Brazil | Exceptional and temporary criteria and procedure for the processing of petitions for the market authorization of medicines, biological products, and in vitro diagnosis products

Title of document
Resolution – RDC number 348, 17 March 2020 (7 page(s), in Portuguese)

Description
This resolution establishes exceptional and temporary criteria and procedure for the processing of petitions for the market authorization of medicines, biological products, and in vitro diagnosis products; and for the post-market authorization of medicines and biological products due to the international public health emergency of the new coronavirus (Covid-19).

Notifying member: Brazil

Notification: G/TBT/N/BRA/990

Objective tag
Protection of human health or safety

Objective
Protection of human health.

Documents

• RDC_348_2020_.pdf

Agency responsible
National Institute of Metrology, Quality and Technology (INMETRO) Telephone: +(55) 21 2145.3817 Email: barreirastecnicas@inmetro.gov.br Web-site: www.inmetro.gov.br/barreirastecnicas

Timing:

• Submission: 25/03/2020
• Reception: 25/03/2020
• Distribution: 26/03/2020
• Final date for comments: N/A
• Proposed date of adoption: N/A