Draft handbook of good manufacturing practices for pharmaceutical products The Republic of Peru hereby advises that the final (definitive) version of the draft "handbook of good manufacturing practices for pharmaceutical products" notified in document G/TBT/N/PER/84 of 28 January 2016 has been issued pursuant to Supreme Decree No. 021-2018-SA, published in the Official Journal El Peruano on 22 August 2018. It will enter into force one (1) year from the day after its publication. http://www.digemid.minsa.gob.pe/Main.asp?Seccion=475

Distribution date: 10 September 2018 | Final date for Comment: 28 April 2025
Products Covered: Pharmaceutical products: biological products: biotech products, classified under Chapter 30 of the Harmonized System or Customs Tariff ;
Regulation Type: Addendum to Regular Notification
Draft handbook of good manufacturing practices for pharmaceutical products The Republic of Peru hereby advises that the final (definitive) version of the draft "handbook of good manufacturing practices for pharmaceutical products" notified in document G/TBT/N/PER/84 of 28 January 2016 has been issued pursuant to Supreme Decree No. 021-2018-SA, published in the Official Journal El Peruano on 22 August 2018. It will enter into force one (1) year from the day after its publication. http://www.digemid.minsa.gob.pe/Main.asp?Seccion=475

Distribution date: 10 September 2018 | Final date for Comment: 28 April 2025
Products Covered: Pharmaceutical products: biological products: biotech products, classified under Chapter 30 of the Harmonized System or Customs Tariff ;
Regulation Type: Addendum to Regular Notification
DEAS 187: 2017, Toothpaste — Specification, Second edition

Distribution date: 14 September 2018 | Final date for Comment: 13 November 2018
This Draft East African Standard specifies the requirements, sampling and test methods for toothpaste (fluoridated and non-fluoridated) for use with a toothbrush in the cleaning of natural teeth
Products Covered: Dentifrices, incl. those used by dental practitioners (HS code(s): 330610); Cosmetics. Toiletries (ICS code(s): 71.100.70)
Regulation Type: Regular notification
DEAS 187: 2017, Toothpaste — Specification, Second edition

Distribution date: 14 September 2018 | Final date for Comment: 13 November 2018
This Draft East African Standard specifies the requirements, sampling and test methods for toothpaste (fluoridated and non-fluoridated) for use with a toothbrush in the cleaning of natural teeth
Products Covered: Dentifrices, incl. those used by dental practitioners (HS code(s): 330610); Cosmetics. Toiletries (ICS code(s): 71.100.70)
Regulation Type: Regular notification
Notice of Modification to the List of Permitted Colouring Agents to Enable the Use of Calcium Carbonate in Unstandardized Confectionery - Reference Number: NOM/ADM-0124

Distribution date: 14 September 2018 | Final date for Comment: 19 November 2018
Health Canada's Food Directorate received a food additive submission seeking approval for the use of calcium carbonate as a colouring agent in the manufacture of hard and soft candies and in inks for writing on various confections. Calcium carbonate is already permitted as food additive for use in Canada in various foods, including unstandardized confectionery, in the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/4-emulsifying-gelling-stabilizing-thickening-agents.html), the List of Permitted pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agents (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/10-adjusting-agents.html), and the List of Permitted Food Additives with Other Accepted Uses (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/8-other-accepted-uses.html). As no safety concerns were raised through Health Canada's assessment, the Department has enabled the use of the food additive calcium carbonate, as described in the information document below, by updating the List of Permitted Colouring Agents (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/3-colouring-agents.html) effective 6 September 2018. The purpose of this communication is to publically announce the Department's decision in this regard and to provide the appropriate contact information for any inquiries or for those wishing to submit any new scientific information relevant to the safety of this food additive.
Products Covered: Calcium carbonate (ICS Codes: 67.220.20)
Regulation Type: Regular notification
Notice of Modification to the List of Permitted Colouring Agents to Enable the Use of Calcium Carbonate in Unstandardized Confectionery - Reference Number: NOM/ADM-0124

Distribution date: 14 September 2018 | Final date for Comment: 19 November 2018
Health Canada's Food Directorate received a food additive submission seeking approval for the use of calcium carbonate as a colouring agent in the manufacture of hard and soft candies and in inks for writing on various confections. Calcium carbonate is already permitted as food additive for use in Canada in various foods, including unstandardized confectionery, in the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/4-emulsifying-gelling-stabilizing-thickening-agents.html), the List of Permitted pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agents (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/10-adjusting-agents.html), and the List of Permitted Food Additives with Other Accepted Uses (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/8-other-accepted-uses.html). As no safety concerns were raised through Health Canada's assessment, the Department has enabled the use of the food additive calcium carbonate, as described in the information document below, by updating the List of Permitted Colouring Agents (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/3-colouring-agents.html) effective 6 September 2018. The purpose of this communication is to publically announce the Department's decision in this regard and to provide the appropriate contact information for any inquiries or for those wishing to submit any new scientific information relevant to the safety of this food additive.
Products Covered: Calcium carbonate (ICS Codes: 67.220.20)
Regulation Type: Regular notification
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Lipase from Trichoderma reesei RF10625 in Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Products - Reference Number: NOM/ADM-0123

Distribution date: 14 September 2018 | Final date for Comment: 19 November 2018
Health Canada's Food Directorate completed a detailed safety assessment of a food additive submission seeking approval for the use of lipase from Trichoderma reesei RF10625 in bread, flour, whole wheat flour and unstandardized bakery products. Lipase from other source organisms is already permitted for use in Canada as a food enzyme in the same foods as those requested by the petitioner. As no safety concerns were identified through Health Canada's assessment, the Department has enabled the use of the food additive lipase from T. reeseiRF10625, as described in the information document below, by modifying the List of Permitted Food Enzymes (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/5-enzymes.html), effective 6 September 2018. The purpose of this communication is to publically announce Health Canada's decision in this regard and to provide the appropriate contact information for inquiries or for submitting new scientific information relevant to the safety of this food additive.
Products Covered: Lipase from Trichoderma reesei RF10625 (ICS Codes: 67.220.20, 67.060)
Regulation Type: Regular notification
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Lipase from Trichoderma reesei RF10625 in Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Products - Reference Number: NOM/ADM-0123

Distribution date: 14 September 2018 | Final date for Comment: 19 November 2018
Health Canada's Food Directorate completed a detailed safety assessment of a food additive submission seeking approval for the use of lipase from Trichoderma reesei RF10625 in bread, flour, whole wheat flour and unstandardized bakery products. Lipase from other source organisms is already permitted for use in Canada as a food enzyme in the same foods as those requested by the petitioner. As no safety concerns were identified through Health Canada's assessment, the Department has enabled the use of the food additive lipase from T. reeseiRF10625, as described in the information document below, by modifying the List of Permitted Food Enzymes (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/5-enzymes.html), effective 6 September 2018. The purpose of this communication is to publically announce Health Canada's decision in this regard and to provide the appropriate contact information for inquiries or for submitting new scientific information relevant to the safety of this food additive.
Products Covered: Lipase from Trichoderma reesei RF10625 (ICS Codes: 67.220.20, 67.060)
Regulation Type: Regular notification
Regulation on the interchangeability of medicines The Republic of Peru hereby advises that the final (definitive) version of the draft regulation on the interchangeability of medicines notified in document G/TBT/N/PER/82 of 14 December 2015 has been issued pursuant to Supreme Decree No. 024-2018-SA, published in the Official Journal El Peruano on 15 September 2018. It will enter into force six (6) months from the day after its publication. https://www.gob.pe/normas-legales?institucion%5B%5D=minsa&term=024-2018

Distribution date: 20 September 2018 | Final date for Comment: 28 April 2025
Products Covered: Pharmaceutical products: Medicines, classified under Chapter 30 of the Harmonized System or Customs Tariff. ;
Regulation Type: Addendum to Regular Notification
Regulation on the interchangeability of medicines The Republic of Peru hereby advises that the final (definitive) version of the draft regulation on the interchangeability of medicines notified in document G/TBT/N/PER/82 of 14 December 2015 has been issued pursuant to Supreme Decree No. 024-2018-SA, published in the Official Journal El Peruano on 15 September 2018. It will enter into force six (6) months from the day after its publication. https://www.gob.pe/normas-legales?institucion%5B%5D=minsa&term=024-2018

Distribution date: 20 September 2018 | Final date for Comment: 28 April 2025
Products Covered: Pharmaceutical products: Medicines, classified under Chapter 30 of the Harmonized System or Customs Tariff. ;
Regulation Type: Addendum to Regular Notification
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