Frequently asked questions
- What kind of licence is required in order to produce medicines in the Macao SAR? What are the requirements of the Health Bureau for the establishment of drug manufacturing premises?
- What is the processing time for the application of “Licence for Pharmaceutical Production”? Is there any charge for the service? How long is the licence valid for?
- Does the Health Bureau issue the certificate of “Good Manufacturing Practice for Pharmaceutical Products (GMP)”? Is there any charge for this service? How long is the certificate valid for?
1. What kind of licence is required in order to produce medicines in the Macao SAR? What are the requirements of the Health Bureau for the establishment of drug manufacturing premises?
Any person who intends to produce medicines in Macao must first obtain an “Industrial Licence” from the Economic and Technological Development Bureau. Next, the Health Bureau will inspect the relevant drug manufacturing premise upon request of the applicant; after verifying the premise has met the corresponding technical requirements for production, the “Licence for Pharmaceutical Production” will be issued.
For the application of “Industrial Licence”, please contact the Economic and Technological Development Bureau at 85972629 or visit the Economic and Technological Development Bureau’s website for details; for the application of “Licence for Pharmaceutical Production”, please refer to the “General Guidelines on Pharmaceutical Production” and “Technical Guidelines on Hygiene in Pharmaceutical Industry”.
2. What is the processing time for the application of “Licence for Pharmaceutical Production”? Is there any charge for the service? How long is the licence valid for?
After receiving a written application for the licence, the Pharmaceutical Affairs Department of the Health Bureau will open a file for follow-up and arrange for an inspection of the drug manufacturing premise; if the premise passes the inspection, the “Licence for Pharmaceutical Production” will be issued within 30 days. This service is free of charge. In general situations, the “Licence for Pharmaceutical Production” is valid for 12 months.
3. Does the Health Bureau issue the certificate of “Good Manufacturing Practice for Pharmaceutical Products (GMP)”? Is there any charge for this service? How long is the certificate valid for?
After receiving a written application for the certificate, the Pharmaceutical Affairs Department of the Health Bureau will open a file for follow-up and arrange for a GMP inspection; if the pharmaceutical manufacturing plant passes the inspection, the GMP certificate will be issued within 40 days. This service is free of charge. In general situations, the GMP certificate is valid for 24 months.