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1.
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Notifying
Member: BRAZIL
If applicable, name of local government involved (Article 3.2 and
7.2):
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2.
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Agency
responsible:
Brazilian
Health Regulatory Agency (ANVISA)
Name and address (including telephone and fax numbers, email and
website addresses, if available) of agency or authority designated to handle
comments regarding the notification shall be indicated if different from
above:
National
Institute of Metrology, Quality and Technology (INMETRO)
Telephone:
+(55) 21 2145.3817
Telefax:
+(55) 21 2563.5637
Email: barreirastecnicas@inmetro.gov.br
Web-site:
www.inmetro.gov.br/barreirastecnicas
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3.
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Notified
under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ],
other:
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4.
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Products
covered (HS or CCCN where applicable, otherwise national tariff heading. ICS
numbers may be provided in addition, where applicable): Pharmaceutics (ICS code(s): 11.120)
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5.
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Title,
number of pages and language(s) of the notified document: Draft resolution 1290, 28 November2024; (17 page(s), in
Portuguese)
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6.
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Description
of content: This Draft Resolution
contains provisions on the market authorization of herbal medicines and the
market authorization and notification of traditional herbal products.
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7.
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Objective
and rationale, including the nature of urgent problems where applicable: The proposal to adapt the quality control requirements was
incorporated into the Brazilian Pharmacopoeia, legally mandatory for the
manufacture and control of medicines in Brazil, and it is now necessary to
incorporate it by Anvisa, with convergence and approximation to international
regulatory requirements.; Protection of human health or safety
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8.
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Relevant
documents:
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9.
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Proposed
date of adoption: To be determined
Proposed date of entry into force: To be determined
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10.
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Final
date for comments: 6 March 2025
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11.
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Texts available from: National enquiry
point [ ] or address, telephone and fax numbers and email and website
addresses, if available, of other body:
Brazilian Health Regulatory Agency (Anvisa)
SIA, Trecho 5, Área Especial 57
Brasília – DF / Brazil
CEP: 71.205-050
Phone.: +(55) 61 3462.5402
Website: www.anvisa.gov.br
The final text is available only in Portuguese and can be downloaded
at:
https://members.wto.org/crnattachments/2024/TBT/BRA/24_08115_00_x.pdf
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