Proyecto de Norma Oficial Mexicana PROY-NOM-248-SSA1-2006, Buenas prácticas de fabricación para establecimientos dedicados a la fabricación de remedios herbolarios (Draft Mexican Official Standard PROY-NOM-248-SSA1-2006: Good manufacturing practices for establishments engaged in the manufacture of herbal remedies)
Distribution date: 07 May 2009 | Final date for Comment: 06 July 2009
The notified draft Mexican Official Standard sets forth the minimum requirements for the processing of herbal remedies marketed in Mexico to ensure that consumers are supplied with good quality products. The draft Standard is binding throughout Mexican territory on all establishments engaged in the manufacture, storage and distribution of herbal remedies for human use which are marketed in Mexico.
Products Covered: Medicinal plants
Regulation Type: Regular notification
Feed and food of non-animal origin
Distribution date: 08 May 2009 | Final date for Comment: 25 April 2025
Please note that sections 5 and 11 of notification G/SPS/N/EEC/341 of 28 April 2009: 5. Title of the notified document: "Draft Commission Regulation of **** Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC" (Document SANCO/4680/2009 Rev. 2 Language: English Number of pages: 20) http://members.wto.org/crnattachments/2009/sps/EEC/09_1563_00_e.pdf 11. Proposed date of entry into force: [ ] Six months from date of publication, and/or (dd/mm/yy): This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It will enter into force 6 (six) months after the date of publication in the OJ. [ ] Trade facilitating measure shall be read accordingly: 5. Title of the notified document: "Draft Commission Regulation of **** implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC" (Document SANCO/4680/2009 Rev. 2 Language: English Number of pages: 20) http://members.wto.org/crnattachments/2009/sps/EEC/09_1563_00_e.pdf 11. Proposed date of entry into force: [ ] Six months from date of publication, and/or (dd/mm/yy): This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply 6 (six) months after the date of publication in the OJ. [ ] Trade facilitating measure
Products Covered:
Regulation Type: Corrigendum to Regular Notification
El Gobierno de Honduras, informa que el RTCA 11.01.04:09 Productos Farmacéuticos. Estudios de estabilidad de medicamentos de uso humano, notificado bajo la signatura G/TBT/N/HND/2, el 9 de diciembre del 2004, ha sido modificado. ; ; El documento puede ser accesado en la siguiente dirección electrónica: ; Secretaria de Industria y Comercio ; Dirección General Producción y Consumo ; Departamento de Normalización ; Boulevard José Cecilio del Valle ; Edificio San José- 3er piso ; Telefax: (+504) 235-5006 ; Correo Electrónico: [email protected] ; Sitio Web: www.sic.gob.hn ; Tegucigalpa- Honduras ; ; Secretaria de Salud ; Dirección General de Regulación Sanitaria ; Centro de Tegucigalpa ; Antiguo edificio BANMA ; Esquina opuesta a Farmacia Regis ; Fax: + (504) 237-9404 / 237-2726 ; E-mail: [email protected] ; Tegucigalpa- Honduras ;
Distribution date: 08 May 2009 | Final date for Comment: 25 April 2025
Products Covered: Central American Tariff System (SAC) Chapter 30
Regulation Type: Addendum to Regular Notification
Draft Decision establishing the Andean Technical Regulation laying down the operating requirements for establishments engaged in the manufacture of domestic hygiene products and absorbent personal hygiene products (28 pages, in Spanish).
Distribution date: 08 May 2009 | Final date for Comment: 07 July 2009
El presente proyecto de reglamento técnico contiene catorce (13) numerales de requisitos (personal, organización, saneamiento e higiene, edificaciones e instalaciones, equipos accesorios y utensilios, mantenimiento y servicios, almacenamiento y distribución, manejo de materias primas e insumos, producción, envase y empaque, aseguramiento de la calidad, documentación y archivo, biblioteca, quejas y reclamos y causales de retiro de productos) y un anexo con una guía para realizar la inspección de establecimientos fabricantes de productos de higiene domestica y productos absorbentes de higiene persona con los criterios de evaluación y calificación para las inspecciones de control y vigilancia.
Products Covered: Domestic hygiene products and absorbent personal hygiene products: 3804.00 – Residual lyes from the manufacture of wood pulp, whether or not concentrated, desugared or chemically treated, including lignin sulphonates, but excluding tall oil of heading 38.03; 1520.00.00 – Glycerol, crude; glycerol waters and glycerol lyes; 28.15 – Sodium hydroxide (caustic soda); potassium hydroxide (caustic potash); peroxides of sodium or potassium; Sodium hydroxide (caustic soda); 281
Regulation Type: Regular notification
Title: Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph ; AGENCY: Food and Drug Administration (FDA), HHS ; ACTION: Final rule ; ; SUMMARY: The Food and Drug Administration (FDA) has issued this final rule to require important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDS). The new labeling is required for all OTC IAAA drug products whether marketed under an OTC drug monograph or an approved new drug application (NDA). The full text includes responses to comments from interested parties. ; ; DATES: Effective date 29 April 2010. Compliance date 29 April 2010. ; ; For further information contact: ; Arlene Solbeck ; Center for Drug Evaluation and Research (CDER) ; Food and Drug Administration ; 10903 New Hampshire Ave., Bldg. 22, MS 5411 ; Silver Spring, MD 20993 USA ; Tel: 301-796-2090 ; Email: [email protected] ; ; Full text at: ; http://edocket.access.gpo.gov/2009/E9-9684.htm ; http://edocket.access.gpo.gov/2009/pdf/E9-9684.pdf ;
Distribution date: 11 May 2009 | Final date for Comment: 25 April 2025
Products Covered: Over-the-counter human drugs, Internal analgesic, antipyretic, and anti-rheumatic drug products (HS: Chapter 3004; ICS: 11)
Regulation Type: Addendum to Regular Notification
Cleaning paste based on synthetic surface active agents
Distribution date: 12 May 2009 | Final date for Comment: 05 June 2009
3rd amendment to SI 733. This amendment changes the normative reference mentioned in paragraph 104 dealing with packaging. This paragraph is the only mandatory part of the standard. According to the amendment, the cleaning paste containers should now comply with the Mandatory Standard SI 2302 part 1, instead of SI 743.
Products Covered: Cleaning paste (ICS: 71.100.40; HS: 3402).
Regulation Type: Regular notification
El Gobierno de Costa Rica, informa que el RTCA 11.01.04:09 Productos Farmacéuticos. Estudios de estabilidad de medicamentos de uso humano, notificado bajo la signatura G/TBT/N/CRI/23, del 7 de diciembre del 2004, ha sufrido modificaciones en su forma y su fondo. Por tal razón se concede un plazo de 60 días a partir de la fecha de notificación para que los países miembros realicen comentarios. ; ; ; El documento puede ser accesado en la siguiente dirección electrónica: http://www.reglatec.go.cr/consulta/rtc-11-01-04-2009.pdf ; ; Centro de Obstáculos Técnicos al Comercio ; Sitio en Internet: http://www.reglatec.go.cr ; Punto de Contacto OMC: [email protected] ; Teléfono: (506) 2235-2700, ext. 265 ; Fax: (506) 2297-1439 ; San José, Costa Rica ; http://members.wto.org/crnattachments/2009/tbt/cri/09_1715_00_s.pdf
Distribution date: 12 May 2009 | Final date for Comment: 25 April 2025
Products Covered: Pharmaceutical products. Stability of medicines for human use (HS tariff headings 3003 and 3004)
Regulation Type: Addendum to Regular Notification
Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (Revision of Agricultural Chemical Residue Standards)
Distribution date: 13 May 2009 | Final date for Comment: 12 July 2009
Proposed maximum residue limits (MRLs) for imicyafos, pyrasulfotole, destomycin A and terdecamycin.
Products Covered: Meat and edible meat offal (HS Codes 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09); Dairy and eggs (HS Codes 04.01, 04.07 and 04.08); Edible vegetables and certain roots and tubers (HS Codes 07.01, 07.02, 07.07, 07.06, 07.09, 07.10, 07.12 and 07.14); Edible fruits (HS Codes 08.07, 08.10, 08.11 and 08.13); and Cereals (HS Codes 10.01, 10.02, 10.03, 10.04, 10.07 and 10.08).
Regulation Type: Regular notification
Proyecto de Resolución del Ministerio de la Protección Social "Por la cual se establece el reglamento técnico sobre los requisitos sanitarios que debe cumplir el chocolate y productos de chocolate para consumo humano, que se procese, envase, transporte, comercialice, expenda, importe o exporte en el territorio nacional" (Draft Ministry of Social Welfare Resolution "Establishing technical regulations on the health requirements to be met by chocolate and chocolate products for human consumption which are processed, packaged, transported, marketed or sold in, imported into or exported from Colombian national territory").
Distribution date: 25 May 2009 | Final date for Comment: 19 August 2009
The notified Resolution covers the following: Purpose; Scope; Definitions; Basic hygiene requirements; Classification; Raw materials; General requirements for table chocolate, chocolate and chocolate substitutes for direct consumption; Physico-chemical and microbiological requirements; Maximum pesticide limits for table chocolate, chocolate and chocolate substitutes; Prohibitions; Packaging and labelling; Requirements for the importation of chocolate and chocolate products; Inspection, monitoring and control, safety measures, penalties, notification and period of validity.
Products Covered: Chocolate and chocolate products
Regulation Type: Regular notification
Reglamento Técnico Centroamericano RTCA 65.05.54:09, Fertilizantes y Enmiendas de Uso Agrícola. Requisitos para el Registro (Central American Technical Regulation (RTCA) No. 65.05.54:09: Fertilizers and soil conditioners for agricultural use. Registration requirements).Text available online at:http://members.wto.org/crnattachments/2009/sps/CRI/09_1825_00_s.pdf
Distribution date: 26 May 2009 | Final date for Comment: 25 July 2009
The notified Technical Regulation lays down the requirements for the registration of fertilizers and soil conditioners for agricultural use. It applies to the registration of agricultural fertilizers and soil conditioners which are manufactured, formulated, extracted from natural sources, packaged, repacked/repackaged, imported, exported, distributed and marketed in countries of the Central American region.
Products Covered: International Classification for Standards (ICS) code 65.080
Regulation Type: Regular notification
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