Basic information
Outline of the system
Raw materials, medicines for human use, diagnostic devices, cosmetics and items for personal or domestic use of animal origin or containing components of animal origin cannot be imported without the corresponding import licence issued by the CECMED or, in the case of cosmetics, INHEM's Health Registration, Control and Quality Department, in order to prevent the entry into Cuban territory of raw materials, medicines for human use, diagnostic devices, cosmetics and items for personal or domestic use of animal origin or containing components of animal origin that are capable of infecting humans with transmissible animal diseases.
Product coverage
The licensing system covers raw materials, medicines for human use, diagnostic devices, cosmetics and items for personal or domestic use of animal origin or containing components of animal origin.
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
Licensing is intended to prevent the entry into Cuban territory of raw materials, medicines for human use, diagnostic devices, cosmetics and items for personal or domestic use of animal origin or containing components of animal origin that are capable of infecting humans with transmissible animal diseases.
Questions for products under restriction as to the quantity or value of imports
Not applicable. There are no restrictions as to the quantity or value of the medicines; licences are awarded strictly on health grounds.
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?
Ministry of Agriculture and Ministry of Public Health Joint Resolution No. 2/2001 and Health Protection Regulation Bureau (BRPS) Resolution No. 9 of 2002. 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 and it is not possible for the Government to abolish the system without legislative approval.
Is it possible for the government to abolish the system without legislative approval?
The legislation does not leave the designation of products subject to licensing to administrative discretion and 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 on the MINCEX approved list 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?
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. In this case, the application for an import certificate for medicines for human use may be filed before the shipment of products covered by a contract by submission of the appropriate official 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
No.
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 five days to issue the licence following receipt of the application.
Which administrative body is responsible for approving application of licences?
Depending on the product, applications are considered by the CECMED or, in the case of cosmetics, by the INHEM's Department of Sanitary Registration, Control and Quality.
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?
An application may be refused where products are deemed to pose a high health risk or are from high risk countries.
Are the reasons for any refusal given to applicants?
The applicant is notified of the reasons for a 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?
No.
What documents are required upon actual importation?
(a) Certificates from the official veterinary services of the country of origin containing the information set out in the Third Paragraph of and in Annex 2 to Ministry of Agriculture and Ministry of Public Health Joint Resolution No. 2/2001.
(b) Copies of the analysis certificates for each of the product batches included in the application.
(c) Express permission or authorization from the Ministry of Public Health for medicines and cosmetics that are unregistered or for which no provisional marketing licence has been issued.
In this case, the following information must also be submitted:
- Product data:
o Generic name;
o Trade name;
o Pharmaceutical form and strength (for medicines);
o Product type (for cosmetics and items for personal or domestic use);
o Presentation;
o Manufacturer;
o Country;
o Marketing entity.
- Quality specifications or technical standard applicable to the product.
- Assessment of suppliers and reasoning behind the choice made.
- Batch release certificate issued by the regulatory authority of the country of origin.
Express permission or authorization from the Ministry of Public Health for raw materials used in the manufacture of medicines or cosmetics that do not have sanitary authorization.
In this case, the following information must also be submitted:
- Product data:
o Generic name;
o Trade name;
o Physical state;
o Presentation;
o Manufacturer;
o Country;
o Marketing entity.
- Quality specifications or technical standard applicable to the product.
- Assessment of suppliers and reasoning behind the choice made.
- Batch release certificate issued by the medicines regulatory authority of the country of origin.
For products undergoing research and development, the import licence application must be supplemented either upon or prior to submission by an explanation from the research entity as to the use of the raw materials or the product in question.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Not applicable.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
Up to six months. When goods covered by a contract are received in two or more separate shipments, a new authorization 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. A licence cannot be extended.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
No.
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.