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Colombia Standards: Pharmaceutical/Cosmetics/Foods

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Colombia Standards: Pharmaceutical/Cosmetics/Foods

Postby bridgat » Tue Nov 18, 2008 4:21 am

Decree 3636 of November 10, 2005 establishes regulations governing the production and importation of medicines, foods, cosmetics, and other products for human consumption and/or use. The documentation requirements are denoted, along with additional documentation for imported items. Not only does this decree cover contents, but also the labeling of packaging and contents on the containers of the product.

The INVIMA, which is attached to the Ministry of Social Welfare, in coordination with the regional health authorities, is responsible for certifying products of public health interest as fit for human consumption. The INVIMA's Food and Alcoholic Beverages Subdirectorate carries out risk assessment and epidemiological surveillance activities in coordination with the National Institute of Health and regional health authorities.

Under Law No. 715 of 2001, sanitary authority at the points at which foodstuffs enter and leave the country is exercised by the regional health authorities and these activities are supported and supervised by the INVIMA. The regional heath authorities have 32 official laboratories which provide support for inspection, surveillance and control. This work is supplemented by the National Public Health Surveillance System coordinated by the National Institute of Health (INS).
The importation of pharmaceutical products for human use require sanitary registration that must be arranged through the INSTITUTO NACIONAL DE VIGILANCIA DE MEDICAMENTOS Y ALIMENTOS (INVIMA), under the regulations of Decree 677 of 1995. Procedures for obtaining and issuing sanitary registration are regulated by Decree 677 of 1995.

Sanitary registration is valid for ten years. Registration renewal requires the same procedures and document submission to INVIMA, within three months before the expiration date. After the sanitary registration expiration date, further imports are not permitted, and sixty days are granted to dispose of merchandise in stock or on the shelf. After sixty days, the pharmaceutical products are confiscated.

Following are the procedures for obtaining of sanitary registration for imported pharmaceutical preparations for human use:

Application form must be submitted (at a minimum) with the following documents:

DOCUMENTS AND CERTIFICATIONS

+ Current general or special power of attorney, duly notarized and registered with a Colombian consulate, if signed abroad.
+ Manufacturer's incorporation and legal representation certificate, issued by the proper authorities and notarized by a Colombian consulate. [NOTE: U.S. companies can attach a Certificate of Good Standing, issued by The Company Corporation, Tel: 1-800-877-4224 or (302) 636-5440].
+ Appointed importer/distributor's certificate of incorporation and legal representation, stating corporate name and street address.
+ Quality certificate for international trade products, issued by the sanitary authorities of the country of origin in accordance with the World Health Organization model, containing at least the following information:
1. Certification of the free sale authorization in the exporting country:
- Active ingredient, pharmaceutical form and concentration;
- Name of the owner of the sanitary registration;
- Registration number and expiration date as applicable.
2. Certification that the industrial installations and production operations meet the country of origin's Good Manufacturing Practices.
3. Certification that the facilities in which the product is manufactured are subject to periodical inspections by sanitary authorities.
* Certificate issued by the Colombian Superintendency of Industry and Commerce stating that the trademark is registered in the name of the interested party or that registration is in process. If the trademark holder is a third party, the trademark use authorization must be attached.
* Manufacturer's authorization for the importer to request the sanitary registration, use the trademark, import, commercialize and distribute the product.
* Payment receipt for HEALTH REGISTER rights as established by Law.

GENERAL PRODUCT INFORMATION
* Name and domicile of the individual/company in whose name the sanitary registration is requested.
* Name and domicile of the product manufacturer
* Product name and trademark(s).

PRODUCT DESCRIPTION
+ Pharmaceutical Laboratory or manufacturer's name.
+ Product composition by posology unit, which must coincide with product composition list approved for granting the sanitary registration. Excipient ingredients specification not required.
+ Manufacturing date.
+ Expiration or caducity date, which in no case should be more than five years, calculated from the manufacturing date.
+ Batch code or number used to identify units manufactured during the same cycle, with the same raw materials and; therefore, considered identical.
+ When required, special storage conditions as established and accepted by the pharmacopoeia, such as temperature range.

For biological products, the following additional information is required:
* Product's physical-chemical composition or biological and immunologic characteristics.
* Indication of its activity, protecting units and capacity, and flocculent doses or germ title.
* Statement of the microorganism's biological state: live, inactivated or killed.

PRODUCT TECHNICAL INFORMATION
o Pharmaceutical form and commercial presentation, specifying container and packing material.
o Product composition or quantitative formula identifying all the substances the product is made of with chemical and generic name in accordance with IUPAC nomenclature, indicating weight and volume percentages. The corresponding formula must be submitted divided in two parts as follows:
1. Active ingredients, excipients, stabilizers, dyes, and carriers.
2. Other compounds in general.
o Structural and condensed formula of active ingredients, as applicable.
o Formula of the standardized lot.
o Detailed description of manufacturing process.
o Certification of the reference standards used for active ingredients quality control, according to the model issued by the World Health Organization (WHO).
o Specifications of raw materials quality control (active ingredients and formula auxiliaries) and all other raw materials used in the manufacturing process.
o Specifications of controls performed during the manufacturing process.
o Presentation of the control results.
o Specifications and results of the finished product quality controls.
o Analysis methodology of the finished product. When this corresponds to one of the pharmacopoeias accepted in Colombia, the manufacturer must state the name of the pharmacopoeia, edition and page. If the finished product analysis methodology does not correspond to any of the pharmacopoeias accepted in Colombia, the manufacturer must submit complete documentation to support the complete analysis validation. For solid pharmaceuticals, whose active ingredient is official in several pharmacopoeias, but the chosen pharmacopoeia does not have the a dissolution test, compliance with the dissolution test required in the United States of America pharmacopoeia –USP- is required.
o Stability protocol. An accelerated test, under simulated temperature and humidity stress, is a minimum requirement. Additionally, natural aging information, obtained during the first three months, must be submitted.
o Product validity period and storing conditions. If only accelerated tests are submitted, the maximum validity shall be three years.
o Results of bio-availability and bio-equivalence studies may be required by INVIMA, in accordance with the concept and parameters issued by the Reviewing Commission for Pharmaceutical Products.

LABELING

Proposed labels in duplicate and scale models of containers and packages with the following information in Spanish:
# Sanitary registration number and expiration date.
# Composition.
# The main label must have visible captions reading, in Spanish: "Venta bajo formula medica u odontologica" (Prescription required) or “Venta libre" (OTC), as needed; or "Mantengase fuera del alcance de los niños" (Keep out of reach of children).
# Pharmaceutical products listed in the Colombian Basic Mandatory Health System as essential medications must also have the caption "Medicamento Esencial", written on a green band.
# Labels and packaging of medications classified and listed as special control drugs by the Revisory Commission must have a vertical violet band with the caption "Medicamento de Control Especial - Usese Bajo Estricta Vigilancia Medica" (Special Control Medicament - Use Under Strict Medical Supervision) and "Medicamento Suceptible de Crear Dependencia" (May cause dependency), as applicable.
# Summary of pharmacological information including:
1. Route of administration.
2. Dosage and frequency.
3. Pharmacological indications and therapeutic use.
4. Contraindications, side effects and warnings.
5. Printed text for posology unit, if applicable.

GENERAL USEFUL INFORMATION:
o All documents originating in a country other than Colombia must be duly notarized by a Colombian consulate.
o When documents are written in a language other than Spanish, an official translation must be attached. Translations are considered official when they are signed by a translator duly authorized by the Colombian Ministry of Justice. A list of official translators is available at the U.S. Embassy in Bogota from the Consular and Commercial Sections.
o The sanitary certification should be requested in the name of the U.S. manufacturer, unless the manufacturer has policies that indicate otherwise.
o U.S. manufacturers must inform INVIMA directly about changes in the names of authorized representatives and importers of their products.
bridgat
 
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