Prior Authorisation for Import of Chinese materia medica, traditional Chinese medicine decoction pieces and extracts

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How to Apply

Time of application: Before applying for the import licence for Chinese materia medica, traditional Chinese medicine decoction pieces and extracts, the applicant must first obtain the relevant prior authorisation for import from the Pharmaceutical Administration Bureau.^Note

Note: The management of granules of traditional Chinese medicines is integrated in the scope of management of traditional Chinese medicine decoction pieces, to which, the present application procedure applies.

Eligibility:

• Companies holding the licence for “firms for import, export and wholesale of pharmaceutical products” issued by the Pharmaceutical Administration Bureau.
• Companies holding the licence for “import, export and wholesale of products used in traditional Chinese medicines” issued by the Pharmaceutical Administration Bureau.
• Chinese medicine pharmaceutical factory.

Application procedures and documents required:

Wholesalers are required to submit the following documents three working days prior to importation:

• Chinese materia medica

1. A copy of the exporter’s licence (plantation trading establishment or agricultural trading market);
2. A list of Chinese materia medica intended to be imported through the relevant trading establishment;
3. Executive standards;
4. A copy of the relevant sales receipts or purchase contract;
5. A completed “Prior Authorisation for Import of Chinese herbal medicines, traditional Chinese medicine decoction pieces and extracts”.[doc][pdf]

• Traditional Chinese medicine decoction pieces

1. A copy of the manufacturer’s licence;
2. A list of Traditional Chinese medicine decoction pieces to be imported through the relevant manufacturer;
3. Execution standards and concoction processes;
4. A copy of the relevant sales receipts or purchase contract;
5. A completed “Prior Authorisation for Import of Chinese herbal medicines, traditional Chinese medicine decoction pieces and extracts”.[doc][pdf]

• Traditional Chinese medicine extracts

1. A copy of the manufacturer’s licence;
2. A copy of the relevant extract standard developed by the manufacturer;
3. Execution standards and concoction processes;
4. A copy of the relevant sales receipts or purchase contract;
5. A completed “Prior Authorisation for Import of Chinese herbal medicines, traditional Chinese medicine decoction pieces and extracts”.[doc][pdf]

• Granules of traditional Chinese medicines

1. The original or a certified copy of a certificate of free sale or equivalent document issued by the competent authority of the country or territory of origin, or the country or territory of source;
2. The original or a certified copy of the manufacturing licence issued by the competent authority of the country or territory of origin;
3. The source, quality control and physicochemical properties of the Chinese materia medica;
4. The method of preparation;
5. Sample packaging, labelling and, if available, instruction leaflet;
6. A copy of the relevant sales receipts or purchase contract;
7. A completed “Prior Authorisation for Import of Chinese herbal medicines, traditional Chinese medicine decoction pieces and extracts”.[doc][pdf]

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Location of Application and Service Hours

Location of application: Pharmaceutical Administration Bureau

Address: Avenida do Comendador Ho Yin, Edifício de Escritórios do Governo (Qingmao), 19.º andar, Macau

Service hours:

Mondays to Thursdays: 09:00-13:00; 14:30-17:45

Fridays: 09:00-13:00; 14:30-17:30

Closed on Saturdays, Sundays and public holidays

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Fees

Free of charge

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Application Processing Time

The prior authorisation will be issued in 3 working days upon receipt of all required documents.

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Relevant Specifications or Requirements

Law No 11/2021 – Law on Pharmaceutical activities in the field of traditional Chinese medicine and registration of traditional Chinese medicines

Administrative Regulation No. 46/2021 – Regulation of the Law on Pharmaceutical activities in the field of traditional Chinese medicine and registration of traditional Chinese medicines

Dispatch of the Secretary for Social Affairs and Culture No. 95/2021 – List of Traditional Chinese Medicine Ingredients applied in the Macao Special Administrative Region

Technical Instruction of the Pharmaceutical Administration Bureau no 24/ISAF/2022 – Regulations for the registration of proprietary Chinese medicines with bovine origin

Technical Instruction of the Pharmaceutical Administration Bureau no 27/ISAF/2022 – Technical requirements of the application for importation of Chinese materia medica, traditional Chinese medicine decoction pieces and extracts

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Application Status Enquiry and Result Collection

Method of result collection: In person

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