Basic information
Outline of the system
At present, Paraguay has import licences administered by the Under Secretariat for Trade in the Ministry of Industry and Trade (MIC); by the National Food and Nutrition Institute (INAN), the National Health Monitoring Directorate (DINAVISA) and the Central Laboratory of the Ministry of Public Health and Social Welfare; the National Plant and Seed Quality and Health Service (SENAVE); the National Animal Quality and Health Service (SENACSA); and the Environment Secretariat (SEAM). They may be of two kinds: automatic and non automatic. The former, as the name implies, are those that are granted subject to the sole requirement of completion of the necessary applications.
These automatic import licences are approved in all cases in which they comply with the legal requirements and are consistent with the provisions of Article 2 of the Agreement on Import Licensing Procedures of the World Trade Organization (WTO).
Product coverage
Medicines, reagents for clinical and laboratory analyses, and medical inputs and equipment
Nature of licensing
Automatic
If Automatic, administrative purpose
To control, register and obtain statistical data.
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
In the case of prior automatic import licence, the procedure is not intended to limit either the quantity or the value of imports.
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 application system covers all countries of origin and shipment.
Expected duration of licensing procedure
Up to ten (10) working days.
Legal requirements
Is the licensing statutorily required?
Decree No.1635/99 regulating Article 175 of Law No.836/80 (Health Code); Law No.1119/97 on health and other products; Decree No.187/50 on the operation of pharmacies, drug stores and other similar establishments throughout the Republic; Decree No.8342/95 establishing regulations for pharmaceutical establishments and the like, partially amending provisions of Decree No.187/50 and repealing Decrees 1730/68; Law No.836/80 Health Code; and Law No.115/90 amending Articles No.270 and No.272 of the Health Code, Law No.836/80.
Yes, licensing is mandatory for a specified universe of goods.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
The legislation stipulates that the designation of the products to be subjected to licensing is left to the discretion of the relevant administration.
Is it possible for the government to abolish the system without legislative approval?
The executive branch does not need to obtain legislative approval in order to abolish these licensing systems. Except in those cases in which the licences are established by international agreements or national laws.
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
All persons and enterprises are entitled to register. Yes, they are eligible, provided they are enrolled in the corresponding register.
What persons or firms are eligible to apply for a licence?
All importers are eligible to apply for licences, the only requirement being that they be enrolled as such in the register of importers of the National Customs Directorate and in the registers of importers of the respective organs previously mentioned.
Is there a registration fee?
Yes, there is a registration fee.
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)
Address
Pasaje San Carlos 916 e/ Parapiti y Estados Unidos
Telephone
+595 21 444-274/449-944
Fax
Contact officer
Ms Maria Ignacia Troche
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 Nacional de Vigilancia Sanitaria, DINAVISA (National Health Monitoring Directorate)
Dirección de Evaluación, Autorización y Registro (Evaluation, Authorization
and Registration Department)
Secretaría Nacional Antidrogas, SENAD (National Anti-Drug Secretariat)
Documentation requirements
What information is required in applications?
The information required in import licence applications is indicated on the respective application forms. (See annexes to the resolutions in force.)
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?
Licence applications can be submitted on any working day preceding the date of import clearance.
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 during which licence applications can be made.
Issuing the license
Can a licence be granted immediately on request?
If, for various reasons, the product has not arrived within the time stipulated and an application has been submitted, then yes an extension can be granted, provided a request is made.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
If all the requirements for granting a licence are met, a licence may be issued within a shorter time-limit.
Which administrative body is responsible for approving application of licences?
The administrative organs are those mentioned in the previous replies.
Must the applications be passed on to other organs for visa, note or approval?
Products generally require approval and registration by more than one administrative organ.
Are there any other conditions attached to the issue of a licence?
There are no conditions other than those mentioned attached to the issue of a licence.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
The Collection Unit is responsible for collecting these tariffs.
What is the amount of the fee or charge?
In the case of DINAVISA, one-time authorizations pay a tariff of Gs. 280,000 (two hundred and eighty thousand Guaranis), other applications pay Gs. 180,000 (one hundred and eighty thousand Guaranis).
Is there any deposit or advance payment required associated with the issue of licences?
The issuing of an import licence is not associated with the lodging of any deposit or advance payment.
Amount or rate?
The issuing of an import licence is not associated with the lodging of any deposit or advance payment.
Is it refundable?
The issuing of an import licence is not associated with the lodging of any deposit or advance payment.
What is the period of retention?
The issuing of an import licence is not associated with the lodging of any deposit or advance payment.
What is the purpose of this requirement?
The issuing of an import licence is not associated with the lodging of any deposit or advance payment.
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?
In all cases of refusal, administrative proceedings may be intiated.
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?
What documents are required upon actual importation?
Each law or regulation specifies the necessary documents. 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?
There are no requirements other than those mentioned above.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
Is there any penalty for the non-utilization of a licence or a portion of a licence?
Once an import licence has been issued, there is no penalty for total or partial non utilization.
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?
The foreign exchange market is free.
Is a licence required as a condition to obtaining foreign exchange?
The foreign exchange market is free.
Is foreign exchange always available to cover licences issued?
The foreign exchange market is free.
What formalities must be fulfilled for obtaining the foreign exchange?
The foreign exchange market is free.
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?
In the case of imports of medicines and chemical precursors, there is no quantitative limitation on importation, except for the annual forecast requirement for the goods controlled by Law No. 1340/88. There is provision for exceptions to the rule.
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?
For products controlled by Law No.1340/88 the quotas are determined by annual forecast.
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 allotted to all the importers enrolled with the National Customs Directorate and in the respective registers of the Ministry of Industry and Trade, the Ministry of Public Health and Social Welfare (DINAVISA) and the Environment Secretariat (SEAM).
Certificates are issued for presentation together with the rest of the documentation required at the time of clearance of the goods.
Quotas cannot be accumulated.
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?
Applications are submitted for each import operation. Licences are allocated to anyone interested in importing goods mentioned in the reply in paragraph 2 of this document. Quantities allocated but not used are not added to quotas for a succeeding period.
What are the minimum and maximum lengths of time for processing applications?
Automatic and non automatic 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?
Licences granted for the purpose of importing products controlled by Law No. 1340/88 are valid for 120 days, i.e. the period between the granting of the authorization and actual 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?
The administrative organs are those mentioned in the previous replies. Products generally require approval and registration by more than one administrative organ.
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 the applications is used for processing all import licences. There are no limits on the quantity of licences per importer, except insofar as the products are subject to an overall quota or forecast.
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?
This mechanism is not used in the procedures for processing the licences previously mentioned.
Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
No.