Glands and other organs for organo-therapeutic uses, blood plasma, human blood, animal blood
- Document symbol
- G/LIC/N/3/MAC/28
- Original language
- English
- Published on
- 15/10/2025
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.
According to Article 9 of the External Trade Law (Law No. 7/2003), external trade activities involving goods listed in the import list (Table B) require an import licence, and the import list (Table B) is issued by the Chief Executive.
According to Article 3-A of Administrative Regulation No. 28/2003 – Regulations on External Trade Activities, the issuance of import licences for goods indicated in Group B2 of Table B falls within the competence of the Health Bureau.
Group B2 of Table B includes specific imported goods classified as Glands and other organs for organo-therapeutic uses, blood plasma, human blood, animal blood, all supervised by the Health Bureau.
They are described as follows:
- Glands and other organs for organo-therapeutic uses (HS code: 3001.90.90)
- Blood plasma (HS code: 3002.12.10, 3002.12.90)
- Human blood (HS code: 3002.90.30)
- Animal blood prepared for therapeutic, prophylactic or diagnostic uses (HS code: 3002.90.40)
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
An import licence issued by Health Bureau is required for the products mentioned above, which are specified in Group B2 of Table B (HS code: 3001.90.90, 3002.12.10, 3002.12.90, 3002.90.30, 3002.90.40) under Annex II of Chief Executive's Decision No. 209/2021.
Q3. The system applies to goods originating in and coming from which countries?
The system applies to goods originating in and coming from all countries/regions outside Macao, China.
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 import licensing is not to restrict the quantity or value of imports, the purpose of the licensing is to regulate import activities, ensure the justification of imports and usage and reduce public health risks.
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 a statutory requirement maintained under Law No. 7/2003, amended by Law No. 3/2016; and Administrative Regulation No. 28/2003, amended by Administrative Regulation No. 19/2016, No. 35/2021, No. 45/2022 and Administrative Regulation No. 27/2023, with implementing Law No.12/2022 on the Legal Regime for the Control of Dangerous Substances; and Chief Executive's Decision No. 209/2021. Legislation does not leave the 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)?
The prior authorization application can be issued within 15 working days, and the import licence will be issue within 2 working days.
Q7.b. Can a licence be granted immediately on request?
Where there is proof of a genuine need, import licences might be processed immediately 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 licence and/or importation may 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 approval of the following authorities should be consulted for transport permit: the Marine and Water Bureau if imported by sea; the Civil Aviation Authority if imported by air; the Public Security Police Force if imported by land; and the Macao Customs Services for customs formalities.
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 import licence will not be refused if the general criteria are met. The applicant has the right to appeal to the Director of Health Bureau if the reasons for refusal are given.
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?
Importers who comply with Article 11 of Law No.7/2003 are eligible to apply for import licences.
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?
Importers are required to submit an import licence, supported by the prior authorization form of the imported products issued by the Health Bureau. The required documents and information are listed on the application forms and prior authorization forms, which can be found in Annex B.
Q11. What documents are required upon actual importation?
The import licence is essentially required upon actual importation. The approval document from the other department when applicable.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
No fee is charged.
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 prior authorization is valid for 90 days from the issue date, and the import licence is valid for 30 days from the issue date. If the products which are being imported contain dangerous substances of Class 6.2 (Infectious substances), the import licence will be valid for 20 days from the issue date. 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-utilization of licence or a portion of a licence.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
The licences 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?
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
There are no other administrative procedures.
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?
There is no foreign exchange control.