Basic information
Outline of the system
Regulation by import control is the means employed by the Ministry of Public Health (MINSAP) to prevent the commercial importation of medicines for human use that are of questionable quality or efficacy or that have been adulterated or tampered with, and the use of which may pose a risk to people's health.
Product coverage
The licensing system covers medicines for human use, medical equipment and devices.
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
There is no restriction on the quantity or value of imports; its purpose is to prevent the commercial importation of medicines, medical equipment and devices for human use that are of questionable quality or efficacy or that have been adulterated or tampered with, and the use of which may pose a risk to people's health.
Questions for products under restriction as to the quantity or value of imports
Not applicable.
The system applies to products originating from which country?
There are no country-based restrictions; all medicines for human use brought into Cuba are covered by the system regardless of their country of origin.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
MINSAP Ministerial Resolution No. 65 of 2003 and CECMED Resolution No. 131 of 2015. The procedure is mandatory for the covered products. 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?
Only importers authorized to import medicines, equipment or medical devices accredited by the Ministry of Foreign Trade and Foreign Investment (MINCEX) and with an import certificate from the CECMED are eligible to apply for licences.
Is there a registration fee?
Is there a published list of authorized importers?
There is 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?
Applications are made electronically using the SICECMED system; all importers are registered on and have access to this system.
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. In this case, an application for an import certificate for medicines for human use may be filed before or after the shipment of products covered by a contract, at the applicant's discretion, by submission of the appropriate form drawn up to that end listing one or more products, provided they are all part of the same contract and shipment.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
Not applicable, a certificate is delivered for each individual shipment, upon request.
Issuing the license
Can a licence be granted immediately on request?
The prescribed processing time is short: a certificate is usually issued in less than five working days and where necessary or in a health service emergency the process can be speeded up.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
The CECMED has up to 10 working days to issue the permit following receipt of the application.
Which administrative body is responsible for approving application of licences?
Only the CEDMED can approve applications.
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?
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?
Applications concerning medicines are refused if the medicines do not have sanitary authorization.
Are the reasons for any refusal given to applicants?
The applicant is notified of the reasons for the refusal.
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?
Not applicable, a certificate is delivered for each individual shipment, upon request.
What documents are required upon actual importation?
Import certificate application on the relevant official form (original and one copy).
- Document attesting to the quality of each of the batches of medicine included in the import application, such as: copy of analysis certificates from the original manufacturer or other national or foreign establishments or laboratories, quality certificate or other document in which the supplier assumes responsibility for the quality of the batches;
- Samples or photocopies of the labels on the packing materials for medicines for human use where the information is not in Spanish (including the patient information leaflet) for the exceptions provided for.
- Copy(ies) of the letter(s) in which the receiving establishment(s) accept the import of medicine(s) for human use, the expiry date of which is less than one year upon entry into the country and stating that they are aware of the shelf life(ves) and that the remaining shelf-life(ves) and quantity(ies) of product are such that they can be used prior to their expiry.
The CECMED reserves the right to request additional information of any kind where it deems it relevant to do so.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
No administrative procedures are required prior to importation; however, as explained above, a medicine must be registered before it enters the country.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
An import certificate is issued for each shipment and covers the product(s) contained in the shipment in line with the properties and quantities specified in the certificate. The certificate is valid for up to six months.
No extension is possible; under the relevant regulations, when medicines for human use covered by a contract are received in two or more separate shipments, a new import certificate must be requested for each shipment of the amount outstanding given that the same document cannot be approved twice, nor can it be subject to corrections or clarifications that may interfere with its proper interpretation.
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.