Technical Regulation RTCA 11.01.02:03: Pharmaceutical Products. Labelling of Pharmaceutical Products for Human Use (12 pages, in Spanish).

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Distribution date: 09 December 2004 | Final date for Comment: 21 April 2025

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

Labelling

Technical Regulation RTCA 11.01.02:03: Pharmaceutical Products. Labelling of Pharmaceutical Products for Human Use (12 pages, in Spanish).

Product Image

Distribution date: 09 December 2004 | Final date for Comment: 21 April 2025

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

Labelling

Central American Technical Regulation RTCA 11.01.04:04: Pharmaceutical Products. Stability of Medicines for Human Use (13 pages, in Spanish).

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Distribution date: 09 December 2004 | Final date for Comment: 21 April 2025

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).

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Distribution date: 09 December 2004 | Final date for Comment: 21 April 2025

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) / Salvadoran Mandatory Standard (NSO) No. 11.01.02:03: Pharmaceutical Products. Labelling of Pharmaceutical Products for Human Use (12 pages, in Spanish).

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Distribution date: 09 December 2004 | Final date for Comment: 21 April 2025

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

Labelling

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).

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Distribution date: 09 December 2004 | Final date for Comment: 21 April 2025

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

Labelling

Amendment to the Scope and Standards of Harmful Feeds (Available only in Korean, 5 pages)

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Distribution date: 15 December 2004 | Final date for Comment: 21 April 2025

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

Food safety Animal feed Human health Aflatoxins Veterinary drugs Contaminants Toxins Feed additives Ochratoxin Mycotoxins

Amendment to the Scope and Standards of Harmful Feeds (Available only in Korean, 5 pages)

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Distribution date: 15 December 2004 | Final date for Comment: 21 April 2025

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

Food safety Animal feed Human health Aflatoxins Veterinary drugs Contaminants Toxins Feed additives Ochratoxin Mycotoxins

MAF Public Notice No. 2004-90, the Proposed Draft Amendment of the Agricultural Products Quality Control Act (2 pages, Available in Korean)

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Distribution date: 15 December 2004 | Final date for Comment: 21 April 2025

Korea introduces the Good Agricultural Practice (GAP) that comprehensively manages agricultural environment including soil and water quality and the factors that can threaten food safety such as agricultural chemicals, heavy metals and hazardous organisms throughout the whole procedure from production to packing of agricultural products to provide high quality and safe agricultural products to consumers as well as the traceability system that manages a series of procedures from production to sales of agricultural products so that the concerned agricultural products can be traced thoroughly if any food safety issues occur. The Proposed Draft includes legal basis for the following: standard of facility and human resources of the organization which certifies GAP standard and procedures of GAP certification registration items of the traceability system subject items and procedures of the traceability system. * This Notification will also be notified to the WTO Secretariat in accordance with relevant provisions of the WTO/TBT Agreement.

Products Covered: Agricultural products designated by the Minister of Agriculture and Forestry (Subject items will be confirmed in 2005)

Regulation Type: Regular notification

Food safety Traceability Human health Contaminants Heavy metals

MAF Public Notice No. 2004-90, the Proposed Draft Amendment of the Agricultural Products Quality Control Act (2 pages, Available in Korean)

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Distribution date: 15 December 2004 | Final date for Comment: 21 April 2025

Korea introduces the Good Agricultural Practice (GAP) that comprehensively manages agricultural environment including soil and water quality and the factors that can threaten food safety such as agricultural chemicals, heavy metals and hazardous organisms throughout the whole procedure from production to packing of agricultural products to provide high quality and safe agricultural products to consumers as well as the traceability system that manages a series of procedures from production to sales of agricultural products so that the concerned agricultural products can be traced thoroughly if any food safety issues occur. The Proposed Draft includes legal basis for the following: standard of facility and human resources of the organization which certifies GAP standard and procedures of GAP certification registration items of the traceability system subject items and procedures of the traceability system. * This Notification will also be notified to the WTO Secretariat in accordance with relevant provisions of the WTO/TBT Agreement.

Products Covered: Agricultural products designated by the Minister of Agriculture and Forestry (Subject items will be confirmed in 2005)

Regulation Type: Regular notification

Food safety Traceability Human health Contaminants Heavy metals

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