Basic information
Outline of the system
The importation of pharmaceuticals, cosmetics, personal hygiene products and domestic hygiene products into the Dominican Republic is regulated by the General Law on Health and by Regulation No. 246 06 on Medicines. Pharmaceuticals classified as prescription psychotropic substances or subject to Law No. 50 88 on Drugs and Controlled Substances, whether finished products or raw materials, are also covered by this legislation.
The body which regulates the entry of such goods into the Dominican Republic is the Department of Drugs and Pharmacies of the Ministry of Public Health and Social Welfare (SESPAS). Importers of controlled medicines, semi finished products, raw materials, solvents and precursor chemicals for pharmaceutical manufacture and distribution must apply for an import permit from the Department of Drugs and Pharmacies of the Ministry of Public Health and Social Welfare. This procedure is coordinated with the Narcotics Control Division (DNCD).
Product coverage
Sanitary recognition for Customs purposes: the established import procedure applies to pharmaceuticals, cosmetics, personal hygiene products, domestic hygiene products and all products subject to Regulation No. 246 06 on Medicines.
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
The procedure is applied for sanitary control purposes. There is no restriction on either quantities or values.
Questions for products under restriction as to the quantity or value of imports
n/a.
The system applies to products originating from which country?
The established procedure applies to products originating in and/or consigned from any country.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
The import procedure for pharmaceuticals is set forth in Regulation No. 246 06 on Medicines and Law No. 50 88 on Drugs and Controlled Substances.
All pharmaceuticals, cosmetics, personal hygiene products and domestic hygiene products, whether finished products, semi finished products or raw materials, are subject to the established procedure.
This procedure applies to all products subject to Regulation No. 246 06 on Medicines.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Regulation No. 246 06 on Medicines was established pursuant to Decree No. 246 06 and can therefore be repealed by the Executive Branch by means of another decree
Is it possible for the government to abolish the system without legislative approval?
The responsibility of SESPAS for import control is provided for in the General Law on Health No. 42 01 and any amendment thereto or the abrogation thereof must be brought before the National Congress.
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
On the date of import they are required to be entered in the Sanitary register of manufacturing and distribution establishments as an authorized importer distributor. Only juridical persons legally authorized to trade in pharmaceuticals are eligible for registration.
What persons or firms are eligible to apply for a licence?
Only natural and legal persons authorized by the SESPAS may import pharmaceuticals.
Is there a registration fee?
No charge has been established for the assessment of import applications and the service is therefore free of charge.
Is there a published list of authorized importers?
The Department of Drugs and Pharmacies keeps a Register of authorized importers, which is a public document.
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Department of Drugs and Pharmacies of the Ministry of Public Health and Social Welfare (SESPAS)
Documentation requirements
What information is required in applications?
What documents is the importer required to supply with the application?
(a) In order to obtain a licence for pharmaceuticals, cosmetics, personal hygiene products or domestic hygiene products, interested parties must supply the following:
-Invoice or import pro forma invoice, stamped by the importing firm and endorsed by the Association of Representatives, Agents and Producers of Pharmaceutical Products (ARAPF) in the case of finished products, or by the Dominican Association of Pharmaceutical Industries (INFADOMI) in the case of raw materials for manufacturing;
-name, form of presentation and concentration of the product, quantity to be imported, manufacturer's name, product's country of origin, valid sanitary registration number for the product in the Dominican Republic, and names of ports of loading and discharge.
(b) With regard to medicines, semi finished products, raw materials, solvents and precursor chemicals subject to Law No. 50 88, the importer is also required to submit:
-A written application containing: importer details, name, form of presentation, concentration and qualitative/quantitative formula of the product, quantity to be imported, manufacturer's name, product's country of origin, sanitary registration number for the product in the Dominican Republic, number of the importer's drug permit, names of ports of loading and discharge, and importer's national tax registration number.
-Exporter details: name, full address, telephone and fax numbers and e mail address.
-Copy of a valid drug permit (obtained from the same administrative body).
Window of submission of an application
How far in advance of importation must application for a licence be made?
Import authorization applications must be made prior to importation. However, in practice, applications are made once goods have arrived in the country.
Applications are processed in two to three working days of receipt.
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 regards the periods for submitting import authorization applications.
Issuing the license
Can a licence be granted immediately on request?
No.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
A licence may only be obtained within a shorter time limit should the product(s) become necessary in the event of the declaration of a state of national emergency.
Which administrative body is responsible for approving application of licences?
Invoices or pro forma invoices attached to import licence applications must be approved by the associations of pharmaceutical importers before being submitted to the Health Authority.
Must the applications be passed on to other organs for visa, note or approval?
Invoices or pro forma invoices attached to import licence applications must be approved by the associations of pharmaceutical importers before being submitted to the Health Authority.
Are there any other conditions attached to the issue of a licence?
There are no other conditions attached to the issue of an import authorization.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
No administrative charge is payable for import authorizations.
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
No deposit or advance payment is required for an import authorization to be issued.
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?
Import authorization applications which fail to meet processing requirements will be rejected.
Are the reasons for any refusal given to applicants?
If an application is rejected, the importer concerned is notified within two to three working days and informed of the reasons therefor.
Have applicants a right of appeal in the event of refusal to issue a licence?
There is no specific legal procedure in this instance, but the interested party may 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 regards the periods for submitting import authorization applications.
What documents are required upon actual importation?
The following documents are required upon actual importation:
- Valid sanitary registration certificate for the products;
- valid sanitary registration certificate for the importing establishment;
- in respect of controlled substances, a valid drug import permit.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Imports are not subject to any other administrative procedures.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
Import authorizations are valid for forty five (45) days; upon expiry of that period, a new one may be issued under the same procedure.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
There are no penalties for the non utilization of an import authorization or a portion thereof.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Import authorizations are not transferable.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
The Government is not involved in procedures for obtaining foreign exchange.
Is a licence required as a condition to obtaining foreign exchange?
Importers must pay the total value of the goods with their own foreign exchange or by bank transaction, and a licence is not required as a condition for obtaining foreign exchange.