• March 18, 2020
  • WTO

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


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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

NotificationG/TBT/N/BRA/984

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

Objective
Protection of human health.

Documents


Agency responsible
National Institute of Metrology, Quality and Technology (INMETRO) Telephone: +(55) 21 2145.3817 Email: [email protected] 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

                   

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