G/LIC/N/2/MAC/6  
 
9 November  2022 
(22-8370) Page: 1/4 
Committee on Import Licensing  Original: English  
 
AGREEMENT ON IMPORT LICENSING PROCEDURES  
NOTIFICATION UNDER ARTICLE 5.1 TO 5.4 OF THE AGREEMENT1 
MACAO, CHINA 
The following notification, dated 24 October  2022, is being circulated at the request of the delegation 
of Macao, China.  
 
 Category  Notification details  
1 Notifying Member  Macao, China  
2 Title of new 
legislation/procedure  1. Law on Pharmaceutical Activity in the Field of Traditional 
Chinese Medicines and the Registration of Proprietary Chinese 
Medicines (Law No. 11/2021)  
2. Enforcement Rules for the Law on Pharmaceutical Activity in 
the Field of Traditional Chinese Medicines and the Registration 
of Proprietary Chinese Medicines (Administrative R egulation 
No. 46/2021)  
3. List of Chinese Medicinal Materials Adopted in the Macao SAR 
(Secretary for Social Affairs and Culture’s Decision 
No. 95/2021)  
3 Date of Publication  
 1. 26 July 2021 
2. 6 December 2021 
3. 28 December 2021 
4 Date of entry into force  1 January 2022 
5 Website link/Official 
publication of the new 
regulation/procedure  1. https://images.io.gov.mo/bo/i/2021/30/lei -11-2021.pdf  
2. https://images.io.gov.mo/bo/i/2021/49/rega -46-2021.pdf  
3. https://images.io.gov.mo/bo/i/2021/52/despsasc -95-2021.pdf   
6 Have you attached a copy 
of the regulation (PDF) to 
the Secretariat  [✓] Yes. ( Please attach a copy of the regulation to the notification. ) 
 
[ ] No.  
7 Type of notification  [✓] (a) New licensing regulation/procedure2; (please answer 
question 8 to 14)  
 
[ ] (b) Changes to a regulation/procedure which has been previously 
notified in document: ______________ ; ( please answer question 
15 and 16 ) 
8 List of products subject to 
licensing  Please provide the HS codes and detailed descriptions of the 
products. In case of a long list, please attach the list as an Annex in 
MS WORD document.  
 
Please refer to the Annex  
9 Nature of licensing  Automatic: [  ] 
 
Non-Automatic: [ ✓] 
10 (a)  Protect public morals;  
 
1 It is understood that the notifying Member has also completed its notification obligations under 
Article  1.4(a) and Article 8.2(b) regarding the relevant law/regulation/procedure notified for by filling this form 
in a full and complete manner.  
2 "New licensing regulation/procedure" is understood to refer to any newly introduced law, regulation or 
procedure, and those wh ich are in force but being notified for the first time to the Committee.  G/LIC/N/2/MAC/6  
 
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   Category  Notification details  
Administrative 
purpose/measure being 
implemented  (b)  Protect human, animal or plant life and health; protect 
environment;  
(c)  Collect trade statistics or market surveillance;  
(d)  Protection of patents, trademarks and copyrights, and 
the prevention of deceptive practices;  
(e)  Pursue obligations under the UN Charter and other 
international treaties ( i.e. CITES, Basel Convention, 
Rotterdam Convention, UNSC Resolutions etc.)  
(f)  Quota (including TRQ) administration;  
(g)  Regulate imports of arms, ammunition or fissionable 
materials and safeguard national security;  
(h)  Other: ______________ (please specify)  
11 Administrative body(ies) 
for submission of 
applications   
 Pharmaceutical Administration Bureau  
Address: Avenida Sidónio Pais, No. 51, Edif . "China Plaza", 1 -4.º 
andar, Macau  
Website: http://www.isaf.gov.mo/   
Telephone: (853) 28524708  
E-Mail: info@isaf.gov.mo   
12 Contact point for 
information on eligibility  Pharmaceutical Administration Bureau  
Department of Registration  
Address: Avenida Sidónio Pais, n.º 51, Edif. "China Plaza ", 1-4.º 
andar, Macau  
Website: http://www.isaf.gov.mo/   
Telephone: (853) 85983514  
Email: dr@isaf.gov.mo   
13 Expected duration of 
licensing procedure  Ongoing  
 
14 A summary of the 
notification in one of the 
WTO official languages   1. Law No. 11/2021 stipulates that unless exempted by law, the 
import, export and wholesale activities of proprietary Chinese 
medicines, toxic Chinese medicinal materials or general Chinese 
medicinal materials included in the "List of Chinese Medicinal 
Materi als Adopted in the Macao SAR ", and their prepared 
portions or extracts shall be subject to licensing. It also 
stipulates that all proprietary Chinese medicines must first be 
registered with the Pharmaceutical Administration Bureau 
before they can be circul ated in the Macao SAR.  
2. Administrative Regulation No. 46/2021 sets out the application 
requirements for import, export and wholesale licenses of 
traditional Chinese medicines and the labelling requirements of 
proprietary Chinese medicines.  
3. Secretary for Soc ial Affairs and Culture 's Decision No. 95/2021 
approves the list of Chinese medicinal materials adopted in the 
Macao SAR.  
15 In the case of 7(b), please 
indicate the type of new 
change(s)  (a)  Termination  
(b)  Suspension  
(c)  Modification o f specific details in existing  
procedures:  
 Product coverage;  
 Administrative purpose;  
 Automatic or Non -automatic;  
 Duration of licensing;  
 Change the nature of quantity/value restriction;  
 Eligibility of applicants;  
 Contact information on eligibility;  
 Administrative body(ies) for submission of application;  
 Documentation requirements (including application form);  
 Period for Application;  
 Administrative body(ies) to issue licence;  
 Processing time for issuing licence;  
 Licence fee/administrative charge;  G/LIC/N/2/MAC/6  
 
- 3 - 
 
   Category  Notification details  
 Deposit/advance payment and relevant conditions;  
 Appeal regulations/procedures;  
 Validity of licence;  
 Other conditions of licence (extension, transferability, 
penalty of non -use etc.);  
 Foreign exchange requirements;  
 Other: __________ (please specify).  
 
16  Please elaborate the 
changes in detail (in one of 
the WTO official languages)   
 
 
 
_______________  
 
  G/LIC/N/2/MAC/6  
 
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  ANNEX  
CHANGES TO THE L IST OF PRODUCTS SUBJECT TO LICENSING BY PHARMACEUTICAL 
ADMINISTRATION BUREAU  
Product  HS Code  
General Chinese medicinal 
materials, prepared portions 
or extracts  0305.59.40, 0305.59.50, 0507.90.12, 0507.90.92, 0508.00.12, 
0508.00.92, 0510.00.20, 1211.90.70, 1301.90.20, 1302.19.20, 
1515.90.20, 152 1.10.20, 2530.90.30, 3001.90.20, 3003.90.40, 
3004.90.50, 3503.00.20, ex. 0814.00.00, ex. 0908.31.00, ex. 0908.32.00,  
ex.1211.50.00 ,  ex. 1702.60.00, ex. 2501.00.90, ex. 2507.00.00, 
ex. 2513.10.00, ex. 2515.11.00, ex. 2520.10.90, ex. 2520.20.90, 
ex. 2524.90.91, ex. 2525.10.00, ex. 2525.20.00, ex. 2526.10.20,  
ex. 2526.20.20, ex. 2528.00.20, ex. 2530.10.00, ex. 2601.11.00, 
ex. 2601.12.00, ex. 2603.00.00, ex. 2802.00.00, ex. 2824.10.00, 
ex. 2833.19.00, ex. 2833.25.00, ex. 2833.29.00, ex. 2833.30.00,  
ex. 2836.99.90, ex. 2906.19.00, ex. 2914.29.10, ex. 3806.10.00, 
ex. 7101.10.00, ex. 7101.21.00, ex. 7101.22.00, ex. 7204.49.90  
Toxic Chinese medicinal 
materials, prepared portions 
or extracts  0507.90.11, 0507.90.91, 0508.00.11, 0508.00.91, 0510.00.10, 
1211.90.60, 1301.90.10, 1302.19.10, 1515.90.10, 1521.10.10, 
2530.90.20, 3001.90.10, 3003.90.30, 3004.90.40, 3503.00.10, 
ex. 2617.90.10, ex. 2805.40.00, ex.  2811.29.20, ex. 2852.10.10, 
ex. 2852.10.20, ex. 2852.10.50, ex. 2852.90.00  
 
Remarks: "ex." refers to products that matched the product descriptions  
 
__________