Narcotic drugs and psychotropic substances, pharmaceutical products and medicines
- Document symbol
- G/LIC/N/3/MAC/26
- Original language
- English
- Published on
- 31/08/2023
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another 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. 17/2009 are listed in the following table. Licensing in relation to substances listed in Tables 1 to 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 Technological 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.
Schedule of amendments for Law No. 17/2009
| Law No. | Effective date |
|---|---|
| Law No. 4/2014 | 03/04/2014 |
| Law No. 10/2016 | 20/12/2016 |
| Law No. 10/2019 | 21/05/2019 |
| Law No. 22/2020 | 24/10/2020 |
| Law No. 10/2021 | 17/07/2021 |
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.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
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.
Q3. The system applies to goods originating in and coming from which countries?
The licensing system applies to the above-mentioned products coming from all countries/territories outside the Macao SAR.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
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.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
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. Legislation does not leave designation of products subject to licensing to administrative discretion. Legislative approval is required when any changes are introduced to the existing system.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
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. The prior authorisation will be issued within three working days, while the import license will be issued on the same day of application.
Q7.b. Can a licence be granted immediately on request?
Where there is proof of a genuine need, import license may exceptionally be granted on request.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may 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.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
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.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
Application for an import license will not be refused if the ordinary criteria are met. Reasons for refusal will be given to the applicant in case of unsuccessful application, and the applicant has the right to appeal to the Director of the Pharmaceutical Administration Bure
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
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. 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. The fee charged for the firm license for the import, export and wholesale of pharmaceutical products is MOP3,000; 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 MOP10,000; and MOP1,500 is charged for the annual renewal. A list of licensed importers is available on 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.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
When applying for a license for the import, export and wholesale of narcotic drugs, psychotropic substances, pharmaceutical products, western medicines, Chinese medicines or 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.
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.
Q11. 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.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
No fee is charged for the issue of the import license.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
No deposit or advance payment is required.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
The import license is valid for 30 days from the day of issuance. The validity cannot be extended.
Q15. 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.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Import licenses are not transferable between importers.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
No.
Other Procedural Requirements
Q18. Are 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.
Q19. Is foreign exchange automatically provided by the banking authorities for goods to be imported? Is a licence required as a condition to obtaining foreign exchange? Is foreign exchange always available to cover licences issued? What formalities must be fulfilled for obtaining the foreign exchange?
No foreign exchange control.