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HK Wholesale Dealer Licence Application

Updated:2018-1-23 17:57:46    Source:www.tannet-group.comViews:574

 A company wishing to deal in any poison and/or pharmaceutical product by way of wholesale dealing must first obtain a Wholesale Dealer Licence. If the poison the company wishes to deal in is a psychotropic drug, then a registered pharmacist must be employed to handle all transactions of the psychotropic drug. Documents and other requirements are as follows:

1. Copy of Business Registration Certificate (Please specify the floor on which the premises is located); Copy of Business Registration Certificate, Branch Business Registration Certificate, Tenancy Agreement or Logistics Services Agreement of storage facilities at other premises (if any):
1) For limited companies:
  a. Copy of Certificate of Incorporation and
  b. Copy of Directors’ List (e.g. “Form NAR1” from Companies Registry or for newly formed limited companies, photocopy of a full set of “Form NC1” or “Form NC1G”).
2) For companies run by sole proprietorship: Copy of “Form 1(a)” from the Business Registration Office.
3) For companies run by partnership: Copy of “Form 1(c)” from the Business Registration Office.

2. A list issued by the applicant with name(s) in English and Chinese, Hong Kong Identity Card number(s) and posts of the sole proprietor/ partners/ directors and staff, the list should be signed by the person-in-charge of business and stamped with applicant chop.

3. A signed declaration of each owner (i.e. sole proprietor or partner) or director, and each key personnel (e.g. person-in-charge of poisons/ pharmaceutical products) indicating whether he/she has been an owner, a director or an employee of other trader(s) of western medicines (i.e. importer/ exporter, retailer, wholesaler or manufacturer, regardless of whether the trader is still in business).

4. Statement(s) of relevant experience of all staff members involved in poisons/ pharmaceutical products Certifications of the above relevant experience, e.g. testimonials from previous employer(s).

5. Scope of Business
(a) Import/ export only: Copy of document(s) showing offer for sale and purchase of antibiotics/ poisons/ dangerous drugs/ pharmaceutical products.
  (i) Price quotations or proforma invoice from your supplier and buyer together with information showing ingredient(s) of the products.
  (ii) Relevant document proving the purchaser in oversea country is legally authorized to handle the antibiotics/ poisons/ dangerous drugs/ pharmaceutical products.
(b) Local distribution involved
  (i) For the applicant who is a product certificate holder of pharmaceutical product, copy of Certificate of Drug/ Product Registration.
  (ii) For the applicant who is not a product certificate holder of pharmaceutical product, copy of Certificate of Drug/ Product Registration AND exclusive agency agreement document(s)/ exclusive agency appointment letter from the product certificate holder.
 (iii) For the applicant dealing in non-pharmaceutical products, exclusive agency agreement document(s)/ exclusive agency appointment letter from your supplier together with information showing ingredient(s) of the products.

6. General requirements for premises
•Only companies occupying commercial premises would normally be considered;
•Companies occupying ground floor or retail premises would normally not be considered;
•Companies operating in secretarial or accountancy service holding companies would not be considered;
•There must be adequate lockable storage facilities with appropriate temperature and humidity for keeping poisons and pharmaceutical products. Detailed requirements on the storage facilities are set out in the “Code of Practice for Holder of Wholesale Dealer Licence” attached.

7. An inspection by a pharmacist inspector will be conducted at the company’s premises. Application for Wholesale Dealer Licence will be considered by the Pharmacy and Poisons (Wholesale Licences) Committee (‘the Committee’). In granting a Wholesale Dealer Licence, the Committee must take into consideration but are not limited to the followings:

•Results of the inspection, which evaluate whether the premises under application are fit for the licence purposes;
•Results of the interview conducted against the applicant or the key personnel which evaluate whether the interviewee(s) is/are fit and possess adequate knowledge to conduct relevant trade;
•Previous drug-related conviction(s), in particular those have significant impact to the public interest, of the applicant or his key personnel;
•Previous disciplinary action(s) against the applicant or his key personnel; and other licensing criteria applicable to the Wholesale Dealer Licence.

8. If a company wishes to deal in a Part 1 Dangerous Drug, then a registered pharmacist must be employed to handle all transactions of the Dangerous Drug. In addition to a Wholesale Dealer Licence, an application for a Wholesale Dealer’s Licence to Supply Dangerous Drugs is required. If a company wishes to deal in a Part 2 Dangerous Drug only, then an application for a Wholesale Dealer’s Licence to Supply Dangerous Drugs (Part 2) is required in addition to a Wholesale Dealer Licence.

These Guidance Notes are to facilitate the application for registration of the premises to conduct retail sale of controlled medicines as an Authorized Seller of Poisons. Documents and other requirements are as follows:

1. Copy of Business Registration Certificate:
1) For limited companies :
   a. Copy of Certificate of Incorporation and
   b. Copy of Directors’ List (e.g. “Form AR1” from Companies Registry or for, newly formed limited companies, photocopy of a full set of “Form NC1” or“Form NC1G”).
2) For companies run by sole proprietorship: Copy of “Form 1(a)” from the Business Registration Office.
3) For companies run by partnership: Copy of “Form 1(c)” from the Business Registration Office.

2. A list including names, in English and Chinese, Hong Kong Identity Card numbers, posts and qualifications of the sole proprietor/ partners/ director(s), the pharmacist, and all the western medicine staff? For Person-in-charge (PIC) and deputy PIC, please also provide statement of relevant working experiences.

3. Signed statement of appointment of all western medicine staff members by the owner (i.e. the sole-proprietor or partner) or the director, indicating their positions in the applicant’s company.

4. A signed declaration by each owner (i.e. sole proprietor or partner) or director, the pharmacist and each western medicine staff member.
(i) indicating whether he/she has been an owner, a director or an employee of other trader(s) of western medicines (i.e. importer/exporter, retailer, wholesaler or manufacturer) in the past three years.
(ii) indicating whether he/she is being investigated/being prosecuted, or has any conviction, of drug-related offences in the past three years.

5. Testimonials from previous employer(s) certifying the above relevant working experience as stated by the sole proprietor/ partners/ director(s), the pharmacist, and all the western medicine staff in the declarations.

6. A signed declaration by limited company, where applicable, indicating whether it is being investigated/being prosecuted, or has any conviction, of drug-related offences in the past three years.

7. Copy of the Certificate of Registration and current Practising Certificate of the registered pharmacist.

8. Floor plan of the Dispensary indicating the total area, and locations for the storage of pharmaceutical products, e.g. in the cockloft (if any), with declaration on if any controlled medicines will be stored other than in the dispensing room. Floor plan of the Dispensing Room indicating the total area, and the fixtures and fittings.

9. Letter of opening hours of the Authorized Seller of Poisons and the attendance hours of the registered pharmacist.

10. Upon receipt of the completed application, interview will be arranged with the person-in-charge and the pharmacist to assess their knowledge and understanding of the relevant legislations and the “Code of Practice for Authorized Seller of Poisons” for operation of an Authorized Seller of Poisons. In addition, inspection will be conducted to assess whether the premises are suitable for conducting retail sale of controlled medicines. All applications will be submitted to the Pharmacy and Poisons Board for consideration.

Under the Pharmacy and Poisons Regulations, pharmaceutical products must be registered with the Pharmacy and Poisons Board before they can be sold, offered for sale, distributed or possessed for the purposes of sale, distribution or other use.

Criteria for registration
Your pharmaceutical product will only be approved for registration if it meets the criteria of safety, efficacy and quality relevant to it.

Who should apply?
If your pharmaceutical product is manufactured in Hong Kong, the person responsible for obtaining registration of the product is the licensed manufacturer, or the licensed wholesale dealer contracting with the licensed manufacturer.

If your pharmaceutical product is manufactured outside Hong Kong, the person responsible for obtaining registration is the licensed wholesale dealer who imported the pharmaceutical product, or the Hong Kong branch, subsidiary, representative, agent or distributor of the overseas manufacturer.

Pharmaceutical products not subject to registration
Products which fall under the following categories are not required to be registered with the Pharmacy and Poisons Board:
(A) products containing only proprietary Chinese medicines or Chinese herbal medicines as defined in the Chinese Medicine Ordinance (Cap. 549);
(B) drug substances imported by licensed manufacturers solely for the purpose of manufacturing their own pharmaceutical products;
(C) products possessed or used under the direction of a registered medical practitioner or a registered dentist for the treatment of a particular patient, or of a registered veterinary surgeon for the treatment of a particular animal;
(D) products imported for re-export only;
(E) products manufactured in Hong Kong for export by the licensed manufacturer only;
(F) products administered for the purposes of a clinical trial/medicinal test in accordance with a clinical trial/medicinal test certificate issued under the Pharmacy and Poisons Regulations.

The following particulars:
1. Soft copy of the business registration certificate of the applicant;

2. An authorized person for the application, contact telephone and facsimile numbers and content of the submission dossier. Please declare in the PRS 2.0 system that the applicant “agrees to submit additional or updated supporting documents when required”;

3. Soft copy and certified true copy of the manufacturer’s licence; For products manufactured outside Hong Kong: Information on the manufacturing facilities and practices of the manufacturer;

4. Soft copy and certified true copy of Good Manufacturing Practices (GMP) certificate of the manufacturer;

5. One set of prototype sales pack for each pack size of the product, complying with the labelling requirements;

6. For products containing a new chemical or biological entity:
1) official evidence of registration approval of the product in two or more of the following countries: Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Holland, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, UK and USA;

2) expert evaluation reports on the safety, efficacy and quality of the product. Curriculum vitae of the expert and the expert’s signature on the corresponding reports are required;

3) European Union Risk Management Plan (EU-RMP) and/or US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) required for the product, if applicable. Information on whether any of the risk management plan activities and mitigation strategies will be implemented in Hong Kong;

4) Proposed package insert of the product. Where the package insert is in the form of a patient information leaflet, a prescribing information leaflet for healthcare professionals for use in Hong Kong should also be submitted;

7. Clinical and scientific documentation substantiating the safety and
efficacy of the product:

8. Documents to support the proposed indications, dosage, route of administration and other contents of the package insert (if any);

9. In the case of applications for registration of pharmaceutical substances: Sample of the pharmaceutical substance as it will be sold to the purchaser.:

10. Detailed and complete qualitative and quantitative composition of the finished product issued by the manufacturer.

11. Specifications of the product issued by the manufacturer. Documents showing compliance with one or more of the following pharmacopoeias must be provided unless otherwise justified: Pharmacopoeia of the People’s Republic of China, British Pharmacopoeia, European Pharmacopoeia, International Pharmacopoeia, Japanese Pharmacopoeia and/or United States Pharmacopoeia.

12. Detailed method of analysis of the product for all tests stated in the finished product specifications. Certificate of analysis of a representative batch of the finished product, issued by the manufacturer or the company performing the analysis;

13. Stability test data of the product;

14. Bioequivalence (BE) data: for anti-epileptic drugs and for critical dose drugs / narrow therapeutic range drugs;

15. Special exemptions are provided for the quality analysis of products containing vitamins, minerals, etc.

16. If materials of animal origin are used in the manufacturing of the product, you should also provide documentary evidence obtained from the manufacturer on the source of the animals, the nature of the animal tissues used in the manufacturing and the production processes, showing compliance with one or more of the safety measures taken to minimize the risk of communicable diseases that can be transmitted  to human, including but not limited to Transmissible Spongiform Encephalopathy (TSE) transmission promulgated by the European Medicines Agency, USA or Australia.

Contact us
If you have further enquire, please feel free to contact Tannet at anytime, anywhere by simply visiting Tannet’s website www.tannet-group.net, or calling Hong Kong hotline at 852-27826888 or China hotline at 86-755-82143422, or emailing to tannetgroup@gmail.com / tannet-solution@hotmail.com

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