Basic information
Outline of the system
The Therapeutic Goods licensing system establishes a system of regulation of therapeutic goods, to establish a national drugs and medical supplies committee, to regulate the import, quality, availability and use of registered therapeutic goods, including narcotic drugs and psychotropic substances and for ancillary purposes.
Importation is considered under Section 10, 11 & 12 of the Therapeutic Goods Act [CAP.12.16].
Product coverage
Import Business Licensing covers all therapeutic goods listed under the registered list of Part III, Section 5(2) of the Therapeutic Goods Act [CAP.12.16].
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Non-Automatic licensing to protect human, animal or plant life and health; protect environment
Products under restriction as to the quantity or value of imports
The Import license shall be limited to those therapeutic goods in the class of the registered list under section 5(2) of the Therapeutic Goods Act 2020 revised edition, authorised as able to be held by the applicant.
Questions for products under restriction as to the quantity or value of imports
See Answers 6.1-6.11.
The system applies to products originating from which country?
The system applies to all goods regardless of their originating country.
Expected duration of licensing procedure
Ongoing
Legal requirements
Is the licensing statutorily required?
The Therapeutic Goods Act 2020 and the Therapeutic Goods Regulations 2020 provide the rules and procedures for therapeutic goods. Yes, licensing is statutorily required, Part IV, Section 11(3) states an application for an import licence shall be made in writing in the form prescribed in the regulations, identify the therapeutic goods that the applicant wishes to import and the class according to the "Tongan Registered List of Medical Drugs" in which they are included, be delivered to the Central Pharmacy and Medical Store, and be accompanied by the specified application fee. Yes, Part IV, Section 12(3) states that granting of an import license is subjected to the approval of the National Drugs and Medical Supplies Committee (NDMSC).
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
No. The Constitution of Tonga states that the King and the Legislative Assembly shall have power to enact laws.
Is it possible for the government to abolish the system without legislative approval?
According to Part VII, Section 35, the Minister may with the consent of the cabinet make regulations for purposes such as fees, manner and form of application or exemptions of specific persons from any provision of the Act.
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
No.
What persons or firms are eligible to apply for a licence?
Part IV, Section 11(1) states that only pharmacists, veterinary practitioners, wholesaler or retailer can apply for an import licence of therapeutic goods. The import licence shall be limited to those therapeutic goods in the class of the registered list under section 5 (2) authorised as able to be held by the applicant.
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Ministry of Health and Pharmaceutical Department
Address
Drug Regulatory Authority, Pharmaceutical Department, Baron Road, Vaiola Motu'a, Nuku'olofa
Telephone
(+676) 24553/7400200
Fax
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Ministry of Health and Pharmaceutical Department
Documentation requirements
What information is required in applications?
In application, information such as Name of Applicant, Applicant's qualification, business address and the classes of medicinal drug for which a license is sought.
What documents is the importer required to supply with the application?
There's no other document just the application form.
Window of submission of an application
How far in advance of importation must application for a licence be made?
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
No.
Issuing the license
Can a licence be granted immediately on request?
No, it has to follow the process of applying for a license to import.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
First of all, license to import is a must for all drugs to be imported. And No, license should be there prior importing any medicinal drugs.
Which administrative body is responsible for approving application of licences?
Yes. According to Part IV, Section 12(3) the granting of an import license is subject to the approval of a single administrative organ – National Drugs and Medical Supplies Committee (NDMSC).
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?
No.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
No.
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
No.
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?
Yes, if the license holder commits any offence and does not comply with the pharmacy act and therapeutic good act.
Are the reasons for any refusal given to applicants?
Have applicants a right of appeal in the event of refusal to issue a licence?
If so, to what bodies and under what procedures?
Importation
Are there any limitations as to the period of year during which importation may be made?
No.
What documents are required upon actual importation?
Import Permit document.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
No.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
Six months validity. And it cannot be extended.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
Yes, other from penalty but they cannot import without a license. Penalties may be imposed by the NDMSC which include revoking the license or any other penalty that the Committee decides is appropriate.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
No, the license is only sent straight to the supplier whom we are going to import the drug from. It cannot be transferred between two importers.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
No, because foreign exchange is done by the suppliers overseas.
Is a licence required as a condition to obtaining foreign exchange?
Is foreign exchange always available to cover licences issued?
What formalities must be fulfilled for obtaining the foreign exchange?
The following questions are only for products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally)
Where is information on allocation and formalities for licences published? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
The information for products under restriction is published at the International Narcotic Control Board (INCB) website (https://www.incb.org/incb/en/narcotic-drugs/index.html) also we have our Essential Drug List which contain the level of drugs that are under restriction. Overall amount, amount allocated for each country and maximum amount allocated to each importer for restricted drugs (Narcotics) is published on INCB website. If there is any exceptions or derogations for licensing requirement it has to be requested and informed to the National Drug and Medical Supplies Committee for the decision to be made.
Is the size of the quota determined: on yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for a fresh licence on a six-monthly or quarterly basis?
The size of the quotas is determined on a yearly basis. The license to imports is also done on a yearly basis and an application for an import license are only made by pharmacist, veterinary practitioner, wholesaler or retailer. Therefore, if there is an emergency order for any of the restricted product to be imported an import permit will be issued.
Are licences allocated for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate)
Licenses to import is allotted to all products. The same license to import other drugs is the same license to import restricted products but for restricted products there is an import permit prepared by the drug regulatory unit and it must be signed by the principal pharmacist and endorsed by the CEO for health, to be finally signed by the Minister for Health prior importation. The import permit contains the name of the importer and all details of the drugs to be imported.
From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
As mentioned above the application for license to import is only for pharmacist, veterinary practitioner, wholesaler or retailer and it is done at the begin of the year. But only Pharmacist is authorised to import restricted products. This is in accordance with Part IV, Section 11(1) of the Act.
What are the minimum and maximum lengths of time for processing applications?
Processing application takes up 1-4 weeks since it has to be granted by the National Drugs and Medical Supplies Committee. So, minimum can be within a week and maximum lengths can be up to a month.
How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
License to import should already be there before importing any product so there shouldn't be any time needed for this.
Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
License application is approved and granted by the National Drug and Medical Supplies committee. So, the applicant must apply for the import license and must submit for approval by the NDMSC.
If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
If the application for license to import is not fully satisfied by the committee, it can be return back to the applicant for re-submission.
In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
We do not use export permit since we do not export any restricted product.
In cases where imports are allocated on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Same as the above answer, we do not have export permit only import permit.
Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
No.