Service Introduction
Registration of medicines used in the Macao SAR.
Service target and eligibility:
- First application
- The applicant must be:
- A pharmaceutical manufacturer producing proprietary medicines or a pharmaceutical company owning proprietary medicines;
- A company holding the licence for “firm for import, export and wholesale of pharmaceutical products”.
- The applicant must be:
- Renewal application
- Registration holder who want to renew a medicine registration
Result of application: The Health Bureau will issue a medicine registration licence to the applicants who comply with the approval requirements.
Enquiry
Executive department and unit: Health Bureau- Department of Pharmaceutical Affairs – Division of Pharmacovigilance and Pharmacoeconomics
Correspondence address: Avenida Sidónio Pais, n.º 51, Edif. “China Plaza”, 1-3.º andar, Macau
Telephone: (853) 8598 3442 / (853) 8598 3441
Facsimile: (853) 2852 4016
E-mail: daf@ssm.gov.mo