Partial amendment to the Minimum Requirements for Radiopharmaceuticals (1 pages, in English)

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Distribution date: 16 September 2015 | Final date for Comment: 24 September 2015

<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">The minimum requirements for r</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">adiopharmaceuticals </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;"></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">are to </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">be partially amended to add the standard</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">s </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">for a </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">radiopharmaceutical </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">to be newly approved.</span></span></span></span></span></span></span></span></span></span>

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)

Regulation Type: Regular notification

Human health

Proyecto de Resolución del Ministerio de Salud y Protección Social y el Ministerio de Ambiente y Desarrollo Sostenible "Por la cual se adopta el reglamento técnico que establece los límites máximos de fósforo y la biodegradabilidad de los tensoactivos presentes en detergentes y jabones, y se dictan otras disposiciones" (Draft Resolution of the Ministry of Health and Social Welfare and the Ministry of the Environment and Sustainable Development "adopting the Technical Regulation establishing the maximum levels of phosphorus and the biodegradability of surfactants in detergents and soaps, and introducing other provisions")

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Distribution date: 17 September 2015 | Final date for Comment: 14 December 2015

The notified text establishes the maximum levels of phosphorus and the biodegradability of surfactants in detergents and soaps. It covers the following: Purpose; Scope; Definitions; Obligations of manufacturers and importers of detergents and soaps; Maximum permissible phosphorus levels; Biodegradability requirement; Conformity assessment procedure; Conformity certificates; Obligation to inform of manufacturers and importers of detergents and soaps for institutional and industrial use; Inspection, monitoring and control; Penalties; Review and updating; Transitional regime; and Period of validity and derogations.

Products Covered: Detergents and soaps (HS codes: 3401, 3402 and 340540)

Regulation Type: Regular notification

Animal health Plant health

Proyecto de Resolución del Ministerio de Salud y Protección Social y el Ministerio de Ambiente y Desarrollo Sostenible "Por la cual se adopta el reglamento técnico que establece los límites máximos de fósforo y la biodegradabilidad de los tensoactivos presentes en detergentes y jabones, y se dictan otras disposiciones" (Draft Resolution of the Ministry of Health and Social Welfare and the Ministry of the Environment and Sustainable Development "adopting the Technical Regulation establishing the maximum levels of phosphorus and the biodegradability of surfactants in detergents and soaps, and introducing other provisions")

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Distribution date: 17 September 2015 | Final date for Comment: 14 December 2015

The notified text establishes the maximum levels of phosphorus and the biodegradability of surfactants in detergents and soaps. It covers the following: Purpose; Scope; Definitions; Obligations of manufacturers and importers of detergents and soaps; Maximum permissible phosphorus levels; Biodegradability requirement; Conformity assessment procedure; Conformity certificates; Obligation to inform of manufacturers and importers of detergents and soaps for institutional and industrial use; Inspection, monitoring and control; Penalties; Review and updating; Transitional regime; and Period of validity and derogations.

Products Covered: Detergents and soaps (HS codes: 3401, 3402 and 340540)

Regulation Type: Regular notification

Animal health Plant health

Proyecto de norma oficial mexicana PROY-NOM-059-SSA1-2015, Buenas prácticas de fabricación de medicamentos (87 pages, in Spanish) (Draft Mexican Official Standard PROY-NOM-059-SSA1-2015: Good manufacturing practices for medicinal products) (87 pages, in Spanish) ;

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Distribution date: 18 September 2015 | Final date for Comment: 05 May 2025

The notified Standard is binding on all establishments engaged in the manufacture and/or importation of medicinal products for human use marketed in Mexico and/or medicinal products for research purposes, as well as on quality control laboratories and warehouses which package, store and distribute medicinal products and the raw materials required for their manufacture. ; ;

Products Covered: Medicaments (HS 30.04) ;

Regulation Type: Regular notification

Human health

Proyecto de norma oficial mexicana PROY-NOM-059-SSA1-2015, Buenas prácticas de fabricación de medicamentos (87 pages, in Spanish) (Draft Mexican Official Standard PROY-NOM-059-SSA1-2015: Good manufacturing practices for medicinal products) (87 pages, in Spanish) ;

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Distribution date: 18 September 2015 | Final date for Comment: 05 May 2025

The notified Standard is binding on all establishments engaged in the manufacture and/or importation of medicinal products for human use marketed in Mexico and/or medicinal products for research purposes, as well as on quality control laboratories and warehouses which package, store and distribute medicinal products and the raw materials required for their manufacture. ; ;

Products Covered: Medicaments (HS 30.04) ;

Regulation Type: Regular notification

Human health

Proyecto de Resolución del Ministerio de Salud y Protección Social y el Ministerio de Ambiente y Desarrollo Sostenible "Por la cual se adopta el reglamento técnico que establece los límites máximos de fósforo y la biodegradabilidad de los tensoactivos presentes en detergentes y jabones, y se dictan otras disposiciones" (Draft Resolution of the Ministry of Health and Social Welfare and the Ministry of the Environment and Sustainable Development "adopting the Technical Regulation establishing the maximum levels of phosphorus and the biodegradability of surfactants in detergents and soaps, and introducing other provisions") (16 pages, in Spanish) ;

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Distribution date: 18 September 2015 | Final date for Comment: 17 November 2015

The notified text establishes the maximum levels of phosphorus and the biodegradability of surfactants in detergents and soaps. It covers the following: Purpose; Scope; Definitions; Obligations of manufacturers and importers of detergents and soaps; Maximum permissible phosphorus levels; Biodegradability requirement; Conformity assessment procedure; Conformity certificates; Obligation to inform of manufacturers and importers of detergents and soaps for institutional and industrial use; Inspection, monitoring and control; Penalties; Review and updating; Transitional regime; and Period of validity and derogations. ; ;

Products Covered: Detergents and soaps (HS codes: 3401, 3402 and 3405400000) ;

Regulation Type: Regular notification

Proyecto de Resolución del Ministerio de Salud y Protección Social y el Ministerio de Ambiente y Desarrollo Sostenible "Por la cual se adopta el reglamento técnico que establece los límites máximos de fósforo y la biodegradabilidad de los tensoactivos presentes en detergentes y jabones, y se dictan otras disposiciones" (Draft Resolution of the Ministry of Health and Social Welfare and the Ministry of the Environment and Sustainable Development "adopting the Technical Regulation establishing the maximum levels of phosphorus and the biodegradability of surfactants in detergents and soaps, and introducing other provisions") (16 pages, in Spanish) ;

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Distribution date: 18 September 2015 | Final date for Comment: 17 November 2015

The notified text establishes the maximum levels of phosphorus and the biodegradability of surfactants in detergents and soaps. It covers the following: Purpose; Scope; Definitions; Obligations of manufacturers and importers of detergents and soaps; Maximum permissible phosphorus levels; Biodegradability requirement; Conformity assessment procedure; Conformity certificates; Obligation to inform of manufacturers and importers of detergents and soaps for institutional and industrial use; Inspection, monitoring and control; Penalties; Review and updating; Transitional regime; and Period of validity and derogations. ; ;

Products Covered: Detergents and soaps (HS codes: 3401, 3402 and 3405400000) ;

Regulation Type: Regular notification

Proyecto de Norma Oficial Mexicana PROY-NOM-164-SSA1-2015, Buenas prácticas de fabricación de fármacos (Draft Mexican Official Standard PROY-NOM-164-SSA1-2015: Good manufacturing practices for pharmaceutical products) (51 pages, in Spanish) ;

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Distribution date: 18 September 2015 | Final date for Comment: 05 May 2025

This Standard is binding on all establishments engaged in the manufacture of pharmaceutical products and active substances marketed in Mexico and pharmaceutical products developed for use in clinical research, and warehouses that distribute pharmaceutical products and active substances. ; ;

Products Covered: Pharmaceutical products (heading 30) ;

Regulation Type: Regular notification

Human health

Proyecto de Norma Oficial Mexicana PROY-NOM-164-SSA1-2015, Buenas prácticas de fabricación de fármacos (Draft Mexican Official Standard PROY-NOM-164-SSA1-2015: Good manufacturing practices for pharmaceutical products) (51 pages, in Spanish) ;

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Distribution date: 18 September 2015 | Final date for Comment: 05 May 2025

This Standard is binding on all establishments engaged in the manufacture of pharmaceutical products and active substances marketed in Mexico and pharmaceutical products developed for use in clinical research, and warehouses that distribute pharmaceutical products and active substances. ; ;

Products Covered: Pharmaceutical products (heading 30) ;

Regulation Type: Regular notification

Human health

Public Notice under the Commodity Inspection Act (5 page, in Chinese; English translation available)

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Distribution date: 21 September 2015 | Final date for Comment: 20 November 2015

<p style="margin:6pt 0cm;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span>Having recognized the need to protect consumers and the environment from hazards arising from the use of restricted chemical substances, in addition to the current regulated EMC and safety aspects of </span></span></span><span lang="EN-GB" style="letter-spacing:-0.1pt;">network media players and projectors</span><span lang="EN-GB" style="letter-spacing:-0.1pt;">,</span><span lang="EN-GB" style="letter-spacing:-0.1pt;"> </span><span lang="EN-GB" style="letter-spacing:-0.1pt;">the Bureau of Standards, Metrology and Inspection (BSMI) proposes to require marking of presence conditions of restricted substances. Such m</span><span lang="EN-GB">arkings shall be made in accordance with Section 5 of CNS 15663 on </span><span lang="EN-GB">the body, packages, stickers or the instruction books of the </span><span lang="EN-GB">product</span><span lang="EN-GB">. For those who utilize website as a means to announce "the presence conditions of the restricted substance</span><span lang="EN-GB">s,</span><span lang="EN-GB">" the website address </span><span lang="EN-GB">shall be clearly stated </span><span lang="EN-GB">on the body, packages, stickers or the instruction books of the </span><span lang="EN-GB">product</span><span lang="EN-GB">. </span></p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">Besides, as </span><span style="font-size:x-small;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;">wireless network media players and external projectors</span><span style="font-size:x-small;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;">are prevalently used by the general public nowadays, the BSMI would like to extend the current inspection scope to cover such products. F</span><span style="font-size:x-small;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;">or wireless network media players and external projectors</span><span style="font-size:x-small;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;">, the same conformity assessment procedure for wired network media players and internal projectors shall apply, i.e. </span><span style="font-size:x-small;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;">Registration of Product Certification (RPC) or Type-approved Batch Inspection (TABI).</span></span></span></span></span></span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana', 'sans-serif';font-size:9pt;"></span></span>

Products Covered: Network media players and projectors (HS: Chapter 85)

Regulation Type: Regular notification

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