G/LIC/N/3/MAC/19  
 
24 June 2016  
(16-3425)  Page: 1/2  
Committee on Import Licensing  Original: English  
 
 REPLIES TO QUESTIONNAIRE ON IMPORT LICENSING PROCEDURES 
NOTIFICATION UNDER ARTICLE 7.3  
OF THE AGREEMENT ON IMPORT LICENSING PROCEDURES (2016) 
MACAO, CHINA 
The following communication, dated 21 June 2016, is being circulated at the request of the 
delegation of Macao, China. 
 
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Macao, China’s import licensing regime, as notified in document G/LIC/N/3/MAC/18, has not been 
modified and still remains valid for 2016, except for the changes introduced with regard to paragraph 10 under II. A, as follows: 
 
II.  HEALTH BUREAU 
A.  ALCOHOLIC BEVERAGES, TOBACCO, VEHICLES AND PETROLEUM PRODUCTS; OPTICAL DISC 
MANUFACTURING EQUIPMENT AND RAW MATERIALS 
 Outline of System 
A. Narcotic drugs and psychotropic substances; pharmaceutical products and medicines 
(including western medicines and Chinese propri etary medicines); milk modified for infant 
feeding; diagnostic and laboratory reagents; pesticides; essential oil; therapeutic preparations for use on the hair; and chemicals, chemical fertilisers, colouring matter and 
dyes 
 Documentational and Other Requirements for License Application  
1 0 .   W h e n  a p p l y i n g  f o r  a  l i c e n s e  t o  d e a l  w i t h  n a r c o t i c  d r u g s ,  p s y c h o t r o p i c  s u b s t a n c e s ,  
pharmaceutical products and medicines, the importer must provide detailed information namely personal identification, certificate of criminal registration and identification of the proposed licensed premises. 
 
The application of an import license of the prod ucts mentioned in the above paragraph must be 
supported by the following documents:  
 
- Authentic copies of registration certificate issued by the health authority of the 
manufacturing or exporting country and production license issued by the manufacturing 
country;  
- Authorised import certificate issued by the Health Bureau (for narcotic drugs and 
psychotropic substances only); and 
- The Prior Authorisation Application Form. 
 
In addition to that, analytical reports or literatures provided by the manufacturer or exporter and the Prior Authorisation Application Form have to be submitted for application of an import license 
of the other items. G/LIC/N/3/MAC/19 
 
- 2 - 
 
  The application of an import license for a drug prod uct containing new chemical or biological entity 
must be supported by the following documents:  - Official evidence of registration approval of the drug product (e.g. original or certified true 
copies of registration or free sale certificates) in two of the following countries: China, 
Germany, Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Denmark, Slovenia, Spain, United States of America, Estonia, Finland, Fr ance, Greece, Holland, Hungary, Italy, Ireland, 
Japan, Latvia, Lithuania, Luxembourg, Malta,  Poland, Portugal, United Kingdom, Czech 
Republic, Slovak Republic, Roma nia, Sweden and Switzerland; 
- Expert evaluation reports on the safety, efficacy and quality of the drug product; 
- 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 product. 
 
The above documents must be provided to the He alth Bureau for evaluation before an import 
license of the drug product may be granted. 
 
Macao, China also wishes to update the Committee on Import Licensing on two revised specimens of Licensing Documents for Group II under Annex B, as attached
1.  
 
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1 Available for consultation in the Secretariat (Market Access Division)(in original languages only).