Sanitary Requirements for importation of bovine fetal serum
Distribution date: 14 October 2008 | Final date for Comment: 13 December 2008
Draft regulation that establishes sanitary requirements for importation of bovine fetal serum.
Products Covered: Bovine fetal serum
Regulation Type: Regular notification
Proposed amendment to the Standards & Specifications for Foods
Distribution date: 15 October 2008 | Final date for Comment: 14 December 2008
To establish standards for benzo(a)pyrene in Rehmanniae Radix Preparata and Rehmannia glutinosa.
Products Covered: Food products
Regulation Type: Regular notification
Proyecto de Decreto "Por el cual se reglamenta la fabricación, comercialización, envase, rotulado o etiquetado, régimen de registro sanitario, de control de calidad, de vigilancia sanitaria y control sanitario de los productos de uso específico y se dictan otras disposiciones"
Distribution date: 29 October 2008 | Final date for Comment: 24 April 2025
La República de Colombia comunica con relación al Decreto Nº 3249 del 18 de septiembre de 2006 "Por el cual se reglamenta la fabricación, comercialización, envase, rotulado o etiquetado, régimen de registro sanitario, de control de calidad, de vigilancia sanitaria y control sanitario de los suplementos dietarios, se dictan otras disposiciones y se deroga el Decreto N° 3636 de 2005" del Ministerio de la Protección Social, notificado mediante el documento identificado con la signatura G/SPS/N/COL/98/Add.2 del 2 de noviembre de 2006, que éste ha sido modificado, mediante el Decreto Nº 3863 del 2 de octubre de 2007 del Ministerio de la Protección Social. Texto disponible en el Ministerio de Comercio, Industria y Turismo, Dirección de Regulación, Organismo Nacional encargado de la notificación:
Products Covered:
Regulation Type: Addendum to Regular Notification
Order of the Government of Kenya "On some protective measures against importation of Milk and Milk products contaminated with toxic industrial chemical melamine from the People's Republic of China and proximity territories" (HS: 0404; ICS: 67.100) (1 page, in English).
Distribution date: 30 October 2008 | Final date for Comment: 24 April 2025
Products Covered: Milk and Milk products
Regulation Type: Regular notification
The Tobacco Control Act, 2007
Distribution date: 30 October 2008 | Final date for Comment: 24 April 2025
Products Covered: Tobacco products (HS: 240310; ICS: 65.160)
Regulation Type: Regular notification
Proyecto de Decreto "Por el cual se reglamenta la fabricación, comercialización, envase, rotulado o etiquetado, régimen de registro sanitario, de control de calidad, de vigilancia sanitaria y control sanitario de los productos de uso específico y se dictan otras disposiciones"
Distribution date: 03 November 2008 | Final date for Comment: 24 April 2025
Sírvanse notar que la fecha del Decreto Nº 3863, mencionado en la notificación G/SPS/N/COL/98/Add.5, debe leerse 2 de octubre de 2008 y no de 2007.
Products Covered:
Regulation Type: Corrigendum to Regular Notification
AGENCY: Food and Drug Administration (FDA), HHS ; ACTION: Final rule ; ; TITLE: Toll-Free Number for Reporting Adverse Events on Labeling for ; Human Drug Products ; ; SUMMARY: This final rule requires the addition of a statement to the labeling for certain human drug products for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act. The statement includes a toll-free number and advises that the number is to be used only for reporting side effects and is not intended for medical advice and affirms the interim final rule's addition of new part 209 to the regulations requiring distribution of the side effects statement. The final rule also responds to comments submitted in response to the request for comments in the proposed rule. ; ; DATES: Effective 28 November 2008. ; ; FOR FURTHER INFORMATION CONTACT: ; Carol Drew ; Center for Drug Evaluation and Research ; Food and Drug Administration ; 10903 New Hampshire Ave., Bldg. 51, Room 6306 ; Silver Spring, MD 20993-0002 USA ; T: 301-796-3601 ; ; Full text is at: ; http://edocket.access.gpo.gov/2008/E8-25670.htm ; http://edocket.access.gpo.gov/2008/pdf/E8-25670.pdf ;
Distribution date: 04 November 2008 | Final date for Comment: 24 April 2025
Products Covered: Human Drug Products (HS Chapter 3003) (ICS 11.120)
Regulation Type: Addendum to Regular Notification
Adhesives for tiles: Definitions and specifications.
Distribution date: 04 November 2008 | Final date for Comment: 03 January 2009
The requirements of the existing standard, SI 4004 part 1dealing with adhesives for tiles, will be declared mandatory.
Products Covered: Adhesives for tiles (HS: 3506) (ICS: 83.180).
Regulation Type: Regular notification
Consumer Protection (Compliance With Safety Standards) Regulations 2008 (10 pages, English) and Consumer Protection (Safety Standards For Toys) Regulations 2008 (5 pages, English).
Distribution date: 06 November 2008 | Final date for Comment: 05 January 2009
1. Consumer Protection (Compliance With Safety Standards) Regulations 2008 ; The draft regulations specify the general procedural requirements with regard to safety standards of consumer goods which include the safety and marking requirements, certification of approval, conformity assessment report, offences and penalties, maintenance of records, authorized agency, transitional period for toys which are marketed in Malaysia. ; ; 2. Consumer Protection (Safety Standards For Toys) Regulations 2008 ; The draft regulation states that toys (as defined in the regulations) that are sold or supplied in Malaysia must conform to the specified safety standards. ; ; The safety standards prescribed under these regulations are: ; MS ISO 8124-1, Safety of toys – Part 1: Safety aspects related to mechanical and physical properties; ; MS ISO 8124-2, Safety of toys – Part 2: Flammability; ; MS ISO 8124-3, Safety of toys – Part 3: Migration of certain elements; ; MS 1774: Part 4, Safety of toys – Part 4: Experimental sets for chemistry and related activities; ; MS 1774: Part 5, Safety of toys – Part 5: Chemical toys (sets) other than experimental sets; ; MS 1774: Part 6:, Safety of toys – Part 6: Graphical symbol for age warning labeling; and ; MS 1725, Safety of Electric Toys. ;
Products Covered: Toys (HS: Chapter 95) (ICS: 97.200.50) ; Toys and any goods designed or intended for use in play by children less than fourteen years of age but does not include the goods listed in Schedule I of Consumer Protection (Safety Standards For Toys) Regulations 2008. ;
Regulation Type: Regular notification
Salvadoran Mandatory Standard (NSO) / 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).
Distribution date: 06 November 2008 | Final date for Comment: 05 January 2009
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 food products marketed in Central American countries.
Products Covered: Pharmaceutical products: HS Chapter 30 (International Classification for Standards (ICS) code 65.020.30)
Regulation Type: Regular notification
Submit your email ID to receive notifications about upcoming courses and events
