Regulatory Updates
Amendment to the Scope and Standards of Harmful Feeds (Available only in Korean, 5 pages)
Distribution date: 15 December 2004
This amendment aims to ensure safe production of livestock products by: withdrawing the designation of the above mentioned animal drugs as feed additives; adding several types of mycotoxins (Aflatoxin B1, G1 & G2, Ochratoxin A) and agricultural chemicals (10 items such as Ethion, Permethrin) into the list of environmental contaminants and agricultural chemicals that need to be controlled. * This Notification will also be notified to the WTO Secretariat in accordance with relevant provisions of the WTO/TBT agreement.
Products Covered: Feeds, Oxytetracycline HCl, Sulfamethazine, Sulfadimethoxine, Kitasamycin, Thiopeptin, Bicosamycin, Hygromycin B, Destomycin A, Nystatin, Erythromycin, Decoquinate, Robenidin HCl, Carbadox, Amprolium, Ethopabate, Sulfaquinoxaline, Halofuzinone, Noxyheptide, Nicarbazine, Zoalene Methylbenzoquate, Ormethoprim, Ronidazole, Morantel citrate, Cyromazine, Roxasone, Cedecamycin, Ivermectin
Regulation Type: Regular notification
Technical Regulation (RTCA) / Salvadoran Mandatory Standard (NSO) No. 11.01.02:03: Pharmaceutical Products. Labelling of Pharmaceutical Products for Human Use (12 pages, in Spanish).
Distribution date: 09 December 2004
This Technical Regulation establishes the minimum requirements governing the labelling of both Central American and foreign pharmaceutical products for human use, irrespective of the terms and conditions of sale, shipping or supply.
Products Covered: Pharmaceutical products (HS tariff heading 30)
Regulation Type: Regular notification
Technical Regulation (RTCA) / Salvadoran Mandatory Standard (NSO) No. 11.01.02:03: Pharmaceutical Products. Labelling of Pharmaceutical Products for Human Use (12 pages, in Spanish).
Distribution date: 09 December 2004
This Technical Regulation establishes the minimum requirements governing the labelling of both Central American and foreign pharmaceutical products for human use, irrespective of the terms and conditions of sale, shipping or supply.
Products Covered: Pharmaceutical products (HS tariff heading 30)
Regulation Type: Regular notification
Central American Technical Regulation RTCA 11.01.04:04: Pharmaceutical Products. Stability of Medicines for Human Use (13 pages, in Spanish).
Distribution date: 09 December 2004
Establece las directrices técnicas para los estudios de estabilidad de los medicamentos, exigidos como requisito en el proceso de registro sanitario o primera renovación, y en caso de cambios posteriores al registro, después de la fecha de publicación de este reglamento, para el establecimiento del período de validez, la fecha de vencimiento de cada lote y las condiciones de almacenamiento de cada producto. Las disposiciones de este reglamento son de aplicación para todos aquellos medicamentos fabricados en el territorio de Centroamérica, así como todos aquellos importados a la misma, para determinar la vida útil de estos y para fines de registro sanitario.
Products Covered: Central American Tariff System (SAC) Chapter 30
Regulation Type: Regular notification
Central American Technical Regulation RTCA 11.01.04:04: Pharmaceutical Products. Stability of Medicines for Human Use (13 pages, in Spanish).
Distribution date: 09 December 2004
Establece las directrices técnicas para los estudios de estabilidad de los medicamentos, exigidos como requisito en el proceso de registro sanitario o primera renovación, y en caso de cambios posteriores al registro, después de la fecha de publicación de este reglamento, para el establecimiento del período de validez, la fecha de vencimiento de cada lote y las condiciones de almacenamiento de cada producto. Las disposiciones de este reglamento son de aplicación para todos aquellos medicamentos fabricados en el territorio de Centroamérica, así como todos aquellos importados a la misma, para determinar la vida útil de estos y para fines de registro sanitario.
Products Covered: Central American Tariff System (SAC) Chapter 30
Regulation Type: Regular notification
Technical Regulation RTCA 11.01.02:03: Pharmaceutical Products. Labelling of Pharmaceutical Products for Human Use (12 pages, in Spanish).
Distribution date: 09 December 2004
Establece los requisitos mínimos que debe cumplir el etiquetado de productos farmacéuticos para uso humano, cualquiera que sea su modalidad de venta, expedición o suministro, tanto para los productos del territorio de Centroamérica como extranjeros.
Products Covered: Central American Tariff System (SAC) Chapter 30
Regulation Type: Regular notification
Technical Regulation RTCA 11.01.02:03: Pharmaceutical Products. Labelling of Pharmaceutical Products for Human Use (12 pages, in Spanish).
Distribution date: 09 December 2004
Establece los requisitos mínimos que debe cumplir el etiquetado de productos farmacéuticos para uso humano, cualquiera que sea su modalidad de venta, expedición o suministro, tanto para los productos del territorio de Centroamérica como extranjeros.
Products Covered: Central American Tariff System (SAC) Chapter 30
Regulation Type: Regular notification
Central American Technical Regulation (RTCA) / Salvadoran Mandatory Standard (NSO) No. 11.01.04:04: Pharmaceutical Products. Stability of Medicines for Human Use (13 pages, in Spanish).
Distribution date: 09 December 2004
This Technical Regulation sets out guidelines for the stability studies required for the sanitary registration and first registration renewal of medicinal products and, in the event of changes to product registration subsequent to the date of publication of this Regulation, guidelines for establishing the period of validity, batch expiry dates and storage conditions of such products. This Regulation applies to all medicines manufactured in or imported to the Central America region both to determine their shelf-life and for sanitary registration purposes.
Products Covered: Pharmaceutical products (International Classification for Standards (ICS) code 11.120.10 and HS tariff heading 30)
Regulation Type: Regular notification
Central American Technical Regulation (RTCA) / Salvadoran Mandatory Standard (NSO) No. 11.01.04:04: Pharmaceutical Products. Stability of Medicines for Human Use (13 pages, in Spanish).
Distribution date: 09 December 2004
This Technical Regulation sets out guidelines for the stability studies required for the sanitary registration and first registration renewal of medicinal products and, in the event of changes to product registration subsequent to the date of publication of this Regulation, guidelines for establishing the period of validity, batch expiry dates and storage conditions of such products. This Regulation applies to all medicines manufactured in or imported to the Central America region both to determine their shelf-life and for sanitary registration purposes.
Products Covered: Pharmaceutical products (International Classification for Standards (ICS) code 11.120.10 and HS tariff heading 30)
Regulation Type: Regular notification
Central American Technical Regulation RTCA 75.01.13:04: Petroleum Products. Aviation Kerosene (Jet A1). Specifications (11 pages, in Spanish).
Distribution date: 09 December 2004
Se aplica a la fracción intermedia de la destilación, que se obtiene entre la Nafta (base para la gasolina) y el diesel, y que presenta las siguientes características de funcionalidad: facilidad de bombeo a bajas temperaturas, facilidad de reencendido a grandes altitudes y combustión óptima, las que lo hacen ideal para turbinas de aviones. Especifica las características físico químicas del combustible utilizado en aeronáutica, específicamente para aviones accionados por turbinas. Este reglamento no se aplica para Gasolina de Aviación conocida como AvGas ("Aviation Gasoline"), cuyas características se especifican en otro reglamento.
Products Covered: Central American Tariff System (SAC) subheading 2710.19.11
Regulation Type: Regular notification
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