Pharmaceutical products
- Document symbol
- G/LIC/N/3/TLS/1
- Original language
- English
- Published on
- 18/11/2025
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
Timor-Leste Ministry of Health is responsible to provide licenses for pharmaceutical products.
All goods imported into Timor-Leste must comply with the rules established in the Customs Code (Decree-Law No. 14/2017 of 5 April 2017. This Code establishes all the rules from the arrival of the goods to the customs territory until their customs clearance, establishing all the necessary requirements regarding obtaining licenses
At the time of importation, the Directorate of the Customs Authority requires all commercial importers to demonstrate that they have a Timor-Leste Taxpayer Identification Number (TIN). Companies must prove they are incorporated. Importers are required to lodge their request to the Directorate of the Customs Authority to clear goods.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
Pharmaceutical products subject to commercial purposes – could be imported by private companies with more detailed processes, without discrimination to any companies with commercial licenses for importing pharmaceutical products.
All products are mentioned in the Ministry of Health Ministerial Diploma No. 12/2004 of 6 October 2004, on the Classification of Medicines are subject to non-automatic licenses. The National Drugs and Medicines Policy requires all parties involved in the procurement, import and distribution of medicines to follow the WHO Certification scheme and the WHO-based guidelines on good distribution and storage practices and good pharmacy practice procedures.
Q3. The system applies to goods originating in and coming from which countries?
The system applies equally to all goods, regardless of the countries they originate from without discrimination. However, once Timor-Leste becomes full member of ASEAN in October 2025, Government Decree no. 9/2025 of 23 July, Procedures applicable to Preferential Rules of Origin regime under Free Trade Agreements (FTA) and other Trade Agreements will be effectively implemented.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
Sectoral import licenses are not intended to restrict the quantity and value of imports. However, any import prohibitions or restrictions are “dictated by reasons of morality and public safety, protection of health and life of humans and animals, preservation of plants and environment, protection of artistic, historical or archaeological heritage protection of industrial and commercial property” (as per Articles 138.3 and 175.2 of Decree-Law No. 14/2017 of 5 April 2017 on the Customs Code). For instance, the prohibition under pharmaceutical products is intended to ensure the quality of products based on the WHO and FAO standards.
Thus, no alternative methods of accomplishing the purposes been considered.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
General requirements by SERVE:
Decree-Law No. 34/2017 of 27 September 2017 on Licensing of Economic Activities sets out the provisions to obtain business authorization.
Decree-Law No. 16/2017 of 17 May 2017 on Commercial Registry sets out the criteria and information requirements for obtaining a business authorization.
Pharmaceutical activities:
Import licensing is maintained and statutorily required under the Decree-Law No. 12/2004 dated 26 May 2004 on Pharmaceutical Activities, which sets out the requirements for licensing the import of and export of medicines for human use.
This Decree-Law is supported by the Ministry of Health’s Ministerial Diplomas and Circulars, as follows:
- Ministerial Diploma No. 12/2004 of 6 October 2004 on Classification of Medicines;
- Ministerial Diploma No. 4/2004 of 14 July 2004 on Percentage of Insurance of Imported Goods;
- Ministerial Diploma No. 10/2004 of 22 September 2004 on Licensing fees for pharmaceutical activities;
- Ministerial Circular No. 3/2017 of 5 October 2017 on Import of Narcotics or Psychotropic Substances;
- Ministerial Circular No. 11/2017 of 18 December 2017 on Natural Medicines.
Procedures
Q6. 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):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? 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?
Q6.II. How is the size of the quotas determined: on a 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 fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted 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 the 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.)
Q6.IV. 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?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. 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?
Q6.VIII. 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?
Q6.IX. 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?
Q6.X. In cases where imports are allowed 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?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
Importation can be made immediately upon granting of sectoral import license. The decision to grant a license shall take place within a maximum period of 90 days counting from the date of submission of the application duly completed, and the license shall be valid for three years.
Import of products by private companies are subject to non-automatic licenses. Authorization to commercialize medicines shall have prior authorization by the Ministry of Health. The Autonomous Service of Medicines and Health Equipment, a public company, shall be the sole public entity with competence to apply for authorisations to commercialize and import medicines. In addition, every decision to grant, refuse renew, not renew, suspend, or revoke licenses shall be communicated to SERVE for registration in their respective file according to Article 7 of the same Decree Law.
However, through the Regulating Commission of Pharmaceutical Activities, exception may apply for the import by private clinics or physicians of medicines that have not yet been the object of commercial authorization whenever:
- For reasons of urgency and through a clinic justification, the medicines are considered to be indispensable for the treatment or the diagnosis of certain pathologies;
- The medicines are exclusively designed for research and clinical experiments.
Q7.b. Can a licence be granted immediately on request?
Both automatic and non-automatic licenses shall undergo a business registration process at SERVE, where companies shall identify the types of commercial activities under their company statutes. In addition, importation of products that fall under medium and high-risk activities shall obtain sectoral licenses with each of their procedures.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
There are no limitations as to the period of the year during application for license and/or importation may be made. For the importation of motor vehicles, the commercial vehicle import authorization is valid for one month only.
Q7.d. 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?
In terms of a commercial license application, besides SERVE, sectoral licenses or authorizations need to go through relevant Ministries or Agencies for approval. However, SERVE still acts as a single window by receiving applications from businesses.
At the time of importation, the Directorate General for Customs Authority has the full competency to inspect goods that are entering or leaving the country based on their licenses.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
According the Article 22 of Decree-Law No. 12/2004 of 26 May 2004, the application for a licence may be refused for the following reasons:
1. The application shall be dismissed whenever:
- The process is not duly completed and no correcting steps are taken within the period of time indicated by the Regulating Commission;
- The medicine is considered to be harmful;
- The therapeutic effect has been insufficiently proved;
- The medicine is susceptible to pose risks to public health;
- The medicine does not contain the declared qualitative and quantitative composition.
2. Applicants shall be notified of the dismissal and the respective justification for purposes of appealing to the Minister of Health, to be filed within a period of 20 days.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
All persons may be eligible to apply for licenses so long as they have obtained their license for commercial activities from SERVE.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
According to Article 17 of the same Decree-Law sets the information required for an application process:
1. Authorisation to commercialise medicines may be applied for by duly licensed importers through an application to be submitted to the Regulating Commission of Pharmaceutical Activities with the following details:
- Civil, fiscal and commercial identification, as well as respective residence or head office;
- Number of the license of the activity;
- Name of the medicine;
- Pharmaceutical form and composition insofar as active substances, excipients, dosage, presentation, and administration way are concerned;
- Therapeutic indication;
- Summary of the characteristics of the medicine;
- Project for labelling and informative leaflet in one of the official languages of Timor-Leste or, provisionally, in English or Indonesian;
- Sample of the medicine;
- Official document, accompanied by a translation into one of the official languages of Timor-Leste, certifying the existence of authorisation to commercialise the medicine in the country of its production and in the country from where it is exported.
2. In addition, the Autonomous Service of Medicines and Health Equipment, a public company, shall be the sole public entity with competence to apply for authorisations to commercialise and import medicines.
3. Other requirements may be demanded following a statute of the Minister of Health.
In this regard, there are no specific format for importation to be completed by importers, rather importers are required to complete the application procedures accordingly.
Q11. What documents are required upon actual importation?
Upon actual importation, the following documents should be attached to the application:
- Copy of bill of lading, air-bill, or truck way-bill;
- Invoice; and
- Packing list.
In addition, supplementary documents should be attached according to the classification of products:
- Copy of the receipt of payment for the vehicle purchase;
- Copy of certificates in relation to health certificates (lab result);
- Certification of pre-shipment inspection;
- Certificate of Commercial Registration;
- Copy of Contract of Buyers and Sellers;
- Certificate of Manufacture Authorization;
- Certificate of Types of Activities; and
- Copy of Tax Identification Number (TIN).
At the actual importation, licence shall be presented to customs authorities for clearance procedures according to the ASYCUDA World System that has been adopted by Timor-Leste.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
Additional fees to obtain sectoral licenses for non-automatic licenses are regulated according to legislations pertaining to each Ministries or Agencies providing sectoral licenses.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
No deposit or advance payment is required under the import licensing systems.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
Article 4 of the same Decree-Law provides the information regarding the validity and time limits of a license, as follow:
- The decision to grant a license shall take place within a maximum period of 90 days counting from the date of submission of the application duly completed, and the license shall be valid for three years.
- Licenses shall be renewable for equal periods whenever the initial conditions are maintained, and the requests for renewals shall be submitted within a minimum period of 30 days before their expiration dates.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for the non-utilization of a license or a portion of a license.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licenses are not transferable between importers.
However, there are some exceptions applied to the sectorial license under Downstream Activity, in which clearly stated under Article 12 of Decree-Law No. 1/2012 of 1 February 2012 on Downstream Sector, as follows:
Article 12
License Transfer
1. The transfer of a License to another company is only valid with prior written authorization from the ANP [now ANPM – National Authority for Petroleum and Minerals] and subject to the requirements established in paragraph 4 of Article 11.
2. In the event of a merger or total acquisition of Licensee's shares by a third party, or even the partial acquisition of Licensee's shares by a third party, but whose acquisition implies transferring the effective control of Licensee to a third party, the ANPM must reassess the situation to assess whether Licensee maintains the necessary requirements to develop the Activities for which it is licensed. If deemed necessary, ANPM may require Licensee to implement corrective measures aimed at maintaining or re-establishing the referred requirements.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
No other administrative procedures are required for import licensing systems.