How to Apply
Time of application
The registration holder shall submit the application for renewal at least 90 days before the expiry of the registration’s validity period.
Application eligibility
The registration holder of the proprietary Chinese medicine may submit the application.
Documents Required
- A duly completed Application Form for Renewal of Registration of Proprietary Chinese Medicines;
- Declaration for renewal of registration of the proprietary Chinese medicine;
- Test report issued by the proprietary Chinese medicine manufacturer or a third-party testing institution for the most recent manufacturing batch of the proprietary Chinese medicine;
- For proprietary Chinese medicines manufactured outside the Macao SAR, the original or certified copy of the certificate of registration or sale of the proprietary Chinese medicine issued by the competent authority of the country or region of origin, or of the country or region of provenance, except for proprietary Chinese medicines manufactured in Hengqin in accordance with Chief Executive Dispatch No. 191/2021;
- Adverse reaction monitoring report of the proprietary Chinese medicine;
- For Improved New Medicines and Innovative Medicines, a report proving that the proprietary Chinese medicine has passed efficacy and stability tests during the registration’s validity period shall also be submitted at the time of the first registration renewal application.
Location of Application and Service Hours
Location of application: Pharmaceutical Administration Bureau – Department of Registration – Division of Traditional Chinese Medicines
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
MOP220.00, including stamp duty.
Note:
In accordance with Article 78(2) of Administrative Regulation No. 46/2021, “paid fees will not be refunded if the application is not accepted, is rejected, or the dossier is filed.”
Application Processing Time
The registration holder shall submit the application for renewal at least 90 days before the expiry of the registration’s validity period.
Relevant Regulations or Requirements
Application Status Enquiry and Result Collection
Method of result collection: In person