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Import License Application for Glands and Other Organs for Organotherapeutic Uses, Blood Plasma, Human Blood, and Animal Blood

Import License Application for Glands and Other Organs for Organotherapeutic Uses, Blood Plasma, Human Blood, and Animal Blood


How to apply

Time of application

A prior authorisation for import and an import license must be applied before applying to import glands and other organs for organotherapeutic uses, blood plasma, human blood, and animal blood prepared for therapeutic, prophylactic or diagnostic uses.

 

Application procedures and documents required

  1. Documents required for Prior Authorisation for Import (must be in Chinese or Portuguese)
    1. A completed Application Form for Prior Authorisation for Import of glands and other organs for organotherapeutic uses, blood plasma, human blood, and animal blood;
    2. A completed Prior Authorisation for Import of glands and other organs for organotherapeutic uses, blood plasma, human blood, and animal blood;
    3. Samples of the goods’ external packaging (descriptions or images);
    4. Descriptions of the goods;
    5. Written consent for export issued by the competent authority in the country/region of export;
    6. Inspection documents or non-pollutant documents for the imports (required on a case-by-case basis);
    7. Information about the institution with confirmed users, location and scope of use (such as medical diagnosis, scientific research, educational experiments, industrial or  examination purposes), and descriptions of the disposal solution;
    8. Supporting documents of the institution receiving the human organs and tissue for diagnosis and transplant purposes (for applications for human transplant purposes only).
  2. Application procedures for the Prior Authorisation for Import (with a validity of 90 days starting from the issue date)
    1. The ‘Application Form for Prior Authorisation for Import’ and ‘Prior Authorisation for Import’ must be completed and submitted together with the aforementioned documents to the Centre for Disease Control and Prevention of the Health Bureau for review and approval;
    2. After all the required application documents have been submitted, a ‘Prior Authorisation for Import’ will be issued within 15 working days if the relevant conditions are satisfied;
    3. Any additional documents required must be submitted within 15 working days after the date when the application is made. The application will be cancelled in the case of late submission of the documents. The submitted documents will be archived and will not be returned.
  3. Application procedures for the Import License (with a validity of 30 days staring from the issue date)
    1. Before importing the goods, the applicant must submit the original ‘Prior Authorisation for Import’ and the completed ‘Import License’  to the Health Bureau;
    2. The ‘Import License’ form is sold at the Printing Bureau. A maximum of 5 items of goods can be listed in the  ‘Import License’ form; any additional items should be listed in the appendix;
    3. Applicants must ensure the consistency of information provided in the ‘Import License’ form and the ‘Prior Authorisation for Import’; no changes can be made without approval.
    4. The Health Bureau issues an ‘Import License’ (usually within 2 working days);
    5. The applicant handles the customs declaration and clearance formalities.

Location and service hours

Service location: Centre for Disease Control and Prevention of the Health Bureau

Address: Avenida do Comendador Ho Yin, Edf. de Escritórios do Governo (Qingmao), 18º andar, Macau

Service hours: Monday-Friday: 09:00-13:00, 14:30-17:45 (until 17:30 on Friday)


Fees

No fees are charged for the application.


Processing Time

After submission of all the required documents, a prior authorisation for import will be issued within 15 working days and an import license will be issued within 2 working days.


Relevant specification or Requirements

Please refer to the following link:

Guidelines for Import Authorisation Application for Glands and Other Organs for Organotherapeutic Uses, Blood Plasma, Human Blood, and Animal Blood


Application forms for download

Application form for the prior authorisation for import of glands and other organs for organotherapeutic uses, blood plasma, human blood, and animal blood

Prior authorisation for import of glands and other organs for organotherapeutic uses, blood plasma, human blood, and animal blood


Application Status Enquiry and Result Collection

Method of service result collection: In person


Related Legislations

Lei n.º 7/2003 – Lei do Comércio Externo

Lei n.º 12/2022 – Regime jurídico do controlo de substâncias perigosas

Regulamento Administrativo n.º 27/2023 – Regulamentação principal do regime jurídico do controlo de substâncias perigosas

Regulamento Administrativo n.º 28/2003 – Regulamento das Operações de Comércio Externo

Despacho do Chefe do Executivo n.º 209/2021

Despacho do Chefe do Executivo n.º 131/2023


Content provider: Health Bureau (SS)

Last modified: 2024-10-10 12:20

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All information on this site is based on the official language of the Macao Special Administrative Region. The English version is the translation from the Chinese originals and is provided for reference only. If you find that some of the contents do not have an English version, please refer to the Traditional Chinese or Portuguese versions.