Regulatory Updates

Distribution date: 18 July 2022

The purpose of this Notice of Intent to Amend is to notify the removal of "Betaine or its salts" from the Veterinary part of the Prescription Drug List (PDL). Only the Veterinary part of the PDL will be revised. Health Canada has conducted a scientific review of betaine for veterinary use against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations that led to this decision. The wording of the qualifier has not changed from that was proposed in the 22 December 2021 Notice of Consultation. The amendment will be communicated to stakeholders through the publication of a Notice of Amendment. 

Products Covered: Prescription status of medicinal ingredients for veterinary use in feed (ICS: 11.220; HS 3004.50.55)

Regulation Type: Addendum to Regular Notification

Distribution date: 18 July 2022

The purpose of this Notice of Intent to Amend is to notify the removal of "Betaine or its salts" from the Veterinary part of the Prescription Drug List (PDL). Only the Veterinary part of the PDL will be revised. Health Canada has conducted a scientific review of betaine for veterinary use against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations that led to this decision. The wording of the qualifier has not changed from that was proposed in the 22 December 2021 Notice of Consultation. The amendment will be communicated to stakeholders through the publication of a Notice of Amendment. 

Products Covered: Prescription status of medicinal ingredients for veterinary use in feed (ICS: 11.220; HS 3004.50.55)

Regulation Type: Addendum to Regular Notification

Distribution date: 15 July 2022 | Final date for Comment: 13 September 2022

The document is to strengthen the supervision of sampling and  testing for cosmetics ,promote the development of cosmetics industry and safeguard the consumers’ health.

Products Covered: Cosmetics (HS code(s): 33); (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Distribution date: 15 July 2022 | Final date for Comment: 13 September 2022

The document is to strengthen the supervision of sampling and  testing for cosmetics ,promote the development of cosmetics industry and safeguard the consumers’ health.

Products Covered: Cosmetics (HS code(s): 33); (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Distribution date: 14 July 2022 | Final date for Comment: 09 September 2022

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Environmental Defense Fund, Maricel Maffini, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Endocrine Society, Environmental Working Group, Healthy Babies Bright Futures, Linda Birnbaum, and the Nicholas School of the Environment at Duke University, proposing that the food additive regulations be amended to remove or restrict authorizations for the use of bisphenol A (BPA). 

Products Covered: Phenols; phenol-alcohols (HS code(s): 2907); Food technology (ICS code(s): 67)

Regulation Type: Regular notification

Distribution date: 14 July 2022 | Final date for Comment: 09 September 2022

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Environmental Defense Fund, Maricel Maffini, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Endocrine Society, Environmental Working Group, Healthy Babies Bright Futures, Linda Birnbaum, and the Nicholas School of the Environment at Duke University, proposing that the food additive regulations be amended to remove or restrict authorizations for the use of bisphenol A (BPA). 

Products Covered: Phenols; phenol-alcohols (HS code(s): 2907); Food technology (ICS code(s): 67)

Regulation Type: Regular notification

Distribution date: 13 July 2022

This normative instruction contains provisions on the production of pilot batches of medicines.

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Regular notification

Distribution date: 13 July 2022

This normative instruction contains provisions on the production of pilot batches of medicines.

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Regular notification

Distribution date: 13 July 2022

This Resolution contains provisions on marketing authorization, renewal of marketing authorization, post-marketing authorization changes and notification of industrialized dynamized drugs.   The current editions of the following pharmacopoeias and compendia should be used as a reference for production methods and quality control of drugs, excipients, active ingredients and industrialized dynamized drugs: I - Brazilian Homeopathic Pharmacopoeia; II - German Homeopathic Pharmacopoeia (GHP/HAB); III - American Homeopathic Pharmacopoeia (HPUS); IV - British Homeopathic Pharmacopoeia (BHP); V - Mexican Homeopathic Pharmacopoeia; VI - Indian Homeopathic Pharmacopoeia; VII - European Pharmacopoeia (Ph. EUR.); VIII - French Pharmacopoeia (PhFr); or IX - Anthroposophical Pharmaceutical Code (APC).

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Regular notification

Distribution date: 13 July 2022

This Resolution contains provisions on marketing authorization, renewal of marketing authorization, post-marketing authorization changes and notification of industrialized dynamized drugs.   The current editions of the following pharmacopoeias and compendia should be used as a reference for production methods and quality control of drugs, excipients, active ingredients and industrialized dynamized drugs: I - Brazilian Homeopathic Pharmacopoeia; II - German Homeopathic Pharmacopoeia (GHP/HAB); III - American Homeopathic Pharmacopoeia (HPUS); IV - British Homeopathic Pharmacopoeia (BHP); V - Mexican Homeopathic Pharmacopoeia; VI - Indian Homeopathic Pharmacopoeia; VII - European Pharmacopoeia (Ph. EUR.); VIII - French Pharmacopoeia (PhFr); or IX - Anthroposophical Pharmaceutical Code (APC).

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Regular notification