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)