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Frequently Asked Questions
Pharmaceutical Service, Department of Health
Pharmaceuticals Registration
Q.1 What product needs to be registered in Hong Kong?
A.1 Under the Pharmacy and Poisons Ordinance (Cap. 138), "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.
Q.2 What is a pharmaceutical product?
A.2 "Pharmaceutical product" means any substance or mixture of substances manufactured, sold, supplied or offered for sale or supply for use in
(a) the diagnosis, treatment, mitigation, alleviation or prevention of disease or any symptom thereof;
(b) the diagnosis, treatment, mitigation, alleviation of any abnormal physical or physiological state or any symptom thereof;
(c) altering, modifying, correcting or restoring any organic function, in human beings or in animals.
The definition is stated in the Pharmacy and Poisons Ordinance (Cap. 138) under section 2. You may purchase this ordinance by calling the Publications Sales Section of Information Services Department at 2537 1910 or by email at puborder@isd.gov.hk. The contents of the relative legislation may also be found at the Department of Justice’s "The Laws of Hong Kong" website www.legislation.gov.hk. You can also find its meaning in the "Guidance Notes on Registration of Pharmaceutical Products", which is posted on our website.
Q.3 How can I check whether the medicine, which I am taking, is registered or not?
A.3 You can find the HK Registration number on the actual sales pack indicated as "HKXXXXX" as this is one of the legal requirements for labeling. In addition, you may also refer to the "Compendium of Pharmaceutical Products" which lists all registered pharmaceutical products in an alphabetical order of the product names. You can purchase it by calling the Publications Sales Section of Information Services Department at 2537 1910 or by email at puborder@isd.gov.hk or view it from our website.
Q.4 How can I apply for drug registration and what documents are required?
A.4 The documents required are as follows, which you can find in the Guidance Notes:
l Application Form
l Sample
l Coloured prototypes sales packs
l Manufacturer’s Licence: original or notarized copy
l Good Manufacturing Practice (GMP) Certificate: original or notarized copy
l Free Sale Certificate from the country of origin: original or notarized copy
l Complete Master Formula
l Finished Product Specifications
l Certificate of Analysis
l Method of Analysis
l Stability Data
Guidance Notes, Application Form, Checklist and Guidelines on the Labelling of Pharmaceutical Products and Requirement of Stability Test Data are available from our office at 3/F, Public Health Laboratory Centre, 382 Nam Cheong Street, Kowloon, or by facsimile (Fax No.: 2803 4962), or from our website.
Q.5 How much does it cost to obtain the product registration certificate and how long is the approval time?
A.5 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.
When the required documents are provided (see A.4), and the criteria of registration are met (see Reg 37(1) of the Pharmacy and Poisons Ordinance), the Pharmaceutical Service has a performance pledge to approve applications for registration of pharmaceutical products within 5 months.
Q.6 Do I need to submit separate applications for different dosage forms / strengths / pack sizes?
A.6 Separate applications are required for different dosage forms and strengths, but not for pack sizes.
Q.7 How can I renew the registration certificate of the product?
A.7 A notice for renewal will be sent to the registration certificate holder around five to six months before the expiry of each certificate. He / she should then submit the certified true copy of the manufacturer’s Good Manufacturing Practice (GMP) Certificate, complete master formula, finished product specifications, real time stability test data and the actual sales pack as required. Renewal will be given if the documents are found to be satisfactory.
Q.8 If there are changes with respect to the product after it has been approved for sale, what should I do?
A.8 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. Application Form and Guidelines are available in our website.
Q.9 What therapeutic claims can I put on the labels?
A.9 Any labeling should not contravene the provisions of the Undesirable Medical Advertisements Ordinance (Cap. 231). You may find out the purposes for which advertising is permitted from the ordinance.
For further enquiries on registration, please call 2319 8458.
Clinical Trial
Q.10 What should I do if I want to conduct a clinical trial?
A.10 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 and a sample of the product, which are listed in the Notes for the Guidance of Applicants posted on our website.
Import/Export of Pharmaceutical Products
Q.11 What is the procedure of importing / exporting a pharmaceutical product?
A.11 First of all, you need to apply for an appropriate 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 the Department of Health, Pharmaceutical Registration and Import/Export Control Service.
For details please refer to the Guidelines posted on our website.
Q.12 Do I have to apply for an import/export licence for medicine for my own use?
A.12 Pharmaceutical products imported or exported in the accompanied personal baggage of a person entering or leaving Hong Kong and which is for his own use and in a quantity which is reasonable for the purpose for which it is imported or exported do not require an import/export licence.
Q.13 If I order medicines from overseas for own use, what should I do?
A.13 In accordance with the Import and Export Ordinance (Cap. 60), importation and exportation of medicines require relevant licences issued by the Trade and Industry Department.
For further enquiries, please call our Import/Export Control Unit at 2319 8460.
Licensing
Q.14 What licences can I obtain from your Service?
l Wholesale Poisons Licence: for person dealing with wholesale of poisons
l Certificate of Registration of Importers and Exporters: for person carrying on business as an importer or exporter of pharmaceutical products
l Licence for Manufacturer: for person dealing with manufacture of pharmaceutical products on licenced premises
l 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
l Licence for Listed Sellers of Poisons: for person dealing with retail sale of Part II poisons
l Antibiotics Permit: for person dealing in and to possess antibiotics
l Licence to Manufacture Dangerous Drug: for person dealing with the manufacture of dangerous drugs
l Wholesale Dealer’s Licence to Supply Dangerous Drug: for person dealing with wholesale of dangerous drugs
Q.15 How can I find out the classifications of medicines?
A.15 Some medicines are legally classified as poisons, dangerous drugs or antibiotics by the Poisons List Regulation (Cap. 138), Dangerous Drugs Ordinance (Cap. 134) and Antibiotics Ordinance (Cap. 137), respectively. You may obtain the relevant ordinances and regulations by calling the Publications Sales Section of Information Services Department at 2537 1910 or by email at puborder@isd.gov.hk . The contents of relevant legislation may also be found at the Department of Justice’s website www.legislation.gov.hk .
Q.16 Are Gold Potassium Cyanide and Silver Potassium Cyanide classified as poison?
A.16 Yes, Gold Potassium Cyanide and Silver Potassium Cyanide are classified as poison under Part 1A of the Poisons List Regulations (Cap. 138).
Q.17 Do I need to apply for a Wholesale Poisons Licence to deal in wholesale of Gold Potassium Cyanide and Silver Potassium Cyanide?
A.17 Yes.
Q.18 How can I apply for the various licences?
A.18 You may fill in the relevant application forms and provide the supporting documents as listed in the checklists for application. Both application guidelines and forms are available from our office, at 3/F, Public Health Laboratory Centre, 382 Nam Cheong Street, Kowloon or from our website.
Q.19 How long does it take to receive my licence?
A.19 The issue of licences is subject to the approval of relevant 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.20 How can I renew my licence?
A.20 A notice for renewal 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.21 If there are changes in my business after I have received the licence, what should I do?
A.21 You should notify any changes of the business, e.g. name of company, address, personnel, etc., of a licence to our Inspection and Licensing section as soon as possible. Some changes, e.g. person-in-charge of poisons, may require approval.
Q.22 How can I apply for the Free Sale Certificate of pharmaceutical products?
A.22 Local Manufacturer of pharmaceutical products with a licence for manufacturer may apply, in writing, for a Free Sale Certificate of pharmaceutical products, subject to the payment of a fee prescribed in the Pharmacy & Poisons Regulation. The current fee is HK$180.
Q.23 Under what circumstances will your inspector come to my premises for inspection once the licence is granted to me?
A.23 Inspections of licensed premises will be performed on a routine and random basis. No prior notice will be given for such inspections. In addition, inspections may also be performed in case there is any change of particulars with respect to your licence.
Q.24 Do I need any licence to sell medicines via the Internet?
A.24 The same licences will be applied for the sale of poisons, dangerous drugs and antibiotics via the Internet.
For further enquiries on licensing, please call 2319 8467.
General
Q.25 How should I deal with expired medicines?
A.25 You need to contact the Environmental Protection Department to arrange the disposal of the expired medicines, you then have to inform our Department about the arrangement and keep relevant records for inspection later.
Q.26 How should I deal with expired dangerous drugs?
A.26 For wholesaler and pharmacies, it is similar to the procedures as stated in A.25, the only exception is that on the date of disposing the expired dangerous drugs, an inspector will be sent to oversee the disposal. For doctors, you may arrange with us and send the expired dangerous drugs to our office for disposal.
Q.27 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.27 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 by email at puborder@isd.gov.hk . The contents of the relevant legislation may be found at the Department of Justice’s website www.legislation.gov.hk .
Q.28 If I have something concerning medicines to complain about, what should I do?
A.28 A complaint hotline is set for the purpose, the number is 2572 2068. You may leave you message and the case will be followed up as soon as possible.
23 March 2009
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2010
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Important notices |
Last Revision Date : 12 June 2010 |