How to Apply
Time of application: Before applying for the import licence for vaccines, the applicant must first obtain the relevant prior authorisation for import from the Pharmaceutical Administration Bureau.
Eligibility: Companies holding the licence for “firms for import, export and wholesale of pharmaceutical products” issued by the Pharmaceutical Administration Bureau.
Application procedures and documents required:
In order for the vaccines to be authorised for import, the applicant should submit in advance the original or certified true copy of the following documents and information:
- Documents listed in the <Prior Authorisation for Import of Medicines (Western Medicines)> webpage;
- All vaccine manufacturers should declare if any bovine-derived substance has been used in the manufacturing process, and furnish the place of origin of the relevant substance(s);
- A relevant “prior authorisation” must be completed for each import application.
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
Fees
Free of charge
Application Processing Time
The prior authorisation will be issued in 3 working days upon receipt of all required documents. (Performance Pledge)
Remarks/ Notes to Application
1. In accordance with the Chief Executive Dispatch no. 120/2005:It is prohibited to produce or import any pharmaceutical products containing bovine-derived substances originating directly or indirectly from areas or countries with confirmed incidence of bovine spongiform encephalopathy.
2. Without prejudice to the provisions of the subsequent paragraphs, the preceding paragraph shall not apply to:
- Medicines of which the importation or production is authorised by the Health Bureau Director in one of the following situations:
- Where an emergency occurs, considering the interests of public health and the absence of an alternative;
- Where the medicine complies with the recommendations of World Health Organization or other equivalent requirements to minimize the risk of transmission of spongiform encephalopathies.
- Bovine-derived materials which, pursuant to the World Health Organization guidelines on transmissible spongiform encephalopathies in relation to pharmaceutical products, are classified as tissues with no potential infectivity for spongiform encephalopathies, such as bones, skin, tendons and milk of cattle.
3. In the manufacture of pharmaceutical products, it is prohibited to use bovine-derived materials of any geographic source that, pursuant to the guidelines specified in subparagraph 2) of the preceding paragraph, are classified as tissues with high potential infectivity for spongiform encephalopathies, such as brain, spinal cord, retina, optic nerve, spinal ganglia, trigeminal ganglia, pituitary gland and dura mater.
Relevant Specifications or Requirements
Technical Instruction of the Health Bureau no. 02/2001 – Regulations on the Import of Pharmaceutical Products Containing Bovine-Derived Substances
Chief Executive Dispatch no. 120/2005 – Regulations on the Production and Import of Drugs Containing Bovine-Derived Substances
Technical Instruction of the Health Bureau no. 02/2000 – Documents Required for Import Licensing of Pharmaceutical Products
Technical Instruction of the Health Bureau no. 03/2005 – Labelling Requirements on the Packaging of Western Medicines
Application Status Enquiry and Result Collection
Method of result collection: In person