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World Trade



8 May 2009

(09 2267)

Committee on Technical Barriers to Trade

Original: Spanish

The following notification is being circulated in accordance with Article 10.6.


Member to Agreement notifying: HONDURAS

If applicable, name of local government involved (Articles 3.2 and 7.2):


Agency responsible: Secretaría de Industria y Comercio, SIC (Ministry of Industry and Trade)

Name and address (including telephone and fax numbers and E mail and Website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:

Dirección General de Integración Económica y Política Comercial (Directorate General of Economic Integration and Trade Policy)

Boulevard José Cecilio del Valle

Edificio San José, 4to piso


Telefax: (+504) 235 5047 / 235 3082

E mail: wduque@sic.gob.hn

Website: http://www.sic.gob.hn

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:


Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):
International Classification for Standards (ICS) code 11.120.99


Title, number of pages and language(s) of the notified document: RTCA 11.03.56:09, Productos Farmacéuticos. Productos Naturales Medicinales para Uso Humano. Verificación de la Calidad (Central American Technical Regulation (RTCA) No. 11.03.56:09: Pharmaceutical products. Natural medicines for human use. Quality control) (8 pages, in Spanish).


Description of content: The notified Technical Regulation establishes the analytical tests which must be carried out by the regulatory authority to verify the quality of natural medicines for human use. The provisions of this Regulation apply to all natural medicines for human use which are imported into or manufactured in Central American countries. The Regulation guidelines are mandatory for all natural medicines the pharmaceutical form of which is administered by any route other than ophthalmic or parenteral.


Objective and rationale, including the nature of urgent problems where applicable: Prevention of practices likely to mislead the consumer and protection of human health.


Relevant documents:

Appendix XVI D, Microbiological quality of pharmaceutical preparations, British Pharmacopoeia, Volume IV. 2007.

• The United States Pharmacopeia 30 and The National Formulary 25. 30th Edition. The United States Pharmacopeial Convention Inc. USA. 2007.

Secretaría de Salud, Comisión Permanente de la Farmacopea de los Estados Unidos Mexicanos (Ministry of Health, Permanent Pharmacopoeia Commission of the United Mexican States), Farmacopea Herbolaria de los Estados Unidos Mexicanos (Herbal Pharmacopoeia of the United Mexican States). Mexico. 2001.

• Arias, Tomas D., Glosario de Medicamentos: Desarrollo, Evaluación y Uso (Glossary of medicines: development, evaluation and use), 1st Edition. Pan American Health Organization, USA. 1999.

• García G., Mildred, Legislación en Iberoamérica sobre Fitofármacos y Productos Naturales (Ibero American legislation on phytomedicines and natural products). Ibero American Programme of Science and Technology for Development (CYTED). Costa Rica, 2000.

RTCA 67.04.50:08, Alimentos. Criterios Microbiológicos para la Inocuidad de Alimentos (Central American Technical Regulation (RTCA) No. 67.04.50:08: Food products. Microbiological criteria for food safety).


Proposed date of adoption:

Proposed date of entry into force:


To be determined


Final date for comments: 60 days as from the date of notification.


Texts available from: National enquiry point [X] or address, telephone and fax numbers and E mail and website addresses, if available, of other body:

The full text of the Regulation is available from:

Secretaria de Salud

Dirección General de Regulación Sanitaria

Centro de Tegucigalpa

Antiguo edificio BANMA

Esquina opuesta a Farmacia Regis

Tegucigalpa, República de Honduras

Telefax: (+504) 237 9404 and 237 2726

E mail: regulacionhon@yahoo.com

Secretaria de Industria y Comercio

Dirección General de Producción y Consumo

Departamento de Normalización

Boulevard José Cecilio del Valle

Edificio San José, 3er piso

Tegucigalpa, República de Honduras

Telefax: (+504) 235 5006

E mail: normalizacion@sic.gob.hn

Website: http://www.sic.gob.hn

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