Trade Regulations

Antibiotics included on extraordinary and temporary import list

Jun, 10, 2021 Posted by Ruth Hollard

Week 202125

ANVISA (the national health surveillance agency) included two antibiotics in the list of drugs authorized for extraordinary and temporary importation due to the Covid-19 pandemic.

The products are polymyxin B and sulfamethoxazole-trimethoprim for intravenous use, both recommended for the treatment of infections, according to guidelines contained in the package insert for each product.

The measure is in the RDC 516/2021 (collegiate board resolution 516/2021), published in the Official Federal Gazette one week ago. The new resolution amended RDC 483/2021, which extraordinarily and temporarily provides the requirements for the import of new medical devices and priority drugs for use in health services, due to the international public health emergency related to Covid-19.

These antibiotics may therefore be imported on an exceptional and temporary basis by public and private bodies and entities, including health establishments and services, in addition to new medical devices and other priority drugs provided for in Annex I of RDC 483/2021.

ANVISA  provided on its portal an exclusive area on the modalities of importing vaccines and priority drugs to fight Covid-19. On the website, it is possible to clarify doubts on the subject, consult the health legislation in force, monitor the time needed for import licensing requests, as well as obtain information related to all imports carried out in the context of the pandemic.


Source: Agência Brasil

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