Brazil | Covid-19 | Extraordinary and temporary procedures for market authorization of Active Pharmaceutical Ingredients, medicines, and healthcare products due to emergency

Title of document
Resolution – RDC number 346, March 12th, 2020 (4 page(s), in Portuguese)

Description
This Resolution establishes extraordinary and temporary criteria and procedure for Good Manufacture Practice Guidelines for market authorization and post-market registration amendments of Active Pharmaceutical Ingredients, medicines, and healthcare products due to the international public health emergency of the new coronavirus (Covid-19).

Notifying member: Brazil

Notification: G/TBT/N/BRA/984

Objective tag
Protection of human health or safety; Reducing trade barriers and facilitating trade

Objective
Protection of human health.

Documents

• RDC_346_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: 18/03/2020
• Reception: 18/03/2020
• Distribution: 18/03/2020
• Final date for comments: N/A
• Proposed date of adoption: N/A