|
|
|
|
|
How
to apply for Import and Export Licence for Chinese Medicines |
|
|
|
|
| Under
the Import and Export Ordinance (the I & E
Ordinance),Chapter 60 of the Laws of Hong Kong, all imports and
exports of pharmaceutical products and medicines must be covered
by import and export licences issued by the Trade and Industry
Department. |
|
|
|
|
According to the Chinese Medicine Ordinance, “proprietary Chinese medicine (pCm)” means any proprietary product- |
| (a) |
composed solely of the following as
active ingredients: |
|
|
| (i) |
any Chinese herbal medicines; or |
| (ii) |
any materials of herbal, animal
or mineral origin customarily used by the Chinese; or |
| (iii) |
any medicines and materials
referred to in subparagraphs (i) and (ii) respectively; |
|
|
| (b) |
formulated in a finished dose form; and |
|
| (c) |
known or claimed to be used for the diagnosis,treatment, prevention or alleviation of any disease or any symptom of a disease in human beings, or for the regulation of the functional states of the human body. |
|
|
|
|
|
| Before you import or export pCm, you must apply for an Import or Export licence to cover the consignment before the arrival or departure of the goods.Application should be submitted by hand after completion of Import Licence (Form 3) or Export Licence (Form 6), to the Pharmaceuticals Import/Export Control Unit of Department of Health, at 3/F., Public Health Laboratory Centre, 382 Nam Cheong Street, Kowloon. |
|
|
| A. Import Licence
(Form 3) |
|
| i. |
Completed Import Licence in quadruplicate (TRA
187); |
| ii. |
A complete formula in one hundred percent of the
ingredients of the product issued by the manufacturer; |
| iii. |
A sales pack of the product together with a
completed sample submission form, which is available at our counter. The label of the product should comply
with the provisions of the Undesirable Medical Advertisement Ordinance Cap.
231.Please
note that the product name and label of proprietary Chinese medicine will be
subject to further assessment and approval when application for registration is
processed under Chinese Medicine Division; |
| iv. |
If the product is imported for local consumption, please
provide re-confirmation receipts to applicants who had submitted the required
documents for registration or original exemption letter; |
| v. |
If the item has never been imported into Hong Kong, "New Item”should be marked under the
description of goods; |
| vi. |
If the item has been classified by the
Pharmaceuticals Registration Section, Department of Heath, please provide the
relevant letter issued to facilitate the processing; and |
| vii. |
Copy
of Wholesaler Licence in Proprietary Chinese Medicines/Chinese Medicines Trader
Transitional Certificate (wholesaler licence in proprietary Chinese medicines) OR copy of Manufacturer Licence/Chinese
Medicines Trader Transitional Certificate (manufacturer licence in proprietary
Chinese medicines), whichever is applicable (starting from 11 Jan
2008). |
|
|
|
|
|
|
| B. Export Licence
(Form 6) |
|
| i. |
Completed Export Licence in triplicate (TRA 394); |
| ii. |
A complete formula in one hundred percent of the ingredients
of the product issued by the manufacturer or sample bearing one hundred percent
of the ingredients of the product; |
| iii. |
If the product is manufactured in Hong Kong,
evidence that application for registration with Chinese Medicines Board under
Chinese Medicine Council of Hong Kong for that product during the period of 19
December 2003 and 30 June 2004 should be provided; and |
| iv. |
Copy
of Wholesaler Licence in Proprietary Chinese Medicines/Chinese Medicines Trader
Transitional Certificate (wholesaler licence in proprietary Chinese medicines) OR copy of Manufacturer Licence/Chinese
Medicines Trader Transitional Certificate (manufacturer licence in proprietary
Chinese medicines), whichever is applicable (starting from 11
Jan 2008). |
|
|
|
|
|
| Please note that: |
| 1. |
After you have submitted your licence, a numbered
receipt will be issued to you at the counter. Please keep it, as you need to present these
receipts to collect your proceeded application after one working day at noon at the same counter. |
| 2. |
Your application will be rejected if insufficient information was provided. |
| 3. |
The sample submitted may be sent to Government Laboratories for analysis and the sample(s) would not be returned. |
| 4. |
Import/Export licences on products containing Rhinoceros ingredients, Tiger parts and Bear ingredients (Ursus species) will not be issued under Animals and Plants (Protection of Endangered species) Ordinance Cap. 187. Import licences on products containing Caulis Aristolochiae Manshuriensis will not be issued according to the guideline of State Food and Drug Administration of The People's Republic of China. |
|
|
|
Pharmaceuticals Import
/Export Control Unit
Department of Health
(Tel No.: 2319 8460) |
|
|
Jan
2008.
|
|
|
|
Important notices