Controlled substances


Basic information


Outline of the system

The importation into Ecuador of narcotic drugs, psychotropic substances, precursors, specific chemicals and medicines containing such substances (hereinafter "controlled substances") appearing in Annex 1 of COMEXI Resolution 450 is subject to an import licence prior to shipment under the Codified Law on Narcotic Drugs and Psychotropic Substances and the relevant United Nations conventions.


Product coverage

Persons wishing to import controlled substances (morphine, fentanyl, benzodiazepine, hydrochloric acid, sodium hydroxide) and medicines containing them listed in the annexes to the Codified Law on Narcotic Drugs and Psychotropic Substances and in COMEXI Resolution 450, regulated by the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA), must be registered with the said agency and must obtain import authorization on a caseby-case basis. Resolution 450 can be found at

Non-automatic import licences issued by the Technical Secretariat for Drugs (SETED shall not be applied for desiccant products with a calcium chloride content of 85% or less.

Nature of licensing



If Automatic, administrative purpose



If Non-Automatic, description of the notified Non-Automatic Licensing regime


Products under restriction as to the quantity or value of imports

The purpose of this system is to reduce the diversion of controlled substances to a minimum and ensure the availability of narcotic drugs and psychotropic substances for medical use.
The import licensing process restricts the quantity of controlled substances imported on the basis of annual quotas assigned to each registered natural or legal person, also taking account of the estimates for narcotic drugs and psychotropic substances established by the International Narcotics Control Board (INCB).


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 controlled substances, whatever country they may come from.


Expected duration of licensing procedure

Eligibility of applicants


Is there a system of registration of persons or firms permitted to engage in importation?

National Agency for Sanitary Regulation, Control and Surveillance (ARCSA)


What persons or firms are eligible to apply for a licence?

All natural or legal persons registered with CONSEP as importers are eligible to apply for an import permit.


Is there a registration fee?

Fee calculated on the basis of the f.o.b. value according to the following table:
f.o.b. value Fee in US$
0 – 3,000 30
3,001 – 5,000 45
5,001 – 10,000 70
10,001 – 50,000 150
50,001 – 100,000 220
Más de 100,001 280


Is there a published list of authorized importers?

Contact point for information on eligibility










E-mail address




Contact officer

Submission of an application


Administrative body(ies) for submission of an application

Documentation requirements


What information is required in applications?

The SICE licence application must contain the following information:
(a) Tariff subheading;
(b) quantity to be imported: unit, weight and f.o.b. value;
(c) country of origin;
(d) port-country of shipment;
(e) port-country of destination;
(f) name of the supplier/exporter;
(g) name of the shipper;
(h) transport route;
(i) name or business name of the importer;
(j) importer's single tax payer identification number (RUC).


What documents is the importer required to supply with the application?

Window of submission of an application


How far in advance of importation must application for a licence be made?

Not applicable.


Are there any limitations as to the period of the year during which application for licence can be made? If so, explain

Not applicable.

Issuing the license


Can a licence be granted immediately on request?

Not applicable.


Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence

Not applicable.


Which administrative body is responsible for approving application of licences?

Not applicable.


Must the applications be passed on to other organs for visa, note or approval?

Not applicable.


Are there any other conditions attached to the issue of a licence?


Fees and other administrative charges


Is there any licensing fee or administrative charge?



What is the amount of the fee or charge?

A fee is paid for registration, annual renewal, and for each import application on the basis of the f.o.b. price.


Is there any deposit or advance payment required associated with the issue of licences?



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?

Applications for a licence are refused when the annual quota granted to each entity by ARCSA is exceeded.


Are the reasons for any refusal given to applicants?

The interested party is informed of this circumstance and may apply for a quota extension. The importer must have available quota shares for the requested shipment. Importers that require a greater annual volume must negotiate the expansion of the quota, providing technical justification for their request.


Have applicants a right of appeal in the event of refusal to issue a licence?


If so, to what bodies and under what procedures?



Are there any limitations as to the period of year during which importation may be made?

Not applicable.


What documents are required upon actual importation?

The importer must submit a written application accompanied by the SICE import licence application, the order form, a copy of the ARCSA payment invoice and, in the case of narcotic drugs, psychotropic substances, precursors and/or medicines containing such substances, a copy of the health registration.


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?

180 days. Extension is not possible.


Is there any penalty for the non-utilization of a licence or a portion of a licence?

No, but the importer is required to notify the non-utilization.


Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?


Foreign Exchange


Is foreign exchange automatically provided by the banking authorities for goods to be imported?



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 INCB's confirmed annual estimates of requirements of narcotic drugs and psychotropic substances are published on ARCSA's website and the annual quotas assigned by ARCSA to registered importers are known to each of the entities concerned.


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 the basis of the INCB's estimates and historical consumption recorded by each entity in ARCSA's system of monthly reports.


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)

Authorizations to import controlled substances and medicines containing such substances are allotted exclusively to importers registered with ARCSA who have an annual quota for the substance to be imported. These authorizations are required for each shipment of imports:the importer must file an application through the Interactive Foreign Trade System (SICE) which will direct it physically to ARCSA. The arrival of the goods must be notified 72 hours in advance for inspection purposes.


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?

Although quotas are allocated annually, applications for licences can be filed at any time during the year, depending on each entity's quota availability.


What are the minimum and maximum lengths of time for processing applications?

Import licences are issued within 15 working days after the application has been entered into the SICE.


How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?

Import licences granted by ARCSA authorize immediate importation.


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?

All applications for the importation of controlled substances and medicines containing such substances are examined by ARCSA.


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?

Import applications are examined in the order in which they are received by ARCSA.


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?

Under Ecuadorian law and the United Nations Conventions of 1961 and 1971, narcotic drugs, psychotropic substances and medicines containing such substances also require export licences issued by the competent authorities in the exporting country.


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?

Not applicable.


Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?

Not applicable.