Proyecto de normativa técnica sanitaria sustitutiva para la obtención del registro sanitario y control de productos naturales procesados de uso medicinal, y de los establecimientos en donde se fabrican, almacenan, distribuyen y comercializan (Draft Substitute Sanitary Technical Regulation on the sanitary registration and control of natural processed products for medicinal use, and of establishments that manufacture, store, distribute or market such products) (25 pages, in Spanish) ;
Distribution date: 03 May 2016 | Final date for Comment: 02 July 2016
The draft notified Technical Regulation covers the following: Purpose and scope; Definitions and abbreviations; Sanitary registration; Obtaining sanitary registration; Evaluation of therapeutic indications; Packaging, labelling and package inserts; Re-registration and changes to sanitary registration; Other authorizations; Importation; Marketing and promotion; Operating permits for pharmaceutical establishments relating to natural processed products for medicinal use; Monitoring and control; and Penalties. ; ;
Products Covered: 3006700000 ;
Regulation Type: Regular notification
; ; ;Acuerdo por el que la Comisión Reguladora de Energía expide por segunda vez consecutiva la norma oficial mexicana de emergencia NOM-EM-005-CRE-2015, especificaciones de calidad de los petrolíferos (Decision of the Energy Regulatory Commission issuing, for the second consecutive time, Emergency Mexican Official Standard NOM-EM-005-CRE-2015 "Quality specifications for petroleum products") ;On 30 October 2015, the Energy Regulatory Commission published in the Official Journal (DOF), on the basis of the texts mentioned, Emergency Mexican Official Standard NOM-EM-005-CRE-2015 "Quality specifications for petroleum products", which was amended pursuant to Resolution RES/898/2015, published in the DOF on 20 January 2016. ;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/catalogomexicano-de-normas ;Email: [email protected] and/or [email protected] ;Text available at: http://www.dof.gob.mx/nota_detalle.php?codigo=5435482&fecha=29/04/2016 ;https://members.wto.org/crnattachments/2016/TBT/MEX/16_1785_00_s.pdf ;
Distribution date: 03 May 2016
Products Covered: Petroleum products (headings 27.01 to 2901.10) ;
Regulation Type: Addendum to Regular Notification
; ; ;Acuerdo por el que la Comisión Reguladora de Energía expide por segunda vez consecutiva la norma oficial mexicana de emergencia NOM-EM-005-CRE-2015, especificaciones de calidad de los petrolíferos (Decision of the Energy Regulatory Commission issuing, for the second consecutive time, Emergency Mexican Official Standard NOM-EM-005-CRE-2015 "Quality specifications for petroleum products") ;On 30 October 2015, the Energy Regulatory Commission published in the Official Journal (DOF), on the basis of the texts mentioned, Emergency Mexican Official Standard NOM-EM-005-CRE-2015 "Quality specifications for petroleum products", which was amended pursuant to Resolution RES/898/2015, published in the DOF on 20 January 2016. ;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/catalogomexicano-de-normas ;Email: [email protected] and/or [email protected] ;Text available at: http://www.dof.gob.mx/nota_detalle.php?codigo=5435482&fecha=29/04/2016 ;https://members.wto.org/crnattachments/2016/TBT/MEX/16_1785_00_s.pdf ;
Distribution date: 03 May 2016
Products Covered: Petroleum products (headings 27.01 to 2901.10) ;
Regulation Type: Addendum to Regular Notification
Proyecto de Reglamento que regula la información mínima del documento que debe contener la validación de técnicas analíticas propias (Draft Regulation on the minimum information to be contained by the document required for the validation of analytical techniques specific to the manufacturer) (7 pages, in Spanish) ;
Distribution date: 02 May 2016 | Final date for Comment: 01 July 2016
The notified draft Regulation establishes the minimum information to be contained by the document required for the assessment of the validation of analytical techniques specific to the manufacturer, which are necessary for the registration and re-registration of and changes regarding pharmaceutical products in the sanitary register. ; ;
Products Covered: Pharmaceutical products, classified under Chapter 30 of the Harmonized System or Customs Tariff. ;
Regulation Type: Regular notification
Proyecto de Reglamento que regula la información mínima del documento que debe contener la validación de técnicas analíticas propias (Draft Regulation on the minimum information to be contained by the document required for the validation of analytical techniques specific to the manufacturer) (7 pages, in Spanish) ;
Distribution date: 02 May 2016 | Final date for Comment: 01 July 2016
The notified draft Regulation establishes the minimum information to be contained by the document required for the assessment of the validation of analytical techniques specific to the manufacturer, which are necessary for the registration and re-registration of and changes regarding pharmaceutical products in the sanitary register. ; ;
Products Covered: Pharmaceutical products, classified under Chapter 30 of the Harmonized System or Customs Tariff. ;
Regulation Type: Regular notification
Proyecto de norma oficial mexicana PROY-NOM-138-SSA1-2015, que establece las especificaciones sanitarias del alcohol etílico desnaturalizado, utilizado como material de curación, así como para el alcohol etílico de 96ºg.l. sin desnaturalizar, utilizado como materia prima para la elaboración y/o envasado de alcohol etílico desnaturalizado como material de curación (Draft Mexican Official Standard PROY-NOM-138-SSA1-2015 establishing the sanitary specifications for denatured ethyl alcohol, used as a wound dressing material, for undenatured 96° G.L. ethyl alcohol, used as a raw material in the production of denatured ethyl alcohol as a wound dressing material, and for packaging establishments) (11 pages, in Spanish) ;
Distribution date: 29 April 2016 | Final date for Comment: 28 June 2016
Ethyl alcohol, or ethanol, is one of the most widely used wound dressing materials, due to its antiseptic properties. However, given that ethyl alcohol can be easily obtained by the general population and is an addictive substance, it may be used inappropriately (ingested), and its consumption may lead to public health problems. Denaturing substances are therefore added to ethyl alcohol, such as denatonium benzoate, sucrose octaacetate and acetone, which give it an unpleasant taste. Nevertheless, it is necessary to issue provisions on the control and processing of this wound dressing material, in order to prevent it from being used for purposes other than those for which it is marketed, namely, to dress wounds. ; ;
Products Covered: Denatured ethyl alcohol (tariff heading: 22072001) ;
Regulation Type: Regular notification
Proyecto de norma oficial mexicana PROY-NOM-138-SSA1-2015, que establece las especificaciones sanitarias del alcohol etílico desnaturalizado, utilizado como material de curación, así como para el alcohol etílico de 96ºg.l. sin desnaturalizar, utilizado como materia prima para la elaboración y/o envasado de alcohol etílico desnaturalizado como material de curación (Draft Mexican Official Standard PROY-NOM-138-SSA1-2015 establishing the sanitary specifications for denatured ethyl alcohol, used as a wound dressing material, for undenatured 96° G.L. ethyl alcohol, used as a raw material in the production of denatured ethyl alcohol as a wound dressing material, and for packaging establishments) (11 pages, in Spanish) ;
Distribution date: 29 April 2016 | Final date for Comment: 28 June 2016
Ethyl alcohol, or ethanol, is one of the most widely used wound dressing materials, due to its antiseptic properties. However, given that ethyl alcohol can be easily obtained by the general population and is an addictive substance, it may be used inappropriately (ingested), and its consumption may lead to public health problems. Denaturing substances are therefore added to ethyl alcohol, such as denatonium benzoate, sucrose octaacetate and acetone, which give it an unpleasant taste. Nevertheless, it is necessary to issue provisions on the control and processing of this wound dressing material, in order to prevent it from being used for purposes other than those for which it is marketed, namely, to dress wounds. ; ;
Products Covered: Denatured ethyl alcohol (tariff heading: 22072001) ;
Regulation Type: Regular notification
<p>Notice of Intent to Amend the Prescription Drug List (PDL): Polymyxin B</p><p>The proposed amendment notified in G/TBT/N/CAN/470 (dated 16 October 2015) was adopted 2 April 2016.</p><p>The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will switch certain uses of Polymyxin B to prescription status for veterinary use by adding it to the Veterinary Prescription Drug List (PDL). Health Canada has conducted a scientific review of Polymyxin B against the set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations.The wording remains unchanged from what was proposed in the Notice of Consultation.</p><p>This revision comes into effect on 22 April 2016 posted on the Health Canada website.</p><p>The full text of the adopted measure can be downloaded from the Internet addresses indicated below:<br /><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-polymyxinb-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-polymyxinb-eng.php</a> (English)<br /><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-polymyxinb-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-polymyxinb-fra.php</a> (French)</p><p>Or requested from:</p><p>Canada's Notification Authority and Enquiry Point <br />Global Affairs Canada <br />Technical Barriers and Regulations Division <br />111 Sussex Drive, Ottawa, ON K1A 0G2 <br />Tel: (343)203-4273 <br />Fax: 613-943-0346<br />E-mail: <a href="mailto:[email protected]">[email protected]</a></p>
Distribution date: 28 April 2016
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS: 3004.90)
Regulation Type: Addendum to Regular Notification
<p>Notice of Intent to Amend the Prescription Drug List (PDL): Polymyxin B</p><p>The proposed amendment notified in G/TBT/N/CAN/470 (dated 16 October 2015) was adopted 2 April 2016.</p><p>The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will switch certain uses of Polymyxin B to prescription status for veterinary use by adding it to the Veterinary Prescription Drug List (PDL). Health Canada has conducted a scientific review of Polymyxin B against the set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations.The wording remains unchanged from what was proposed in the Notice of Consultation.</p><p>This revision comes into effect on 22 April 2016 posted on the Health Canada website.</p><p>The full text of the adopted measure can be downloaded from the Internet addresses indicated below:<br /><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-polymyxinb-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-polymyxinb-eng.php</a> (English)<br /><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-polymyxinb-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-polymyxinb-fra.php</a> (French)</p><p>Or requested from:</p><p>Canada's Notification Authority and Enquiry Point <br />Global Affairs Canada <br />Technical Barriers and Regulations Division <br />111 Sussex Drive, Ottawa, ON K1A 0G2 <br />Tel: (343)203-4273 <br />Fax: 613-943-0346<br />E-mail: <a href="mailto:[email protected]">[email protected]</a></p>
Distribution date: 28 April 2016
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS: 3004.90)
Regulation Type: Addendum to Regular Notification
Import inspection requirement for commodities classified under 18 specific CCC codes if they are used for food or food additives
Distribution date: 26 April 2016 | Final date for Comment: 25 June 2016
Commodities classified under 18 specific CCC codes shall follow the "Regulations of Inspection of Imported Foods and Related Products" if they are used for food or food additives. The importers shall apply for inspection to the Food and Drug Administration, Ministry of Health and Welfare.
Products Covered: Those food additives or foods classified under 18 specific CCC codes
Regulation Type: Regular notification
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