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Pharmaceutical Manufacturers
Pharmaceutical Manufacturers
About Us (English Only)
Latest News (English Only)
Licensing of 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)
Revised 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)
Disciplinary Actions Against Pharmaceutical Manufacturers
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)
Meetings with Local Manufacturers (English Only)
Frequently Asked Questions (English Only)
Pharmaceutical Manufacturers
