Regulatory Updates
<p>Notice of Intent to Amend the Prescription Drug List (PDL): Esomeprazole</p><p>The proposed amendment notified in G/TBT/N/CAN/468 (dated 2 October 2015) was adopted on 4 February 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 Esomeprazole to nonprescription status for human use by modifying the Human Prescription Drug List (PDL). The Veterinary List will remain unchanged. Health Canada has conducted a scientific review of Esomeprazole against the set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations. The wording, which has not changed from what was proposed in the 2 October 2015 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-noa-ad-esomeprazole-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-esomeprazole-eng.php</a> (English)<br /><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-esomeprazole-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-esomeprazole-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 (TIB)<br />111 Sussex Drive<br />Ottawa, ON K1A 0G2<br />Canada<br />Telephone: (343) 203-4273<br />Fax: (613) 943-0346<br />Email: <a href="mailto:enquirypoint@international.gc.ca">enquirypoint@international.gc.ca</a> </p>
Distribution date: 10 February 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): Esomeprazole</p><p>The proposed amendment notified in G/TBT/N/CAN/468 (dated 2 October 2015) was adopted on 4 February 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 Esomeprazole to nonprescription status for human use by modifying the Human Prescription Drug List (PDL). The Veterinary List will remain unchanged. Health Canada has conducted a scientific review of Esomeprazole against the set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations. The wording, which has not changed from what was proposed in the 2 October 2015 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-noa-ad-esomeprazole-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-esomeprazole-eng.php</a> (English)<br /><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-esomeprazole-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-esomeprazole-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 (TIB)<br />111 Sussex Drive<br />Ottawa, ON K1A 0G2<br />Canada<br />Telephone: (343) 203-4273<br />Fax: (613) 943-0346<br />Email: <a href="mailto:enquirypoint@international.gc.ca">enquirypoint@international.gc.ca</a> </p>
Distribution date: 10 February 2016
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): Ibuprofen</span><br /><br />The proposed amendment notified in G/TBT/N/CAN/469 (dated 2 October 2015) was adopted 5 February 2016.<br /><br />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 Ibuprofen to nonprescription status for human use by modifying the Human Prescription Drug List (PDL). The Veterinary List will remain unchanged. Health Canada has conducted a scientific review of Ibuprofen against the set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations. The wording has not changed from what was proposed in the 2 October 2015 Notice of Consultation.<br /><br />This revision will be in effect six months from the date of this Notice posted on the Health Canada website.<br /><br />The full text of the adopted measure can be downloaded from the Internet addresses indicated below:<br />http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-ibuprofen-eng.php (English)<br />http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-ibuprofen-fra.php (French)<br /></p><p>or requested from:</p>Canada's Notification Authority and Enquiry Point<br />Global Affairs Canada<br />Technical Barriers and Regulations Division (TIB)<br />111 Sussex Drive<br />Ottawa, ON K1A 0G2<br />Canada<br />Telephone: (343) 203-4273<br />Fax: (613) 943-0346<br />Email: <a href="mailto:enquirypoint@international.gc.ca">enquirypoint@international.gc.ca</a>
Distribution date: 10 February 2016
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): Ibuprofen</span><br /><br />The proposed amendment notified in G/TBT/N/CAN/469 (dated 2 October 2015) was adopted 5 February 2016.<br /><br />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 Ibuprofen to nonprescription status for human use by modifying the Human Prescription Drug List (PDL). The Veterinary List will remain unchanged. Health Canada has conducted a scientific review of Ibuprofen against the set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations. The wording has not changed from what was proposed in the 2 October 2015 Notice of Consultation.<br /><br />This revision will be in effect six months from the date of this Notice posted on the Health Canada website.<br /><br />The full text of the adopted measure can be downloaded from the Internet addresses indicated below:<br />http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-ibuprofen-eng.php (English)<br />http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-ibuprofen-fra.php (French)<br /></p><p>or requested from:</p>Canada's Notification Authority and Enquiry Point<br />Global Affairs Canada<br />Technical Barriers and Regulations Division (TIB)<br />111 Sussex Drive<br />Ottawa, ON K1A 0G2<br />Canada<br />Telephone: (343) 203-4273<br />Fax: (613) 943-0346<br />Email: <a href="mailto:enquirypoint@international.gc.ca">enquirypoint@international.gc.ca</a>
Distribution date: 10 February 2016
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Addendum to Regular Notification
Projet d'Arrêté relatif aux méthodes et techniques de contrôle de la conformité des produits primaires, des produits alimentaires et des aliments pour animaux à l'importation (Draft Order on conformity control methods and techniques for imported primary products, food products and animal feed)
Distribution date: 09 February 2016
The notified text establishes the conformity control methods and techniques to be employed at the borders on imported primary products, food products and animal feed. Controls on imported goods must be performed prior to customs clearance on the basis of documents submitted by the importer or his authorized representative. Border controls on imported goods involve: 1) documentation checks; 2) identity checks; and 3) physical checks. The notified text details the control procedures. Where goods are refused clearance, the importer or his duly authorized representative may submit a reasoned appeal within eight days of the date of notification of refusal of clearance. The importer or his representative may remove the goods before obtaining the results of the analyses. The importer is responsible for storing the goods, secured by an official customs seal, at premises approved by the National Office for Food Safety (ONSSA) while awaiting the results of the analyses.
Products Covered: Live animals and animal products, plants and plant products and all food products and animal feed, additives, agricultural inputs, pesticides, and veterinary drugs and products.
Regulation Type: Regular notification
Projet d'Arrêté relatif aux méthodes et techniques de contrôle de la conformité des produits primaires, des produits alimentaires et des aliments pour animaux à l'importation (Draft Order on conformity control methods and techniques for imported primary products, food products and animal feed)
Distribution date: 09 February 2016
The notified text establishes the conformity control methods and techniques to be employed at the borders on imported primary products, food products and animal feed. Controls on imported goods must be performed prior to customs clearance on the basis of documents submitted by the importer or his authorized representative. Border controls on imported goods involve: 1) documentation checks; 2) identity checks; and 3) physical checks. The notified text details the control procedures. Where goods are refused clearance, the importer or his duly authorized representative may submit a reasoned appeal within eight days of the date of notification of refusal of clearance. The importer or his representative may remove the goods before obtaining the results of the analyses. The importer is responsible for storing the goods, secured by an official customs seal, at premises approved by the National Office for Food Safety (ONSSA) while awaiting the results of the analyses.
Products Covered: Live animals and animal products, plants and plant products and all food products and animal feed, additives, agricultural inputs, pesticides, and veterinary drugs and products.
Regulation Type: Regular notification
; ; ;Mexican Official Standard NOM-164-SSA1-2015 "Good manufacturing practices for pharmaceutical products" ; ;The Mexican Ministry of Health published draft Mexican Official Standard PROY-NOM-164-SSA1-2015 "Good manufacturing practices for pharmaceutical products" in the Official Journal (Diario Oficial de la Federación) (http://www.dof.gob.mx) on 9 September 2015. The replies to the comments received regarding this draft Standard were published on 13 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 ;Email: normasomc@economia.gob.mx and sofia.pacheco@economia.gob.mx ;Website: http://www.economia.gob.mx/comunidad-negocios/normalizacion/catalogo-mexicano-de-normas ;Text available online at: ;http://dof.gob.mx/nota_detalle.php?codigo=5424377&fecha=04/02/2016 ;https://members.wto.org/crnattachments/2016/TBT/MEX/16_0516_00_s.pdf ; ;
Distribution date: 09 February 2016
Products Covered: Pharmaceutical products (heading 30) ;
Regulation Type: Addendum to Regular Notification
; ; ;Mexican Official Standard NOM-164-SSA1-2015 "Good manufacturing practices for pharmaceutical products" ; ;The Mexican Ministry of Health published draft Mexican Official Standard PROY-NOM-164-SSA1-2015 "Good manufacturing practices for pharmaceutical products" in the Official Journal (Diario Oficial de la Federación) (http://www.dof.gob.mx) on 9 September 2015. The replies to the comments received regarding this draft Standard were published on 13 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 ;Email: normasomc@economia.gob.mx and sofia.pacheco@economia.gob.mx ;Website: http://www.economia.gob.mx/comunidad-negocios/normalizacion/catalogo-mexicano-de-normas ;Text available online at: ;http://dof.gob.mx/nota_detalle.php?codigo=5424377&fecha=04/02/2016 ;https://members.wto.org/crnattachments/2016/TBT/MEX/16_0516_00_s.pdf ; ;
Distribution date: 09 February 2016
Products Covered: Pharmaceutical products (heading 30) ;
Regulation Type: Addendum to Regular Notification
; ; ;Mexican Official Standard NOM-059-SSA1-2015 "Good manufacturing practices for medicinal products" ; ;The Mexican Ministry of Health published draft Mexican Official Standard PROY-NOM-059-SSA1-2015 "Good manufacturing practices for medicinal products" in the Official Journal (Diario Oficial de la Federación) (http://www.dof.gob.mx) on 9 September 2015. The replies to the comments received during the public consultation period were published on 13 January 2016 and the final version of this Mexican Official Standard was published on 5 February 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 ;Email: normasomc@economia.gob.mx and sofia.pacheco@economia.gob.mx ;Website: http://www.economia.gob.mx/comunidad-negocios/normalizacion/catalogo-mexicano-de-normas ;Text available online at: ;http://dof.gob.mx/nota_detalle.php?codigo=5424575&fecha=05/02/2016 ;https://members.wto.org/crnattachments/2016/TBT/MEX/16_0529_00_s.pdf ; ;
Distribution date: 09 February 2016
Products Covered: Medicaments (HS 30.04) ;
Regulation Type: Addendum to Regular Notification
; ; ;Mexican Official Standard NOM-059-SSA1-2015 "Good manufacturing practices for medicinal products" ; ;The Mexican Ministry of Health published draft Mexican Official Standard PROY-NOM-059-SSA1-2015 "Good manufacturing practices for medicinal products" in the Official Journal (Diario Oficial de la Federación) (http://www.dof.gob.mx) on 9 September 2015. The replies to the comments received during the public consultation period were published on 13 January 2016 and the final version of this Mexican Official Standard was published on 5 February 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 ;Email: normasomc@economia.gob.mx and sofia.pacheco@economia.gob.mx ;Website: http://www.economia.gob.mx/comunidad-negocios/normalizacion/catalogo-mexicano-de-normas ;Text available online at: ;http://dof.gob.mx/nota_detalle.php?codigo=5424575&fecha=05/02/2016 ;https://members.wto.org/crnattachments/2016/TBT/MEX/16_0529_00_s.pdf ; ;
Distribution date: 09 February 2016
Products Covered: Medicaments (HS 30.04) ;
Regulation Type: Addendum to Regular Notification
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