Licence for Manufacturer

• Overview of Legislation for Manufacturers (English Only)

• Licence for Manufacturer
• Application for Licence for Manufacturer
• Application for Licence for Manufacturer (e-form)
• Application for Change of Key Personnel and Manufacturing Premises
• Application for Free Sale Certificate of Pharmaceutical Product and Certificate of Pharmaceutical Product
• Application for Free Sale Certificate of Pharmaceutical Product and Certificate of Pharmaceutical Product (e-form)
• GMP Guide for Pharmaceutical Products (With effect between 1 October 2015 and 30 June 2025)(English Only)
• Revised GMP Guide for Pharmaceutical Products (With effect from 1 July 2025)(English Only)

• Licence for Manufacturer (Secondary Packaging)
• Application for Licence for Manufacturer (Secondary Packaging)
• Application for Licence for Manufacturer (Secondary Packaging) (e-form)
• Hong Kong Guide to GMP for the Secondary Packaging of Pharmaceutical Products (With effect between 1 October 2015 and 30 June 2025)
• Hong Kong Guide to GMP for the Secondary Packaging of Pharmaceutical Products (July 2024 version) (With effect from 1 July 2025)
• Guidance for Industry on Secondary Packaging (English Only)

• Registration as Authorized Person
• Application for Registration as Authorized Person
• Application for Registration as Authorized Person (e-form)
• Application for Renewal of Registration as Authorized Person
• Application for Renewal of Registration as Authorized Person (e-form)
• Guidance on Application for Registration as Authorized Person

• Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel
• Guidance on Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel of Licensed Manufacturers in Hong Kong
• List of approved Continuing Professional Development Activities (English Only)
• Continuing Professional Development (CPD) Record Form (English Only)

• Inspection of Manufacturers
• Inspection of Manufacturers of Pharmaceutical Products
• Appeal Rights and Procedures (English Only)

• Current Guidelines and Code of Practice
• GMP Guide
• Code of Practice for Licensed Manufacturers and Registered Authorized Persons
• Pharmaceutical Products Recall Guidelines
• Adverse Drug Reactions Reporting Guidelines
• Guidance on Disposal of Unserviceable/Expired Medicines
• Guidance for Industry
  • Contract Testing Laboratories (English Only)
  • Material Supplier Management (Draft for Information) (English Only)
  • Product Quality Review (English Only)
  • Process Validation (Draft for Information) (English Only)
  • Microbiology Laboratories (English Only)
  • Quality Risk Management (English Only)
  • Computerised System Validation (English Only)
  • Guidance for Industry-Manufacture of Unregistered Product for Particular Patients
  • Request for Permission of Manufacture of Unregistered Pharmaceutical Product by Licensed Manufacturer for Treatment of Particular Patients
  • Premises Design for Manufacturers of Advanced Therapy Products (English Only)
  • Sample Retention for Advanced Therapy Products (Draft for Information) (English Only)