Basic information
Outline of the system
Venezuela administers the following import systems to protect public health:
Licence from the Ministry of Health and Social Development (MSDS). These licences are required to import certain foodstuffs, medicines and active principles. The Directorate of Food Hygiene and the Directorate of Drugs, Medicines and Cosmetics of the MSDS, as pertinent, are responsible for evaluating conditions for the allocation of these automatic licences. Food importers must register in a food or alcoholic beverages health register, during which procedure a technical assessment is performed of the foodstuff to determine whether it is apt for human consumption under COVENIN rules, the General Food Regulations or special provisions of the MSDS. Importers of medications and active principles must register prior to making imports under a procedure that is intended to ensure the effectiveness, safety and quality of the medicines to be imported. All medicines presented for inclusion in the health register will be evaluated by the Rafael Rangel National Institute of Hygiene, which will perform the control tests required under domestic legislation.
Product coverage
The system of import licensing for food and medicines applies to a total of 301 tariff subheadings (See Products).
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 purpose of import licences is to safeguard human health and life.
Questions for products under restriction as to the quantity or value of imports
Not applicable.
The system applies to products originating from which country?
Import licences are issued without discrimination as to the country of origin of the goods.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
Obtaining an import licence is a statutory requirement.
The legal basis for the import licensing system is:
- Official Gazette No. 5039, extraordinary edition of 9 February 1996, publishing Decree 989 of 20 December 1995, the Customs Tariff.
- Official Gazette No. 25864 of 16 January 1959, publishing Decree 501 which promulgated the General Food Regulations.
- Official Gazette No. 35921 of 15 March 1996, publishing Resolution No. SG 081 of the Ministry of Health and Social Development which promulgates complementary standards to the General Food Regulations.
- Official Gazette No. 37006 of 3 August 2000, publishing the Law on Medicines.
- Official Gazette No. 16551 of 7 July 1928, publishing the Pharmaceutical Profession Law.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
The executive is empowered to abolish the licensing system without legislative approval and to designate products to be subjected to licensing requirements.
Is it possible for the government to abolish the system without legislative approval?
The executive is empowered to abolish the licensing system without legislative approval and to designate products to be subjected to licensing requirements.
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
All persons, firms and institutions are eligible to apply for import licences.
What persons or firms are eligible to apply for a licence?
All persons, firms and institutions are eligible to apply for import licences.
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?
The application form for licences to import food and medicines subject to this system requires general information on the importer, name and description of the product, tariff code of the product, country of consignment, use and destination, and port or airport of entry (see Annexes 4 and 5).
What documents is the importer required to supply with the application?
In addition, the importer is required to attach a health certificate issued by the competent authority in the country of origin and legalized by a Venezuelan consulate and a certificate stating that the good is freely sold and consumed in the country of origin to the application for the import licence. For imports of medicines, the importer must provide the firm’s trade register, a copy of the pharmacist’s degree, evidence of good standing with the Association of Pharmacists, power of attorney from the parent company to the agency, health certificate of free sale in the country of origin, qualitative formula and analytical information on the product.
Window of submission of an application
How far in advance of importation must application for a licence be made?
Applications for import licences can be made at any time of the year five to 20 working days in advance of the date of import, which is the minimum time required for processing,
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
Applications for import licences can be made at any time of the year five to 20 working days in advance of the date of import, which is the minimum time required for processing,
Issuing the license
Can a licence be granted immediately on request?
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Article 86 of the Organic Law on Customs requires that goods comply with the customs regulations in effect on the date of their arrival at the primary zone and the importer is required to present all the necessary documentation.
Which administrative body is responsible for approving application of licences?
The following authorities, depending on the product in question: the Food Hygiene Directorate of the MSDS for food, the Directorate of Drugs, Medicines and Cosmetics of the MSDS for medicines and active principles.
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?
No.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
Yes.
What is the amount of the fee or charge?
Importers of food and medicines are required to pay a revenue stamp of 232 bolivars for each application and 11,600 bolivars per product. Importers of products subject to LOSEP are required to pay revenue stamps in the amount of 198,000 bolivars.
Is there any deposit or advance payment required associated with the issue of licences?
No deposit or advance payment is required to obtain an import licence.
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?
In the event a licence is refused, the importer is notified of the reasons for the refusal.
Have applicants a right of appeal in the event of refusal to issue a licence?
In the event a licence is refused, the importer may appeal for reconsideration of the administrative decision through regular or jurisdictional channels, as established in the Organic Law on Administrative Procedures.
If so, to what bodies and under what procedures?
In the event a licence is refused, the importer may appeal for reconsideration of the administrative decision through regular or jurisdictional channels, as established in the Organic Law on Administrative 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?
At the time the imports are made, the importer is required to present the health licence for the import of foodstuffs or medicines issued by the MSDS, or the import licence for chemicals subject to control and registration and a receipt for the notification sent to the Anti-Drug Command of the National Guard.
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?
Import licences for food and medicines are valid for four months. Import licences for products subject to LOSEP are valid for 180 days. The periods can be extended if the import was not made for reasons beyond the importer’s control.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
There are no penalties.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Import licences are not transferable.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
In Venezuela, the currency is freely convertible. There are no restrictions on access to foreign exchange.