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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): Medicaments consisting of two or more constituents mixed together
for therapeutic or prophylactic uses, not in measured doses or put up for
retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003);
Medicaments consisting of mixed or unmixed products for therapeutic or
prophylactic uses, put up in measured doses "incl. those for transdermal
administration" or in forms or packings for retail sale (excl. goods of
heading 3002, 3005 or 3006) (HS code(s): 3004)
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5.
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Title,
number of pages and language(s) of the notified document: Draft resolution 1283, 19 September 2024; (3 page(s), in
Portuguese)
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6.
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Description
of content: This Draft Resolution
contains provisions on the Good Pharmacovigilance Practices for Medicine
Registration Holders for human use, to include the mandatory use of the
WHODrug Dictionary to describe medicines when sending notifications.
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7.
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Objective
and rationale, including the nature of urgent problems where applicable: This draft resolution aims to maintain convergence with
international standards.; 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: 13 November 2024
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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:
Draft :https://antigo.anvisa.gov.br/documents/10181/6872326/CONSULTA+P%C3%9ABLICA+N%C2%BA+1283+CPROR.pdf/e3ee2bbf-453e-42ff-acee-4d55fd9ffb45
Comment form: http://pesquisa.anvisa.gov.br/index.php/258731?lang=pt-BR
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