Norm on imports of medicines and medical devices reaches the end of its validity, according to Anvisa

With the emergence of the pandemic, Brazil needed to supply itself with essential products to face Covid-19 in hospital environments. For this, the RDC 483/2021 was created as an emergency, which aimed to supply the national market in order to meet all the needs of the delicate moment that the country and the world were experiencing.

As announced by Anvisa, Resolution of the Collegiate Board (RDC) 483/2021, which provided for the requirements for importing medicines identified as priorities for use in health services and new medical devices, did not obtain its extension, according to information at the Ordinary Public Meeting 22, on November 10, 2021.

The effects of the rule ended on November 13, due to its exceptional and temporary nature, in March 2021, when the resolution was edited due to the critical moment of the Covid-19 pandemic in Brazil. In that period, there was an increase in ICU admissions, and, for this reason, there was a shortage of drugs in the national market, especially those for anesthesia and sedation for orotracheal intubation in cases where mechanical breathing was necessary.

What were the requirements for 483 resolution?

Primarily, the waiver of product regularization did not exempt the importer from complying with other requirements in relation to medicines and medical devices, nor from carrying out post-market monitoring. The responsibility to guarantee the quality, effectiveness and safety of imported products was still an obligation of the importer, and compliance according to Anvisa, traceability of products and identification of those responsible for distribution were mandatory.

In this way, the importer could perform the electronic import petition, containing the inscription "AUTHORIZED ACCORDING TO RDC No. 483, OF 2021, with all data referring to the batch,quality control report and other documents that might be necessary.

In the case of imports of medicines, proof of prequalification by the WHO or of regularization valid in countries whose competent regulatory authority is a member of the ICH was required. In the case of medical devices, the requirement was to have proof of prequalification by the WHO or valid
regularization in a country whose regulatory authority is a member of the IMDRF.

Thus, both the importer and Anvisa were co-responsible for the best import practices, even if in an emergency and adverse conditions, valuing the quality and safety of these products and materials so that they could reach their final destination and fulfill their role in favor of social well-being.

Current situation in the country

Currently, the pandemic in Brazil is contained, with indicators showing a decrease in serious cases. It is also necessary to observe that technical areas of Anvisa and entities of the productive sector interpret that there is again a balance in the relationship between consumption and demand for
medicines and health products regulated in the country. For more information about product registration and regulation at Anvisa, contact us and learn more bout our services. Licempre is a company specialized in consulting and advising on the registration of companies and products in Organs responsible bodies, such as ANVISA and INMETRO.