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1.
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Notifying
Member: VIET NAM
If applicable, name of local government involved (Articles 3.2 and 7.2):
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2.
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Agency
responsible:
Administration
Science, Technology and Training
Ministry of
Health
138A Giang Vo
Str., Ba Dinh Dist., Ha Noi, Viet Nam
Tel: (84-24)
33846688 - Fax: 32373236
Email:
cuck2dt@moh.gov.vn
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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 codes or national tariff lines. ICS numbers may
be provided in addition, where applicable): Medicinal products
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5.
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Details of notified document(s) (title,
number of pages and languages, means of access): Draft Circular
Stipulating Clinical Trial Regulations for Medicinal Products; (29 page(s),
in Vietnamese)
Link to notified document(s) and/or contact
details for agency or authority which can provide copies upon request:
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6.
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Description
of content: Draft Circular
providing regulations on the following matters:
·_
Promulgation
and application of Good Clinical Practice (GCP);
·_
Assessment of
compliance with Good Clinical Practice and the documentation and procedures
for conducting clinical drug trials.
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7.
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Objective
and rationale, including the nature of urgent problems where applicable: Protection of human health or safety
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8.
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Relevant
documents:
- This draft
Circular is issued pursuant to the Law on Promulgation of Legal Documents
(2015, as amended in 2020), Decree No. 34/2016/ND-CP (as amended by Decree No.
154/2020/ND-CP), and Decision No. 1610/QD-TTg dated 19 December 2024 of the
Prime Minister, which assigns ministries to draft implementing regulations
for laws adopted at the 8th session of the 15th National Assembly;
- The
Circular provides detailed regulations for the implementation of Law No.
44/2024/QH15 and addresses difficulties and inconsistencies in the
implementation of Decree No. 54/2017/ND-CP (as amended by Decrees No.
155/2018/ND-CP and No. 88/2023/ND-CP) guiding the implementation of the Law
on Pharmacy.
Relevant notifications:
·_
G/TBT/N/VNM/336
·_
G/TBT/N/VNM/15/Add.1
·_
G/TBT/N/VNM/15
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9.
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Proposed
date of adoption: 1 October 2025
Proposed date of entry into force: 1 January 2026
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10.
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Provision of comments
Final
date for comments: 1 September 2025
[X] 60 days from notification
Contact details of agency or authority designated to handle comments
regarding the notification:
Administration
Science, Technology and Training
Ministry of
Health
138A Giang Vo
Str., Ba Dinh Dist., Ha Noi, Viet Nam
Tel: (84-24)
33846688 - Fax: 32373236
Email:
cuck2dt@moh.gov.vn
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