Regulatory Updates
Proyecto de Decreto del Ministerio de Salud y Protección Social "Por el cual se reglamentan los regímenes de registros sanitarios, de vigilancia y control sanitario y publicidad de los productos fitoterapéuticos" (Draft Ministry of Health and Social Welfare Decree "Regulating the sanitary registration, sanitary surveillance and control and advertising systems for phytotherapeutic products") (25 pages, in Spanish) ;
Distribution date: 23 May 2016 | Final date for Comment: 22 July 2016
Scope; Definitions; Pharmacopoeias and officially approved reference texts; Classification of phytotherapeutic products; Colombian Vade-mecum of Medicinal Plants; Good manufacturing practices; Quality control; General provisions governing the sanitary registration system; Sanitary registration for medicinal plant-based pharmaceutical preparations; Sanitary registration for traditional phytotherapeutic products; Containers, labelling and packaging for phytotherapeutic products; Phytotherapeutic product brand names; Language of wording on labels, tags, packaging and inserts; Sanitary control and surveillance system; Notification and period of validity. ; ;
Products Covered: Phytotherapeutic products (30.04.90.29) ;
Regulation Type: Regular notification
; ; ;Response to comments received regarding draft Mexican Official Standard PROY-NOM-073-SSA1-2014, Stability of drugs, medicaments and herbal remedies, published in the Mexican Official Journal (Diario Oficial de la Federación) (http://www.dof.gob.mx/) on 17 May 2016. ;On 26 February 2015, the Ministry of Health published draft Mexican Official Standard PROY-NOM-073-SSA1-2014, Stability of drugs, medicaments and herbal remedies, in the Mexican Official Journal http://www.dof.gob.mx/ for public consultation. ;Any comments should be addressed to: ;Secretaría de Economía (Ministry of the Economy) ;Subsecretaría de Competitividad y Normatividad (Undersecretariat of Competitiveness and Standardization) ;Dirección General de Normas (General Directorate of Standards) ;Tel.: (+52) 55 5729-9100, Ext. 43244 ;Fax: (+52) 55 5520-9715 ;Website: http://www.economia.gob.mx/comunidad-negocios/normalizacion/catalogo-mexicano-de-normas ;Email: normasomc@economia.gob.mx and/or sofia.pacheco@economia.gob.mx ;Text available at: ;http://www.dof.gob.mx/nota_detalle.php?codigo=5437392&fecha=17/05/2016 ;https://members.wto.org/crnattachments/2016/TBT/MEX/16_1960_00_s.pdf ; ;
Distribution date: 19 May 2016
Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Essential oils, whether or not terpeneless, incl. concretes and absolutes; resinoids; extracted oleoresins; concentrates of essential oils in fats, fixed oils, waxes or the like, obtained by enfleurage or maceration; terpenic by-products of the deterpenation of essential oils; aqueous distillates and aqueous solutions of essential oils (HS code(s): 3301)
Regulation Type: Addendum to Regular Notification
; ; ;Response to comments received regarding draft Mexican Official Standard PROY-NOM-073-SSA1-2014, Stability of drugs, medicaments and herbal remedies, published in the Mexican Official Journal (Diario Oficial de la Federación) (http://www.dof.gob.mx/) on 17 May 2016. ;On 26 February 2015, the Ministry of Health published draft Mexican Official Standard PROY-NOM-073-SSA1-2014, Stability of drugs, medicaments and herbal remedies, in the Mexican Official Journal http://www.dof.gob.mx/ for public consultation. ;Any comments should be addressed to: ;Secretaría de Economía (Ministry of the Economy) ;Subsecretaría de Competitividad y Normatividad (Undersecretariat of Competitiveness and Standardization) ;Dirección General de Normas (General Directorate of Standards) ;Tel.: (+52) 55 5729-9100, Ext. 43244 ;Fax: (+52) 55 5520-9715 ;Website: http://www.economia.gob.mx/comunidad-negocios/normalizacion/catalogo-mexicano-de-normas ;Email: normasomc@economia.gob.mx and/or sofia.pacheco@economia.gob.mx ;Text available at: ;http://www.dof.gob.mx/nota_detalle.php?codigo=5437392&fecha=17/05/2016 ;https://members.wto.org/crnattachments/2016/TBT/MEX/16_1960_00_s.pdf ; ;
Distribution date: 19 May 2016
Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Essential oils, whether or not terpeneless, incl. concretes and absolutes; resinoids; extracted oleoresins; concentrates of essential oils in fats, fixed oils, waxes or the like, obtained by enfleurage or maceration; terpenic by-products of the deterpenation of essential oils; aqueous distillates and aqueous solutions of essential oils (HS code(s): 3301)
Regulation Type: Addendum to Regular Notification
Use of food additives in edible caseinates
Distribution date: 13 May 2016
The proposal notified in G/SPS/N/EU/156 (22 February 2016) is now adopted as Commission Regulation (EU) 2016/691 of 4 May 2016 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of food additives in edible caseinates (Text with EEA relevance) [OJ L 120, 5 May 2016, pp. 4-6]. This Regulation applies from 25 May 2016. http://members.wto.org/crnattachments/2016/SPS/EEC/16_1918_00_e.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_1918_00_f.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_1918_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Use of food additives in edible caseinates
Distribution date: 13 May 2016
The proposal notified in G/SPS/N/EU/156 (22 February 2016) is now adopted as Commission Regulation (EU) 2016/691 of 4 May 2016 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of food additives in edible caseinates (Text with EEA relevance) [OJ L 120, 5 May 2016, pp. 4-6]. This Regulation applies from 25 May 2016. http://members.wto.org/crnattachments/2016/SPS/EEC/16_1918_00_e.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_1918_00_f.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_1918_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
; ; ;DRAFT MEXICAN OFFICIAL STANDARD PROY-NOM-199-SCFI-2015 "ALCOHOLIC BEVERAGES - DESIGNATIONS, PHYSICO-CHEMICAL SPECIFICATIONS, COMMERCIAL INFORMATION AND TEST METHODS", PUBLISHED ON 29 FEBRUARY 2016 ; ;On 29 February 2016, the Mexican Ministry of the Economy published draft Mexican Official Standard PROY-NOM-199-SCFI-2015 "Alcoholic beverages - Designations, physico-chemical specifications, commercial information and test methods" in the Mexican Official Journal (Diario Oficial de la Federación - http://www.dof.gob.mx) for public consultation with a comment period of 60 calendar days. ; ;Please be advised that this public comment period has been extended by 30 calendar days. ; ;Any comments should be addressed to: ;Secretaría de Economía ;Subsecretaría de Competitividad y Normatividad ;Dirección General de Normas ;Tel.: (+52) 55 5729-9100, Ext. 43244 ;Fax: (+52) 55 5520-9715 ;Website: http://www.economia.gob.mx/comunidad-negocios/normalizacion/catalogo-mexicano-de-normas ;Email: normasomc@economia.gob.mx; sofia.pacheco@economia.gob.mx; Karla.fernandez@economia.gob.mx ;Text available online at: http://dof.gob.mx/nota_detalle.php?codigo=5428197&fecha=29/02/2016 ; ;
Distribution date: 13 May 2016
Products Covered: Alcoholic beverages (Heading 22; International Classification for Standards (ICS) code 67.160.10) ;
Regulation Type: Addendum to Regular Notification
; ; ;DRAFT MEXICAN OFFICIAL STANDARD PROY-NOM-199-SCFI-2015 "ALCOHOLIC BEVERAGES - DESIGNATIONS, PHYSICO-CHEMICAL SPECIFICATIONS, COMMERCIAL INFORMATION AND TEST METHODS", PUBLISHED ON 29 FEBRUARY 2016 ; ;On 29 February 2016, the Mexican Ministry of the Economy published draft Mexican Official Standard PROY-NOM-199-SCFI-2015 "Alcoholic beverages - Designations, physico-chemical specifications, commercial information and test methods" in the Mexican Official Journal (Diario Oficial de la Federación - http://www.dof.gob.mx) for public consultation with a comment period of 60 calendar days. ; ;Please be advised that this public comment period has been extended by 30 calendar days. ; ;Any comments should be addressed to: ;Secretaría de Economía ;Subsecretaría de Competitividad y Normatividad ;Dirección General de Normas ;Tel.: (+52) 55 5729-9100, Ext. 43244 ;Fax: (+52) 55 5520-9715 ;Website: http://www.economia.gob.mx/comunidad-negocios/normalizacion/catalogo-mexicano-de-normas ;Email: normasomc@economia.gob.mx; sofia.pacheco@economia.gob.mx; Karla.fernandez@economia.gob.mx ;Text available online at: http://dof.gob.mx/nota_detalle.php?codigo=5428197&fecha=29/02/2016 ; ;
Distribution date: 13 May 2016
Products Covered: Alcoholic beverages (Heading 22; International Classification for Standards (ICS) code 67.160.10) ;
Regulation Type: Addendum to Regular Notification
; ; ;The Republic of Colombia hereby advises that the 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 ", the draft version of which was notified on 18 September 2015 by the World Trade Organization in document G/TBT/N/COL/214, was issued on 3 May 2016 pursuant to Resolution No. 0689 of the Ministry of Health and Social Welfare and the Ministry of the Environment and Sustainable Development, which will enter into force on 6 November 2016. ;Text available online at: http://extranet.comunidadandina.org/SIRT/public/index.aspx ;Enquiry Point: ;Contact person: Daniel Héctor Rico R. ;Email: drico@mincit.gov.co;puntocontacto@mincit.gov.co ;Calle 28, N° 13A - 15, tercer piso ;Bogotá, D.C., Colombia ;Tel.: (+57-1) 606 7676, Ext. 1690 ;Website: http://www.mincit.gov.co/publicaciones.php?id=33051 ;Also available at: ;https://members.wto.org/crnattachments/2016/TBT/COL/16_1880_00_s.pdf ;
Distribution date: 12 May 2016
Products Covered: Detergents and soaps (HS codes: 3401, 3402 and 3405400000) ;
Regulation Type: Addendum to Regular Notification
; ; ;The Republic of Colombia hereby advises that the 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 ", the draft version of which was notified on 18 September 2015 by the World Trade Organization in document G/TBT/N/COL/214, was issued on 3 May 2016 pursuant to Resolution No. 0689 of the Ministry of Health and Social Welfare and the Ministry of the Environment and Sustainable Development, which will enter into force on 6 November 2016. ;Text available online at: http://extranet.comunidadandina.org/SIRT/public/index.aspx ;Enquiry Point: ;Contact person: Daniel Héctor Rico R. ;Email: drico@mincit.gov.co;puntocontacto@mincit.gov.co ;Calle 28, N° 13A - 15, tercer piso ;Bogotá, D.C., Colombia ;Tel.: (+57-1) 606 7676, Ext. 1690 ;Website: http://www.mincit.gov.co/publicaciones.php?id=33051 ;Also available at: ;https://members.wto.org/crnattachments/2016/TBT/COL/16_1880_00_s.pdf ;
Distribution date: 12 May 2016
Products Covered: Detergents and soaps (HS codes: 3401, 3402 and 3405400000) ;
Regulation Type: Addendum to Regular Notification
Sanitary measure on detergents and soaps
Distribution date: 11 May 2016
The Republic of Colombia hereby advises that the 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 ", the draft version of which was notified on 17 September 2015 by the World Trade Organization in document G/SPS/N/COL/259, was issued pursuant to Resolution No. 0689 of 3 May 2016 of the Ministry of Health and Social Welfare and the Ministry of the Environment and Sustainable Development, which will enter into force on 6 November 2016.Text available at: http://members.wto.org/crnattachments/2016/SPS/COL/16_1881_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
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