Outline of the system
To import biological material or pathological material, the interested party must complete a form including all the information required by the office of the National Fisheries Service (SERNAPESCA). This document can be submitted in person to the SERNAPESCA office in the region where the customs clearance of the material is to be carried out (submit two copies), or by email to firstname.lastname@example.org.
Importation of biological/pathological materials – (for private use): Any person or firm wishing to import biological or pathological material must have the Service's authorization prior to its arrival.
Definition of biological material: Material including inactivated tissues of hydrobiological species, cell lines, diagnostic kit (antigen or antibody), culture media or genetic material of microorganisms, used for diagnostic, research or quality control purposes.
Definition of pathological material: Tissues, not inactivated, extracted from hydrobiological species or strains of pathogenic microorganisms imported for laboratory analysis.
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 licence is not intended to restrict the quantity or value of imports; rather it seeks to prevent the entry, through such imports, of diseases and their causal agents, in particular diseases which are not present in Chilean national territory and diseases covered by a specific surveillance or eradication programme in the country. However, depending on the type of material to be imported and the assessment carried out by SERNAPESCA, SERNAPESCA may make further requests if deemed necessary.
Questions for products under restriction as to the quantity or value of imports
The system applies to products originating from which country?
It applies to biological/pathological material coming from all countries.
Expected duration of licensing procedure
Is the licensing statutorily required?
Laws and regulations under which the licensing is maintained:
Supreme Decree No. 430 of 1991 (Consolidated text of the general law on fisheries and aquaculture). Ministry of the Economy, Development and Tourism. National Fisheries and Aquaculture Service (SERNAPESCA) Supreme Decree No. 319 of 2001.
Approves regulations on measures to protect against, control and eradicate high risk diseases of hydrobiological species. "The importation into the country of pathological material (for private use) is forbidden, unless authorized by the Service".
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?
All natural and legal persons are eligible to apply for import permits.
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Submission of an application
Administrative body(ies) for submission of an application
What information is required in applications?
The interested party must submit a form entitled "Solicitud para importar material biológico o patológico" ("Application to import biological or pathological material").
What documents is the importer required to supply with the application?
For both biological and pathological material, the importer must submit the following documentation together with the application: Transport documents (copy of air waybill or courier waybill), commercial documents (invoice) and letter signed by the importer stating the specific requirements depending on the material to be imported.
Other documents to be submitted with the application depending on the type of material to be imported (biological or pathological) are listed in point No. 11. The form "application to import biological or pathological material" is attached.
Window of submission of an application
How far in advance of importation must application for a licence be made?
Import applications for biological material must be submitted at least three working days in advance of the arrival of the product and, for pathological material, seven working days in advance.
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.
Issuing the license
Can a licence be granted immediately on request?
Licences cannot be granted immediately.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Which administrative body is responsible for approving application of licences?
Consideration of licence applications is effected in full by a single administrative organ (Chilean National Fisheries and Aquaculture Service, SERNAPESCA). Background information will be assessed pursuant to Law No. 19.880 on bases of administrative procedures governing the acts of state administration bodies.
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?
There are no other conditions.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
What is the amount of the fee or charge?
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?
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?
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.
What documents are required upon actual importation?
Specific requirements for biological material:
1. Letter signed by the importer describing the characteristics of the material to be imported (the common and scientific name must always be stated for material derived from hydrobiological species) and the destination of the material, and containing a detailed description of its use and final disposal.
2. The following certificates must also be supplied for the biological material listed below:
(a) Cell lines and culture media: sterility certificate provided by the supplier.
(b) Genetic material from microorganisms: certificate provided by the supplier certifying that the material is not infectious and is purified RNA/DNA. The documentation must state whether the genetic material is complete or split.
(c) Diagnostic kit (antigen or antibody): certificate attesting that it relates to non infectious inactivated material, provided by the supplier.
Specific procedures and requirements for pathological material:
1. The importation into the country of pathological material is forbidden, unless authorized by the Service.
2. In the event of an application to import pathological material, the application must be formally submitted to the Head of the Animal Health Department at the National Directorate of SERNAPESCA, together with a letter signed by the importer that clearly identifies the goods to be imported, the techniques used to identify the strains of pathogenic microorganisms, the purpose of the importation and the biosecurity measures, in particular biocontainment measures, at the destination facilities, during transport and final disposal. Where appropriate, it must also be reported if they are genetically modified organisms.
3. Entry of pathological material shall only be authorized if the biosecurity conditions reported by the importer provide guarantees as to the biocontainment and proper disposal of the material to be imported.
4. Once the background has been assessed, and if the importation is approved, the interested party and regional directorate at the point of entry will be informed.
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?
The licence has no period of validity.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
There are no penalties for the non utilization of the licence.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences are not transferable between importers.
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?