Application for Registration of Medicines (Western Medicines)

Service Introduction

Registration of medicines used in the Macao SAR.

Service target and eligibility:

1. First application
   1. The applicant must be:
      1. A pharmaceutical manufacturer producing proprietary medicines or a pharmaceutical company owning proprietary medicines;
      2. A company holding the licence for “firm for import, export and wholesale of pharmaceutical products”.
2. Renewal application
   1. Registration holder who want to renew a medicine registration

Result of application: The Pharmaceutical Administration Bureau will issue a medicine registration licence to the applicants who comply with the approval requirements.

Enquiry

Executive department and unit: Pharmaceutical Administration Bureau – Department of Registration

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: info@isaf.gov.mo