Committee on Technical Barriers to Trade - Notification - Macao, China - Traditional chinese medicines

NOTIFICATION

The following notification is being circulated in accordance with Article 10.6

 

1.

Notifying Member: MACAO, CHINA

If applicable, name of local government involved (Article 3.2 and 7.2):

2.

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

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], other:

4.

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)

5.

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)

6.

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.

7.

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

8.

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

9.

Proposed date of adoption: 1. 19/07/2021

2. 24/11/2021

Proposed date of entry into force: 1 January 2022

10.

Final date for comments: Not Applicable

11.

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