Muestras de material biológico
- Document symbol
- G/LIC/N/3/CUB/13
- Original language
- English
- Published on
- 09/09/2024
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
El Control del movimiento transfronterizo de muestras de material biológico es el mecanismo adoptado por el Ministerio de Salud Pública, en lo adelante MINSAP, para garantizar el cumplimiento de las normas y disposiciones nacionales e internacionales vigentes relativas al traslado, desde o hacia el extranjero, de muestras de material biológico con el objetivo de prevenir riesgos sanitarios.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
Se aplica a Cualquier espécimen o porción procedente de células y sus componentes, tejidos, órganos y líquidos biológicos (suero, plasma, sangre, saliva, lágrimas, orina, sudor, semen, exudados nasofaríngeos y vaginales, líquido céfalo raquídeo), microorganismos y otros que puedan constituir un riesgo sanitario para el ser humano.
Q3. The system applies to goods originating in and coming from which countries?
Este procedimiento se aplica a productos provenientes de cualquier país del mundo y los de origen cubano que sean exportados.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
Resolución Ministerial No 132 de 2004 del Ministerio de Salud Pública. Resolución No 7 de 2008 del Buró Regulatorio para la Protección de la Salud. Se requiere por ley el otorgamiento de licencias. La legislación no deja la designación de productos sujetos a licencia a discreción administrativa no es posible que el gobierno invalide el sistema sin la aprobación legislativa.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
Las autorizaciones técnicas específicas que requieran ser otorgadas por una Autoridad Competente para ejecutar operaciones de importación deben obtenerse, previo a la suscripción del contrato que corresponda y en su defecto, siempre antes de la ejecución de la operación comercial entendida como la fecha de embarque de las mercancías, acorde al nivel de riesgo y características para cada caso en particular. Para este caso la solicitud debe presentarse antes de realizar el movimiento en el momento que se recibe la notificación de que ha sido enviado, no obstante, dado el caso, es posible presentar la solicitud con el producto en Aduana.
Q7.b. Can a licence be granted immediately on request?
Sí, para los casos cuando el producto está en Aduana el responsable puede coordinar con el centro para obtener el permiso lo más rápido posible siempre que cumpla los requisitos exigidos.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
No.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Para este sistema no, no obstante, este tipo de productos está sujeto a regulaciones de otros organismos y a veces un mismo producto necesita más de un permiso (CITMA, DSA MINAG) para la extracción en Aduana.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
Las circunstancias en que se rechaza están dentro del procedimiento ordinario establecido.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
Si, la solicitud puede ser realizada tanto por personas naturales como jurídicas.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
Formulario que entrega la autoridad.
Q11. What documents are required upon actual importation?
Solicitud según el modelo oficial vigente.
- Aprobación de la Comisión CITMA MINSAP si se trata de un proyecto de investigación. En caso de proyectos de investigación que involucren el movimiento de muestras de material biológico en varias ocasiones, y que previamente hayan sido aprobados, se declarará y referirá la autorización inicial otorgada (número de autorización).
- Dictamen técnico del Instituto de Hematología e Inmunología en caso de tratarse de muestras de medula ósea.
- Notificación del Viceministerio de Asistencia Médica en caso de muestras con fines de diagnóstico clínico.
- Notificación oficial del CNGM que declare que se ha realizado el depósito de las muestras testigos, en caso de muestras de ADN humano.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
Las tarifas están descentralizadas y se sustentan en los principios generales establecidos para la determinación de los precios mayoristas descentralizados, dispuestos en las Resoluciones 324 de 2020 y 337 de 2021 del Ministerio de Finanzas y Precios, así como en la Resolución 328/2020 del propio ministerio, sobre el tratamiento tarifario para servicios iguales que antes del ordenamiento se aplicaban en pesos cubanos o convertibles.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
El periodo de validez esa de 3 meses, sin en el transcurso de ese tiempo no ha llegado el material en cuestión se solicita una prórroga presentada nuevamente la documentación (modelo).
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Si las muestras forman parte de un proyecto de investigación éste debe contar con la aprobación de la Comisión CITMA MINSAP en cuya metodología se requiere de un grupo de permisos de otros organismos.