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Frequently Asked Questions

General Information
Registration of Pharmaceutical Products
Clinical Trial
Import/ Export of Pharmaceutical Products
Licensing
Others

General Information

  • Q.1 What is considered as a “pharmaceutical product” or “medicine” in Hong Kong?

    A.1 Under the Pharmacy and Poisons Ordinance (Cap. 138) (PPO), "pharmaceutical product" or “medicine” means any substance or mixture of substances manufactured, sold, supplied or offered for sale or supply for use in-

    1. the diagnosis, treatment, mitigation, alleviation or prevention of disease or any symptom thereof;
    2. the diagnosis, treatment, mitigation, alleviation of any abnormal physical or physiological state or any symptom thereof;
    3. altering, modifying, correcting or restoring any organic function,

    in human beings or in animals.

    For more details about the PPO, please refer to the website of Bilingual Laws Information System of Department of Justice below:
    http://www.legislation.gov.hk/blis_pdf.nsf/6799165D2FEE3FA94825755E0033E532/
    0F66D4839C78DBDA482575EE00438DD5?OpenDocument&bt=0

  • Q.2 What is the difference in the control between Western medicine and Chinese medicine in Hong Kong?

    A.2 In general, Western medicine refers to pharmaceutical product as defined above in A.1 and is controlled under the Pharmacy and Poisons Ordinance (Cap. 138). For Chinese medicine, it is controlled under Chinese Medicine Ordinance (Cap. 549). The sale, manufacturing, dispensing or compounding of Chinese herbal medicines or proprietary Chinese medicines as defined in section 2 of the Chinese Medicine Ordinance (Cap 549) or other materials of herbal, animal or mineral origin customarily used by the Chinese for medicinal purpose is exempted from regulation under the Pharmacy and Poisons Ordinance (Cap. 138).

    You may find more information on the regulation of Chinese medicines on the Chinese Medicine Council’s website (www.cmchk.org.hk) or the website of the Chinese Medicine Division of Department of Health (www.cmd.gov.hk). You may also call the Chinese Medicines Division of Department of Health (Tel.: 2319 5119) for enquiries relating to Chinese medicines.

  • Q.3 How can I know more about the legal requirements of handling pharmaceutical products in Hong Kong?

    A.3 The regulation of pharmaceutical products are mainly provided under the following Laws of Hong Kong:

    • Pharmacy and Poisons Ordinance (Cap. 138)
    • Antibiotics Ordinance (Cap. 137)
    • Dangerous Drugs Ordinance (Cap. 134)
    • Undesirable Medical Advertisements Ordinance (Cap. 231)
    • Public Health and Municipal Services Ordinance (Cap. 132)
    • Import and Export Ordinance (Cap. 60)

    The printed versions of these Laws of Hong Kong can be purchased from the Publications Sales Unit of Information Services Department (Tel.: 2537 1910) or from the Government Bookstore (www.bookstore.gov.hk). For the contents of the relevant legislation, please refer to the website of Bilingual Laws Information System of Department of Justice below:
    http://www.legislation.gov.hk/eng/home.htm

  • Q.4 Are all pharmaceutical products sold in Hong Kong registered?

    A.4 As stipulated under Reg.36(1) of the Pharmacy and Poisons Regulations (Cap. 138A), "pharmaceutical products" must be registered before they can be sold, offered for sale, distributed or possessed for the purposes of sales, distribution or other use in Hong Kong.

    Sale of unregistered pharmaceutical products is an offence under the Pharmacy and Poisons Ordinance (PPO). The maximum penalty is a fine of $100,000 and two years' imprisonment.

  • Q.5 Once registered, can all pharmaceutical products be freely sold in Hong Kong?

    A.5 Registered pharmaceutical products are subject to various kinds of control over their sale to protect the health of the public. In Hong Kong, the Poisons List under the Poisons List Regulations (Cap. 138B) lists out those ingredients classified as poisons. Some poisons are further categorized under different Parts of the Poisons List and different Schedules under the Pharmacy and Poisons Regulations (Cap. 138A) according to their potency, toxicity and potential side-effects.

    Such categorization determines the different levels of control over their sale. For example, pharmaceutical products that do not contain any poisons or contain Part II poisons are referred as Over-The-Counter medicines (OTC). The former can be sold in any retail shops while the latter can be sold in Authorized Sellers of Poisons (ASP, usually known as pharmacies or dispensaries) and Listed Sellers of Poisons (LSP, usually known as medicine stores). Pharmaceutical products containing Part I poisons can only be sold in pharmacies (ASP) in the presence and under the supervision of registered pharmacists.

    Some Part I Poisons are further classified into the First Schedule and the Third Schedule with additional restrictions on their sale at the retailers (the Second Schedule refers to drugs exempted as “poisons”). The sale of pharmaceutical products containing Part I First Schedule Poisons further requires keeping sale records which include the date of sale, the name, number of identity card, address and signature of the purchaser, the name and quantity of the medicine as well as the purpose for which it is required. The sale of pharmaceutical products containing prescription only medicines (Part I Third Schedule Poisons) must be authorized by a prescription from a registered medical practitioner, a registered dentist or a registered veterinary surgeon.

    Antibiotics defined under the Antibiotics Ordinance (Cap. 137) and dangerous drugs defined under the Dangerous Drugs Ordinance (Cap. 134) are also prescription only medicines.

  • Q.6 Why do the outer boxes of some pharmaceutical products bear the word “poison”? Are these medicines poisonous?

    A.6 According to the PPO, all Part I poisons and certain Part II poisons must be labelled with the word “poison”. These medicines should only be obtained from licensed retailers and be used upon professional advice of healthcare professional.

    The word “poison” serves as a warning to consumers as using incorrect dosage or improper use of these medicines may cause serious health damage. It is important that these medicines should be taken upon the advice or instruction of healthcare professional to ensure the safe use of these medicines.

Registration of Pharmaceutical Products

  • Q.7 How can I apply for drug registration and what documents are required?

    A.7 Application for the initial registration of a pharmaceutical product or substance shall be made in the form prescribed and shall be accompanied by the fee prescribed. When an application is approved, the applicant will receive the Certificate of Registration for the product/substance upon payment.

    A pharmaceutical product will only be approved for registration if it meets the criteria of safety, efficacy and quality relevant to it. For the documents required, please refer to the “Guidance Notes on Registration of Pharmaceutical Products/Substances” which is available at the webpage of Our Office:
    http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/guid.pdf

    The relevant application form and guidelines are available from the Drug Registration and Import/Export Control Division at 3/F, Public Health Laboratory Centre, 382 Nam Cheong Street, Kowloon, or refer to the website of Our Office below:
    http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/
    pr_guide_main.html

  • Q.8 How much does it cost to obtain the product registration certificate and how long is the approval time?

    A.8 There is a fee of HK$1,100 in application for registration of a pharmaceutical product. When an approval is granted, the applicant will be issued with a registration certificate on payment of HK$1,370.

    The performance pledge for processing an application for registration of pharmaceutical product is within 5 months if, and only if, the required documents are provided (see A.7), and the criteria of registration are met (see Reg 37(1) of the Pharmacy and Poisons Regulations). For the contents of the relevant legislation, please refer to the website of Bilingual Laws Information System of Department of Justice below:
    http://www.legislation.gov.hk/blis_pdf.nsf/6799165D2FEE3FA94825755E0033E532/
    98C7D17989BE0FD1482575EE0043A3C8/$FILE/CAP_138A_e_b5.pdf

  • Q.9 Do I need to submit separate applications for different dosage forms / strengths / pack sizes?

    A.9 You need to submit separate applications for different dosage forms and strengths, but not for different pack sizes.

  • Q.10 What particulars of a pharmaceutical product need registration in Hong Kong?

    A.10 The Pharmacy and Poisons Regulations stipulated that when a pharmaceutical product is registered, certain particulars are included in the registration. The particulars to be registered shall-

    1. in the case of a product or substance, be-
      1. its name;
      2. its specifications;
      3. its label;
      4. its package insert, if any;
      5. the name and address of the manufacturer; and
      6. the name and address of the applicant;
    2. in the case of a product, further be-
      1. its dose form;
      2. the quantity or quantities of the dose form contained in its unit package or unit packages;
      3. the name and quantity of all its active ingredients;
      4. the name and quantity of all its excipients; and
      5. its proposed indication, dosage and route of administration.

    Change in any of the above registered particulars without approval would render the product an unregistered pharmaceutical product. For application for change of particulars, please refer to the “Guidance Notes on Change of Registered Particulars of a Registered Pharmaceutical Product” which is available at the webpage of Our Office:
    http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/copGuide.pdf

  • Q.11 How can I renew the registration certificate of the product?

    A.11 A notice for renewal will be sent to the registration certificate holder around three to four months before the expiry of each certificate. A registration certificate issued shall be renewable on payment of the fee prescribed.

  • Q.12 If there are changes with respect to the product after it has been approved for sale, what should I do?

    A.12 Before there is a change in any one of the registered particulars of a registered pharmaceutical product, the registration certificate holder of the product should apply for approval for the change. Please note, however, product name, active ingredients and dose form cannot be changed and new registration is required. Approval for the change must be granted before sale of products with the new particulars. Where the change is approved, it shall be approved to take effect from a certain date. Before that certain date, products with the new particulars cannot be offered for sale in the market.

    Application form and “Guidelines on Application for Change of Registered Particulars of a Registered Pharmaceutical Product”, please refer to the website of Our Office below:
    http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/
    lcopGuide.html

  • Q.13 What medical claims can I put on the labels?

    A.13 Claims should be supported by reputable references or data from clinical trial. In addition, please also note that the labeling should not contravene the provisions of the Undesirable Medical Advertisements Ordinance (Cap. 231). For details, please refer to the “Guidelines on Undesirable Medical Advertisements Ordinance” which is available at the webpage of Our Office:
    http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/
    other_useful_information/umao_guidelines.html

Clinical Trial

  • Q.14 What should I do if I want to conduct a clinical trial?

    A.14 You need to apply for a Certificate of Clinical Trial in order to conduct any clinical trial on human beings. Application form should be accompanied by a sample of the product and supporting documents which are listed in the Checklist posted on our website. For application form and checklist, please refer to the website of Our Office below:
    http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/
    clinicalTrial.html

Import/ Export of Pharmaceutical Products

  • Q.15 What is the procedure of importing / exporting a pharmaceutical product?

    A.15 First of all, you need to apply for an appropriate trader licence for handling different classes of drugs. (Please refer to the FAQ on Licensing). For every single importation / exportation, you need to apply for an Import Licence (Form 3) / Export Licence (Form 6) from Drug Registration and Import/Export Control Division of Department of Health. For details, please refer to the guidelines and forms on “Import and Export” which is available at the webpage of Our Office:
    http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/
    useful_guidelines_forms.html

  • Q.16 Do I have to apply for an import/export licence if I want to import nicotine in a delivering device commonly known as e-cigarette for the purpose of re-export?

    A.16 Nicotine in a delivering device commonly known as e-cigarette is regarded as pharmaceutical product in Hong Kong. For every single importation/ exportation, you need to apply for an Import Licence (Form 3) / Export Licence (Form 6) from Drug Registration and Import/Export Control Division of Department of Health.

  • Q.17 How can I apply for an import/export licence if I want to import e-cigarettes for re-export?

    A.17 Firstly, you need to be a holder of a Wholesale Poisons Licence. Secondly, you are required to submit the Import Licence with the Export Licence(s) of matching quantity. Thirdly, you are required to provide sufficient evidence to show that the product can be lawfully re-exported to the receiving country.

  • Q.18 What kinds of documents are required to support that e-cigarettes can be lawfully re-exported to the importing country?

    A.18 Example of such documents are copy of Certificate of Drug/Product Registration issued by the regulatory authority of the receiving country, and import certificate or import licence of the product issued by the regulatory authority of the receiving country.

Licensing

  • Q.19 What licences should I apply for when dealing with pharmaceutical trade?

    A.19 Depending on the nature of your business and the application that you submitted, various licences stipulated under the Pharmacy and Poisons Ordinance (Cap. 138), Antibiotics Ordinance (Cap. 137) and Dangerous Drugs Ordinance (Cap. 134) will be issued upon application and the decision of the relevant regulatory authorities:

    • Wholesale Poisons Licence: for person dealing in wholesale and/or import/export of poisons
    • Certificate of Registration of Importers and Exporters: for person carrying on business as an importer or exporter of pharmaceutical products
    • Licence for Manufacturer: for person dealing in the manufacture of pharmaceutical products
    • Certificate for Registration of Premises of an Authorized Seller of Poisons: for premises of an authorized seller of poisons where poisons are kept for retail purposes
    • Licence for Listed Sellers of Poisons: for person dealing in retail sale of Part II poisons
    • Antibiotics Permit: for person dealing in and/or to possess antibiotics
    • Licence to Manufacture Dangerous Drug: for person dealing in the manufacture of dangerous drugs
    • Wholesale Dealer’s Licence to Supply Dangerous Drug: for person dealing in wholesale of dangerous drugs
  • Q.20 What is a “poison”?

    A.20 “Poison” means a substance which is specified in the Poisons List under Poisons List Regulation, made under Cap. 138 of Laws of Hong Kong. The outer box of the substance must be labeled with the word “poison” as it is a legal requirement. It does not imply that the substance is poisonous. For details of the Poisons List Regulations, please refer to the website of Bilingual Laws Information System of Department of Justice below:
    http://www.legislation.gov.hk/blis_pdf.nsf/6799165D2FEE3FA94825755E0033E532/
    4F982AF8176DD0CB482575EE0043B7A4/$FILE/CAP_138B_e_b5.pdf

  • Q.21 What is an “antibiotic”?

    A.21 “Antibiotic” refers to substance specified and defined in Schedule 1 of the Antibiotics Regulations, made under Cap. 137 of Laws of Hong Kong, and to their salts and derivatives and to the salts of such derivatives regardless of the method of production. For details of the Antibiotics Regulations, please refer to the website of Bilingual Laws Information System of Department of Justice below:
    http://www.legislation.gov.hk/blis_pdf.nsf/6799165D2FEE3FA94825755E0033E532/
    9F602A38F9E61DEA482575EE004382EF/$FILE/CAP_137A_e_b5.pdf

  • Q.22 What is a “dangerous drug”?

    A.22 Dangerous drug means any of the drugs or substances specified in Part I of the First Schedule of the Dangerous Drugs Ordinance, Cap. 134 of Laws of Hong Kong. For details of the Dangerous Drugs Ordinance, please refer to the website of Bilingual Laws Information System of Department of Justice below:
    http://www.legislation.gov.hk/blis_pdf.nsf/6799165D2FEE3FA94825755E0033E532/
    3E899AC9660B2ACE482575EE00430767/$FILE/CAP_134_e_b5.pdf

  • Q.23 How can I apply for the various licences?

    A.23 You may fill in the relevant application forms and provide the supporting documents as listed in the checklists for application. For application guidelines and forms, please refer to the website of Our Office below:
    http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/
    lic_guide_main.html

  • Q.24 How long does it take to receive my licence in general?

    A.24 The issue of licences is subject to the approval of relevant regulatory authorities. If the applicant can satisfy the requirements, it normally takes about one to two months from the date of application to obtain the licence.

  • Q.25 If there are changes in my business after I have received the licence, what should I do?

    A.25 You should notify any changes of the business, e.g. name of company, address, personnel, etc., of a licence to our Traders Licensing and Compliance Division as soon as possible. Some changes, e.g. person-in-charge of poisons, may require approval.

  • Q.26 How can I renew my licence?

    A.26 A notice for renewal of licence/demand notes will be sent to the licensee one to two months before the expiry date of each licence. The licensee should follow the instructions for payment and collection of each licence.

  • Q.27 How can I apply for the Free Sale Certificate of pharmaceutical products?

    A.27Local Manufacturer of pharmaceutical products with a licence for manufacturer may apply, in writing, for a Free Sale Certificate of its own pharmaceutical products, subject to the payment of a fee prescribed in the Pharmacy & Poisons Regulation. The current fee is HK$180.

  • Q.28 Under what circumstances will your inspector come to my premises for inspection once the licence is granted to me?

    A.28 Inspections of licensed premises will be performed on a routine and random basis. No prior notice will be given for such inspections. In addition, if there is any change of particulars with respect to your licence, the related premises may also be inspected.

  • Q.29 Do I need any licence to sell medicines via the Internet?

    A.29 The same licences mentioned in A.19 will be applicable to the sale of poisons, dangerous drugs and antibiotics via the Internet.

  • Q.30 Are Gold Potassium Cyanide and Silver Potassium Cyanide classified as poison?

    A.30 Yes, Gold Potassium Cyanide and Silver Potassium Cyanide are classified as poison under Part IA of the Poisons List Regulations (Cap. 138).

  • Q.31 Do I need to apply for a Wholesale Poisons Licence to deal in wholesale of Gold Potassium Cyanide and Silver Potassium Cyanide?

    A.31 Yes.

  • Q.32 Do I need to apply for a Wholesale Poisons Licence to deal in wholesale (including local sale, import and export) of nicotine in a delivering device commonly known as e-cigarette?

    A.32 Yes. In Hong Kong, nicotine is a poison under the Pharmacy and Poisons Ordinance, and hence controlled by the Ordinance. In addition, nicotine in a delivering device is pharmaceutical product and subject to registration requirement and import/export control (see A.16).

  • Q.33 How can I apply for the Wholesale Poisons Licence to import nicotine in a delivering device commonly known as e-cigarette for re-export?

    A.33 You should fill in the application form for Wholesale Poisons Licence and provide the supporting documents as listed in the checklists. Moreover, applicants should provide sufficient evidence to demonstrate that nicotine in the delivering device can be lawfully re-exported into the receiving country. This might include copy of Certificate of Drug/Product Registration issued by the regulatory authority of the receiving country.

  • Q.34 How can I apply for the Wholesale Poisons Licence to distribute nicotine in a delivering device commonly known as e-cigarette in Hong Kong?

    A.34 You should fill in the application form for Wholesale Poisons Licence and provide the supporting documents as listed in the checklist. Moreover, prior registration of the product with the Pharmacy and Poisons Board is required.

Others

  • Q.35 How should I deal with expired medicines?

    A.35 You need to register with Environmental Protection Department as a Chemical Waste Producer and then contact the authorized chemical waste collectors to arrange for the disposal of the expired medicines. Relevant records should also be kept for inspection later. For details, please refer to the “Guidelines on disposal of unserviceable/ expired medicines for all licencees” which is available at the webpage of Our Office:
    http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/
    disposaldrugsguideline.pdf"

  • Q.36 How should I deal with expired dangerous drugs?

    A.36 It is similar to the procedures as stated in A.35, the only exception is that you need to contact Our Office for arrangement of an inspector to oversee the disposal for Dangerous Drugs.

  • Q.37 I would like to advertise for medicine, health food and Chinese proprietary medicine to consumers, what laws do I have to be aware of?

    A.37 In advertising for these products, you must observe the Undesirable Medical Advertisements Ordinance (Cap. 231) which prohibits the advertising of products and treatments for the prevention or treatment of diseases and conditions listed in the Ordinance. You may obtain the relevant ordinance by calling the Publications Sales Section of Information Services Department at 2537 1910 or from the Government Bookstore (www.bookstore.gov.hk). The contents of the relevant legislation may be found at the Department of Justice’s website www.legislation.gov.hk, or refer to the “Guidelines on Undesirable Medical Advertisements Ordinance (Cap. 231)” which is available at the webpage of Our Office:
    http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/
    other_useful_information/umao_guidelines.html

  • Q.38 If I want to raise a complaint about a product marketed with a Hong Kong registration number, what should I do?

    A.38 If the product you have on hand is labelled with the registration number indicated as HK-XXXXX, you can contact Our Office (Tel.:2572 2068) for any complaint on the pharmaceutical product. You can also send us an email at pharmgeneral@dh.gov.hk with details of your complaint.

    However, if the product’s registration number is indicated as HKP-XXXXX, HKNT-XXXXX or HKC-XXXXX, it is a proprietary Chinese medicine. You should contact the Chinese Medicines Division of Department of Health (Tel.: 2319 5119).

  • Q.39 If I suspect that a shop is selling counterfeit medicine, what should I do?

    A.39 You are encouraged to report suspected counterfeiting activities to the Customs and Excise Department by:

    • Customs Hotline (24-hour)
      (852) 2545 6182
    • Fax
      (852) 2543 4942; or
    • Mail
      Commissioner of Customs and Excise
      G.P.O Box No. 1166
  • Q.40 If I have more questions about pharmaceutical business, can I call your Office?

    A.40 For further enquiries, you can call the following telephone numbers:

    • Registration/ clinical trial: 2319 8458;
    • Import and export: 2319 8460; and
    • Licensing: 3107 2194 (wholesale); 2319 8467 (retail)

Appendix I

Category of medicine Requirements on wholesale dealing Examples of medicines Related laws
1. Non-poison No restriction on local wholesale dealing,
Licence required for import and export dealing:
  • Wholesale Poisons Licence, or
  • Certificate of Registration of Importers and Exporters
Simple pain-relieving drug containing paracetamol Pharmacy and Poisons Ordinance, Cap. 138
2. Part II poison Holder of Wholesale Poisons Licence Cold and flu medication containing chlorpheniramine Pharmacy and Poisons Ordinance, Cap. 138
3. Part I poison The requirements as item 2 above, plus relevant record prescribed under Reg. 28 of the Pharmacy and Poisons Regulations, Cap. 138A Ibuprofen (a non-steroidal anti- inflammatory pain killer), cough syrup containing less than or equal to 0.1% codeine Pharmacy and Poisons Ordinance, Cap. 138
4. Part I First Schedule poison Cough syrup containing more than 0.1% but less than 0.2% of codeine Pharmacy and Poisons Ordinance, Cap. 138
5. Part I First & Third Schedules poison Anti-hypertensive drug, anti-diabetic drug Pharmacy and Poisons Ordinance, Cap. 138
6. Antibiotic Holder of Antibiotics Permit, with relevant record prescribed under s. 7(2) of the Antibiotics Ordinance (Cap. 137) Amoxycillin, cephalexin, erythromycin Antibiotics Ordinance, Cap. 137
7. Dangerous drug Holder of Wholesale Dealer’s Licence to supply Dangerous Drugs and a registered pharmacist must be employed to handle all transactions of the Dangerous Drug, with relevant record prescribed under Reg. 5 of the Dangerous Drugs Regulations (Cap. 134A) Diazepam, phentermine Dangerous Drugs Ordinance, Cap 134
15 February 2012
 
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