Basic information
Outline of the system
The control of cross-border movement of samples of biological material is the means employed by the Ministry of Public Health (MINSAP) to ensure compliance with the national and international standards and provisions in force on the movement into or out of the country of samples of biological material with the aim of preventing risks to health.
Product coverage
It covers any specimen or portion of cells and their components, tissues, organs and biological liquids (serum, plasma, blood, saliva, tears, urine, sweat, semen, nasopharyngeal and vaginal exudates, and cerebrospinal fluid), microorganisms and other elements that may pose a risk to human health.
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
Not applicable.
Questions for products under restriction as to the quantity or value of imports
Not applicable, there is no restriction as to quantity or value; this is a health monitoring system.
The system applies to products originating from which country?
This procedure applies to goods from any country in the world and to Cuban export products.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
MINSAP Ministerial Resolution No.132 of 2004. Health Protection Regulation Bureau (BRPS) Resolution No.8 of 2007. 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?
What persons or firms are eligible to apply for a licence?
In this case, a health licence can be applied for by natural or legal persons.
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
CECMED
Address
Telephone
(+53) 7271-8645; 7271-0710
Fax
Contact officer
Director: Olga Lidia Jacobo Casanova
Submission of an application
Administrative body(ies) for submission of an application
Documentation requirements
What information is required in applications?
Form issued by the authority.
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?
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
No.
Issuing the license
Can a licence be granted immediately on request?
Yes, as stated above, when the product is at customs the person concerned can liaise with CECMED to obtain a licence as quickly as possible provided that the requirements have been satisfied.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
In this case, the application must be made before the movement is under way and upon receipt of notification of shipment; however, if necessary, an application may be made with the product at Customs.
Which administrative body is responsible for approving application of licences?
Not under this system; however products of this type are subject to regulation by other bodies and sometimes a single product requires more than one licence (CITMA, DSA, MINAG) before it can be removed from Customs.
Must the applications be passed on to other organs for visa, note or approval?
Not under this system; however products of this type are subject to regulation by other bodies and sometimes a single product requires more than one licence (CITMA, DSA, MINAG) before it can be removed from Customs.
Are there any other conditions attached to the issue of a licence?
Not applicable.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
Yes.
What is the amount of the fee or charge?
The procedure costs CUP 750.
Is there any deposit or advance payment required associated with the issue of licences?
Not applicable.
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?
The circumstances under which an application may be refused are within 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?
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?
Relevant official application form.
- Approval of the MINSAP CITMA Committee for research projects. For research projects that involve the movement on separate occasions of samples of biological material that have received prior approval, the initial licence granted must be referred to (licence number).
- Technical report from the Haematology and Immunology Institute for samples of bone marrow.
- Notification from the Vice Ministry of Health Care for samples for clinical diagnostic purposes.
- For human DNA samples, official notification from the CNGM stating that the control samples have been deposited.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
If the samples are part of a research project then the project must have been approved by the MINSAP CITMA Committee, which requires a number of licences from other bodies.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
The period of validity is three months; if the material in question has not arrived within that time, an application for an extension can be made by re submitting the documentation (form).
Is there any penalty for the non-utilization of a licence or a portion of a licence?
Not applicable.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Not applicable.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Not applicable.
Is a licence required as a condition to obtaining foreign exchange?
Not applicable.
Is foreign exchange always available to cover licences issued?
Not applicable.
What formalities must be fulfilled for obtaining the foreign exchange?
Not applicable.