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Useful Guidelines

Drug Registration (With PRS 2.0 information)
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)
  
  Account Registration Form (e-CTS)
  
  Guidance Notes on New Account Registration for e-CTS
  
  Login to e-CTS System
  
  e-CTS User Guide
  
  e-CTS Video Demonstration
  
  Frequently Asked Questions on 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)
- 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)
- Frequently Asked Question
Wholesale Trader
Retail Trader
Manufacturer
- Licence for Manufacturer
- Licence for Manufacturer (Secondary Packaging)
- Registration as Authorized Person
- Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel
- Code of Practice for Licensed Manufacturers and Registered Authorized Persons
- Manufacture of Unregistered Product for Particular Patients
- Guidance on Disposal of Unserviceable/Expired Medicines
Undesirable Medical Advertisements Ordinance (Cap. 231)