Basic information
Outline of the system
Imports of narcotic drugs and psychotropic substances are regulated by the 1961 and 1971 United Nations Conventions, respectively. These Conventions establish the need for an annual forecast and an import licence for each international movement.
Based on the above, annual forecasts are provided for in Article 8 of Supreme Decrees Nos. 404/83 and 405/83.
Once the forecasts have been approved, a request is made for the import licence, which in Chile is called the official import certificate, in accordance with Article 10 of Supreme Decrees Nos. 404/83 and 4085/83.
To give effect to the importation, a customs destination certificate must be obtained, and to obtain the full enjoyment of the goods, a use and disposal certificate is required.
Product coverage
Licensing systems apply to all narcotic drugs and psychotropic substances.
Nature of licensing
Automatic
If Automatic, administrative purpose
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 quantity to be imported is limited to that authorized in the official import certificate, in order to comply with the provisions of the 1961 and 1971 Conventions.
Questions for products under restriction as to the quantity or value of imports
The quantities that may be imported are determined by the International Narcotics Control Board https://www.incb.org/incb/en/psychotropics/status-of-assessments.html
and https://www.incb.org/documents/Psychotropics/assessment/2022/Assesments_...
The system applies to products originating from which country?
Applicable to any country that issues export licences for narcotic drugs and psychotropic substances on the basis of a valid and lawfully issued official import certificate.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
The laws and regulations under which the licensing is maintained are:
- Supreme Decree No. 404/83 https://www.bcn.cl/leychile/navegar?idNorma=13057.
- Supreme Decree No. 405/83 https://www.bcn.cl/leychile/navegar?idNorma=13066.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Is it possible for the government to abolish the system without legislative approval?
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
Only establishments authorized in Article 8 of Supreme Decrees Nos. 404/83 and 405/83.
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Documentation requirements
What information is required in applications?
Forecast: no mandatory documentation, but it must include the following elements:
1. Amount requested.
2. Background information supporting the amount requested.
Official import certificate: no mandatory documentation, but it must include the following elements:
1. Authorized import forecast.
In addition, the following must be indicated in the application:
(a) Name and address of the establishment or of the legal representative, in the case of a legal entity;
(b) Identity details of the technical director of the establishment or of the health professional responsible, in the case of medical or scientific research institutions;
(c) Name and address of the exporter and country of origin of the product;
(d) Generic name and chemical nomenclature of the drug or product;
(e) Quantity to be imported;
(f) Pharmaceutical form, name and nature of the container, in the case of pharmaceutical preparations or specialties; and
(g) Customs office through which the product is to be imported.
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?
The time frame is relative. It depends on the evaluation time of the exporting country, which must issue an export licence based on the official import certificate issued by the country.
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 restrictions.
Issuing the license
Can a licence be granted immediately on request?
Although an official import certificate may be issued quickly, it will not have its international counterpart in the form of an export licence from the country of origin, in contravention of the above-mentioned Conventions.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
It is not possible to receive goods at a port without an official import certificate.
Which administrative body is responsible for approving application of licences?
The Public Health Institute alone is responsible for import licences for this type of product.
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?
Not applicable.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
Forecast assessments cost $ 52,371.-
- Applying for an official import certificate costs $ 99,816.-
- A customs destination certificate costs $ 43.519.-
- A use and disposal certificate costs $ 24,658.-
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
Payment for these services is a condition for the issue of the associated licences.
Amount or rate?
Is it refundable?
It is non 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?
Forecasts may be rejected in the following cases:
(a) Country balance insufficient to meet forecast requirements.
(b) Historical statistics of national and international movements do not justify what is requested in the forecast.
(c) The background information presented does not justify what is requested in the forecast.
(d) Establishment not authorized in Article 8 of Supreme Decrees Nos. 404/83 and 405/83.
Are the reasons for any refusal given to applicants?
The applicant is always aware of the status of their application and the considerations that determine the granting or refusal thereof.
Have applicants a right of appeal in the event of refusal to issue a licence?
In the event of refusal, the user may submit an appeal.
If so, to what bodies and under what procedures?
In the event of refusal, the user may submit an appeal for reconsideration to the Director of the Public Health Institute.
Importation
Are there any limitations as to the period of year during which importation may be made?
There are no restrictions.
What documents are required upon actual importation?
Actual importation requires an invoice or purchase order for the product, a transport document or detention letter for the product, a certificate of analysis of origin, a decision authorizing importation for exceptional use, if applicable (for pharmaceutical products without sanitary registration, in accordance with Article 99 of the Health Code, the decision is issued by the Public Health Institute), and an official import certificate for drugs, narcotics or psychotropic substances, if applicable, authorized by the Public Health Institute.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
All products to be distributed in the country require prior sanitary registration, as established in the Regulation on Pharmaceutical Products (Supreme Decree No. 3/10).
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
he forecast is valid for the calendar year in which it is issued.
Official import certificates are valid for four months.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
No, there is no penalty.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences are not transferable between importers.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Not applicable.
Is a licence required as a condition to obtaining foreign exchange?
Not applicable.
Is foreign exchange always available to cover licences issued?
Not applicable.
What formalities must be fulfilled for obtaining the foreign exchange?
Not applicable.