing flammable substances.
RDC No. 350 also establishes that companies manufacturing cosmetics and sanitizers can manufacture and sell 70% alcohol in its various forms of presentation. On the other hand, companies that manufacture drugs, sanitizers, or cosmetics may receive donations of raw materials used in the manufacture of antiseptic or sanitizing preparations, provided they meet the technical requirements of quality and safety defined by the manufacturer of the finished product.
Finally, RDC No. 356, of March 23, sets forth the requirements for the manufacture, import, and purchase of medical devices identified as priorities for use in health services. To facilitate the supply of such products in the domestic market, the resolution also waives the need for an AFE and other health regulatory authorizations for the manufacture and import of the following products for use in health services: surgical masks, N95, PFF2, or equivalent particulate respirators, goggles, facial protectors, disposable hospital clothing (waterproof and non-waterproof aprons/caps), caps and head coverings, valves, circuits, and respiratory connections.
The strategic actions adopted by Anvisa seek to mitigate the effects of the covid-19 pandemic, making access possible and increasing the volume of regularized products that can be used to tackle the pandemic. As mentioned before, such measures are extraordinary and temporary, since the resolutions are valid for 180 days.
