How to Apply
Time of application: No relevant provisions.
Application eligibility
- Applicant: Hospitals providing healthcare services in the Macao SAR;
- The manufacturing site of the hospital preparation must comply with the quality management requirements for the production of hospital preparations.
Documents Required
- A duly completed Application Form for Hospital Preparations;
- Description and supporting documents proving that the use of the proprietary Chinese medicine complies with the definition of hospital preparations;
- Quality standards and samples of the packaging, label or package insert;
- Declaration of undertaking responsibility for monitoring adverse drug reactions;
- General documents and Pharmaceutical Study Data of the hospital preparation;
- Declaration that the manufacturing process complies with the quality management requirements for the production of hospital preparations.
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
No fee is required.
Application Processing Time
The review and approval of the application dossier will be completed within 90 days from the date of receipt of all required application documents. If the application is approved, the Pharmaceutical Administration Bureau will issue the authorization certificate for hospital preparations to the applicant.
Relevant Regulations or Requirements
Application Status Enquiry and Result Collection
Method of result collection: In person