Basic information
Outline of the system
A licence is required to import raw materials, foodstuffs, food additives, materials, equipment or utensils in contact with food, cosmetics, products for personal hygiene or use, toys, products manufactured from tobacco, products and technologies to treat water for consumption, industry or recreation, equipment and utensils for food use that incorporate these items. The purpose of this requirement is to ensure that commercial certainty, the hygiene status and use of these items at national level are maintained at the levels and within the ranges that are authorized under international commitments.
Product coverage
Health Registration of foodstuffs, raw materials, food additives, materials, equipment or utensils in contact with food, cosmetics, products for personal hygiene or use, toys, products manufactured from tobacco, products and technologies to treat water for consumption, industry or recreation.
Assessment and monitoring with a view to approving or not approving a foodstuff or product as fit for human consumption or human use; the assessment ascertains physical, chemical, biological and toxicologic properties using laboratory analyses in accordance with the health standards in force. Health or other certificates issued by the competent authorities in the country of origin must be submitted prior to such analyses, enabling the country to meet its international obligations, including as a signatory to the WTO SPS and TBT Agreements, relating to food safety, labelling and other specifications based on the standards of the Codex Alimentarius and the International Organization for Standardization (ISO).
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
This licensing is not intended to restrict the quantity or value of imports.
Questions for products under restriction as to the quantity or value of imports
Not applicable.
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
Legal requirements
Is the licensing statutorily required?
The licensing procedure under the sanitary registration system is governed by Law No. 41 on "Public Health"; Decree-Law No. 9 on food safety; and MINSAP Resolutions No. 262/2020 on sanitary registration of foodstuffs and cosmetics and No. 275/2003 on manufactured tobacco products.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
The legislation specifies the products covered by this licensing system.
Is it 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?
Those eligible to apply are domestic or foreign legal person that takes on certain powers under contract from a manufacturer or owner of raw materials, foodstuffs, cosmetics, items for personal or domestic use, toys, products and technologies to treat water for consumption, industry or recreation and products manufactured from tobacco in Cuban territory.
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Department of Sanitary Registration and Control, INHEM-MINSAP
Address
Telephone
(+53) 54704746
Fax
Contact officer
Head of department: Ahindris Calzadilla Cambra
Submission of an application
Administrative body(ies) for submission of an application
Documentation requirements
What information is required in applications?
In order to submit an application for Health Registration, a producer, importer and/or marketing business must be registered with the Health Registration Authority, a process that requires them to submit:
- A list of general information.
- Photocopies of the licences from the National Register of Foreign Representations and the Chamber of Commerce of the Republic of Cuba for the authorized activity, or a Ministry of Foreign Trade Resolution for products for import or a Health Licence from the producing establishment and the corporate purpose of the entity for domestic products.
- Each registered entity must keep the information upon which accreditation is based up to date, and modify it in line with any changes.
- Only a business or entity that is in compliance with these requirements can make an application to the Registration Authority in respect of its products.
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?
Applications for a licence must be made before importation, although there is no set time limit for this.
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 the licence application may be submitted or the importation effected.
Issuing the license
Can a licence be granted immediately on request?
Goods arriving in port without a licence must hold approval from the State Health Inspectorate which by way of exception will determine the methodology to use on a case-by-case basis. A licence cannot be granted immediately on request.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Which administrative body is responsible for approving application of licences?
Importing entities are required, prior to importation, to register their products with the INHEM Health Registration Authority, and to notify the State Health Inspectorate of the destination of the products.
The committee of experts analyses the products submitted to it for consideration and makes a decision on each one, as follows:
Authorized: Indicates that the product satisfies all the requirements laid down by the health authority.
Provisionally authorized: Indicates that the product, its packaging and/or labelling has failed to satisfy one of the non-essential requirements laid down by the competent health authority and lays down a time limit for compliance. If the product fails to satisfy the requirements upon the expiry of the time limit, it will be classed as prohibited.
Prohibited: Indicates that the product does not satisfy the conditions relating to nutrition, hygiene and/or presentation required for distribution in Cuba.
Products deemed by the Committee of Experts to be "Pending" will have a maximum of 30 days from the date they are declared "Pending" for the client to supplement the information required or to comply with any other stipulation laid down by the committee. If the requirement is not complied with in the allotted time frame then the product in question will be discontinued and removed from the Health Registration procedure.
The maximum period allowed for a technical opinion on the product will be 20 working days counted from the submission of the sample with documentation until the date of the final decision, depending on the type of analysis required.
Issuance of a Health Certificate: Once a product has been approved, a Health Certificate for it will be drawn up and issued. It will be valid for three years unless the product proves to be harmful to health or the certificate is withdrawn at the request of the party concerned. An application for an import licence may be refused if any of the requirements set forth in the legislation is not met; the applicant is notified in writing of the grounds for the refusal. No appeal lies from a refusal.
Must the applications be passed on to other organs for visa, note or approval?
The Health Registration Authority is supported in the performance of its duties by a committee of expert advisers, specialist technical committees and test laboratories accredited by the INHEM.
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?
Payment is required both for sanitary registration and for laboratory analyses of the samples that applicants are required to submit.
What is the amount of the fee or charge?
The amount varies according to the tariff applicable to the product.
Is there any deposit or advance payment required associated with the issue of licences?
There is an advance payment requirement associated with the issue of licences in accordance with the established rate.
Amount or rate?
The Regulations and Indicators Handbook of the Health Registration Authority and details on current fees can be found on the INHEM website (https://instituciones.sld.cu/inhem/).
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?
None.
Are the reasons for any refusal given to applicants?
The applicant is notified in writing of the reasons for the refusal.
Have applicants a right of appeal in the event of refusal to issue a licence?
In the event of refusal to issue a licence, the applicant has the right of appeal to the competent authority.
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?
There are no limitations as to the period of the year during which the licence application may be submitted or the importation effected.
What documents are required upon actual importation?
The documents required are the certificate of registration with the Health Registration Authority and a Health Import Permit.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
The Health Registration Authority reserves the right, where it deems it relevant and always in conjunction with the State Health Inspectorate, to conduct a technical visit to the producer, marketer or controlling entity prior to issuing the licence or during the period of validity of registration in order to establish the degree to which the products comply with the requirements to which they are subject.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
Licences are valid for three years. They must be renewed three months before they expire via the submission of technical files, certification and samples but the fee is half that for the initial application. After that time, the licence expires and the product is regarded as a new product.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
Not applicable with regard to registration, but non-utilization may be penalized by the State Health Inspectorate.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Yes, licences are transferable where authorized by the holder of the original import registration.
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.