Regulatory Updates
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: arlene.solbeck@fda.hhs.gov ; ; 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
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
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
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: normalizacion@sic.gob.hn ; 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: regulacionhon@yahoo.com ; Tegucigalpa- Honduras ;
Distribution date: 08 May 2009
Products Covered: Central American Tariff System (SAC) Chapter 30
Regulation Type: Addendum to Regular Notification
Feed and food of non-animal origin
Distribution date: 08 May 2009
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
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
Medida sanitaria mediante la cual se establecen los requisitos para los lactosueros en polvo como materia prima de alimentos para consumo humano
Distribution date: 06 May 2009
La República de Colombia comunica con relación al proyecto de modificación "parcial del articulo 6° Requisitos fisicoquímicos y microbiológicos de los lactosueros en polvo, de la Resolución Nº 2997" del Ministerio de la Protección Social, notificado mediante el documento identificado con la signatura G/SPS/N/COL/126/Add.2 del 22 de julio de 2008, que éste ha sido expedido mediante la Resolución Nº 715 del 13 de marzo de 2009 del Ministerio de la Protección Social.
Products Covered:
Regulation Type: Addendum to Regular Notification
El Gobierno de El Salvador, informa que el NSO RTCA 11.01.04:04 Productos Farmacéuticos. Estudios de estabilidad de medicamentos de uso humano, notificado bajo la signatura G/TBT/N/SLV/52 de fecha 9 de diciembre de 2004, ha sido modificado. ; ; El documento puede ser solicitado a la siguiente dirección: ; Ministerio de Economía ; Dirección de Administración de Tratados Comerciales ; Alameda Juan Pablo II y Calle Guadalupe Plan Maestro San Salvador ; El Salvador ; Teléfono: (503) 2231 5788 ; Fax: (503) 2231 5789 ; Correo electrónico: ezelada@minec.gob.sv ; o dirección, números de teléfono y de telefax, correo electrónico y dirección del sitio Web, en su caso, de otra institución: ; ; Consejo Nacional de Ciencia y Tecnología (CONACYT) ; Colonia Médica, Avenida Dr. Emilio Alvarez, pasaje Dr. Guillermo Rodríguez Pacas, #51 ; Teléfono:(503) 2226 2800 ; Fax:(503) 2225 6255 ; Sitio Web: www.conacyt.gob.sv ; Mayor Información: Ing. Rogelio Guerrero al 2234-8411 o e-mail: evanegas@conacyt.gob.sv ;
Distribution date: 05 May 2009
Products Covered: Pharmaceutical products (International Classification for Standards (ICS) code 11.120.10 and HS tariff heading 30)
Regulation Type: Addendum to Regular Notification
Salvadoran Mandatory Standard (NSO)/Central American Technical Regulation (RTCA) No. 11.03.56:09: Pharmaceutical products. Natural medicines for human use. Quality control (8 pages, in Spanish).
Distribution date: 05 May 2009 | Final date for Comment: 04 July 2009
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.
Products Covered: Pharmaceutical products (HS Chapter 30; International Classification for Standards (ICS) code 11.120.99)
Regulation Type: Regular notification
NTON 11 023-09/RTCA 65.05.54:09, Fertilizantes y Enmiendas, de Uso Agrícola. Requisitos para el Registro (Nicaraguan Mandatory Technical Standard (NTON)/Central American Technical Regulation (RTCA) No. 65.05.54:09: Fertilizers and soil conditioners for agricultural use. Registration requirements)
Distribution date: 01 May 2009 | Final date for Comment: 30 June 2009
The aim of the notified Regulation is to lay 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: Fertilizers
Regulation Type: Regular notification
Cement: Sulphate-resisting Portland cements (4 pages in Hebrew).
Distribution date: 30 April 2009 | Final date for Comment: 29 June 2009
3rd amendment to the Mandatory Standard SI 1 part 2 dealing with sulphate-resisting Portland cements. This amendment includes changes in the list of reference standards related to this standard, as well as changes in the testing method for soluble chrome mentioned in paragraph 9 dealing with chemical properties.
Products Covered: Sulphate-resisting Portland cements (ICS: 91.100.010; HS: 2523).
Regulation Type: Regular notification
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