Source: http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/faq.html
Timestamp: 2016-08-28 16:33:46
Document Index: 471434118

Matched Legal Cases: ['art 2', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 2', 'art 1', 'art 2', 'art 1', 'art 1', 'art 2', 'art 1', 'art 1', 'art 1']

Drug Office - Frequently Asked Questions
Skip to main content Other Useful Information > Frequently Asked Questions
Import/ Export of Pharmaceutical Products
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” means any substance, or combination of substances (A) presented as having properties for treating or preventing disease in human beings or animals; or (B) that may be used in, or administered to, human beings or animals, either with a view to - (i) restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action; or (ii) making a medical diagnosis.
For more details about the Pharmacy and Poisons Ordinance and Pharmacy and Poisons (Amendment) Ordinance 2015, please refer to the websites below:
http://www.legislation.gov.hk/blis_pdf.nsf/6799165D2FEE3FA94825755E0033E532/
0F66D4839C78DBDA482575EE00438DD5?OpenDocument&bt=0 http://www.gld.gov.hk/egazette/pdf/20151905/es1201519052.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 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:
Antibiotics Ordinance (Cap. 137)
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. 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 處方藥物” or “Drug under Supervised Sales 監督售賣藥物”? A.6 According to the Pharmacy and Poisons Ordinance, all Part 1 poisons and Part 2 poisons must be labelled with the word "Poison 毒藥" or other applicable words specified in the above Ordinance. The word "Poison 毒藥" 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 監督售賣藥物"; pharmaceutical products or medicines containing poisons included in the Third Schedule should be labelled with the words "Prescription Drug 處方藥物".
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 the pharmaceutical product is manufactured in Hong Kong, the person applying for registration of the product should be the licensed manufacturer, or the licensed wholesale dealer contracting with the licensed manufacturer. If the pharmaceutical product is manufactured outside Hong Kong, the person applying for registration of the product should be a licensed wholesale dealer importing the pharmaceutical product, or the local 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
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 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$1,370.
The performance pledge for processing an application for registration of pharmaceutical product is within 5 months after the required documents have been provided (see A.7), and the criteria of registration are met (see Reg 37(1) of the Pharmacy and Poisons Regulations). For details of the relevant legislation, please refer to the website of Bilingual Laws Information System of Department of Justice below:
http://www.legislation.gov.hk/blis_pdf.nsf/6799165D2FEE3FA94825755E0033E532/98C7D17989BE0FD1482575EE0043A3C8/$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-
in the case of a product or substance, be-
its specifications;
its label;
its package insert, if any;
the name and address of the manufacturer; and
in the case of a product, further be-
the quantity or quantities of the dose form contained in its unit package or unit packages;
the name and quantity of all its active ingredients;
the name and quantity of all its excipients; and
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 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. 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. For pharmaceutical products containing vitamins, minerals etc., please refer to the “Guidelines on the Testing of Pharmaceutical Products containing Vitamins, Minerals, etc.” at the website of our office below:
http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Guid-test-pp.pdf?v=ql2j0fk.
Q.13 How can I renew the registration certificate of the product?
A.13 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 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. 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.15 What medical claims can I put on the labels?
A.15 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
Q.16 What should I do if I want to conduct a clinical trial?
A.16 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 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
Q.17 What is the procedure of importing / exporting a pharmaceutical product?
A.17 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:
Q.18 What is the legal requirement for import of an unregistered drug for treatment of a particular patient?
A.18 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 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 Registration and Import/Export Control Division of Department of Health.
Q.19 What are the application documents required for importing an unregistered drug for treatment of a particular patient?
A.19 The importer needs to apply for an Import Licence (Form 3) from the Drug Registration 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:
Letter of a registered medical doctor stating the drug’s name, required quantity and patient’s information at least with his/her full name;
Certificate of Analysis of the drug issued by the manufacturer;
Product information, e.g. product insert;
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);
Drug trader licence of the importer, e.g. wholesale dealer licence; and
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:
Q.20 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.20 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.21 How can I apply for an import/export licence if I want to import e-cigarettes for re-export?
A.21 Firstly, you need to be a holder of a Wholesale Dealer 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.
(* From 6 February 2015, holders of valid Wholesale Poisons Licence or Certificate of Registration of Importers and Exporters will be regarded as Wholesale Dealer Licence holders until the expiry of their licence or certificate.)
Q.22 What kinds of documents are required to support that e-cigarettes can be lawfully re-exported to the importing country?
A.22 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.
Q.23 What licences should I apply for when dealing with pharmaceutical trade?
A.23 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
(* From 6 February 2015, holders of valid Wholesale Poisons Licence or Certifcate of Registration of Importers and Exporters will be regarded as Wholesale Dealer Licence holders until the expiry of their licence or certificate.)
Q.24 What is a “poison”?
A.24 “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 監督售賣藥物”; pharmaceutical products containing poisons included in the Third Schedule should be labelled with the word “Prescription Drug 處方藥物”. The outer container of non-pharmaceutical products containing poisons must still be labeled with the word “Poison 毒藥”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:
http://www.legislation.gov.hk/blis_pdf.nsf/6799165D2FEE3FA94825755E0033E532/98C7D17989BE0FD1482575EE0043A3C8/$FILE/CAP_138A_e_b5.pdf Q.25 What is an “antibiotic”?
A.25 “Antibiotic” refers to substance specified and defined in Schedule 1 of the Antibiotics Regulations, made under Cap. 137 of Laws of Hong Kong, and to their salts and derivatives and to the salts of such derivatives regardless of the method of production. For details of the Antibiotics Regulations, please refer to the website of Bilingual Laws Information System of Department of Justice below:
http://www.legislation.gov.hk/blis_pdf.nsf/6799165D2FEE3FA94825755E0033E532/9F602A38F9E61DEA482575EE004382EF/$FILE/CAP_137A_e_b5.pdf
Q.26 What is a “dangerous drug”?
A.26 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.27 How can I apply for the various licences?
A.27 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.28 How long does it take to receive my licence in general?
A.28 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.29 If there are changes in my business after I have received the licence, what should I do?
A.29 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.30 How can I renew my licence?
A.30 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.31 How can I apply for the Free Sale Certificate of pharmaceutical products?
A.31Local 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.32 Under what circumstances will your inspector come to my premises for inspection once the licence is granted to me?
A.32 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.33 Do I need any licence to sell medicines via the Internet?
A.33 The same licences mentioned in A.23 will be applicable to the sale of poisons, dangerous drugs and antibiotics via the Internet.
Q.34 Are Gold Potassium Cyanide and Silver Potassium Cyanide classified as poison?
A.34 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.35 Do I need to apply for a Wholesale Dealer Licence* to deal in wholesale of Gold Potassium Cyanide and Silver Potassium Cyanide?
A.35 Yes.
Q.36 Do I need to apply for a Wholesale Dealer Licence* to deal in wholesale (including local sale, import and export) of nicotine in a delivering device commonly known as e-cigarette?
A.36 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.20).
Q.37 How can I apply for the Wholesale Dealer Licence* to import nicotine in a delivering device commonly known as e-cigarette for re-export?
A.37 You should fill in the application form for Wholesale Dealer 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.38 How can I apply for the Wholesale Dealer Licence* to distribute nicotine in a delivering device commonly known as e-cigarette in Hong Kong?
A.38 You should fill in the application form for Wholesale Dealer 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.
Q.39 How should I deal with expired medicines?
A.39 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.40 How should I deal with expired dangerous drugs?
A.40 It is similar to the procedures as stated in A.39, the only exception is that you need to contact our office for arrangement of an inspector to oversee the disposal for Dangerous Drugs.
Q.41 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.41 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:
Q.42 If I want to raise a complaint about a product marketed with a Hong Kong registration number, what should I do?
A.42 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.43 If I suspect that a shop is selling counterfeit medicine, what should I do?
A.43 You are encouraged to report suspected counterfeiting activities to the Customs and Excise Department by:
Customs Hotline (24-hour)
(852) 2543 4942; or
G.P.O Box No. 1166
Q.44 If I have more questions about pharmaceutical business, can I call your office?
A.44 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)
Requirements on wholesale dealing
Holder of Wholesale Dealer Licence* plus relevant record prescribed under Reg. 28 of the Pharmacy and Poisons Regulations,Cap. 138A	Simple pain-relieving drug containing paracetamol
Pharmacy and Poisons Ordinance, Cap. 138	2.
Part 2 poison
Cold and flu medication containing chlorpheniramine
Pharmacy and Poisons Ordinance, Cap. 138	3.
Part 1 poison
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 1 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 1 First & Third Schedules poison
Anti-hypertensive drug, anti-diabetic drug
Pharmacy and Poisons Ordinance, Cap. 138	6.
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.
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	(* From 6 February 2015, holders of valid Wholesale Poisons Licence or Certificate of Registration of Importers and Exporters will be regarded as Wholesale Dealer Licence holders until the expiry of their licence or certificate.)