Basic information
Outline of the system
Licences are required for import of pharmaceutical products and medicines. These import measures are applied for safety, health, security, or for fulfilment of HKSAR's international obligations. Import licences for these products are issued by the Department of Health under delegation from the Trade and Industry Department.
Product coverage
Pharmaceutical products and medicines
Nature of licensing
Automatic
If Automatic, administrative purpose
To enhance the monitoring of the import and export of unregistered pharmaceutical products and medicines for prevention of illegal diversion into the local market.
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The principal objective of the import licensing system is for the protection of public health but not to restrict the quantity or value of imports.
Questions for products under restriction as to the quantity or value of imports
Not applicable as the import licensing system is not intended to restrict the quantity or value of imports.
The system applies to products originating from which country?
The import licensing system applies to products coming from all places.
Expected duration of licensing procedure
The import licensing system is an ongoing requirement.
Legal requirements
Is the licensing statutorily required?
The import licensing system is a statutory requirement maintained under the Pharmacy and Poisons Ordinance (Cap. 138), Import and Export (General) Regulations (Cap. 60A), Import and Export Ordinance (Cap. 60) and Dangerous Drugs Ordinance (Amendment of First Schedule) Order 2022
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Legislation does not leave designation of product to be subject to licensing to administrative discretion.
Is it possible for the government to abolish the system without legislative approval?
Any changes to the import licensing system require legislative approval.
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
For pharmaceutical products and medicines, only those products which have been registered with the Pharmacy and Poisons Board are allowed to be imported for the purpose of local sale or distribution.
What persons or firms are eligible to apply for a licence?
A company is required to hold an appropriate dealer's licence issued by the Pharmacy and Poisons Board before it can apply for an import licence. Application for the dealer's licence is open to all business enterprises dealing in pharmaceutical products and medicines.
Is there a registration fee?
A fee is charged for the licence, which may range from HK$625 to HK$2,680 depending on the type of licence.
Is there a published list of authorized importers?
There is a published list of licensed wholesale dealers and manufacturers in the Drug Office website: http://www.drugoffice.gov.hk.
Contact point for information on eligibility
Ministry/Authority
Drug Import/Export Control Unit, Drug Office, Department of Health
Address
3/F Public Health Laboratory Centre, 382 Nam Cheong Street, Shek Kip Mei, Kowloon, Hong Kong
Telephone
(852) 2319 8460
Fax
(852) 2803 4962
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Drug Import/Export Control Unit, Drug Office, Department of Health
Documentation requirements
What information is required in applications?
In general, information to be supplied includes particulars of the importer, of the importation and of the products to be imported. Sample of the Import Licence Form 3 (for pharmaceutical products and medicines) is available at:
https://www.tid.gov.hk/english/aboutus/form/sampleform/files/tra187.pdf
What documents is the importer required to supply with the application?
Importer is required to provide a copy of valid trader's licence issued by the Pharmacy and Poisons Board.
Window of submission of an application
How far in advance of importation must application for a licence be made?
Application for import licences should be lodged in advance of importation taking into account the processing time.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
There are no limitations as to the period of the year during which application for licence can be made.
Issuing the license
Can a licence be granted immediately on request?
In exceptional cases, a licence can be granted immediately on request.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
The processing time for pharmaceutical products is two working days.
Which administrative body is responsible for approving application of licences?
Department of Health is the sole administrative organ for the processing and approval of import licences.
With effect from 31 December 2021, the Drug Office, Department of Health would only accept and process applications for import and export licences / certificates for pharmaceutical products and dangerous drugs ("IE and DD licences") submitted online via the Pharmaceutical Licence Application and Movement Monitoring System ("PLAMMS"). Manual application submission for IE and DD licences would no longer be accepted.
https://www.drugoffice.gov.hk/eps/do/en/doc/PLAMMS_Important_Notice_2021...(Eng).pdf
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
The licensing conditions are printed on the front or back of the import licences
Sample of the Import Licence Form 3 (for phamaceutical products and medicines) is available at: (http://www.tid.gov.hk/english/aboutus/form/sampleform/files/tra187.pdf.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
No licensing fee or administrative charge is required for import licence applications.
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
No deposit or advance payment is required.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
Under normal circumstances, an application for an import licence is usually granted if it meets the ordinary criteria.
Are the reasons for any refusal given to applicants?
Reasons for refusal will be given to the applicant.
Have applicants a right of appeal in the event of refusal to issue a licence?
Applicants may appeal to the Chief Executive of the HKSAR in the event of refusal to issue an import licence. The Chief Executive may confirm, vary or reverse the decision of the Director General of Trade and Industry. The right to appeal to the Chief Executive is provided in relevant statutes.
If so, to what bodies and under what procedures?
Applicants may appeal to the Chief Executive of the HKSAR in the event of refusal to issue an import licence. The Chief Executive may confirm, vary or reverse the decision of the Director General of Trade and Industry. The right to appeal to the Chief Executive is provided in relevant statutes.
Importation
Are there any limitations as to the period of year during which importation may be made?
There are no limitations as to the period of the year during which importation may be made.
What documents are required upon actual importation?
The import licence is the only document required upon actual importation.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
Unless otherwise stated, an import licence is valid for six months. The period of validity can be extended by the Director General of Trade and Industry depending on the merits of individual requests.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for non-utilization. Importers should however cancel or amend the licences.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
The licence is not transferable.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
The banking authorities automatically provide foreign exchange for goods to be imported.
Is a licence required as a condition to obtaining foreign exchange?
No licence is required as a condition to obtaining foreign exchange.