January 4, 2019
WTO

Resolution on the outsourcing of production stages, of control analyzes quality, transport and storage medicines and biological products.

Brazil South America

Consultations Regulatory Pharma

Title of document
Resolution - RDC 257, 20 December 2018 (1 page(s), in Portuguese)

Description
This present Resolution changes RDC 234 of 20 June 2018, regarding the outsourcing of production steps, quality control analysis, transportation and storage of medicaments and biological products, among other measures.

Notifying member: Brazil

Notification: G/TBT/N/BRA/854

Objective tag
Protection of human health or safety

Objective
Protection of Human Health

Documents

RDC_257_2018_.pdf

Agency responsible
National Institute of Metrology, Quality and Technology (INMETRO) Telephone: +(55) 21 2563.2918 Telefax: +(55) 21 2563.5637 Email: barreirastecnicas@inmetro.gov.br Web-site: www.inmetro.gov.br/barreirastecnicas The comments to this Draft Regulation shall be sent to http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=33294

Timing:

Submission: 27/12/2018
Reception: 03/01/2019
Distribution: 04/01/2019
Final date for comments: N/A
Proposed date of adoption: N/A

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Resolution on the outsourcing of production stages, of control analyzes quality, transport and storage medicines and biological products.

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