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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 (ICS code(s): 11.120.10)
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5.
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Title,
number of pages and language(s) of the notified document: Draft resolution 1294, 28 November 2024; (1 page(s), in
Portuguese)
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6.
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Description
of content: This Draft Resolution
contains provisions on the classification in the priority category of
petitions for market registration, post-market registration and prior
approval in clinical research of medicines
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7.
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Objective
and rationale, including the nature of urgent problems where applicable: This draft resolution seeks to standardize some procedures and
criteria regarding the judgment of Administrative Health Processes (PAS).;
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: 10 February 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://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00001293&sgl_tipo=CPB&sgl_orgao=DC/ANVISA/MS&vlr_ano=2024&seq_ato=000&cod_modulo=134&cod_menu=1696
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