Regulatory Updates
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) ;
Distribution date: 18 September 2015
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
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) ;
Distribution date: 18 September 2015
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
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) ;
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) ;
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-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) ;
Distribution date: 18 September 2015
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
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) ;
Distribution date: 18 September 2015
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
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")
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
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")
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
Partial amendment to the Minimum Requirements for Radiopharmaceuticals (1 pages, in English)
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
Partial amendment to the Minimum Requirements for Radiopharmaceuticals (1 pages, in English)
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
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