World Trade Organization

Import Licensing Procedures

Medicamentos Controlados Fase II

Document symbol
G/LIC/N/3/DOM/9
Original language
Spanish
Published on
21/11/2024

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.

Este procedimiento aplica a todos los permisos de importación de medicamentos controlados fase II desde que se genera la solicitud hasta que se autoriza la liberación de la mercancía.

Purposes and Coverage of Licensing

Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.

Autorización de Importación de Medicamentos Controlados Fase II: Permiso otorgado por el Ministerio de Salud Pública y Asistencia Social (MISPAS) y la Dirección Nacional de Control de Drogas (DNCD) para el ingreso al país de dichos bienes. Aplica a las sustancias descrita en el siguiente cuadro. 

CÓDIGO ARANCELARIO

DESCRIPCIÓN DEL PRODUCTO

2933.31.00

- - Piridina y sus sales

2933.72.00

- - Clobazam (DCI) y metiprilón (DCI)

2933.41.00

- - Levorfanol (DCI) y sus sales

2933.99.00

- - Los demás

2932.95.00

- - Tetrahidrocannabinoles (Todos los isómeros)

2939.11.00

- - Concentrados de paja de adormidera, buprenorfina (DCI), codeína, dihidrocodeína (DCI), etilmorfina, etorfina (DCI), folcodina (DCI), heroína, hidrocodona (DCI), hidromorfona (DCI), morfina, nicomorfina (DCI), oxocodona (DCI), oximorfona (DCI), tebacona (DCI) y tebaína; sales de estos productos.

2939.42.00

- - Seudoefedrina (DCI) y sus sales

2921.46.00

- - Anfetamina (DCI), benzofetamina (DCI), dexanfetamina (DCI), etilanfetamina (DCI) fencanfamina (DCI), fentermina (DCI), lefetamina (DCI), levanfetamina (DCI) y mefenorex (DCI); sus sales

2939.61.00

- - Ergometrina (DCI) y sus sales

2933.19.90

- - - Los demás

2933.55.00

- - Loprazolam (DCI), meclocualona (DCI), metacualona (DCI) y zipeprol (DCI); sales de estos productos

2922.44.00

- - Tilidina (DCI) y sus sales

2922.14.00

- - Dextropropoxifeno (DCI) y sus sales

2934.91.00

- - Aminorex (DCI), brotizolam (DCI), clotiazepam (DCI), cloxazolam (DCI), dextromoramida (DCI), fendimetracina (DCI), fenmetrazina (DCI), haloxazolam (DCI), ketazolam (DCI), meoscarb (DCI), oxazolam (DCI), pemolina (DCI), y sulfentanil (DCI); sales de estos productos

2933.91.00

- - Alprazolam (DCI), camazepam (DCI), clonazepam (DCI), , clorazepato, clordiacepóxido (DCI), delorazepam (DCI), diazepam (DCI), estazolam (DCI), etiloflacepato (DCI), fludiazepam (DCI), flunitrazepam (DCI), flurazepam (DCI), halazepam (DCI), lofrazepato de etilo (DCI), lorazepam (DCI), lormetazepam (DCI), mazindol (DCI), medazepam (DCI), midazolam (DCI), nimetazepam (DCI), nitrazepam (DCI), nordazepam (DCI), oxazepam (DCI), pinazepam (DCI), prazepam (DCI), pirovalerona (DCI), prazepam (DCI), temazepam (DCI), tetrazepam (DCI) y triazolam (DCI); sales de estos productos

2939.19.00

- - Los demás

2933.33.00

- - Alfentanilo (DCI), anileridina (DCI), bezitramida (DCI), bromazepam (DCI), carfentanilo (DCI),

2939.44.00

- - Norefedrina y sus sales

2939.62.00

 - Ergotamina (DCI) y sus sales

2939.63.00

- - Ácido lisérgico y sus sales

2933.53.00

- - Alobarbital (DCI), amobarbital (DCI), barbital (DCI), butalbital (DCI), butobarbital, ciclobarbital (DCI), fenobarbital (DCI), metilfernobarbital (DCI), pentobarbital (DCI), secbutabarbital (DCI), secobarbital (DCI) y vinilbital (DCI); sales de estos productos

2933.71.00

- - 6- Hexanolactama (épsilon-caprolactama)

2941.90.90

- - Los demás

2922.31.00

- - Anfepramona (DCI); metadona (DCI) y normetadona (DCI); sales de estos productos

2926.30.00

- Fenoproporex (DCI) y sus sales; intermedio de la metadona (DCI) (4-ciano-2-dimetilamino-4,4-difenilbutano)

2939.51.00

- - Fenetilina (DCI) y sus sales

2933.79.90

- - - Las demás

Q3. The system applies to goods originating in and coming from which countries?

El procedimiento establecido se aplica a los productos de origen y/o procedencia de todos los países.

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?

No, su objetivo es controlar las actividades, los responsables y los tiempos de respuesta establecidos en el proceso de importación de medicamentos controlados fase II.

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?

La base legal que circunscribe el servicio es:

El trámite de licencias, permisos o autorizaciones de importación es legalmente obligatorio para los productos sujetos a regulación. Estas normativas definen los productos que requieren dichos trámites. Sólo en casos de emergencia nacional, el gobierno tiene la facultad de suspender este sistema.

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):

N/A

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?

N/A

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?

N/A

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.)

N/A

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?

N/A

Q6.V. What are the minimum and maximum lengths of time for processing applications?

N/A

Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?

N/A

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?

N/A

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?

N/A

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?

N/A

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?

N/A

Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?

N/A

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)?

Cinco (5) días laborables luego de recibido por la Dirección Nacional de Control de Drogas (DNCD). 

Q7.b. Can a licence be granted immediately on request?

Debe solicitarse cada vez que se realice una importación de medicamentos controlados fase II. 

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 hay limitaciones de fechas para presentar una solicitud de autorización de importación.

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?

No. Además de la Dirección General de Medicamentos, Alimentos y Productos Sanitarios (DIGEMPAS) del Ministerio de Salud Pública y Asistencia Social (MISPAS) interviene el Departamento de Químicos y Precursores de la Dirección Nacional de Control de Drogas (DNCD).

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?

Cuando la persona física o moral que se encuentre acusada de violación de la Ley núm. 50-88 sobre Drogas y Sustancias Controladas de la República Dominicana, hasta tanto intervenga la sentencia irrevocable correspondiente.

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?

Sólo las empresas farmacéuticas importadoras de medicamentos terminados o materias primas controladas, con el Certificado CLASE B vigente. Es obligatorio para los fabricantes o vendedores, mantener un récord de las reducciones en peso o volumen de drogas controladas o insumos, cuando estas obedezcan a acciones atmosféricas, y comunicarlo por escrito al Ministerio de Estado de Salud Pública y Asistencia Social (MISPAS), así como a la Dirección Nacional de Control de Drogas (DNCD), tan pronto sean comprobadas.

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?

  • Para la solicitud del permiso de importación el usuario de este servicio deberá cumplir con lo siguiente:
    • Realizar solicitud electrónica vía el Sistema de Ventanilla Única de Comercio Exterior (VUCE).
    • Factura Comercial / Factura Proforma.
    • Permiso de Importación del MISPAS - DNCD.
    • Certificado de análisis de la empresa fabricante. 
    • Certificado de Buenas Prácticas de Manufactura (elaborados).
    • Certificado de Libre Venta.
    • Bill of Loanding / Guía aérea.
    • Certificado Clase B vigente.
    • Registro Sanitario Medicamento. 
    • Carta DNCD que autoriza la sustancia a importar.
    • Carta de solicitud de Importación a MISPAS y DNCD.

Q11. What documents are required upon actual importation?

Se requiere los siguientes documentos: 

  • Factura Comercial.
  • Permiso de Importación del MISPAS - DNCD.
  • Certificado de análisis de la empresa fabricante. 
  • Certificado de Buenas Prácticas de Manufactura (elaborados).
  • Certificado de Libre Venta.
  • Bill of Loanding / Guía aérea.
  • Registro Sanitario Medicamento. 
  • Carta DNCD que autoriza la sustancia a importar.
  • Carta de solicitud de Importación a MISPAS y DNCD.
  • Certificado Clase B vigente.

Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?

No. 

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.

N/A

Conditions of Licensing

Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?

Los permisos de importación de medicamentos o materias primas controladas por la Ley 50-88 sobre Drogas y Sustancias Controladas tienen una vigencia de 180 días. Una vez caducado debe solicitarse nuevamente.  

Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?

La no utilización de una licencia no implica sanción alguna.

Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?

Las licencias no son transferibles.

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?

Para importar cualquier medicamento controlado, sus preparaciones o especiales farmacéuticas que las contengan, es indispensable obtener un Certificado de Inscripción Clase B.

Other Procedural Requirements

Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?

Las importaciones no están sujetas a otros procedimientos administrativos.

Q19. Is foreign exchange automatically provided by the banking authorities for goods to be imported? Is a licence required as a condition to obtaining foreign exchange? Is foreign exchange always available to cover licences issued? What formalities must be fulfilled for obtaining the foreign exchange?

Las empresas autorizadas realizan sus transacciones para el pago de sus contingentes mediante conexión internet banking con la empresa exportadora, bajo las regulaciones de la banca internacional y las legislaciones locales.