Department of Health

Pharmaceuticals Registration and Import/Export Control Section

Import and Export Licences

Notes for the Guidance of Applicants

               To avoid undue delay in the endorsement of applications for import and export licences, applicants are requested to note the followings :-

1.

An application for Import Licence Form 3 covering pharmaceutical products for local sale or distribution must be accompanied by a copy of the Certificate of Registration or Certificate for Clinical Trial/Medicinal Test of the product to be imported.

2.

If the applicant is not the holder of a registration certificate of the product to be imported, the application must be supported by a written authorization from the relevant product registration certificate holder.

3.

 Full details concerning the products to be imported or exported such as description, quantity, literature, medicinal/therapeutic uses, product insert, etc should be provided.  If the product is registered in Hong Kong, please state the Hong Kong Registration Number on the Import/Export Licence.

4.

Applicant’s signature and company’s chop should be given on the application.

5.

The Import Licence Form 3 should be completed in quadruplicate (original, duplicate, triplicate and copy) and Export Licence Form 6 in triplicate (original, duplicate and triplicate).

6.

If the applicant is holder of Antibiotics Permit, Wholesale Poisons Licence, Certificate of Registration as an Importer and Exporter, Manufacturer’s Licence, Wholesale Dealer’s Licence to supply Dangerous Drugs or Licence to manufacture Preparations of Dangerous Drugs, a copy of the relevant valid licence or permit should accompany the application for the import or export licence.

7.

If the product to be imported is:

(a)

for the purpose of clinical trial or medicinal test; or

(b)

for the treatment of a particular patient under the direction of a registered medical practitioner or for the treatment of a particular animal under the direction of a registered veterinary surgeon;

(c)

for the purpose of manufacturing pharmaceutical products by the manufacturer concerned for its own manufacturing, or

(d)

for the purpose of application for registration of the product

please state (a), (b) , (c) or (d) as the case may be, should be clearly stated on the licence.

These notes are only a general guide and must not be treated as a complete or authoritative statement of the law on any particular case. Copies of the Pharmacy and Poisons Ordinance and Regulations can be purchased by calling the Publications Sales Section of Information Services Department at 2537 1910.