Outline of the system
For these purposes, biological agents are defined as viable micro-organisms and their products, prions and other organisms which cause or may cause disease in humans, animals and plants; organisms are defined as any biological entity that is genetically modified or exotic to the country, capable of reproduction or of transferring genetic material.
Licences are granted for the use, testing, production, release, importation and exportation of, and research into, biological agents and their products, and organisms and parts thereof containing genetic information, in the national territory, and at the various stages of the construction of facilities posing a biological risk. This procedure is in conformity with the Cartagena Protocol on Biosafety to the Convention on Biological Diversity and the Convention on the Prohibition of the Development, Production and Stockpiling of Biological and Toxin Weapons and on their Destruction.
Non-automatic licensing; to administer the import restrictions applied in accordance with current legislation. Biological safety authorization is a form of environmental licence, through which the CITMA, after having carried out a risk assessment, authorizes a natural or legal person to conduct certain activities in accordance with a number of conditions and requirements. Authorization can be granted in the form of a licence, permit, notification or report.
Licences are the form of biological safety authorization used for activities posing the highest level of risk, which include the importation of biological agents and their products, and organisms and parts thereof containing genetic information. For the importation of parts of biological agents containing genetic information, which is a lower risk activity, a biological safety notification is required.
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 system does not provide for a limit to the quantity or value of imports; this depends instead on the risk analysis carried out in each case
Questions for products under restriction as to the quantity or value of imports
The system applies to products originating from which country?
This procedure applies to goods from any country in the world.
Expected duration of licensing procedure
Is the licensing statutorily required?
Decree-Law No.190 on biological safety. Section 1, Article 4(c) establishes the responsibilities of the CITMA, which include granting, suspending and withdrawing licences for activities relating to the use, testing, production, release, importation and exportation of, and research into, biological agents and their products, and organisms and parts thereof containing genetic information.
Resolution No.180/2007. "Regulations for the granting of Biological Safety Authorization". Chapter 1, Article 6(e) provides that prior biological safety authorization must be obtained in order to import and export biological agents and their products, and organisms and parts thereof containing genetic information.
Resolution No.2/2004. "Regulations governing the Accounting and Control of Biological Materials, Equipment and Technology". Chapter IV, Article 26 establishes the safeguards report as an essential requirement for activities relating to the transfer of biological agents, organisms, equipment and technology.
The legislation specifies which organisms are subject to control, i.e. biological agents that affect humans, animals and plants; genetically modified organisms; exotic species; and parts of any of these containing genetic information. These products constitute the converge of biological safety regulation and the scope of risk control.
The granting of licences is statutorily required
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
The legislation does not leave the designation of products subject to licensing to administrative discretion.
Is it possible for the government to abolish the system without legislative approval?
It is not 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?
Importers must be registered in the National Register for Exporters and Importers of the Chamber of Commerce of the Republic of Cuba.
What persons or firms are eligible to apply for a licence?
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Office for Environmental Regulation and Safety (ORSA)
Director: Juan Bautista Sosa Marín
Submission of an application
Administrative body(ies) for submission of an application
What information is required in applications?
What documents is the importer required to supply with the application?
In order to obtain an import licence, the applicant must submit the following elements to the competent authority:
- Written application for an environmental licence;
- Certified copy of the requesting entity's charter;
- Certified copy of the document officially appointing the owner of the requesting entity;
- A technical file containing the general information referred to in Annexes 5, 6, 11, 12 and 13 to Resolution No. 180/2007 pertaining to the specific product to be imported.
Window of submission of an application
How far in advance of importation must application for a licence be made?
The specific technical authorizations to carry out import operations must be granted by a competent authority and be obtained prior to the signing of the relevant contract. Where this is not possible, they must always be obtained before the start of the commercial operation (defined as the date of shipment of the goods), according to the level of risk and nature of each individual case.
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 an application may be made.
Issuing the license
Can a licence be granted immediately on request?
In Cuba's case, it is not possible to grant authorization immediately except under very exceptional circumstances, as the products concerned pose a risk to those handling them, to the community and to the environment. Enough time is therefore needed to carry out a risk analysis that includes bibliographical consultation, consultation with experts and the application of risk identification techniques.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
The application assessment process can vary from 30 (notification) to 90 (licences other than for the importation of genetically modified organisms intended for release into the environment) or 270 (importation of genetically modified organisms intended for release into the environment) working days from the date of receipt of the application, provided that the information submitted is complete. Should further information be required, the process will be suspended until the relevant information has been received. Authorization must therefore be requested in accordance with the established time limits. The timeframe and procedures for the safeguards report are the same as for the biological safety import licence for biological materials, equipment or technology.
Which administrative body is responsible for approving application of licences?
Examination of biological safety licence applications is the job of the ORSA. However, in the course of its examination, it may need to call on experts from other administrative bodies to assist in reaching a final decision.
Must the applications be passed on to other organs for visa, note or approval?
Applications are also submitted to ORSA for an opinion on whether or not the activities are appropriate. ORSA's technical report is binding for the granting of a biological safety licence.
Are there any other conditions attached to the issue of a licence?
The issuing of a licence is subject to the conditions laid down in the legislation on biological safety.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
What is the amount of the fee or charge?
Import licences cost between CUP 4,032 and 10,390.
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?
In general, applications for biological safety import licences may be refused for two reasons:
- The activity's adverse effects on human, animal and plant health or the environment are so evident that authorization is inadvisable in the light of the conditions in the country.
- The anticipated benefits are not worth the risks involved.
In addition to the granting or refusal of a licence, other decisions may be taken:
- The granting of a licence with certain conditions attached to its validity: the competent authority may approve a planned activity and issue a licence with the rider that the holder will make the requisite changes or improvements within the specified time limit or else the licence will lose its validity;
- Deferral: granting of the licence is deferred when changes or improvements to the planned activity are needed in order to remedy safety defects and so forestall any adverse effects.
All the procedures are described in and regulated by Resolution No.180/2007 "Regulations for the granting of Biological Safety Authorization".
Are the reasons for any refusal given to applicants?
In the event of refusal or deferral, the competent authority must state the grounds in writing, accounting for the decision in detail.
Have applicants a right of appeal in the event of refusal to issue a licence?
Appeal against the competent authority's decision lies within 10 working days of the date of notification
If so, to what bodies and under what procedures?
Appeal against the competent authority's decision as appropriate, to:
- The Director-General of ORSA.
- The Minister of the CITMA when the impugned decision is upheld by the Director-General of ORSA.
The authority concerned must rule within 15 working days of the date on which the appeal was filed.
Are there any limitations as to the period of year during which importation may be made?
What documents are required upon actual importation?
Upon importation, the relevant biological safety licence is required.
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 period of validity of a licence depends on the assessment made by the specialist in charge of the process. To renew a licence upon its expiry, a new letter of application must be submitted to ORSA.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
Penalties are imposed only if importation takes place without biological safety authorization or after the licence expiry date.
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?