G/LIC/N/1/MAC/6  
 
24 June 2016  
(16-3424)  Page: 1/2  
Committee on Import Licensing  Original: English  
 
 AGREEMENT ON IMPORT LICENSING PROCEDURES 
NOTIFICATION UNDER ARTICLE 1.4(A)1 AND/OR 8.2(B)2 OF THE AGREEMENT 
MACAO, CHINA 
The following notification, dated 21 June 2016, is be ing circulated at the request of the delegation 
of Macao, China.  
1. Notification under Article 1. 4(a) [X];  Article 8.2(b) [X] (If the notification is made 
under both Articles please mark both with an X)
 
2. Source(s) where the Import Licensin g Procedure(s) has(ve) been published 
(Official Gazette, publication, website, etc.):  
 http://en.io.gov.mo    
3. Date of publication1:  23 March 2016  
Effective date of requirement:  24 March 2016  
4. Copy(ies) of publication (in case of Art. 1.4(a))3 and/or legislation (in case of 
Art. 8.2(b))4 is(are) available for consultation by Members: 
[X] at the WTO Secretariat (Market Access Division)  (In this case please attach 
copies of the publication and or legislation, if possible in electronic format:  Microsoft 
Word or compatible software)  
and/or 
[X] by request at the following addr ess and fax numbers, and/or e-mail and 
website: 
 Macao Economic Services 
 Rua Dr. Pedro José Lobo, 1-3, 6/F, Macao   Fax: (853) 2871 2553 
 Email: info@economia.gov.mo  
5. In the case that they are not in one of the three WTO official languages, 
(English, French or Spanish)  a SUMMARY of the publication (in case of Art. 
1.4(a)) and/or the legislatio n (in case of Art. 8.2(b))4: 
  According to the Decision of the Director of Health Bureau no. 04/SS/2016, the 
 application of an import license for a drug product containing new chemical or biological  entity must be supported by the following documents:   
 -  official evidence of registration approval of the drug product; 
 -  expert evaluation reports on the safety , efficacy and quality of the drug product; G/LIC/N/1/MAC/6 
 
- 2 - 
 
    -  electronic copy of clinical studies substantiating the use of the drug product in Asian  
populations, or evaluation reports on its clinical experiences in Asian countries or  
 regions; 
 -  European Union Risk Management Plan (EU-RMP) or US Food and Drug 
Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) for the drug products. 
 
6. Other pertinent data or information (i.e. title of the proposed or adopted 
law/regulation establishing th e Import Licensing Procedure): 
  According to the Decision of the Director of Health Bureau no. 04/SS/2016, the 
application of an import license for a drug product containing new chemical or biological 
entity must be supported by the required documents.  
 
 
__________  
                                                
1 "[...] Publication shall take place, whenever prac ticable, 21 days prior to the effective date of the 
requirement but in all events not later than such effect ive date.  Any exception, de rogations or changes in or 
from the rules concerning licensing procedures or the list of products subject to import licensing shall also be 
published in the same manner and with in the same time periods as specifie d above."  See Art. 1.4(a) of the 
Agreement. 
2 "Each Member shall inform the Committee of any chan ges in its laws and regulations relevant to this 
Agreement and in the administration  of such laws and regulations." 
3 "The rules and all information concerning procedures  for the submission of applications, including the 
eligibility of persons, firms and institutions to make such applications, the admini strative body(ies) to be 
approached, and the lists of products subject to the li censing requirement shall be published, in the sources 
notified to the Committee on Import Li censing [...] Copies of th ese publications shall also  be made available to 
the Secretariat."  See Art. 1.4(a) of the Agreement and document G/LIC/3 "Proce dures for Notification and 
Review under the Agreement on Import Licensing Procedures". 
4 See document G/LIC/3 "Procedures for Notificati on and Review under th e Agreement on Import 
Licensing Procedures".