Chinese Medicine Regulatory Office

Chinese Medicines and Proprietary Chinese Medicines

Table of Content
Chinese Medicines Traders
#
Name of Form
Form
Online Form
Checklist
Guidelines
1.
Application Form for Retailer Licence in Chinese Herbal Medicines (Form 1A)
Application Form for Retailer Licence in Chinese Herbal Medicines (Form 1A)
Online Form - Application Form for Retailer Licence in Chinese Herbal Medicines (Form 1A)
Documentation Checklist - Application for Retailer Licence in Chinese Herbal Medicines (Checklist 2A)
Handbook of the Application for Chinese Medicines Trader Licences
2.
Application Form for Wholesaler Licence in Chinese Herbal Medicines (Form 1B)
Application Form for Wholesaler Licence in Chinese Herbal Medicines (Form 1B)
Online Form - Application Form for Wholesaler Licence in Chinese Herbal Medicines (Form 1B)
Documentation Checklist - Application for Wholesaler Licence in Chinese Herbal Medicines (Checklist 2B)
Handbook of the Application for Chinese Medicines Trader Licences
3.
Application Form for Wholesaler Licence in Proprietary Chinese Medicines (Form 1C)
Application Form for Wholesaler Licence in Proprietary Chinese Medicines (Form 1C)
Online Form - Application Form for Wholesaler Licence in Proprietary Chinese Medicines (Form 1C)
Documentation Checklist - Application for Wholesaler Licence in Proprietary Chinese Medicines (Checklist 2C)
Handbook of the Application for Chinese Medicines Trader Licences
4.
Application Form for Manufacturer Licence in Proprietary Chinese Medicines (Form 1D)
Application Form for Manufacturer Licence in Proprietary Chinese Medicines (Form 1D)
Online Form - Application Form for Manufacturer Licence in Proprietary Chinese Medicines (Form 1D)
Documentation Checklist - Application for Manufacturer Licence in Proprietary Chinese Medicines (Checklist 2D)
Handbook of the Application for Chinese Medicines Trader Licences
5.
Application Form for Renewal of Chinese Medicines Trader Licences (Form 11)
Application Form for Renewal of Chinese Medicines Trader Licences (Form 11)
Online Form - Application Form for Renewal of Chinese Medicines Trader Licences (Form 11)
Documentation Checklist - Application for Renewal of Chinese Medicines Trader Licences (Checklist 11R)
Guidance Notes of Application for Renewal of Chinese Medicines Trader Licences
6.
Application Form for Change of Address Specified in Chinese Medicines Trader Licences (Form 12)
Application Form for Change of Address Specified in Chinese Medicines Trader Licences (Form 12)
Online Form - Application Form for Change of Address Specified in Chinese Medicines Trader Licences (Form 12)
Guidance Notes of Application for Change of Address Specified in Chinese Medicines Trader Licences
7.
Application Form for Sale of Chinese Herbal Medicines via the Internet
Application Form for Sale of Chinese Herbal Medicines via the Internet
Online Form - Application Form for Sale of Chinese Herbal Medicines via the Internet
Guidance Notes of Application for Sale of Chinese Herbal Medicines via the Internet for Retails of Wholesalers of Chinese Herbal Medicines
8.
Guidance Notes of Application for Certified Copy of Chinese Medicines Trader Licences and Certificates
Guidance Notes of Application for Certified Copy of Chinese Medicines Trader Licences and Certificates
If you encounter problems when downloading the form, please call 2319 5119 or email to cmro@dh.gov.hk for assistance.


Registration of proprietary Chinese medicines
#
Name of Form
Form
Online Form
Checklist
Guidelines
1.
Application Form for Registration of Proprietary Chinese Medicines
Application Form for Registration of Proprietary Chinese Medicines
Online Form - Application Form for Registration of Proprietary Chinese Medicines
Guide for Completion of Application Form for Registration of Proprietary Chinese Medicines
Checklist (1) (Group I registration)
Checklist (1) (Group I registration)
Checklist (2) (Group II registration)
Checklist (2) (Group II registration)
Checklist (3) (Group III registration)
Checklist (3) (Group III registration)
2.
Application Form for Renewal of Registration of Proprietary Chinese Medicines
Application Form for Renewal of Registration of Proprietary Chinese Medicines
Online Form - Application Form for Renewal of Registration of Proprietary Chinese Medicines
Checklist for Submission of Supplementary Documents for Renewal of Registration of Proprietary Chinese Medicines (sample) (Chinese version only)
(Chinese
version
only)
Guidance Notes on Application for Renewal of Registration of Proprietary Chinese Medicines (Chinese version only)
(Chinese
version
only)
3.
Reply Slip for Confirmation of Non-renewal of Registration of Proprietary Chinese Medicines
Reply Slip for Confirmation of Non-renewal of Registration of Proprietary Chinese Medicines (Chinese version only)
Online Form - Reply Slip for Confirmation of Non-renewal of Registration of Proprietary Chinese Medicines (Chinese version only)
4.
Application Form for Certificate of Sale of Proprietary Chinese Medicines
Application Form for Certificate of Sale of Proprietary Chinese Medicines
Online Form - Application Form for Certificate of Sale of Proprietary Chinese Medicines
Guideline for Application for Certificate of Sale of Proprietary Chinese Medicines (Chinese version only)
(Chinese
version
only)
5.
Application Form for Variation of Registered Particulars of Registered Proprietary Chinese Medicines
Application Form for Variation of Registered Particulars (applicable for products issued with a "certificate of registration of proprietary Chinese medicine")
Online Form - Application Form for Variation of Registered Particulars (applicable for products issued with a "certificate of registration of proprietary Chinese medicine")

If you encounter problems when downloading the form, please call 3904 9130 or email to cmro@dh.gov.hk for assistance.


Good Manufacturing Practice (GMP) in respect of proprietary Chinese medicines
#
Name of Form
Form
Online Form
Checklist
Guidance Notes
Guidelines
for the Trade
1.
Application Form for Certificate for Manufacturer (Good manufacturing practice in respect of proprietary Chinese medicines) (Form 1E)
Application Form for Certificate for Manufacturer (Good manufacturing practice in respect of proprietary Chinese medicines) (Form 1E)
Online Form-Application Form for Certificate for Manufacturer (Good manufacturing practice in respect of proprietary Chinese medicines) (Form 1E)
Documentation Checklist - Application for Certificate for Manufacturer (Good manufacturing practice in respect of proprietary Chinese medicines) (Checklist 2E)
Guidance Notes on the Application for Certificate for Manufacturer (Good manufacturing practice in respect of proprietary Chinese medicines)
Documentation Requirements on Application for Certificate for Manufacturer (Good Manufacturing Practice in respect of Proprietary Chinese Medicines) (Guidelines for the Trade)
If you encounter problems when downloading the form or related documents, please call 3908 7296 or email to cmro@dh.gov.hk for assistance.
For more information on GMP, please visit GMP for Proprietary Chinese Medicines Web Resources.


Exemption in accordance with section 158(1) by a person or institution concerned with education or scientific research) (Registration of proprietary Chinese medicines/Chinese Medicines Trader Licences)
#
Name of Form
Form
Online Form
Guidelines
1.
Form of the exemption application in accordance with section 158(1) by a person or institution concerned with education or scientific research in relation to Chinese herbal medicines (E1A)
Form of the exemption application in accordance with section 158(1) by a person or institution concerned with education or scientific research in relation to Chinese herbal medicines (E1A)
Online Form - Form of the exemption application in accordance with section 158(1) by a person or institution concerned with education or scientific research in relation to Chinese herbal medicines (E1A)
Guidelines on application of exemption in relation to Chinese herbal medicines or manufacturer licence or wholesaler licence in proprietary Chinese medicines by a person or institution concerned with education or scientific research in accordance with section 158(1) of the Chinese Medicine Ordinance (Chinese version only)
(Chinese
version
only)
2.
Form of the exemption application in accordance with section 158(1) by a person or institution concerned with education or scientific research in relation to manufacturer licence or wholesaler licence in proprietary Chinese medicines (E1B)
Form of the exemption application in accordance with section 158(1) by a person or institution concerned with education or scientific research in relation to manufacturer licence or wholesaler licence in proprietary Chinese medicines (E1B)
Online Form-Form of the exemption application in accordance with section 158(1) by a person or institution concerned with education or scientific research in relation to manufacturer licence or wholesaler licence in proprietary Chinese medicines (E1B)
Guidelines on application of exemption in relation to Chinese herbal medicines or manufacturer licence or wholesaler licence in proprietary Chinese medicines by a person or institution concerned with education or scientific research in accordance with section 158(1) of the Chinese Medicine Ordinance (Chinese version only)
(Chinese
version
only)
3.
Form of the exemption application in accordance with section 158(1) by a person or institution concerned with education or scientific research in relation to proprietary Chinese medicine registration by institution (E1C)
Form of the exemption application in accordance with section 158(1) by a person or institution concerned with education or scientific research in relation to proprietary Chinese medicine registration by institution (E1C)
Online Form - Form of the exemption application in accordance with section 158(1) by a person or institution concerned with education or scientific research in relation to proprietary Chinese medicine registration by institution (E1C)
Guidelines on application of exemption in relation to proprietary Chinese medicine registration by a person or institution concerned with education or scientific research in accordance with section 158(1) of the Chinese Medicine Ordinance (Chinese version only)
(Chinese
version
only)
4.
Form of the exemption application in accordance with section 158(1) by a person or institution concerned with education or scientific research in relation to proprietary Chinese medicine registration by Chinese medicine manufacturer (E1D)
Form of the exemption application in accordance with section 158(1) by a person or institution concerned with education or scientific research in relation to proprietary Chinese medicine registration by Chinese medicine manufacturer (E1D)
Online Form - Form of the exemption application in accordance with section 158(1) by a person or institution concerned with education or scientific research in relation to proprietary Chinese medicine registration by Chinese medicine manufacturer (E1D)
Guidelines on application of exemption in relation to proprietary Chinese medicine registration by a person or institution concerned with education or scientific research in accordance with section 158(1) of the Chinese Medicine Ordinance (Chinese version only)
(Chinese
version
only)
If you encounter problems when downloading the form, please call 2319 5119 (Chinese Medicines Traders) or 3904 9130 (Registration of proprietary Chinese medicines) or email to cmro@dh.gov.hk for assistance.


Clinical Trial and Medicinal Test of proprietary Chinese medicines
#
Name of Form
Form
Online Form
Checklist
Guidelines
1.
Application Form for Certificate for Clinical Trial and Medicinal Test
Application Form for Certificate for Clinical Trial and Medicinal Test
Online Form - Application Form for Certificate for Clinical Trial and Medicinal Test
Checklist for Certificate for Clinical Trial and Medicinal Test Application (Translated copy*)
Guidance Notes for Holders of the Certificate for Clinical Trial and Medicinal Test (Translated copy*)
If you encounter problems when downloading the form, please call 3904 9130 or email to cmro@dh.gov.hk for assistance.


Import and Export Control of Chinese Medicines
#
Name of Form
Form
Checklist
Guidelines
1.
Export License of Proprietary Chinese Medicine (TRA_CMRO_E)
Export License Form (TRA_CMRO_E)
Guidelines for Application for Import/Export Licence of Proprietary Chinese Medicine
2.
Export License of Chinese Herbal Medicines (TRA_CMRO_E)
Export License Form (TRA_CMRO_E)
Guidelines for Application for Import/Export Licence of Chinese Herbal Medicines
If you encounter problems when downloading the form, please call 3904 9230 or email to cmro@dh.gov.hk for assistance.