1.
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Notifying Member: MACAO, CHINA
If applicable, name of local government
involved (Article 3.2 and 7.2):
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2.
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Agency responsible:
Pharmaceutical Administration Bureau
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:
Economic and Technological Development
Bureau
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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): Traditional
Chinese medicines (Please refer to the Annex)
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5.
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Title, number of pages and language(s) of the notified document: 1.
Law on Pharmaceutical Activity in the Field of Traditional Chinese Medicines
and the Registration of Proprietary Chinese Medicines (Law No. 11/2021, 35
pages, in Chinese and Portuguese)
2. Enforcement Rules for the Law on Pharmaceutical Activity in the
Field of Traditional Chinese Medicines and the Registration of Proprietary
Chinese Medicines (Administrative Regulation No. 46/2021, 42 pages, in
Chinese and Portuguese)
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6.
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Description of content: 1.
Law No. 11/2021 stipulates the technical requirements of Chinese medicine
manufacturers and entities engaged in the import, export and wholesale
activities of traditional Chinese medicines. It requires that the packaging,
labelling and package insert of proprietary Chinese medicines to be written
in at least Chinese or Portuguese. It also stipulates that all proprietary
Chinese medicines must first be registered with the Pharmaceutical
Administration Bureau before they can be circulated in the Macao SAR.
2. Administrative Regulation No. 46/2021 supplements Law No. 11/2021
with enforcement rules such as those on the information required to be
displayed on the packaging or labelling of proprietary Chinese medicines.
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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; Protection of
animal or plant life or health
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8.
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Relevant documents:
1. Law No. 11/2021
https://images.io.gov.mo/bo/i/2021/30/lei-11-2021.pdf
2. Administrative Regulation No. 46/2021
https://images.io.gov.mo/bo/i/2021/49/rega-46-2021.pdf
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9.
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Proposed date of adoption: 1. 19/07/2021
2. 24/11/2021
Proposed date of entry into force: 1
January 2022
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10.
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Final date for comments: Not
Applicable
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11.
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Texts
available from: National enquiry point [X] or
address, telephone and fax numbers and email and website addresses, if available,
of other body:
https://members.wto.org/crnattachments/2022/TBT/MAC/22_7141_00_e.pdf
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