Frequently Asked Questions

General Information

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

  A.1 Under the Pharmacy and Poisons Ordinance, “Pharmaceutical product” or “medicine” —

  (a) means a substance, or combination of substances that —
  
  (i) is presented as having properties for treating or preventing disease in human beings or animals; or
  (ii) may be used in or administered to human beings or animals with a view to —
  
  (A) restoring, correcting or modifying physiological functions by exerting a pharmacological,
  immunological or metabolic action; or
  (B) making a medical diagnosis; and
  
  (b) includes an advanced therapy product.
  

  For more details about the Pharmacy and Poisons Ordinance and Pharmacy and Poisons (Amendment) Ordinance 2020, please refer to the websites below:
  https://www.elegislation.gov.hk/index/chapternumber?p0=1&TYPE=1&TYPE=2&TYPE=3&CAP_NO_FR=138&_lang=en

  https://www.gld.gov.hk/egazette/pdf/20202430/es12020243019.pdf



• 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 Regulatory Office of Department of Health (www.cmro.gov.hk). You may also call the Chinese Medicine Regulatory Office 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:
  https://www.elegislation.gov.hk/index/chapternumber?p0=1&TYPE=1&TYPE=2&TYPE=3&_lang=en

• 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. The maximum penalty is a fine at level 6 of Criminal Procedure Ordinance Cap 221 ($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 Tenth Schedule of the Pharmacy and Poisons Regulations (Cap. 138A) lists out those ingredients classified as poisons. Some poisons are further categorized under different Parts of the Poisons List and other 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 2 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 1 poisons can only be sold in pharmacies (ASP) in the presence and under the supervision of registered pharmacists.
  
  Some Part 1 Poisons are further classified into the First Schedule and the Third Schedule with additional restrictions on their sale at the retailers. The sale of pharmaceutical products containing Part 1 First Schedule poisons further requires keeping sales 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 1 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“Prescription Drug 处方药物” or “Drug under Supervised Sales 监督售卖药物”?

  A.6 According to the Pharmacy and Poisons Ordinance, all Part 1 poisons and Part 2 poisons must be labelled with the word "Poison 毒药" or other applicable words specified in the above Ordinance. The word "Poison 毒药" was used to serve as a warning to consumers as improper use of these medicines may cause serious health damage in the past. These medicines should only be used upon advice from healthcare professionals
  
  With effect from 5 August 2016, pharmaceutical products or medicines containing Part 1 poisons (except those included in the Third Schedule) should be labelled with the words "Drug under Supervised Sales 监督售卖药物"; pharmaceutical products or medicines containing poisons included in the Third Schedule should be labelled with the words "Prescription Drug 处方药物".

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 specified form and shall be accompanied by the fee prescribed. 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.
  
  When an application is approved, the applicant will receive the Certificate of Drug / Product Registration upon payment of the fee.
  
  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 below:
  http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/guid.pdf
  
  New application for Registration of Pharmaceutical Products / Substances shall be submitted via PRS 2.0 at the following website:
  https://www.drugoffice.gov.hk/prs2-ext/client_authentication.jsp
  
  The relevant guidelines are available from the Drug Evaluation and Import/Export Control Division at Suites 2002-05, 20/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, Kowloon, or at the webpage 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 for each application for registration of a pharmaceutical product. When the approval is granted, after the applicant will be issued with a product registration certificate on payment of HK$1,370.
  
  The performance pledge for processing an application for registration of pharmaceutical product is within 5 months after the required documents have been provided (see A.7), and the criteria of registration are met (see Reg 37(1) of the Pharmacy and Poisons Regulations). For details of the relevant legislation, please refer to the website of Bilingual Laws Information System of Department of Justice below:
  https://www.elegislation.gov.hk/index/chapternumber?p0=1&TYPE=1&TYPE=2&TYPE=3&CAP_NO_FR=138&_lang=en

• 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.
  For non-injectable products which differ only in package size, only one application is required for various pack sizes. For injectable products with different container volumes, separate applications are required.

• 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 Registered Pharmaceutical Products/Substances” which is available at the webpage of our office:
  http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/copGuide.pdf

• Q.11 What are the labeling requirements of pharmaceutical products?

  A.11 Pharmaceutical products must comply with the labelling requirements as stated in the Pharmacy and Poisons Ordinance. The labelling requirements of pharmaceutical products are summarized below:
  a. Name of the product.
  b. Name and quantity of each active ingredient.
  c. Name and address of the manufacturer.
  d. Hong Kong registration number.
  e. Batch number.
  f. Expiry date.
  g. Product pack size and unit of quantity.
  h. Storage conditions (and specific storage conditions, if any).
  
  Moreover, additional labels and/or warnings may be required for certain products or classes of products based on their legal classification, dose form, and ingredients. For details, please refer to the Pharmacy and Poisons Ordinance and “Guidelines on the Labelling of Pharmaceutical Products” available at the website of our office below: http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Label_Gl_e.pdf?v=od28rw1

• Q.12 What are the testing requirements of pharmaceutical products?

  A.12 Applicant should provide the specifications of the product issued by the manufacturer in compliance with relevant pharmacopoeial standards, unless otherwise justified. Besides, certificate of analysis of a representative batch of the finished product issued by the manufacturer or the company performing the analysis should be submitted. For details, please refer to the “Guidance Notes on Registration of Pharmaceutical Products/Substances” which is available at the webpage of our office below:
  http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/guid.pdf?v=5yh39x9.
  

• Q.13 How can I renew the registration certificate of the product?

  A.13 A notice for renewal will be sent via PRS 2.0 to the registration certificate holder around three to four months before the expiry of each certificate. A registration certificate issued shall be renewable upon meeting conditions as stipulated in regulation 36(7) of the Pharmacy and Poisons Regulations (Cap 138A) and the certificate is generally valid for 5 years.

• Q.14 If there are changes with respect to the product after it has been approved for sale, what should I do?

  A.14 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.
  Applications for change of registered particulars of a registered pharmaceutical product shall be submitted via PRS 2.0 at the following website:
  https://www.drugoffice.gov.hk/prs2-ext/client_authentication.jsp
  
  For the “Guidance Notes on Change of Registered Particulars of Registered Pharmaceutical Products/Substances”, please refer to the website of our office below:
  http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/
  lcopGuide.html

• Q.15 Are there any changes to the label and/or sales pack of a registered pharmaceutical product that do not require application for change of registered particulars?

  A.15 For the purpose of clarity, change(s) to the label and/or sales pack which are not considered as change of registered particulars of a registered pharmaceutical product may include the following:
  1. Relocation of lot no., expiry date or manufacturing date;
  2. Relocation of HK registration number;
  3. Relocation of the text (e.g.“Prescription Drug 处方药物” or “Drug under supervised sales 监督售卖药物”) as specified in Schedule 5 of the Pharmacy and Poisons Regulation;
  4. Relocation of registration number in other countries;
  5. Enlargement of font size;
  6. Realignment of text information; or
  7. Addition/removal/relocation of merchantile codes, e.g. barcode, for logistic purpose only.

  However, if you intend to make the above changes together with any additional statement(s) to the label or sales pack of a registered pharmaceutical product, you shall then apply for change of registered particulars for that registered pharmaceutical product. For further details of the requirements, please refer to Q&A 14.
  

• Q.16 What medical claims can I put on the labels?

  A.16 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.html

Clinical Trial

• Q.17 What should I do if I want to conduct a clinical trial?

  A.17 You need to apply for a Certificate of Clinical Trial in order to conduct any clinical trial on human beings. Application should be submitted via the Electronic Clinical Trial System (e-CTS) at https://www.drugoffice.gov.hk/CTCInterWeb/jsp, accompanied by supporting documents. For detailed instructions, please refer to the “Guidance Notes on the Application for Certificate for Clinical Trial/Medicinal Test” which is available at the webpage of our office below:
  http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/useful_guidelines_forms.html

• Q.18 What are the documentation requirements for application of the Certificate of Clinical Trial on First-in-Human (FIH) trials of pharmaceutical products ?

  A.18 The documentation requirement to support FIH applications is not significantly different to that for later phase studies. The pharmaceutical product need not be registered in other countries before the FIH trial can be conducted in Hong Kong.The applicant may arrange to have pre-submission meeting with Drug Office for FIH trial of a pharmaceutical product. For enquiry regarding the pre-submission meeting, please contact Drug Office at Tel.: 3974 4180.

Import/ Export of Pharmaceutical Products

• Q.19 What is the procedure of importing / exporting a pharmaceutical product?

  A.19 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 Evaluation 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.20 What is the legal requirement for import or manufacturing of an unregistered drug for treatment of a particular patient?

  A.20 According to regulation 36(1) of the Pharmacy and Poisons Regulations (PPR), pharmaceutical products must be registered before they can be sold, offered for sale or distribute or possessed for the purposes of sale, distribution or other use in Hong Kong. The above requirement is not applicable in the case of possession or use where the pharmaceutical product or substance is possessed or is to be used for the purpose of treatment by a registered medical practitioner or a registered dentist of a particular patient in accordance with regulation 36(1A)(ab) of the PPR.
  
  Under the Import and Export Ordinance (Cap. 60), all imports of pharmaceutical products must be covered by import licences. For every single importation, the importer needs to apply for an Import Licence (Form 3) from the Drug Evaluation and Import/Export Control Division of Department of Health.
  
  A holder of a licence to manufacture pharmaceutical products under regulation 29 of the PPR may manufacture an unregistered drug for the treatment of particular patients by a registered medical practitioner or a registered dentist by obtaining prior permission from the Pharmacy and Poisons (Manufacturers Licensing) Committee in accordance with the “Guidance for Industry–Manufacture of Unregistered Pharmaceutical Product for Treatment of Particular Patients” available at the website of our office below:
  https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/pharmaceutical_manufacturer/index.html

• Q.21 What are the application documents required for importing an unregistered drug for treatment of a particular patient?

  A.21 The importer needs to apply for an Import Licence (Form 3) from the Drug Evaluation and Import/Export Control Division of the Department of Health. For the application of import licence of unregistered pharmaceutical product for treatment of a particular patient, it will be considered on case by case basis. The following documents are generally required:

  1.	Letter of a registered medical doctor or dentist stating the drug’s name, required quantity and patient’s information at least with his/her full name;
  2.	Certificate of Analysis of the drug issued by the manufacturer;
  3.	Product information, e.g. product insert;
  4.	Proof of registration of the drug in overseas (If the drug has not been registered anywhere in the world, clinical documents to support the safety and efficacy of the drug);
  5.	Drug trader licence of the importer, e.g. wholesale dealer licence; and
  6.	Duly completed Import Licence (Form 3).

    For details of registration, drug trader licence(s) application and importation / exportation of pharmaceutical products, please refer to the website of our office below:
  http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/
  useful_guidelines_forms.html

    For the application documents required for application of import licence for importing an unregistered advanced therapy product (ATP) for treatment of a particular patient, please refer to the “Guidance on Application of Import and Export Licences – Advanced Therapy Products” which is available at the webpage of our office at
  https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/atp_regulation.html

• Q.22 What are the application documents required for importing advanced therapy products (ATPs)?

  A.22 In Hong Kong, advanced therapy products (ATPs) are regulated as pharmaceutical products under the Pharmacy and Poisons Ordinance, Cap. 138 (PPO). For documents required for application of import licence for importing ATPs, please refer to the “Guidance on Application of Import and Export Licences – Advanced Therapy Products”, available at the webpage of our office at: https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/atp_regulation.html

• Q.23 What are the documents required for obtaining prior permission for manufacturing an unregistered drug for the treatment of particular patients?

  A.23 A licensed manufacture should make a request to the Pharmacy and Poisons (Manufacturers Licensing) Committee via the Manufacturers Regulatory Unit of the Drug Office. Each request will be considered on a case-by-case basis. The request form and the associated checklist of documents to be provided are available at the website of our office below: https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/pharmaceutical_manufacturer/index.html

• Q.24 Do I have to apply for an import/ export licence if I want to import nicotine-containing alternative smoking products ("ASPs") for the purpose of re-export?

  A.24 The Smoking (Public Health) Ordinance (Cap. 371, Laws of Hong Kong) prohibits the import, manufacture or sale, or use in certain places, of ASPs. All nicotine-containing ASPs, except when the nicotine is contained in tobacco, are pharmaceutical product in Hong Kong. The Drug Evaluation and Import/Export Control Division of Department of Health will not issue import/export licence for the purpose of importing nicotine-containing ASPs that are not registered pharmaceutical product in Hong Kong for re-export.

Licensing

• Q.25 What licences should I apply for when dealing with pharmaceutical trade?

  A.25 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 Dealer Licence: for person dealing in wholesale and/or import/export of poisons and/or 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 2 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.26 What is a “poison”?

  A.26 “Poison” means a substance which is specified in the Poisons List under Tenth Schedule of Pharmacy and Poisons Regulation (Cap. 138A) Laws of Hong Kong. With effective from 5 August 2016, pharmaceutical products containing Part 1 Poison (except those included in the Third Schedule Poison) should be labelled with the word “Drug under Supervised Sales 监督售卖药物”; pharmaceutical products containing poisons included in the Third Schedule should be labelled with the word “Prescription Drug 处方药物”. The outer container of non-pharmaceutical products containing poisons must still be labeled with the word “Poison 毒药”as it is a legal requirement. It does not necessarily imply that the substance is poisonous. For details of the Poisons List, please refer to the website below:
  https://www.elegislation.gov.hk/index/chapternumber?p0=1&TYPE=1&TYPE=2&TYPE=3&CAP_NO_FR=138&_lang=en
  

• Q.27 What is an “antibiotic”?

  A.27 “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:
  https://www.elegislation.gov.hk/index/chapternumber?p0=1&TYPE=1&TYPE=2&TYPE=3&CAP_NO_FR=137&_lang=en

• Q.28 What is a “dangerous drug”?

  A.28 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:
  https://www.elegislation.gov.hk/index/chapternumber?p0=1&TYPE=1&TYPE=2&TYPE=3&CAP_NO_FR=134&_lang=en

• Q.29 How can I apply for the various licences?

  A.29 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.30 How long does it take to receive my licence in general?

  A.30 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.31 If there are changes in my business after I have received the licence, what should I do?

  A.31 You should notify any changes of the business, e.g. name of company, address, personnel, etc., of a licence to our Licensing and Compliance Division as soon as possible. Some changes, e.g. person-in-charge of poisons, may require approval.

• Q.32 How can I renew my licence?

  A.32 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.33 How can I apply for the Free Sale Certificate of pharmaceutical products?

  A.33 Local Manufacturer of pharmaceutical products with a licence for manufacturer may fill in the application form 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. For the guidance on application and the application form, please refer to the website of our office below: http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/
  useful_guidelines_forms.html

• Q.34 Under what circumstances will your inspector come to my premises for inspection once the licence is granted to me?

  A.34 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.35 Do I need any licence to sell medicines via the Internet?

  A.35 The same licences mentioned in A.25 will be applicable to the sale of poisons, dangerous drugs and antibiotics via the Internet.

• Q.36 What licences do I need to deal in wholesale of preparations specified in Part II of Schedule 1 of the Dangerous Drugs Ordinance (Cap. 134)(DDO)?

  A.36 For traders who wish to engage in business of wholesale dealing in preparations specified in Part II of Schedule 1 of the DDO, they are required to first apply for and obtain a "Wholesaler Dealer's Licence to Supply Dangerous Drugs", as well as a "Wholesale Dealer Licence". For details, please refer to below links of the Drug Office (https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/lic_guide_main.html) and the Bilingual Laws Information System of Department of Justice (https://www.elegislation.gov.hk/index/chapternumber?p0=1&TYPE=1&TYPE=2&TYPE=3&CAP_NO_FR=134&_lang=en).

• Q.37 Are Gold Potassium Cyanide and Silver Potassium Cyanide classified as poison?

  A.37 Yes, Gold Potassium Cyanide and Silver Potassium Cyanide are classified as poison under Part 1A of Tenth Schedule of Pharmacy and Poisons Regulation (Cap. 138A) .

• Q.38 Do I need to apply for a Wholesale Dealer Licence to deal in wholesale of Gold Potassium Cyanide and Silver Potassium Cyanide?

  A.38 Yes.

• Q.39 What is cold chain management?

  A.39 Cold chain management involves performing a chain of tasks to ensure the proper storage and distribution of cold chain products to users from the manufacturer. Cold chain is interconnected with refrigeration equipment that allows products to be stored at recommended temperatures to maintain their potency.

• Q.40 How can I apply for the licence(s) required when dealing in wholesale of advanced therapy products (ATPs)?

  A.40 Advanced therapy products (ATPs) are defined as pharmaceutical products for human use, specified in Section 2 of the Pharmacy and Poisons Ordinance (Cap. 138). Relevant licences depending on the nature of your business and the application submitted are required, which include:

  • Wholesale Dealer Licence—for person dealing in wholesale and/or import/export of ATPs
  • Antibiotics Permit—for person dealing in and/or to possess antibiotics

  Application for licence to deal in wholesale of ATPs would be assessed by the Pharmacy and Poisons (Wholesale Licences) Committee on a case by case basis with special focus on nature of each ATP product.
  
  For application guidelines and forms, please refer to the website of our office below:https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/useful_guidelines_forms.html
  
  For more information regarding the regulation, classification, labelling, record keeping and traceability of ATPs, please refer to the website of our office below: https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/atp_regulation.html

Others

• Q.41 How should I deal with expired medicines?

  A.41 For pharmaceutical traders licensed under the Dangerous Drugs Ordinance (Cap. 134), the Antibiotics Ordinance (Cap. 137) and/or the Pharmacy and Poisons Ordinance (Cap. 138) of the Laws of Hong Kong, 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 “Guidance on Disposal of Unserviceable/Expired Medicines for Licensed Pharmaceutical Traders” which is available at the webpage of our office:
  http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/
  drugdisposalguidance_eng.pdf

• Q.42 How should I deal with expired dangerous drugs?

  A.42 It is similar to the procedures as stated in A.43, the only exception is that you need to contact Licensing & Compliance Division of our office for arrangement of an inspector to oversee the disposal for dangerous drugs.

• Q.43 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.43 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.html

• Q.44 If I want to raise a complaint about a product marketed with a Hong Kong registration number, what should I do?

  A.44 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 Medicine Regulatory Office of Department of Health (Tel.: 2319 5119).

• Q.45 If I suspect that a shop is selling counterfeit medicine, what should I do?

  A.45 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.46 If I have more questions about pharmaceutical business, can I call your office?

  A.46 For further enquiries, you can call the following telephone numbers:

  • Registration: 3974 4175;
  • Import and Export / Clinical Trial: 3974 4180; and
  • Licensing: 2961 8028

• Q.47 How is cannabidiol regulated in Hong Kong?

  A.47 Cannabidiol (CBD) has been added to the First Schedule to the Dangerous Drugs Ordinance (DDO) (Cap. 134), and the substance will be under the same strict control as other dangerous drugs under the DDO starting from 1 February 2023.
  
  Any person who manufactures, imports, exports, diverts or supplies Dangerous Drugs or products containing Dangerous Drugs should apply for licences or permits issued by the Department of Health in accordance with Dangerous Drugs Ordinance. Under the Dangerous Drugs Ordinance, trafficking in dangerous drugs, or illicitly importing to and exporting from Hong Kong, procuring, supplying, manufacturing, or dealing in or with dangerous drugs, constitutes a criminal offence. The maximum penalty is life imprisonment and a fine of $5 million. Possession and consumption of the substance in contravention of the DDO will be subject to a maximum penalty of seven years' imprisonment and a fine of $1 million. For pharmaceutical product containing CBD, it is also subject to regulatory control under the Pharmacy and Poisons Ordinance, Cap. 138 and Import and Export Ordinance, Cap. 60.

• Q.48 Tell me more about the recent changes in the sales control of codeine-containing medicines.

  A.48 Starting from 26 January 2024, it is a legal requirement for pharmacy to record the purchaser's personal information, including Identity Card number, when supplying codeine-containing medicines without doctor's prescription.
  
  The Government had always been concerned about the abuse of codeine containing medicines, the Pharmacy and Poisons Board of Hong Kong reviewed the regulatory control of codeine-containing medicines and decided to strengthen the sales control of non-prescription codeine-containing medicines. With effect from 26 January 2024, all medicines containing less than 0.2% of codeine are regulated as Part 1 Schedule 1 poisons under the Pharmacy and Poisons Regulations (Cap. 138A).
  
  In other words, when supplying a codeine-containing medicines, an Authorized Seller of Poisons ('pharmacy' or 'dispensary') must make an entry in the book (known as "poisons book") with particulars of the purchaser, including his/her name, address and Identity Card number. The purchaser is also required to sign in the poisons book accordingly. This requirement only applies to non-prescription codeine-containing medicines, i.e. medicines containing less than 0.2% codeine.

• Q.49 Does the Drug Office provide medicine testing service to public?

  A.49 The Drug Office is a law enforcement agency over the legislations concerning medicines.
  
  In general, the Drug Office does not provide testing service to public. If you wish to test a medicine, you may approach the private laboratories.
  
  The Hong Kong Accreditation Service (HKAS) of the Innovation and Technology Commission provides accreditation to laboratories located in Hong Kong through the Hong Kong Laboratory Accreditation Scheme (HOKLAS). You may wish to refer to the website of HKAS with list of accredited laboratories: https://www.itc.gov.hk/en/quality/hkas/index.html

Appendix I