Regulatory Updates
<p><span style="text-decoration:underline;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Notice of Intent to Amend the Prescription Drug List (PDL): Diclofenac</span></span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>The proposed amendment notified in G/TBT/N/CAN/402 (dated 13 November 2013) was adopted 21 February 2014.</span></span></span></p><p align="left" style="background:white;text-align:left;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>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 diclofenac 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 diclofenac against a set of established and publicly available criteria outlined in section C.01.040.3 of the <em>Food and Drug Regulations</em>. </span></span></span><span style="color:black;"><span lang="EN" style="color:black;">The wording remains unchanged from what was proposed in the Notice of Consultation.</span></span><em></em></p><p align="left" style="background:white;text-align:left;"><span style="color:black;font-size:x-small;font-face:Verdana;"><span lang="EN" style="color:black;font-size:9pt;">This revision will be in effect six months from the date of this Notice posted on the Health Canada website.</span></span></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_noi_adi_diclofenac-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_diclofenac-eng.php</a> (English)</p><p><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_diclofenac-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_diclofenac-fra.php</a> (French)</p><p style="text-align:left;">or requested from:</p><p style="text-align:left;">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]">[email protected]</a></p>
Distribution date: 06 March 2014
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): Minoxidil</span></p><p>The proposed amendment notified in G/TBT/N/CAN/400 (dated 13 November 2013) was adopted 21 February 2014.</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 minoxidil 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 minoxidil 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>This revision will be in effect six months from the date of this Notice 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_noi_adi_minoxidil-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_minoxidil-eng.php</a> (English)</p><p><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_minoxidil-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_minoxidil-fra.php</a> <br />(French)</p><p style="text-align:left;">or requested from:</p><p style="text-align:left;">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]">[email protected]</a></p>
Distribution date: 06 March 2014
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): Minoxidil</span></p><p>The proposed amendment notified in G/TBT/N/CAN/400 (dated 13 November 2013) was adopted 21 February 2014.</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 minoxidil 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 minoxidil 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>This revision will be in effect six months from the date of this Notice 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_noi_adi_minoxidil-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_minoxidil-eng.php</a> (English)</p><p><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_minoxidil-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_minoxidil-fra.php</a> <br />(French)</p><p style="text-align:left;">or requested from:</p><p style="text-align:left;">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]">[email protected]</a></p>
Distribution date: 06 March 2014
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Addendum to Regular Notification
Notice of Consultation- Prescription Drug List (PDL): Hydrocortisone (3 pages, in English and French) .
Distribution date: 05 March 2014 | Final date for Comment: 04 May 2014
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:Calibri;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-GB;mso-bidi-language:AR-SA;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the listing for hydrocortisone on the Prescription Drug List (PDL).</span></span>
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Regular notification
Notice of Consultation- Prescription Drug List (PDL): Hydrocortisone (3 pages, in English and French) .
Distribution date: 05 March 2014 | Final date for Comment: 04 May 2014
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:Calibri;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-GB;mso-bidi-language:AR-SA;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the listing for hydrocortisone on the Prescription Drug List (PDL).</span></span>
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Regular notification
; ; ;The Republic of Ecuador hereby advises that the first revision (1R) of Ecuadorian Standardization Institute Technical Regulation (RTE INEN) No. 061 "Paint", notified in document G/TBT/N/ECU/77/Add.1 of 8 May 2012, was issued pursuant to Resolution No. 13 373 of 22 October 2013 of the Under-Secretariat for Quality of the Ministry of Industry and Productivity, published in Official Journal No. 123 of 14 November 2013. ; ;Text available from: ; ;Ministerio de Industrias y Productividad (Ministry of Industry and Productivity) ;Subsecretaría de la Calidad (Under-Secretariat for Quality) ;Organismo Nacional encargado de la Notificación (National Notification Authority) ; ;Contact person: Marlon Martínez B. ;Yánez Pinzón No. 26-12 y Av. Colón, Edf. Rigel ;Quito, Ecuador ;Tel.: +593 2 394-8760, Ext. 2358/2255 ;Email: [email protected]; [email protected] ;Text available online at: http://members.wto.org/crnattachments/2014/tbt/ECU/14_1015_00_s.pdf ; ;
Distribution date: 03 March 2014
Products Covered: 3208100000, 3208200000, 3208900000, 3209100000, 3209900000, 3210001000, 3210002000, 3210009000
Regulation Type: Addendum to Regular Notification
; ; ;The Republic of Ecuador hereby advises that the first revision (1R) of Ecuadorian Standardization Institute Technical Regulation (RTE INEN) No. 061 "Paint", notified in document G/TBT/N/ECU/77/Add.1 of 8 May 2012, was issued pursuant to Resolution No. 13 373 of 22 October 2013 of the Under-Secretariat for Quality of the Ministry of Industry and Productivity, published in Official Journal No. 123 of 14 November 2013. ; ;Text available from: ; ;Ministerio de Industrias y Productividad (Ministry of Industry and Productivity) ;Subsecretaría de la Calidad (Under-Secretariat for Quality) ;Organismo Nacional encargado de la Notificación (National Notification Authority) ; ;Contact person: Marlon Martínez B. ;Yánez Pinzón No. 26-12 y Av. Colón, Edf. Rigel ;Quito, Ecuador ;Tel.: +593 2 394-8760, Ext. 2358/2255 ;Email: [email protected]; [email protected] ;Text available online at: http://members.wto.org/crnattachments/2014/tbt/ECU/14_1015_00_s.pdf ; ;
Distribution date: 03 March 2014
Products Covered: 3208100000, 3208200000, 3208900000, 3209100000, 3209900000, 3210001000, 3210002000, 3210009000
Regulation Type: Addendum to Regular Notification
; ; ;By means of this Addendum No. 2, the Republic of Ecuador advises that Amendment No. 2 to Emergency Technical Regulation of the Ecuadorian Standardization Institute (RTE INEN) No. 093 "Cosmetic products", notified in document G/TBT/N/ECU/116 of 22 November 2013, was issued pursuant to Resolution No. 14 042 of 30 January 2014 of the Under-Secretariat for Quality of the Ministry of Industry and Productivity, published in Official Journal No. 187 of Wednesday 19 February 2014. ; ;Text available from: ; ;Ministerio de Industrias y Productividad (Ministry of Industry and Productivity) ;Subsecretaría de la Calidad (Under-Secretariat for Quality) ;Organismo Nacional encargado de la Notificación (National Notification Authority) ; ;Contact person: Marlon Martínez B. ;Yánez Pinzón No. 26-12 y Av. Colón, Edf. Rigel ;Quito, Ecuador ;Tel.: +593 2 394-8760, Ext. 2358/2255 ;Email: [email protected]; [email protected] ; ;
Distribution date: 03 March 2014
Products Covered: 3303.00.00.00, 3304.10.00.00, 3304.20.00.00, 3304.30.00.00, 3304.91.00.00, 3305.10.00.00, 3305.20.00.00, 3305.30.00.00, 3305.90.00.00, 3306.10.00.00, 3306.90.00.00, 3307.10.00.00, 3307.20.00.00, 3307.30.00.00 and 3307.90.90.00 ;
Regulation Type: Addendum to Regular Notification
; ; ;By means of this Addendum No. 2, the Republic of Ecuador advises that Amendment No. 2 to Emergency Technical Regulation of the Ecuadorian Standardization Institute (RTE INEN) No. 093 "Cosmetic products", notified in document G/TBT/N/ECU/116 of 22 November 2013, was issued pursuant to Resolution No. 14 042 of 30 January 2014 of the Under-Secretariat for Quality of the Ministry of Industry and Productivity, published in Official Journal No. 187 of Wednesday 19 February 2014. ; ;Text available from: ; ;Ministerio de Industrias y Productividad (Ministry of Industry and Productivity) ;Subsecretaría de la Calidad (Under-Secretariat for Quality) ;Organismo Nacional encargado de la Notificación (National Notification Authority) ; ;Contact person: Marlon Martínez B. ;Yánez Pinzón No. 26-12 y Av. Colón, Edf. Rigel ;Quito, Ecuador ;Tel.: +593 2 394-8760, Ext. 2358/2255 ;Email: [email protected]; [email protected] ; ;
Distribution date: 03 March 2014
Products Covered: 3303.00.00.00, 3304.10.00.00, 3304.20.00.00, 3304.30.00.00, 3304.91.00.00, 3305.10.00.00, 3305.20.00.00, 3305.30.00.00, 3305.90.00.00, 3306.10.00.00, 3306.90.00.00, 3307.10.00.00, 3307.20.00.00, 3307.30.00.00 and 3307.90.90.00 ;
Regulation Type: Addendum to Regular Notification
; ; ;By means of this Addendum No. 1, the Republic of Ecuador advises that Amendment No. 1 to Emergency Technical Regulation of the Ecuadorian Standardization Institute (RTE INEN) No. 093 "Cosmetic products", notified in document G/TBT/N/ECU/116 of 22 November 2013, was issued pursuant to Resolution No. 14 004 of 3 January 2014 of the Under-Secretariat for Quality of the Ministry of Industry and Productivity, published in Official Journal No. 173 of Thursday 30 January 2014. ; ;Text available from: ; ;Ministerio de Industrias y Productividad (Ministry of Industry and Productivity) ;Subsecretaría de la Calidad (Under-Secretariat for Quality) ;Organismo Nacional encargado de la Notificación (National Notification Authority) ; ;Contact person: Marlon Martínez B. ;Yánez Pinzón No. 26-12 y Av. Colón, Edf. Rigel ;Quito, Ecuador ;Tel.: +593 2 394-8760, Ext. 2358/2255 ;Email: [email protected]; [email protected] ; ;
Distribution date: 03 March 2014
Products Covered: 3303.00.00.00, 3304.10.00.00, 3304.20.00.00, 3304.30.00.00, 3304.91.00.00, 3305.10.00.00, 3305.20.00.00, 3305.30.00.00, 3305.90.00.00, 3306.10.00.00, 3306.90.00.00, 3307.10.00.00, 3307.20.00.00, 3307.30.00.00 and 3307.90.90.00 ;
Regulation Type: Addendum to Regular Notification
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