Basic information
Outline of the system
The import of narcotic drugs and psychotropic substances is subject to licensing control under Decree-Law No.34/99/M and Law No.17/2009. Law No.17/2009 has been amended several times, the schedule of amendments for Law No.10/2019 are listed in the following table.
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Schedule of amendments for Law No. 10/2019 |
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Law No. |
Effective date |
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Law No. 4/2014 |
03/04/2014 |
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Law No. 10/2016 |
20/12/2016 |
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Law No. 10/2019 |
21/05/2019 |
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Law No. 22/2020 |
24/10/2020 |
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Law No. 10/2021 |
17/07/2021 |
Licensing in relation to substances listed in Tables 1-4 of Law No.17/2009 is administered by the Pharmaceutical Administration Bureau, whereas the controlled chemicals of 1988 UN Convention, as listed in Tables 5 to 6 appended to the Law, are administered by the Economic and Technicalogical Development Bureau. (Details of the licensing system of the controlled chemicals of 1988 UN Convention are specified in Section D of Part III.) In this regard, narcotic drugs and psychotropic substances mentioned in this section refer to substances administered by the Pharmaceutical Administration Bureau, as specified in Tables 1 to 4 of Law No.17/2009.
The import of narcotic drugs, psychotropic substances, pharmaceutical products and medicines (including western medicines, Chinese medicines and natural medicines) is controlled through (i) licensing of importers and (ii) issuing of import license. An importer of narcotic drugs, psychotropic substances, pharmaceutical products, western medicines, Chinese medicines or natural medicines has to be licensed with the Pharmaceutical Administration Bureau before applying for an import license to import these products for each consignment. Import licenses are also required for importation of the other items specified above. Importers of such products have to apply for the import licenses from the Pharmaceutical Administration Bureau to import the mentioned products for each consignment.
The licensing system is intended for public health reasons and to fulfil the Macao SAR’s international obligations.
Product coverage
An import license issued by the Pharmaceutical Administration Bureau is required for the import of all of the above-mentioned products, which are specified in the Group B1 of Table B under Annex II of Chief Executive's Decision No.209/2021, and Tables 1 to 4 appended to the current version of Law No.17/2009.
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Non-automatic licensing to protect human life or health
Products under restriction as to the quantity or value of imports
The purpose of the import licensing system is not to restrict the quantity or value of imports, but for public health reasons and to prevent diversion of narcotic drugs and psychotropic substances into illicit markets.
Questions for products under restriction as to the quantity or value of imports
Not applicable.
The system applies to products originating from which country?
The licensing system applies to the above-mentioned products coming from all countries/territories outside the Macao SAR.
Expected duration of licensing procedure
Ongoing
Legal requirements
Is the licensing statutorily required?
The import licensing system is statutorily provided under the Decree-Law No.34/99/M; Decree Law No.58/90/M; Law No.7/2003, amended by Law No.3/2016; Administrative Regulation No.28/2003, amended by Administrative Regulation No.19/2016 and Administrative Regulation No.35/2021; the current version of Law No.17/2009; and Law No.11/2021.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Legislation does not leave designation of products subject to licensing to administrative discretion.
Is it possible for the government to abolish the system without legislative approval?
Legislative approval is required when any changes are introduced to the existing system.
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
Narcotic drugs, psychotropic substances, pharmaceutical products, western medicines, Chinese medicines and natural medicines have to be registered with the Pharmaceutical Administration Bureau, before they can be allowed to be imported for the purpose of local sale or distribution.
What persons or firms are eligible to apply for a licence?
A company is required to hold an appropriate firm license issued by the Pharmaceutical Administration Bureau before it can apply for an import license. Application for the firm license is open to all qualified traders which comply with Article 11 of Law No.7/2003 and other relevant legislations.
Is there a registration fee?
The fee charged for the firm license for the import, export and wholesale of pharmaceutical products is MOP 3,000; the fee charged for the firm license for the import, export and wholesale of Chinese medicines and natural medicines is also MOP3,000; and the charge for the annual renewal of either license is MOP400. A licensed firm for the import, export and wholesale of pharmaceutical products has to hold an additional permit if it engages in the import of narcotic drugs and psychotropic substances. The fee charged for the said permit is MOP 10,000; and MOP 1,500 is charged for the annual renewal.
Is there a published list of authorized importers?
A list of licensed importers is available on the Pharmaceutical Administration Bureau website or upon request. The information regarding the importers is published on the Official Gazette when the registration license is issued to them.
Contact point for information on eligibility
Ministry/Authority
Economic and Technological Development Bureau
Address
Rua Dr. Pedro José Lobo, 1-3, Luso International Bank Building, 2/F., Macao, China
Telephone
(853) 8597 2281
Fax
(853) 2871 2551
Contact officer
Mr. Tai Kin Ip (Director)
Submission of an application
Administrative body(ies) for submission of an application
Pharmaceutical Administration Bureau
Avenida Sidónio Pais, No.51, Edif. "China Plaza", 1-4° andar, Macau
http://www.isaf.gov.mo/
Tel: (853) 28524708
E-mail: info@isaf.gov.mo
Documentation requirements
What information is required in applications?
When applying for a license for the import, export and wholesale of narcotic drugs, psychotropic substances, pharmaceutical products, western medicines, Chinese medicines and natural medicines, the importer must provide detailed information including but not limited to personal identification, certificate of criminal record and design plan of the proposed licensed premises.
What documents is the importer required to supply with the application?
When applying for an import license of pharmaceutical products, western medicines, Chinese medicines, natural medicines and other products regulated by the Pharmaceutical Administration Bureau as mentioned in the above paragraph, the importers are required to submit a duly completed import license, supported by the prior authorization form of the importing products issued by the Pharmaceutical Administration Bureau.
When applying for an import license of narcotic drugs or psychotropic substances, the importers are required to submit a duly completed import license, supported by the import certificate and prior authorization form of the importing narcotic drugs/psychotropic substances issued by the Pharmaceutical Administration Bureau.
Window of submission of an application
How far in advance of importation must application for a licence be made?
Application for import license should be submitted in advance of importation taking into account the processing time. Prior authorisation for the importation of registered narcotic drugs, psychotropic substances, pharmaceutical products, western medicines, Chinese medicines, natural medicines and other regulated items should be obtained from the Pharmaceutical Administration Bureau before applying for an import license.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
There is no limitation of time as to the period of the year during which application for license and/or importation is to be made.
Issuing the license
Can a licence be granted immediately on request?
Where there is proof of a genuine need, import license may exceptionally be granted on request.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
The prior authorisation will be issued within three working days, while the import license will be issued on the same day of application.
Which administrative body is responsible for approving application of licences?
The Pharmaceutical Administration Bureau is the sole administrative organ responsible for the authorization of import licenses of most of the mentioned categories of products except those medicines covered under CITES. The Economic and Technological Development Bureau is the competent authority for issuing import licenses for those medicines containing ingredients subject to CITES protection, and the Pharmaceutical Administration Bureau is meanwhile involved in offering recommendations on authorisation of application for the said import license.
Must the applications be passed on to other organs for visa, note or approval?
There is no limitation of time as to the period of the year during which application for license and/or importation is to be made.
Are there any other conditions attached to the issue of a licence?
No.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
No fee is charged for the issue of the import license.
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
No deposit or advance payment is required.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
Application for an import license will not be refused if the ordinary criteria are met.
Are the reasons for any refusal given to applicants?
Reasons for refusal will be given to the applicant in case of unsuccessful application
Have applicants a right of appeal in the event of refusal to issue a licence?
Yes the applicant has the right to appeal.
If so, to what bodies and under what procedures?
The applicant has the right to appeal to the Director of the Pharmaceutical Administration Bureau.
Importation
Are there any limitations as to the period of year during which importation may be made?
There is no limitation of time as to the period of the year during which application for license and/or importation is to be made.
What documents are required upon actual importation?
The valid import license is the only document required upon actual importation. Samples of the application forms and the import license are attached in Annex B.
Annex B - Specimens of Licensing documents for Group II.pdfAre there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
No other administrative procedures are required prior to importation.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
The import license is valid for 30 days from the day of issuance. The validity cannot be extended.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for the non-utilisation of an import license.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Import licenses are not transferable between importers.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
No foreign exchange control.