Guidelines & Forms
Guidelines & Forms
Classification of Pharmaceutical Products/Substances
Guidance Notes on Classification of Products as "Pharmaceutical Products" under the Pharmacy and Poisons Ordinance (Cap. 138)
Guidance on Classification of Advanced Therapy Products
Poison or Antibiotic? A Guide to "Class" Entries
Drug Registration
(With PRS 2.0 information)
Registration of Pharmaceutical Products
Guidance Notes on Registration of Pharmaceutical Products/Substances
Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity
Guidance on Application of Certificate of Drug/ Product Registration – Advanced Therapy Products
Guidance Notes on Registration of Biosimilar Products
Guidance Notes on Registration of Medical Gases
Change of Registered Particulars of a Registered Pharmaceutical Product
Guidance Notes on Change of Registered Particulars of Registered Pharmaceutical Products/Substances
Renewal of Pharmaceutical Product Registration
Notification for Renewal of Registration Certificate
Supplementary Information for Drug Registration
Guidelines on the Labelling of Pharmaceutical Products
Guidelines on the Labelling of Pharmaceutical Products
Letters Issued by Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee on Labelling of Pharmaceutical Products (Indexed by Date)
Letters Issued by Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee on Labelling of Pharmaceutical Products from year 2015 (Indexed by Ingredient)
Guidance on Labelling Requirements of Product Code, Unique Donation Identifier and Unique Recipient Identifier for Advanced Therapy Products
Frequently Asked Questions and Answers on Phase 2 Requirement of Bioavailability and Bioequivalence Studies
Questions and Answers on PIC/S GMP Requirements for Registration of Imported Pharmaceutical Products
Request Form for Assessment of GMP Compliance for Manufacturer Outside Hong Kong by the Drug Office
General Requirements for Master Formula and Specifications for Non-Biological Products
Requirement of Elemental Impurities Levels/Limits in Registered Pharmaceutical Products
Requirement of Microbiological Quality of Registered Pharmaceutical Products in Non-sterile Dosage Forms
Supplementary Notes for Application for Registration of Biological Products Involving Alternative / Back Up Manufacturer(s) for Manufacturing Steps (English version only)
Statement of Purpose
Pharmaceuticals Registration System
(PRS 2.0)
Clinical Trial/Medicinal Test
(With e-CTS information)
Application for Certificate for Clinical Trial/Medicinal Test
Certificate for Clinical Trial / Medicinal Test: Guidance Notes for Applicants
Notice of requirement on reporting of local drug related safety report, progress report and final study report in clinical trial
Cover sheet for application for change of Certificate for Clinical Trial/Medicinal Test and subsequent submission
General Workflow for Processing Application for Clinical Trial Certificate
Frequently Asked Questions on Application for the Certificate for Clinical Trial/Medicinal Test
Electronic Clinical Trial System (e-CTS)
Application for Import & Export Licences for Pharmaceutical Products & Medicines (including products for clinical trial)
Guidance for Application for Import and Export Licences for Pharmaceutical Products and Medicines (including products for clinical trial)
Statement of Purpose
Import and Export
(With PLAMMS information)
Application for import and export licences (for pharmaceutical and Medicine)
Guidance for Application for Import and Export Licences for Pharmaceutical Products and Medicines
Guidance Notes on Application for an Export Compulsory Licence of Pharmaceutical Products Under the Patents Ordinance
Statement of Purpose
Application for import and export licences (for Dangerous Drug)
Import and Export of Dangerous Drugs - Guidance Notes for Applicants
Application for import and export licences via Pharmaceuticals Licence Application and Movement Monitoring System (PLAMMS)
Account Registration Form (PLAMMS)
Guidance Notes on Application for New On-line User Account Registration for PLAMMS
Login to PLAMMS System
Guidance Notes for the Application of Import and Export Licences for unregistered pharmaceutical products for re-export purpose
PLAMMS User Guide
Example of Import Licence Form 3 (PLAMMS)
Example of Export Licence Form 6 (PLAMMS)
Frequently Asked Question
Wholesale Trader
Application for wholesale dealing of medicines (with Effective from Sept 2023)
Application for wholesale dealing of medicines (e-form) (with Effective from Sept 2023)
Application for Change of Particulars for Licence Holder of Wholesale Dealer Licence (with Effective from May 2024)
Pharmaceutical Products Recall Guidelines (with Effective from March 2024)
Guidance Notes on Manufacture, Wholesale, Storage and Transport of Medical Gases
Guidance on Disposal of Unserviceable/Expired Medicines (with Effective from May 2020)
Code of Practice for Holder of Wholesale Dealer Licence (with effect from 1 August 2021)
Retail Trader
Application for Retail dealing of medicines
Labelling of Dispensed Medicines
Code of Practice for Authorized Seller of Poisons (2021) (with effect from 1 August 2021)
Guidance on Disposal of Unserviceable/Expired Medicines
"Guideline on Current Good Radiopharmacy Practice (cGRPP) for the Small Scale Preparation of Radiopharmaceticals" issued by the European Association of Nuclear Medicine
Code of Practice for Listed Seller of Poisons (2021) (with effect from 1 August 2021)
Manufacturer
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)
Inspection of Manufacturers of Pharmaceutical Products
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)
Code of Practice for Licensed Manufacturers and Registered Authorized Persons
Manufacture of Unregistered Product for Particular Patients
Guidance for Industry-Manufacture of Unregistered Product for Particular Patients
Request Form for Permission of Manufacture of Unregistered Pharmaceutical Product by Licensed Manufacturer for Treatment of Particular Patients
Guidance Notes on Manufacture, Wholesale, Storage and Transport of Medical Gases
Guidance on Disposal of Unserviceable/Expired Medicines
Undesirable Medical Advertisements Ordinance (Cap. 231)
Guidelines on Undesirable Medical Advertisements Ordinance(Cap. 231)
Annex A- Examples of Prohibited and Allowable Claims under Schedule 1 & 2 (in Chinese only)
Annex B- Supplementary Guidelines on Regulation of Six Groups of Health Claims of Orally Consumed Products
Frequently Asked Questions
Briefing Video
Regulation of Advanced Therapy Products
Regulation of Medical Gases
Guidelines
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