<p><span style="text-decoration:underline;">Notice of Intent to Amend the Prescription Drug List (PDL): Omeprazole</span></p><p></p><p>The proposed amendment notified in G/TBT/N/CAN/401 (dated 13 November 2013) was adopted 17 March 2014.</p><p></p><p>The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will revise the listing for omeprazole on the Prescription Drug List (PDL). Only the Human part of the PDL is to be revised; the listing for Veterinary use will remain unchanged. Health Canada has conducted a scientific review of omeprazole against a set of established and publicly available criteria outlined in section C.01.040.3 of the <em>Food and Drug Regulations</em>. The wording remains unchanged from what was proposed in the Notice of Consultation.</p><p></p><p>This revision will be in effect six months from the date of this Notice posted on the Health Canada website.</p><p></p><p>The full text of the adopted measure can be downloaded from the Internet addresses indicated below:</p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';"><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-eng.php</a> (English)</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';"><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-fra.php</a> (French)</span></span></p><p></p><p align="left" style="text-align:left;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>or requested from:</span></span></span></p><p align="left" style="text-align:left;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Canadian Enquiry Point<br />Standards Council of Canada<br />200-270 Albert Street<br />Ottawa, Ontario<br />K1P 6N7<br />Tel.: (613) 238-3222<br />Fax: (613) 569-7808<br />E-mail: <a href="mailto:[email protected]"><span style="color:blue;"><span style="color:blue;">[email protected]</span></span></a></span></span></span></p><p></p><p></p><p></p><p></p><p><span style="text-decoration:underline;"></span></p>http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-eng.php http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-fra.php

Distribution date: 28 March 2014 | Final date for Comment: 15 May 2025
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Addendum to Regular Notification
<p><span style="text-decoration:underline;">Notice of Intent to Amend the Prescription Drug List (PDL): Omeprazole</span></p><p></p><p>The proposed amendment notified in G/TBT/N/CAN/401 (dated 13 November 2013) was adopted 17 March 2014.</p><p></p><p>The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will revise the listing for omeprazole on the Prescription Drug List (PDL). Only the Human part of the PDL is to be revised; the listing for Veterinary use will remain unchanged. Health Canada has conducted a scientific review of omeprazole against a set of established and publicly available criteria outlined in section C.01.040.3 of the <em>Food and Drug Regulations</em>. The wording remains unchanged from what was proposed in the Notice of Consultation.</p><p></p><p>This revision will be in effect six months from the date of this Notice posted on the Health Canada website.</p><p></p><p>The full text of the adopted measure can be downloaded from the Internet addresses indicated below:</p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';"><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-eng.php</a> (English)</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';"><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-fra.php</a> (French)</span></span></p><p></p><p align="left" style="text-align:left;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>or requested from:</span></span></span></p><p align="left" style="text-align:left;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Canadian Enquiry Point<br />Standards Council of Canada<br />200-270 Albert Street<br />Ottawa, Ontario<br />K1P 6N7<br />Tel.: (613) 238-3222<br />Fax: (613) 569-7808<br />E-mail: <a href="mailto:[email protected]"><span style="color:blue;"><span style="color:blue;">[email protected]</span></span></a></span></span></span></p><p></p><p></p><p></p><p></p><p><span style="text-decoration:underline;"></span></p>http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-eng.php http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-fra.php

Distribution date: 28 March 2014 | Final date for Comment: 15 May 2025
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Addendum to Regular Notification
Resolución 01-2014 de la Comisión Nacional de Registro y Control de Sustancias Tóxicas (Resolution No. 01-2014 of the National Commission for the Registration and Control of Toxic Substances)

Distribution date: 31 March 2014 | Final date for Comment: 15 May 2025
Mechanism for the regulation and control of hazardous toxic substances; cancellation of the registration of certain substances.The notified text establishes a period of one (1) year from the entry into force of the Resolution during which any remaining stocks of these molecules may be marketed in the country.It also establishes import and marketing controls for paraquat-based products containing the following health protection agents: emetics, colourant and odorant. During the marketing of the products, records shall be kept of the quantities sold, the buyers of the products, and the crops on which the products will be used.The text bans the free marketing and storage of aluminium phosphide and the registration, importation, marketing and use of brodifacoum, bromadiolone and flocoumafen in powder form.
Products Covered: Toxic substances (molecules of carbofuran, aldicarb, endosulfan, terbufos, methomyl, ethoprophos, paraquat, chlorpyrifos, aluminium phosphide, brodifacoum, bromadiolone, and flocoumafen).
Regulation Type: Regular notification
Resolución 01-2014 de la Comisión Nacional de Registro y Control de Sustancias Tóxicas (Resolution No. 01-2014 of the National Commission for the Registration and Control of Toxic Substances)

Distribution date: 31 March 2014 | Final date for Comment: 15 May 2025
Mechanism for the regulation and control of hazardous toxic substances; cancellation of the registration of certain substances.The notified text establishes a period of one (1) year from the entry into force of the Resolution during which any remaining stocks of these molecules may be marketed in the country.It also establishes import and marketing controls for paraquat-based products containing the following health protection agents: emetics, colourant and odorant. During the marketing of the products, records shall be kept of the quantities sold, the buyers of the products, and the crops on which the products will be used.The text bans the free marketing and storage of aluminium phosphide and the registration, importation, marketing and use of brodifacoum, bromadiolone and flocoumafen in powder form.
Products Covered: Toxic substances (molecules of carbofuran, aldicarb, endosulfan, terbufos, methomyl, ethoprophos, paraquat, chlorpyrifos, aluminium phosphide, brodifacoum, bromadiolone, and flocoumafen).
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

Distribution date: 02 April 2014 | Final date for Comment: 01 June 2014
The MHLW will withdraw all the provisional maximum residue limits (MRLs) set at the time of introduction of the positive list system for the following 29 agricultural chemicals. The 29 agricultural chemicals are classified into the following categories: i) Those that are neither registered nor approved in Japan and that are not planned to be registered; ii) Those for which MRLs are set in some commodities in certain foreign countries but that are not permitted to be used; iii) Those that are permitted to be used in certain foreign countries but commodities containing those are not exported to Japan; and iv) Those that have been in part evaluated by JMPR (Joint FAO/WHO Meeting on Pesticide Residues) or JECFA (Joint FAO/WHO Expert Committee on Food Additives) but for which Codex MRLs are neither set nor expected to be set. Further to several import examinations conducted during the past ten years, no detection of these substances has been reported. Therefore, the MHLW has concluded that food commodities containing these agricultural chemicals are unlikely to be distributed in Japan in the future and the withdrawal of the MRLs for these agricultural chemicals is unlikely to have negative effects on international trade. Pesticide: Anirazine, Aramite, Azaconazole, Barban, Bromophos, Bromophos-ethyl, Chlorbenside, Chlorbufam, Chloroxuron, Chlozolinate, Di-allate, 1,1-dichloro-2,2-bis(4-ethylphenyl)ethane, Dimethirimol, Dinoterb, Dioxathion, Diphenamid, Foramsulfuron, Formothion, Mecarbam, Methacrifos, Monolinuron, Naptalam, Nitrothal-isopropyl, Pyrazophos, Sulprofos Pesticide/Veterinary drug: Fenchlorphos Veterinary drugs: 2-Acetylamino-5-nitrothiazole, Bithiionol, Miloxacin
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04, 03.06 and 03.07) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06) - Cacao and cacao preparations (HS Code: 18.01)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

Distribution date: 02 April 2014 | Final date for Comment: 01 June 2014
The MHLW will withdraw all the provisional maximum residue limits (MRLs) set at the time of introduction of the positive list system for the following 29 agricultural chemicals. The 29 agricultural chemicals are classified into the following categories: i) Those that are neither registered nor approved in Japan and that are not planned to be registered; ii) Those for which MRLs are set in some commodities in certain foreign countries but that are not permitted to be used; iii) Those that are permitted to be used in certain foreign countries but commodities containing those are not exported to Japan; and iv) Those that have been in part evaluated by JMPR (Joint FAO/WHO Meeting on Pesticide Residues) or JECFA (Joint FAO/WHO Expert Committee on Food Additives) but for which Codex MRLs are neither set nor expected to be set. Further to several import examinations conducted during the past ten years, no detection of these substances has been reported. Therefore, the MHLW has concluded that food commodities containing these agricultural chemicals are unlikely to be distributed in Japan in the future and the withdrawal of the MRLs for these agricultural chemicals is unlikely to have negative effects on international trade. Pesticide: Anirazine, Aramite, Azaconazole, Barban, Bromophos, Bromophos-ethyl, Chlorbenside, Chlorbufam, Chloroxuron, Chlozolinate, Di-allate, 1,1-dichloro-2,2-bis(4-ethylphenyl)ethane, Dimethirimol, Dinoterb, Dioxathion, Diphenamid, Foramsulfuron, Formothion, Mecarbam, Methacrifos, Monolinuron, Naptalam, Nitrothal-isopropyl, Pyrazophos, Sulprofos Pesticide/Veterinary drug: Fenchlorphos Veterinary drugs: 2-Acetylamino-5-nitrothiazole, Bithiionol, Miloxacin
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04, 03.06 and 03.07) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06) - Cacao and cacao preparations (HS Code: 18.01)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

Distribution date: 02 April 2014 | Final date for Comment: 01 June 2014
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: oxine copper
Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.04, 12.05, 12.06, 12.07 and 12.10)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

Distribution date: 02 April 2014 | Final date for Comment: 01 June 2014
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: oxine copper
Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.04, 12.05, 12.06, 12.07 and 12.10)
Regulation Type: Regular notification
Letter by the Federal Service for Veterinary and Phytosanitary Supervision No. FS-EN-7/17213 as of 9 December 2013

Distribution date: 02 April 2014 | Final date for Comment: 15 May 2025
The Russian Federation notified the letter of the State Sanitary Inspector in G/SPS/N/RUS/41 (as of 19 December 2013). This letter introduced a temporary restriction on live poultry, hatching eggs, fluff and feather, poultry and poultry products meat, which were not heat treated (no less than 70°C), feed and feed additives for poultry (except feed additives of chemical and microbiological synthesis), equipment previously used for maintenance, slaughter and cutting of poultry. The measure was introduced due to the outbreak of low pathogenic avian influenza on the territory of Ten Boer municipality of Groningen province, the Netherlands. The Federal Service for Veterinary and Phytosanitary Supervision (letter as of 25 March 2014 No. FS-AS-8/4439) introduced a temporary restriction on live poultry, hatching eggs, fluff and feather, poultry and poultry products meat, which were not heat treated (no less than 70°C), feed and feed additives for poultry (except feed additives of chemical and microbiological synthesis), equipment previously used for maintenance, slaughter and cutting of poultry. The measure was introduced from 31 March 2014 due to the outbreak of low pathogenic avian influenza H5N3 on the territory of Zaltbommel municipality of Gelderland province, the Netherlands. At the moment the measure applies to import of above listed goods from two Dutch municipalities: Ten Boer municipality of Groningen province (from 11 December 2013) and Zaltbommel municipality of Gelderland province (from 31 March 2014). Footnote: The letter of the Federal Service for Veterinary and Phytosanitary Supervision No. FS-AS-8/4439 as of 25 March 2014 is available in Russian on the following weblink: http://www.fsvps.ru/fsvps/laws/3868.html.
Products Covered:
Regulation Type: Addendum to Emergency Notification (SPS)
Letter by the Federal Service for Veterinary and Phytosanitary Supervision No. FS-EN-7/17213 as of 9 December 2013

Distribution date: 02 April 2014 | Final date for Comment: 15 May 2025
The Russian Federation notified the letter of the State Sanitary Inspector in G/SPS/N/RUS/41 (as of 19 December 2013). This letter introduced a temporary restriction on live poultry, hatching eggs, fluff and feather, poultry and poultry products meat, which were not heat treated (no less than 70°C), feed and feed additives for poultry (except feed additives of chemical and microbiological synthesis), equipment previously used for maintenance, slaughter and cutting of poultry. The measure was introduced due to the outbreak of low pathogenic avian influenza on the territory of Ten Boer municipality of Groningen province, the Netherlands. The Federal Service for Veterinary and Phytosanitary Supervision (letter as of 25 March 2014 No. FS-AS-8/4439) introduced a temporary restriction on live poultry, hatching eggs, fluff and feather, poultry and poultry products meat, which were not heat treated (no less than 70°C), feed and feed additives for poultry (except feed additives of chemical and microbiological synthesis), equipment previously used for maintenance, slaughter and cutting of poultry. The measure was introduced from 31 March 2014 due to the outbreak of low pathogenic avian influenza H5N3 on the territory of Zaltbommel municipality of Gelderland province, the Netherlands. At the moment the measure applies to import of above listed goods from two Dutch municipalities: Ten Boer municipality of Groningen province (from 11 December 2013) and Zaltbommel municipality of Gelderland province (from 31 March 2014). Footnote: The letter of the Federal Service for Veterinary and Phytosanitary Supervision No. FS-AS-8/4439 as of 25 March 2014 is available in Russian on the following weblink: http://www.fsvps.ru/fsvps/laws/3868.html.
Products Covered:
Regulation Type: Addendum to Emergency Notification (SPS)
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