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)
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
Protection of human health or safety; Reducing trade barriers and facilitating trade
Protection of human health.
National Institute of Metrology, Quality and Technology (INMETRO)
Telephone: +(55) 21 2145.3817
Email: [email protected]
- Submission: 18/03/2020
- Reception: 18/03/2020
- Distribution: 18/03/2020
- Final date for comments: N/A
- Proposed date of adoption: N/A