Regulatory Updates

; This addendum aims to inform that the Conformity Assessment Procedure, issued by Inmetro – National Institute of Metrology, Standardization and Industrial Quality, and notified under G/TBT/N/BRA/375 (school items), was now adopted as a final text, published on 9 December 2010, as Ministerial Act n º 481, 7 December 2011 (Portaria n º 481, de 7 de Dezembro de 2010), which revokes the Ministerial Act Nº188, 8 June 2007 (Portaria Inmetro Nº 188, de 08 de junho de 2007) to the stated date of 9 June 2012. ; ; ; The full text of this measure is available in Portuguese and can be downloaded at: ; ; http://www.inmetro.gov.br/legislacao/rtac/pdf/RTAC001637.pdf ;

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Distribution date: 10 January 2011

Products Covered: ): pencil sharpeners (HS 8214.10); backpacks and briefcases (HS 4202); drawing sets (HS 9017); Ball point pens; felt tipped and other porous -tipped pens and markers; fountain pens, stylograph pens and other pens; duplicating stylos; propelling or sliding pencils (HS 9608); student rubber (HS 4016); child scissors (HS 8214); student glue (HS 3505) and others school items.

Regulation Type: Addendum to Regular Notification

; This addendum aims to inform that the Conformity Assessment Procedure, issued by Inmetro – National Institute of Metrology, Standardization and Industrial Quality, and notified under G/TBT/N/BRA/375 (school items), was now adopted as a final text, published on 9 December 2010, as Ministerial Act n º 481, 7 December 2011 (Portaria n º 481, de 7 de Dezembro de 2010), which revokes the Ministerial Act Nº188, 8 June 2007 (Portaria Inmetro Nº 188, de 08 de junho de 2007) to the stated date of 9 June 2012. ; ; ; The full text of this measure is available in Portuguese and can be downloaded at: ; ; http://www.inmetro.gov.br/legislacao/rtac/pdf/RTAC001637.pdf ;

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Distribution date: 10 January 2011

Products Covered: ): pencil sharpeners (HS 8214.10); backpacks and briefcases (HS 4202); drawing sets (HS 9017); Ball point pens; felt tipped and other porous -tipped pens and markers; fountain pens, stylograph pens and other pens; duplicating stylos; propelling or sliding pencils (HS 9608); student rubber (HS 4016); child scissors (HS 8214); student glue (HS 3505) and others school items.

Regulation Type: Addendum to Regular Notification

Implementation Rules for Compulsory Certification of Fire Fighting Apparatus - Fire Extinguishing Agents (24pages, in Chinese)

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Distribution date: 10 January 2011 | Final date for Comment: 11 March 2011

The implementation rules specify the scope, certification model, major processes of certification, general requirements for certification, use of certificates and certification marks, fee-charging, etc.

Products Covered: Fire extinguishing agents ; ICS: HS: 3813.0010 ;

Regulation Type: Regular notification

Implementation Rules for Compulsory Certification of Fire Fighting Apparatus - Fire Extinguishing Agents (24pages, in Chinese)

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Distribution date: 10 January 2011 | Final date for Comment: 11 March 2011

The implementation rules specify the scope, certification model, major processes of certification, general requirements for certification, use of certificates and certification marks, fee-charging, etc.

Products Covered: Fire extinguishing agents ; ICS: HS: 3813.0010 ;

Regulation Type: Regular notification

Regulations on the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products (162 pages, in Spanish)

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Distribution date: 10 January 2011 | Final date for Comment: 11 March 2011

The notified text contains 283 articles, eight supplementary, transitional and final provisions and 6 annexes, and establishes the regulatory provisions of Law No. 29459 on pharmaceutical products, medical devices and sanitary products, which govern the registration, control and surveillance of these products, in accordance with the National Medicinal Drug Policy.

Products Covered: Pharmaceutical products:  Medicine, herbal medicine, dietary products and sweeteners, and biological and galenic products (classified under Chapter 30 of the Harmonized System or in the Customs Tariff); Medical devices (falling within tariff headings 9018, 9019, 9021, 9022 and 9402 of the Harmonized System or Customs Tariff); Sanitary products:  Cosmetics, domestic hygiene products and absorbent personal hygiene products (falling within the following tariff headings of the Harmonized System or Customs Tariff:  3303, 3304, 3305, 3401, 3402, 4818, 5601, subheading 3808.91.3401, 3402, 3809.91.00, 4818 and 5601)

Regulation Type: Regular notification

Human health

Regulations on the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products (162 pages, in Spanish)

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Distribution date: 10 January 2011 | Final date for Comment: 11 March 2011

The notified text contains 283 articles, eight supplementary, transitional and final provisions and 6 annexes, and establishes the regulatory provisions of Law No. 29459 on pharmaceutical products, medical devices and sanitary products, which govern the registration, control and surveillance of these products, in accordance with the National Medicinal Drug Policy.

Products Covered: Pharmaceutical products:  Medicine, herbal medicine, dietary products and sweeteners, and biological and galenic products (classified under Chapter 30 of the Harmonized System or in the Customs Tariff); Medical devices (falling within tariff headings 9018, 9019, 9021, 9022 and 9402 of the Harmonized System or Customs Tariff); Sanitary products:  Cosmetics, domestic hygiene products and absorbent personal hygiene products (falling within the following tariff headings of the Harmonized System or Customs Tariff:  3303, 3304, 3305, 3401, 3402, 4818, 5601, subheading 3808.91.3401, 3402, 3809.91.00, 4818 and 5601)

Regulation Type: Regular notification

Human health

RTCA 65.03.57:10, Plaguicidas. Plaguicidas de uso doméstico y de uso profesional. Requisitos de etiquetado (Central American Technical Regulation (RTCA) No. 65.03.57:10: Pesticides. Pesticides for domestic and professional use. Labelling requirements).Text available online in Spanish at: http://www.mineco.gob.gt/Presentacion/ExplorarDirectorio.aspx?titulo=TituloIntegracionEconomica&subtitulo=Sistema+de+Integraci%u00f3n+Centroamericana&llaveExploracion=Integraci%u00f3n+Centroamericana

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Distribution date: 20 December 2010 | Final date for Comment: 18 February 2011

The aim of the notified Technical Regulation is to establish the information and specifications that must appear on the labels of pesticides for domestic and professional use. It applies to the labels of pesticides for domestic and professional use, in their different formulations and presentations, marketed in Central American countries.

Products Covered: Pesticides. Pesticides for domestic and professional use (International Classification for Standards (ICS) code 65.100)

Regulation Type: Regular notification

Human health Pesticides Labelling

RTCA 65.03.57:10, Plaguicidas. Plaguicidas de uso doméstico y de uso profesional. Requisitos de etiquetado (Central American Technical Regulation (RTCA) No. 65.03.57:10: Pesticides. Pesticides for domestic and professional use. Labelling requirements).Text available online in Spanish at: http://www.mineco.gob.gt/Presentacion/ExplorarDirectorio.aspx?titulo=TituloIntegracionEconomica&subtitulo=Sistema+de+Integraci%u00f3n+Centroamericana&llaveExploracion=Integraci%u00f3n+Centroamericana

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Distribution date: 20 December 2010 | Final date for Comment: 18 February 2011

The aim of the notified Technical Regulation is to establish the information and specifications that must appear on the labels of pesticides for domestic and professional use. It applies to the labels of pesticides for domestic and professional use, in their different formulations and presentations, marketed in Central American countries.

Products Covered: Pesticides. Pesticides for domestic and professional use (International Classification for Standards (ICS) code 65.100)

Regulation Type: Regular notification

Human health Pesticides Labelling

RTCA 65.03.57:10, Plaguicidas. Plaguicidas de uso doméstico y de uso profesional. Requisitos de etiquetado (Central American Technical Regulation (RTCA) No. 65.03.57:10: Pesticides. Pesticides for domestic and professional use. Labelling requirements).Text available online in Spanish at: http://members.wto.org/crnattachments/2010/sps/CRI/10_4584_00_s.pdf

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Distribution date: 20 December 2010 | Final date for Comment: 18 February 2011

The aim of the notified Regulation is to establish the information and specifications that must appear on the labels of pesticides for domestic and professional use. It applies to the labels of pesticides for domestic and professional use, in their different formulations and presentations, marketed in Central American countries.

Products Covered: Pesticides. Pesticides for domestic and professional use (International Classification for Standards (ICS) code 65.100)

Regulation Type: Regular notification

Human health Pesticides Labelling

RTCA 65.03.57:10, Plaguicidas. Plaguicidas de uso doméstico y de uso profesional. Requisitos de etiquetado (Central American Technical Regulation (RTCA) No. 65.03.57:10: Pesticides. Pesticides for domestic and professional use. Labelling requirements).Text available online in Spanish at: http://members.wto.org/crnattachments/2010/sps/CRI/10_4584_00_s.pdf

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Distribution date: 20 December 2010 | Final date for Comment: 18 February 2011

The aim of the notified Regulation is to establish the information and specifications that must appear on the labels of pesticides for domestic and professional use. It applies to the labels of pesticides for domestic and professional use, in their different formulations and presentations, marketed in Central American countries.

Products Covered: Pesticides. Pesticides for domestic and professional use (International Classification for Standards (ICS) code 65.100)

Regulation Type: Regular notification

Human health Pesticides Labelling

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