WORLD TRADE G/TBT/N/HND/56 15 December 2008 ORGANIZATION (08-6141) Committee on Technical Barriers to Trade Original: Spanish NOTIFICATION The following notification is being circulated in accordance with Article 10.6. 1. Member to Agreement notifying: HONDURAS If applicable, name of local government involved (Articles 3.2 and 7.2): 2. Agency responsible: Secretaría de Industria y Comercio, SIC (Ministry of Industry and Trade Name and address (including telephone and fax numbers, e-mail and web-site 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 Tegucigalpa Fax: (+504) 235 5047/235 3082 E-mail: pcomercial@sic.gob.hn Web site: www.sic.gob.hn 3. Notified under Article 2.9.2 [ X ], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other: 4. 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 65.020.30 5. Title, number of pages and language(s) of the notified document: RTCA 65.05.51:08 Medicamentos veterinarios y productos afines, establecimientos que los fabrican, comercializan, fraccionan o almacenan. Requisitos de registro sanitario y control. (Central American Technical Regulation (RTCA) No. 65.05.51:08: Veterinary drugs and related products, and establishments engaged in the manufacture, marketing, fractioning or storage thereof. Sanitary registration and control requirements) (37 pages, in Spanish). 6. Description of content: The aim of the notified Regulation is to establish provisions governing the sanitary registration and control of veterinary drugs and related products and establishments in this sector. This Regulation applies to all veterinary drugs marketed in Central American countries. 7. Objective and rationale, including the nature of urgent problems where applicable: Protection of human and animal health and the environment. . /. G/TBT/N/HND/56 Page 2 8. 9. Relevant documents: - Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA), Titles 9 and 21, United States of America; - International Programme on Chemical Safety (IPCS), World Health Organization (WHO); - Codex Alimentarius Commission: Maximum Residue Limits (MRLs) approved for veterinary drugs and pesticides; - European Medicines Agency (EMEA): Maximum Residue Limits (MRLs) approved for veterinary drugs and pesticides; - United States Pharmacopoeia; - European Pharmacopoeia. Proposed date of adoption: Proposed date of entry into force: Upon publication in the Diario Oficial (Official Journal). To be determined 10. Final date for comments: 60 days as from the date of this notification 11. Texts available from: National enquiry point [ X ] or address, telephone and fax numbers, e-mail and web site addresses, if available of the other body: Secretaría de Industria y Comercio Direccion General Producción y Consumo Departamento de Normalización Boulevard José Cecilio del Valle Edificio San José, 3er piso Tegucigalpa Telefax: (+504) 235 5006 E-mail: normalizacion@sie.gob.hn Web site: www.sic.gob.hn Secretaria de Agricultura y Ganadería Servicio Nacional de Sanidad Agropecuaria (SENASA) Blvd. Centro América, Ave. La FAO, República de Honduras Tel: (+504) 231 0786 Fax: (+504) 239 11 44 Web site: www.sag.gob.hn