Basic information
Outline of the system
Entry authorization is required for narcotic substances and dangerous drugs.
Product coverage
See Decree No. 5213/2005 "updating the list of narcotic substances and dangerous drugs".
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Non-automatic licensing: Quota administration.
Products under restriction as to the quantity or value of imports
Entry authorization for narcotic substances and dangerous drugs is administered in accordance with annual import estimates submitted to the health authority by the importer.
Questions for products under restriction as to the quantity or value of imports
Please see Answers 6.1-6.11.
The system applies to products originating from which country?
The system applies to goods originating in and coming from all countries.
Expected duration of licensing procedure
Up to two days
Legal requirements
Is the licensing statutorily required?
Decree No. 5213/2005 of the National Anti Drug Secretariat (SENAD) updating the list of narcotic substances and dangerous drugs, pursuant to Article 1 of Law No. 1340 of 22 November 1988, and establishing rules for the handling and marketing thereof.
Law No.836/80 Health Code; Law No.115/90 amending Articles No.270 and No.272 of the Health Code, Law No.836/80; Decree No.18425/02 updating the list of narcotic substances and dangerous drugs, pursuant to Article 1 of Law No.1.340 of 22 November 1988, and establishing rules for the use and marketing thereof.
Yes, it is statutorily required.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
The legislation itself establishes the products subject to licensing.
Is it possible for the government to abolish the system without legislative approval?
The Executive has the power 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?
All importers are eligible to apply for licences, as long as they are registered as such in the register of imports of the National Customs Directorate.
What persons or firms are eligible to apply for a licence?
All persons and enterprises are entitled to register.
Is there a registration fee?
A registration fee is charged.
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Ministerio de Salud Pública y Bienestar Social (Ministry of Public Health and Social Welfare)
Dirección de Vigilancia Sanitaria (Health Monitoring Directorate)
Address
Iturbe N°883 entre Fulgencio R. Moreno y Manuel Domínguez
Telephone
(+595) 21 449-944, Ext. 209
Fax
(+595) 21 449-944
Contact officer
Armando Andino
Submission of an application
Administrative body(ies) for submission of an application
Ministerio de Salud Pública y Bienestar Social (Ministry of Public Health and Social Welfare)
Dirección de Vigilancia Sanitaria (Health Monitoring Directorate)
Documentation requirements
What information is required in applications?
The following are required: name of person in charge; professional registration number and photocopy of registration; photocopy of identity card; address; name of product; presentation; active ingredient; health registration number; country of origin; provenance.
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
No.
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?
Yes.
Must the applications be passed on to other organs for visa, note or approval?
Yes.
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?
Yes, there is a fee of G 420,936.
What is the amount of the fee or charge?
Yes, there is a fee of G 420,936.
Is there any deposit or advance payment required associated with the issue of licences?
Yes, there is a fee of G 420,936.
Amount or rate?
Yes, there is a fee of G 420,936.
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?
There are no reasons for refusal other than those that derive from failure to comply with the requirements and in all cases the interested party is notified so that the errors observed can be rectified.
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?
In all cases, in addition to the import licence or authorization, the documents needed for import clearance are required.
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?
The import licence is valid for 30 days from the date of issue, with the possibility of extension at the importer's request.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
No.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences are non transferable and only issued to the holders themselves or authorized persons or agents duly accredited as such.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
There are no restrictions on access to foreign exchange.
Is a licence required as a condition to obtaining foreign exchange?
There are no restrictions on access to foreign exchange.
Is foreign exchange always available to cover licences issued?
There are no restrictions on access to foreign exchange.
What formalities must be fulfilled for obtaining the foreign exchange?
There are no restrictions on access to 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?
It is not published. Importers may request information in advance and do so in writing. Importation takes place only if the annual import estimates are submitted to the health authority. Exceptions or derogations from the requirement are requested in writing.
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?
Quota size is stipulated on a yearly basis.
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)
Licences are allocated to all importers of narcotic substances and dangerous drugs.
Certificates are issued and must be presented together with the rest of the documentation required for inward customs clearance.
Each official import certificate is valid for one single dispatch. Where products are imported in a smaller quantity than that authorized, the remaining amount is cancelled.
They are not made known, although the information is available at the request of the interested parties.
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?
Within the first 90 days of each year, importers must notify the health authority of their product import estimates for the following calendar year, so that the Ministry of Health can determine, on the basis of the information provided by the applicant, the quantity that may be imported during that period.
What are the minimum and maximum lengths of time for processing applications?
Licences are issued within the time limits stipulated in the Agreement.
How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
The period of validity for import certificates is 120 days from the date of issue.
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?
The administrative organ is the Ministry of Public Health and Social Welfare.
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?
The criterion of chronological order of submission of applications is used for processing all import licences. There are no limits on the quantity of licences per importer.
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?
Not applicable.
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?
No.