ANVISA published yesterday (September 3^rd) RDC 419/2020 extending the validity of the RDC 346/2020 which defines extraordinary and temporary criteria and procedures for GMP Certification, for  registration purposes and post-registration changes to active pharmaceutical ingredients, medicines and medical devices, due to the international public health emergency of the new Coronavirus.

RDC 346/2020, published in March, was originally valid for 180 days. With this new Resolution, RDC 346/2020 will now be valid for as long as the Public Health Emergency, declared by the Ministry of Health in February (Ordinance nº 188), is in force.

Under the terms of the Resolution, temporary and emergency use of information from Foreign Regulatory Authorities is allowed to replace Health Inspections carried out by ANVISA.

In addition, the emergency use of remote inspection mechanisms are temporary allowed, replacing the on-site sanitary inspection for purposes of obtaining GMP Certification. Although it is not yet being practiced by ANVISA, remote inspections may be carried out by means of videoconferencing technologies and data transmission to verify compliance with the GMP.

Good Manufacturing Practices Certifications granted under the terms of the Resolution will be valid for two years, counting from the publication date in the Brazilian Official Gazette (DOU).

In case the manufacturer can’t comply with the terms previously described, a tem­porary GMP Certificate can be granted if:

*      The medical device is used in cases of serious health risk for the control, diagnosis, prevention or treatment to meet the health needs caused by Covid-19 and;

*      It is an essential product to maintain life whose availability is threatened by shortages (imminent or installed) in the national market due to the pandemic and;

*      GMP Certificate is the only impediment to the registration and commercialization of the product.

It is still necessary to present technical documentation and ANVISA’s fee will be still applicable.

The Certificate granted under those terms will be valid for 180 days. After the temporary certification is over, ANVISA must adopt, on a priority basis, the conventional certification mechanisms.

Domo team is working to keep clients and the community updated on the latest moves from Brazilian Regulatory Agencies, and working closely with ANVISA and INMETRO. Therefore, we have made available for Download a complete overview on the actions taken by the Agencies.

Click here to download “An Overview on Brazilian Regulatory Agencies’ temporary measures to enable market

access of COVID-19 related medical devices”.

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DOMO Salute Team