Malaysia #6449 (v.3)

Base data

Notified in
Version validity
24/10/2023 - present
Current active version v.3
Reporting member
Malaysia
In force from
End date
In force
General description
Non-automatic licensing on the import of products for the purpose of clinical trials
National legal basis
Sale of Drugs Act 1952 [Act 368]

Control of Drugs and Cosmetics Regulations 1984
Administrative mechanism
Administered by Ministry of Health (MOH).

Details of the requirement on Malaysian Guideline for Application of Clinical Trial Import License and Clinical Trial Exemption can be accessed here:
https://www.npra.gov.my/easyarticles/images/users/1140/Malaysian-Guideline-for-Application-of-CTIL-and-CTX-7.1-Edition-16.09.2021.pdf
Responsible entities
Ministry of Health
HS version
HS 2022
Referenced WTO document symbol

Meta data

WTO justifications

XX:(a) - (a) necessary to protect public morals;

GATT 1994 (GATT 1947 provisions)

Reported as: Articles XX(a) and XX(b) of the GATT

XX:(b) - (b) necessary to protect human, animal or plant life or health;

GATT 1994 (GATT 1947 provisions)

Reported as: Articles XX(a) and XX(b) of the GATT
Non-WTO commitments
Affected partners
Non-affected partners

Measures

Reported restrictions
NAL
Symbol
NAL

Tariff lines

3001
3001
Products for the purpose of clinical trials
3002
3002
Products for the purpose of clinical trials
3003
3003
Products for the purpose of clinical trials
3004
3004
Products for the purpose of clinical trials
3005
3005
Products for the purpose of clinical trials