Professional Guide: Registration of Pharmaceutical Products and Substances in Hong Kong

This guide provides essential information for healthcare professionals, manufacturers, and distributors regarding the registration of pharmaceutical products and substances in Hong Kong.

Regulatory Framework

Governing Legislation

• Pharmacy and Poisons Ordinance (Cap. 138)

  • Primary legislation for pharmaceutical products
  • Registration requirements and procedures
  • Enforcement provisions

• Supporting Ordinances

  • Antibiotics Ordinance (Cap. 137)
  • Dangerous Drugs Ordinance (Cap. 134)
  • Undesirable Medical Advertisements Ordinance (Cap. 231)

Registration Requirements

Products Requiring Registration

1. Pharmaceutical Products

   • Products with medicinal claims
   • Products containing drug substances
   • Products affecting physiological functions
   • Advanced therapy products

2. Exemptions

   • Traditional Chinese medicines
   • Manufacturing materials
   • Professional use products
   • Re-export products
   • Clinical trial products

Application Process

Eligibility Criteria

1. Local Manufacturers

   • Must be a licensed manufacturer
   • Must have GMP certification
   • Must comply with PIC/S standards

2. Importers

   • Must be a licensed wholesale dealer
   • Must have manufacturer authorization
   • Must meet import requirements

Required Documentation

1. Basic Information

   • Business registration certificate
   • Manufacturer's authorization
   • Application authorization

2. Technical Documentation

   • GMP certificate
   • Free Sale Certificate
   • Product specifications
   • Quality control data

3. Special Requirements

   • Animal origin materials documentation
   • Multiple manufacturer declarations
   • Bioequivalence data (if applicable)

Quality Standards

Manufacturing Requirements

1. GMP Compliance

   • PIC/S GMP standards
   • Quality management system
   • Facility requirements

2. Quality Control

   • Release specifications
   • Stability data
   • Validation protocols

Pharmacopoeial Standards

• Chinese Pharmacopoeia
• British Pharmacopoeia
• European Pharmacopoeia
• International Pharmacopoeia
• Japanese Pharmacopoeia
• United States Pharmacopoeia

Application Submission

Online System

• Use PRS 2.0 system
• Submit electronic documents
• Pay application fee (HK$1,100)

Supporting Documents

• Submit original certificates
• Provide certified copies
• Include translations if needed

Post-Approval Requirements

Registration Fee

• HK$1,370 per product
• Payable upon approval
• Required for certificate collection

Compliance Obligations

1. Documentation

   • Maintain records
   • Update information
   • Report changes

2. Quality Assurance

   • Regular testing
   • Stability monitoring
   • Complaint handling

Special Considerations

Patent Rights

• Board does not consider patents
• Applicants responsible for compliance
• Potential infringement risks
• Legal consultation recommended

Multiple Manufacturers

• Single manufacturing pathway preferred
• Alternative pathways require separate applications
• Clear documentation of roles required

Application Tracking

Progress Monitoring

• Track application status
• Quote file reference
• Contact Drug Registration Unit
• Follow up as needed

Important Notes

Legal Compliance

• Follow current legislation
• Monitor regulatory updates
• Maintain documentation
• Ensure quality standards

Professional Responsibility

• Verify product eligibility
• Ensure complete documentation
• Monitor application progress
• Maintain compliance

Contact Information

Drug Office, Department of Health

• Website: www.drugoffice.gov.hk

Additional Resources

• Legislation: www.elegislation.gov.hk