Changes to Registered Information of Proprietary Chinese Medicines

How to Apply

Time of application

Before implementing the relevant changes to the registered information of a proprietary Chinese medicine in the Macao SAR, the Pharmaceutical Administration Bureau must be notified or prior authorization from the Pharmaceutical Administration Bureau must be obtained.

Application eligibility

The registration holder of the proprietary Chinese medicine may submit the application.

Documents Required

A duly completed Application Form for Changes to Registered Information of Proprietary Chinese Medicines;
The following information shall be submitted according to the items to be changed:

General documents;
Pharmaceutical Study Data;
Pharmacological and Toxicological Study Data;
Clinical Study Data.

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

The fee for changes to registered information of proprietary Chinese medicines is MOP100.00. (Fee is charged per item of information to be changed; for related changes, all involved items are calculated as a single item.)

Notes:

1. The above fee is subject to an additional 10% stamp duty;

2. 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

Minor changes: The registration holder must notify the Pharmaceutical Administration Bureau at least 30 days before implementing the relevant changes in the Macao SAR.

Authorization-type changes:

Moderate changes
The Pharmaceutical Administration Bureau shall make a decision within 90 days from the date on which the applicant submits the application for changes to registered information and all complete required information.

Major changes
The Pharmaceutical Administration Bureau shall make a decision within 240 days from the date on which the applicant submits the application for changes to registered information and all complete required information.