Canada Gazette, Part I, Volume 158, Number 49: GOVERNMENT NOTICES
December 7, 2024
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Ministerial Condition No. 21943
Ministerial condition
(Paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999)
Whereas the Minister of the Environment and the Minister of Health (the ministers) have assessed information pertaining to the substance quaternary ammonium compounds, plant based alkylethylbis(hydroxyethyl), Et sulfates (salts), Confidential Accession Number 19740-8;
And whereas the ministers suspect that the substance is toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999 (the Act),
The Minister of the Environment, pursuant to paragraph 84(1)(a) of the Act, hereby permits the manufacture or import of the substance subject to the conditions of the following annex.
Marc D’Iorio
Assistant Deputy Minister
Science and Technology Branch
On behalf of the Minister of the Environment
ANNEX
Conditions
(Paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999)
1. The following definitions apply in these ministerial conditions:
- “engineered hazardous waste landfill facility”
- means a facility that is part of an overall integrated hazardous waste management system where wastes that do not require additional treatment or processing are sent and where hazardous materials are confined or controlled for the duration of their effective contaminating lifespan.
- “notifier”
- means the person who has, on August 2, 2024, provided to the Minister of the Environment the prescribed information concerning the substance, in accordance with subsection 81(1) of the Canadian Environmental Protection Act, 1999 (the Act);
- “substance”
- means quaternary ammonium compounds, plant based alkylethylbis(hydroxyethyl), Et sulfates (salts), Confidential Accession Number 19740-8.
2. The notifier may manufacture or import the substance subject to the present ministerial conditions.
Restrictions
3. The notifier shall manufacture or import the substance only for use as an antistatic agent for fibreglass and plastics.
4. The notifier shall transfer the physical possession or control of the substance only to a person who agrees to use it in accordance with section 3.
5. At least 120 days prior to beginning manufacturing the substance in Canada, the notifier shall inform the Minister of the Environment, in writing, and provide the following information:
- (a) the anticipated annual quantity to be manufactured;
- (b) the address of the manufacturing facility within Canada;
- (c) a description of the expected modes for its transportation and storage;
- (d) a description of the size and type of container used for its transportation and storage;
- (e) an identification of the components of the environment into which it is anticipated to be released;
- (f) its anticipated releases into municipal wastewater systems;
- (g) a description of the methods recommended for its destruction or disposal;
- (h) a summary of all other information and test data in respect of the chemical that are in the possession of the notifier, or to which they may reasonably be expected to have access, and that permit the identification of hazards to the environment and human health and the degree of environmental and public exposure to the chemical;
- (i) any factors that may limit environmental exposure;
- (j) the following information related to the manufacturing process of the substance in Canada:
- (i) a brief description of the manufacturing process that details the precursors of the substance, the reaction stoichiometry and the nature (batch or continuous) and scale of the process,
- (ii) a flow diagram of the manufacturing process that includes features such as process tanks, holding tanks and distillation towers, and
- (iii) a brief description of the major steps in manufacturing operations, the chemical conversions, the points of entry of all reactants and the points of release of the substance, and the processes to eliminate environmental release.
Disposal of the substance
6. The notifier must
- (a) thoroughly rinse any containers or transportation vessels that contained the substance prior to their disposal or reconditioning and
- (i) incorporate the rinsate as a component of the antistatic agent formulations for fibreglass and plastics, or
- (ii) dispose of the rinsate as waste in accordance with subparagraph (b)(i) or (ii); and
- (b) destroy or dispose of any waste and containers or transportation vessels that contained the substance in the following manner:
- (i) incinerate them in accordance with the laws of the jurisdiction where the disposal facility is located, or
- (ii) deposit them in an engineered hazardous waste landfill facility, in accordance with the laws of the jurisdiction where the landfill is located.
Environmental release
7. Where any release of the substance or waste to the environment occurs, the notifier shall immediately take all measures necessary to prevent any further release, and to limit the dispersion of any release. Furthermore, the notifier shall, as soon as possible in the circumstances, inform the Minister of the Environment by contacting an enforcement officer designated under the Act.
Other requirements
8. The notifier shall, prior to transferring the physical possession or control of the substance, waste or containers or transportation vessels that contained the substance to any person:
- (a) inform the person, in writing, of the terms of the present ministerial conditions; and
- (b) obtain, prior to the first transfer of the substance, waste or containers or transportation vessels that contained the substance, written confirmation from this person that they were informed of the terms of the present ministerial conditions and agree to comply with the present ministerial conditions.
Record-keeping requirements
9. (1) The notifier shall maintain electronic or paper records, with any documentation supporting the validity of the information contained in these records, indicating:
- (a) the use of the substance;
- (b) the quantity of the substance that the notifier manufactures, imports, purchases, distributes, sells and uses;
- (c) the name and address of each person to whom the notifier transfers the physical possession or control of the substance;
- (d) the name and address of each person in Canada who disposed of the substance, waste, containers or transportation vessels that contained the substance for the notifier, the method used to do so and the quantities of the substance, waste, containers or transportation vessels shipped to that person; and
- (e) the written confirmation referred to in subsection 8(b).
(2) If the address referred to in paragraph (1)(c) or paragraph (1)(d) changes, the notifier must update the electronic or paper records mentioned in subsection (1) accordingly within 30 days after learning of the change.
(3) The notifier shall create the electronic or paper records mentioned in subsection (1) no later than 30 days after the date the information or documents become available.
(4) The notifier shall maintain the electronic or paper records mentioned in subsection (1)
- (a) in English, French, or both languages; and
- (b) at the notifier’s principal place of business in Canada, or at the principal place of business in Canada of their representative, for a period of at least five years after they are made.
(5) Any records mentioned in subsection (1) that are kept electronically must be in an electronically readable format.
Coming into force
10. The present ministerial conditions come into force on November 22, 2024.
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Significant New Activity Notice No. 21862
Significant New Activity Notice
(Section 85 of the Canadian Environmental Protection Act, 1999)
Whereas the Minister of the Environment and the Minister of Health have assessed information in their possession in respect of the substance phosphoric acid, mixed decyl and octyl esters, potassium salts, Chemical Abstracts Service Registry Number 70879-47-9, under section 83 of the Canadian Environmental Protection Act, 1999;
Whereas the substance is not specified on the Domestic Substances List;
And whereas the ministers suspect that a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Act,
Therefore, the Minister of the Environment indicates, pursuant to section 85 of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of that Act applies with respect to the substance in accordance with the Annex.
The Honourable Steven Guilbeault
Minister of the Environment
ANNEX
Information Requirements
(Section 85 of the Canadian Environmental Protection Act, 1999)
1. The following definitions apply in this notice:
- “cosmetic”
- means a cosmetic as defined in section 2 of the Food and Drugs Act; and
- “substance”
- means phosphoric acid, mixed decyl and octyl esters, potassium salts, Chemical Abstracts Service Registry Number 70879-47-9.
2. In relation to the substance, a significant new activity is
- (a) the use of the substance in the manufacture of a cosmetic, in which the substance is present in a concentration that is greater than 1% by weight; or
- (b) the use of the substance, in a quantity greater than or equal to 10 kg in a calendar year, in the distribution for sale of a cosmetic, in which the substance is present in a concentration that is greater than 1% by weight.
3. Despite section 2, a use of the substance is not a significant new activity if the substance is used:
- (a) as a research and development substance or site-limited intermediate substance, as these terms are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers) [the Regulations]; or
- (b) in the manufacture of a product that is for export only.
4. For each proposed significant new activity, the following information must be provided to the Minister of the Environment at least 90 days before the day on which the activity begins:
- (a) a description of the significant new activity in relation to the substance;
- (b) the anticipated annual quantity of the substance to be used or distributed;
- (c) the information specified in paragraphs 7(c) and (d) of Schedule 4 to the Regulations;
- (d) the information specified in paragraphs 8(f) and (g) of Schedule 5 to the Regulations;
- (e) the function of the substance in the cosmetic;
- (f) information sufficient to assess eye irritation and corrosion at concentrations relevant to the intended end-use(s) of the substance;
- (g) information sufficient to assess skin irritation and corrosion at concentrations relevant to the intended end-use(s);
- (h) information sufficient to assess dermal penetration of the substance;
- (i) all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they may reasonably be expected to have access, and that permit the identification of the adverse effects that the substance may have on the environment and human health and the degree of environmental and public exposure to the substance;
- (j) the name of every government department or agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the significant new activity and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and the risk management actions in relation to the substance imposed by the department or agency;
- (k) the name, civic and postal addresses, telephone number and, if any, the fax number and email address of the person proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf; and
- (l) a certification that the information is accurate and complete, dated and signed by the person proposing the significant new activity if they are resident in Canada or, if not, by the person resident in Canada who is authorized to act on their behalf.
5. Any studies provided under paragraph 4(f), 4(g) and 4(h) must be conducted in accordance with the Principles of Good Laboratory Practice set out in Annex II of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted by the OECD on May 12, 1981, that are current at the time the studies are conducted.
6. The information provided under section 4 is to be assessed within 90 days after the day on which it is received by the Minister.
Transitional provisions
7. Despite section 2, in the period between the date of publication of the present notice and December 7, 2025, a significant new activity is
- (a) the use of the substance in a quantity greater than 100 kg in the manufacture of a cosmetic, in which the substance is present in a concentration that is greater than 1% by weight; or
- (b) the use of the substance in a quantity greater than 100 kg in the distribution for sale of a cosmetic, in which the substance is present in a concentration that is greater than 1% by weight.
8. For greater certainty, in respect of calendar year 2025, the quantity of substance that is used or distributed for sale before December 7 of that calendar year is not considered for the purposes of section 2.
EXPLANATORY NOTE
(This explanatory note is not part of the Significant New Activity Notice.)
Description
This Significant New Activity (SNAc) Notice is a legal instrument adopted by the Minister of the Environment pursuant to section 85 of the Canadian Environmental Protection Act, 1999 (the Act) to apply the SNAc provisions of that Act to the substance phosphoric acid, mixed decyl and octyl esters, potassium salts, Chemical Abstracts Service Registry Number (CAS) 70879-47-9. The Notice is now in force and it has force of law. It is therefore mandatory for a person who intends to use the substance for a significant new activity as defined in the Notice to meet all the applicable requirements set out in the Notice.
A SNAc Notice does not constitute an endorsement from the Minister of the Environment, the Department of the Environment or the Government of Canada of the substance to which it relates, nor does it constitute an exemption from any other laws or regulations that are in force in Canada and that may apply to this substance or activities involving the substance.
Applicability of the Significant New Activity Notice
The Notice requires that any person (individual or corporation) engaging in a significant new activity in relation to the substance phosphoric acid, mixed decyl and octyl esters, potassium salts, Chemical Abstracts Service Registry Number (CAS) 70879-47-9, submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Notice at least 90 days prior to using the substance for the significant new activity.
In order to address the human toxicity concerns, the Notice requires notification in relation to the use of the substance in the manufacture of a cosmetic as defined in section 2 of the Food and Drugs Act in which the substance is present in a concentration that is greater than 1% by weight. The Notice also requires notification in relation to the use of the substance, in a quantity greater than or equal to 10 kg/year, in the distribution for sale of a cosmetic as defined in section 2 of the Food and Drugs Act in which the substance is present in a concentration that is greater than 1% by weight.
A SNAN is required 90 days before the use of the substance in a significant new activity.
Activities not subject to the Notice
Uses of the substance that are regulated under the acts of Parliament listed in Schedule 2 of the Act, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act are excluded from the Notice. The Notice also does not apply to transient reaction intermediates, impurities, contaminants, partially unreacted materials, or in some circumstances to items such as, but not limited to, wastes, mixtures, or manufactured items. However, it should be noted that individual components of a mixture may be subject to notification under the provisions of the Act. See subsection 81(6) and section 3 of the Act, and section 3.2 of the Guidance Document for the New Substances Notification Regulations (Chemicals and Polymers) for additional information.
Activities involving the use of the substance as a research and development substance or a site-limited intermediate or an export-only product are excluded from the Notice. The terms “research and development substance” and “site-limited intermediate substance” are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers).
Information to be submitted
The Notice sets out the information that must be provided to the Minister 90 days before the day on which the substance phosphoric acid, mixed decyl and octyl esters, potassium salts, Chemical Abstracts Service Registry Number (CAS) 70879-47-9 is used for a significant new activity. The Department of the Environment and the Department of Health will use the information submitted in the SNAN to conduct risk assessments within 90 days after the complete information is received.
The assessment of the substance identified potential ocular, dermal, and systemic toxicity associated with the potential use of the substance in cosmetics as defined in section 2 of the Food and Drugs Act. The SNAc Notice is issued to gather toxicity information to ensure that the substance will undergo further assessment before significant new activities are undertaken.
The information requirements in the Notice relate to general information in respect of the substance, details surrounding its use, exposure information, and toxicity to human health and the environment. Some of the information requirements reference the New Substances Notification Regulations (Chemicals and Polymers).
Additional guidance on preparing a SNAN can be found in section 9.6.2 of the Guidance Document for the New Substances Notification Regulations (Chemicals and Polymers).
Transitional provision
A transitional provision is included in the Notice to facilitate compliance by persons who may already have imported or manufactured up to 100 kg of the substance and started activities with it in concentrations that are greater than 1% by weight in a cosmetic as defined in section 2 of the Food and Drugs Act. The Notice comes into force immediately. However, for the period between the publication of the Notice and December 7, 2025, the substance may be used in a quantity not exceeding 100 kg in the manufacture or the distribution for sale of a cosmetic as defined in section 2 of the Food and Drugs Act, in which the substance is present in a concentration that is greater than 1% by weight. On December 8, 2025, the threshold will be lowered.
Compliance
When assessing whether or not a substance is subject to SNAc provisions, a person is expected to make use of information in their possession or to which they may reasonably have access. This means information in any of the notifier’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product are expected to have access to import records, usage information and the relevant Safety Data Sheets (SDSs).
Although an SDS is an important source of information on the composition of a product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products. Therefore, an SDS may not list all product ingredients that may be subject to a SNAc notice due to human health or environmental concerns. Any person requiring more detailed information on product composition is encouraged to contact their supplier.
Where a person involved in activities with the substance obtains information that reasonably supports the conclusion that the substance is toxic or is capable of becoming toxic, the person is obligated, under section 70 of the Act, to provide that information to the Minister without delay.
A company can submit a SNAN on behalf of its clients. For example, in cases where a person takes possession or control of a substance from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by an original SNAN submitted by the person from whom they obtained the substance.
Under section 86 of the Act, any person who transfers the physical possession or control of a substance subject to a SNAc notice must notify all persons to whom the physical possession or control is transferred of the obligation to comply with the notice, including the obligation to notify the Minister of any SNAc and to provide all the required information outlined above.
A pre-notification consultation (PNC) is recommended for notifiers who wish to consult with the program during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans.
For further information, please contact the Substances Management Information Line (substances@ec.gc.ca [email], 1‑800‑567‑1999 [toll-free in Canada], and 819‑938‑3232 [outside of Canada]).
The Act is enforced in accordance with the publicly available Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999. In instances of non-compliance, consideration is given to the following factors, when deciding which enforcement measure to take: nature of the alleged violation, effectiveness in achieving compliance with the Act and its regulations and consistency in enforcement.
DEPARTMENT OF HEALTH
DEPARTMENT OF HEALTH ACT
Notice of annual increase of Health Canada’s Drug Master Files and Certificate of Pharmaceutical Product fees
Notice is hereby given that the Minister of Health, under the Ministerial Authority to Enter into Contract, updates the fees that are payable for the provision of Drug Master Files and Certificate of Pharmaceutical Product services by 2%, rounded up to the nearest dollar.
The current fees and the fees updated as of April 1, 2025, are listed below.
Any inquiries or comments about the updated fees can be directed to Rosslynn Miller-Lee, Director General, Business Facilitation and Modernization Directorate, Health Products and Food Branch, 613‑327‑0798 (telephone) or cro-brc@hc-sc.gc.ca (email).
| Services | Fee as of April 1, 2024 | Fee as of April 1, 2025 |
|---|---|---|
| Certificate of Pharmaceutical Product (or a supplemental copy of a Certificate of Pharmaceutical Product) | $100 | $102 |
| New Master Files (file registration) | $1,379 | $1,407 |
| Drug Master Files — letter of access | $196 | $200 |
| Drug Master Files — update | $599 | $611 |
DEPARTMENT OF HEALTH
FINANCIAL ADMINISTRATION ACT
Notice of annual adjustment of fees for dealer’s licences
Notice is hereby given, under section 19.2 of the Financial Administration Act, that in keeping with section 4 of the Fees in Respect of Dealer’s Licences Regulations, the fee for dealer’s licences: human drugs will increase by the annual 2% amount, rounded up to the nearest dollar. Under subsection 17(1) of the Service Fees Act (a fee is adjusted in each fiscal year — on the anniversary of a date that is selected by the responsible authority with respect to the fee before the first adjustment — by the percentage change over 12 months in the April All-items Consumer Price Index [CPI] for Canada, as published by Statistics Canada under the Statistics Act, for the previous fiscal year), the dealer’s licence: veterinary drugs [as per the Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations] will be adjusted by the CPI. Health Canada has chosen April 1 as the anniversary date. The CPI for this year is 2.7%.
The current fees and the fees updated as of April 1, 2025, are listed below.
Any inquiries or comments about the updated fees can be directed to Rosslynn Miller-Lee, Director General, Business Facilitation and Modernization Directorate, Health Products and Food Branch, 613‑327‑0798 (telephone) or cro-brc@hc-sc.gc.ca (email).
| Type of licence | Fee as of April 1, 2024 | Fee as of April 1, 2025 |
|---|---|---|
| Dealer’s licence (human drugs) | $5,841 | $5,958 |
| Dealer’s licence (veterinary drugs) | $2,098.99 | $2,155.66 |
DEPARTMENT OF HEALTH
FOOD AND DRUGS ACT
Notice of annual adjustment of the Fees in Respect of Drugs and Medical Devices Order
Notice is hereby given, under subsection 30.61(1) of the Food and Drugs Act, that in keeping with section 4.1 of the 2020 Fees in Respect of Drugs and Medical Devices Order, every fee outlined in the Order is to be adjusted annually based on the Consumer Price Index (CPI), rounded up to the nearest dollar. The CPI is calculated based on the percentage change over 12 months in the April All-items CPI for Canada, as published by Statistics Canada under the Statistics Act, for the previous fiscal year. The CPI for this year is 2.7%.
Some fees in the Fees in Respect of Drugs and Medical Devices Order are currently being phased in over seven years.
The current fees and the fees updated as of April 1, 2025, are listed below.
Any inquiries or comments about the updated fees can be directed to Rosslynn Miller-Lee, Director General, Business Facilitation and Modernization Directorate, Health Products and Food Branch, 613‑327‑0798 (telephone) or cro-brc@hc-sc.gc.ca (email).
Human Drug Submission Review
Part 2 — Drugs
| Section in the Fees in Respect of Drugs and Medical Devices Order | Submission class | Fee as of April 1, 2024 | Fee as of April 1, 2025 |
|---|---|---|---|
| Section 9 | New active substance | $590,346 | $606,286 |
| Clinical or non-clinical data and chemistry and manufacturing data | $305,690 | $313,944 | |
| Clinical or non-clinical data only | $122,232 | $125,533 | |
| Comparative studies | $68,889 | $70,750 | |
| Chemistry and manufacturing data only | $42,384 | $43,529 | |
| Clinical or non-clinical data only, in support of safety updates to the labelling | $22,372 | $22,977 | |
| Labelling only | $6,161 | $6,328 | |
| Labelling only (generic drugs) | $2,315 | $2,378 | |
| Administrative submission | $975 | $1,002 | |
| Disinfectant — full review | $12,839 | $13,186 | |
| Labelling only (disinfectants) | $2,886 | $2,964 | |
| Drug identification number application — labelling standard | $1,861 | $1,912 |
| Section in the Fees in Respect of Drugs and Medical Devices Order | Type of submission | Component | Fee as of April 1, 2024 | Fee as of April 1, 2025 |
|---|---|---|---|---|
| Section 21 | Application for drug identification number (DIN) | Information, other than that referred to in the item below, to support an application for a drug identification number, including the submission of labelling material for a second review, if required | $2,257 | $2,606 |
| Published references or other data | $1,569 | $1,812 | ||
| Documentation to support a change of manufacturer, a change to the name of a manufacturer or a change to the brand name of a drug | $786 | $906 | ||
| Notification — veterinary health product | Information contained in a notification filed under subsection C.01.615(1) of the Food and Drug Regulations in respect of a veterinary health product | $562 | $578 | |
| New drug submissions (NDS) | Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in one animal species (in the case of an antiparasitic drug, several indications in one food animal species) | $50,015 | $57,787 | |
| Efficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species | $30,298 | $35,006 | ||
| Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration and dosage form and two indications in one animal species | $72,735 | $84,038 | ||
| Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species | $98,491 | $113,795 | ||
| Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration | $9,079 | $10,491 | ||
| Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength | $1,505 | $1,739 | ||
| For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species | $68,199 | $78,793 | ||
| For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species | $90,918 | $105,044 | ||
| For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration | $9,079 | $10,491 | ||
| For food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in an additional species | $45,446 | $52,506 | ||
| Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug | $15,150 | $17,505 | ||
| Chemistry and manufacturing data to support one strength of a single dosage form | $15,150 | $17,505 | ||
| Chemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as the item above | $7,578 | $8,756 | ||
| Documentation to support a change of manufacturer | $786 | $906 | ||
| Supplement to a new drug submission (SNDS) | Efficacy data to support an additional indication in one animal species | $39,406 | $45,528 | |
| Efficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species | $30,298 | $35,006 | ||
| Efficacy and safety data (in the intended species) to support an indication in another animal species | $50,015 | $57,787 | ||
| Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration and dosage form and two indications in one animal species | $72,735 | $84,038 | ||
| Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species | $98,491 | $113,795 | ||
| Efficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species | $24,225 | $27,990 | ||
| Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration | $9,079 | $10,491 | ||
| Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength | $1,505 | $1,739 | ||
| For food-producing animals, residue depletion studies to establish a new withdrawal period for a change in the dosage or route of administration of an approved dosage form in one species | $9,079 | $10,491 | ||
| For food-producing animals, metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage and route of administration of an approved dosage form in an additional species | $45,446 | $52,506 | ||
| For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, a maximum residue limit and a withdrawal period | $22,724 | $26,254 | ||
| For the concurrent use of two drugs in a species of food-producing animals, residue depletion studies to determine if an extension to existing withdrawal periods is required | $18,187 | $21,013 | ||
| Chemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process | $15,150 | $17,505 | ||
| Chemistry and manufacturing data to support a change in formulation or dosage form | $7,578 | $8,756 | ||
| Chemistry and manufacturing data to support a change in the packaging or sterilization process | $6,043 | $6,982 | ||
| Chemistry and manufacturing data to support an extension of the expiry date | $4,541 | $5,246 | ||
| Chemistry and manufacturing data to support the concurrent use of two drugs | $4,541 | $5,246 | ||
| Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage form | $1,505 | $1,739 | ||
| Documentation to support a change to the brand name of a drug | $786 | $906 | ||
| Abbreviated new drug submission (ANDS) or supplement to an abbreviated new drug submission (SANDS) | Comparative (pharmacodynamic, clinical or bioavailability) data to support a single route of administration and dosage form | $9,079 | $10,491 | |
| For food-producing animals, residue depletion studies to confirm that the withdrawal periods for each species fall within the conditions of use for the Canadian reference product | $9,079 | $10,491 | ||
| Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug | $15,150 | $17,505 | ||
| Chemistry and manufacturing data to support a single dosage form | $15,150 | $17,505 | ||
Documentation to support
|
$786 | $906 | ||
| Preclinical submission | Efficacy and safety data (in the intended species) and protocol to support the conduct of clinical studies relative to a single dosage form, route of administration and indication in one species | $15,150 | $17,505 | |
| Efficacy data and protocol to support the conduct of clinical studies relative to a single route of administration and indication with a dosage form for which a notice of compliance has been issued for use in the species to be treated | $12,114 | $13,997 | ||
| For food-producing animals, toxicity, metabolism and residue depletion studies to establish a temporary acceptable daily intake, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species | $45,446 | $52,506 | ||
| For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species | $68,199 | $78,793 | ||
| For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species | $90,918 | $105,044 | ||
| For food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism studies to establish a withdrawal period for a single dosage form, dosage and route of administration in an additional species | $22,724 | $26,254 | ||
| Chemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient | $15,150 | $17,505 | ||
| Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient | $7,578 | $8,756 | ||
| Sale of new drug for emergency treatment | Information and material to support the sale of a new drug to be used in the emergency treatment of a non-food-producing animal |
$60 | $62 | |
| Information and material to support the sale of a new drug to be used in the emergency treatment of a food-producing animal | $120 | $124 | ||
| Experimental studies certificate | Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal | $1,130 | $1,161 | |
| Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a non-food-producing animal |
$566 | $582 | ||
| Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal | $3,406 | $3,498 | ||
| Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a food-producing animal | $566 | $582 | ||
| Notifiable change or protocol review | Information and material to support an application for a notifiable change | $4,072 | $4,705 | |
| A protocol that is filed with the Minister and may support a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission or abbreviated new drug submission, a preclinical submission or information and material that is filed for the purpose of obtaining an experimental studies certificate | $4,072 | $4,705 |
| Section in the Fees in Respect of Drugs and Medical Devices Order | Activity | Fee as of April 1, 2024 | Fee as of April 1, 2025 |
|---|---|---|---|
| Sections 33 and 41 | Fabrication — sterile dosage form | $48,255 | $49,558 |
| Sections 34 and 42 | Importation | $37,259 | $38,265 |
| Sections 35 and 43 | Fabrication — non-sterile dosage form | $35,774 | $36,740 |
| Sections 36 and 44 | Distribution | $19,017 | $19,531 |
| Sections 37 and 45 | Wholesaling | $11,098 | $11,398 |
| Sections 38 and 46 | Packaging/labelling | $6,975 | $7,164 |
| Sections 39 and 47 | Testing | $5,757 | $5,913 |
| Section 40 | Foreign site (each) | $1,059 | $1,088 |
| Section in the Fees in Respect of Drugs and Medical Devices Order | Activity | Fee as of April 1, 2024 | Fee as of April 1, 2025 |
|---|---|---|---|
| Sections 33 and 41 | Fabrication — sterile dosage form | $47,588 | $49,215 |
| Sections 34 and 42 | Importation | $30,099 | $38,265 |
| Sections 35 and 43 | Fabrication — non-sterile dosage form | $24,671 | $31,671 |
| Sections 36 and 44 | Distribution | $13,583 | $17,437 |
| Sections 37 and 45 | Wholesaling | $5,431 | $6,973 |
| Sections 38 and 46 | Packaging/labelling | $6,975 | $7,164 |
| Sections 39 and 47 | Testing | $3,695 | $4,744 |
| Section 40 | Foreign site (each) | $1,059 | $1,088 |
| Section in the Fees in Respect of Drugs and Medical Devices Order | Type of drug | Fee as of April 1, 2024 | Fee as of April 1, 2025 |
|---|---|---|---|
| Section 52 | Disinfectant | $1,684 | $1,730 |
| Non-prescription | $3,246 | $3,334 | |
| Drug other than one referred to in item 1 or 2 (above) | $5,385 | $5,531 |
| Section in the Fees in Respect of Drugs and Medical Devices Order | Type of drug | Fee as of April 1, 2024 | Fee as of April 1, 2025 |
|---|---|---|---|
| Section 56 | Veterinary drug | $552 | $567 |
Part 3 — Medical devices
| Section in the Fees in Respect of Drugs and Medical Devices Order | Category | Fee as of April 1, 2024 | Fee as of April 1, 2025 |
|---|---|---|---|
| Section 60 | Applications for Class II licence | $615 | $632 |
| Applications for Class II licence amendment | $316 | $325 | |
| Applications for Class III licence | $13,559 | $13,926 | |
| Applications for Class III licence (near patient) | $28,884 | $29,664 | |
| Applications for Class III licence amendment — changes in manufacturing | $4,279 | $4,395 | |
| Applications for Class III licence amendment — significant changes not related to manufacturing | $10,884 | $11,178 | |
| Applications for Class IV licence | $29,405 | $30,199 | |
| Applications for Class IV licence amendment — changes in manufacturing | $4,279 | $4,395 | |
| Applications for Class IV licence amendment — significant changes not related to manufacturing | $15,558 | $15,979 | |
| Applications for Class II, III or Class IV licence or licence amendment — private label medical device | $171 | $176 |
| Section in the Fees in Respect of Drugs and Medical Devices Order | Fee category | Fee as of April 1, 2024 | Fee as of April 1, 2025 |
|---|---|---|---|
| Section 71 | Medical device | $5,283 | $5,426 |
| Section in the Fees in Respect of Drugs and Medical Devices Order | Fee category | Fee as of April 1, 2024 | Fee as of April 1, 2025 |
|---|---|---|---|
| Section 77 | Medical device | $440 | $452 |
DEPARTMENT OF HEALTH
PATENT ACT
Notice of annual increase of fee pursuant to the Certificate of Supplementary Protection Regulations
Notice is hereby given, that in keeping with subsection 9(1) of the Certificate of Supplementary Protection Regulations, the fee will increase by the annual 2% amount, rounded up to the nearest dollar.
The current fee and the fee updated as of April 1, 2025, are listed below.
Any inquiries or comments about the updated fee can be directed to Rosslynn Miller-Lee, Director General, Business Facilitation and Modernization Directorate, Health Products and Food Branch, 613‑327‑0798 (telephone) or cro-brc@hc-sc.gc.ca (email).
| Type of certificate | Subsection in Certificate of Supplementary Protection Regulations | Fee as of April 1, 2024 | Fee as of April 1, 2025 |
|---|---|---|---|
| Certificate of Supplementary Protection | 9(1) | $10,356 | $10,564 |
DEPARTMENT OF INDUSTRY
TELECOMMUNICATIONS ACT
Notice No. TIPB-002-2024 — Petition to the Governor in Council concerning Telecom Regulatory Policy CRTC 2024-180
Notice is hereby given that a petition was received by the Governor in Council (GIC) under section 12 of the Telecommunications Act with respect to Telecom Regulatory Policy CRTC 2024-180, Competition in Canada’s Internet service markets, a decision issued by the Canadian Radio-television and Telecommunications Commission (CRTC).
Subsection 12(1) of the Telecommunications Act provides that, within one year after a decision by the CRTC, the GIC may, on petition in writing presented to the GIC within 90 days after the decision, or on the GIC’s own motion, by order, vary or rescind the decision or refer it back to the CRTC for reconsideration of all or a portion of it.
Submitting comments
Submissions regarding this petition should be filed by January 13, 2025. All comments received will be posted on Innovation, Science and Economic Development Canada’s Spectrum management and telecommunications website.
Submissions should be addressed to the Director General, Telecommunications and Internet Policy Branch, Innovation, Science and Economic Development Canada, preferably in electronic format (Microsoft Word or Adobe PDF) to the following email address: telecomsubmission-soumissiontelecom@ised-isde.gc.ca. Written copies can be sent to the Director General, Telecommunications and Internet Policy Branch, Innovation, Science and Economic Development Canada, 10th Floor, 235 Queen Street, Ottawa, Ontario K1A 0H5.
All submissions should cite the Canada Gazette, Part I, the publication date, the title and the notice reference number (TIPB-002-2024).
Obtaining copies
Copies of the petition, as well as copies of all relevant documents and submissions received in response, may be obtained electronically on the Spectrum management and telecommunications website, under Petitions and Public Notices. It is the responsibility of interested parties to check the public record from time to time to keep abreast of submissions received.
Official versions of notices can be viewed on the Canada Gazette website.
December 6, 2024
Andre Arbour
Director General
Telecommunications and Internet Policy Branch
PRIVY COUNCIL OFFICE
Appointment opportunities
We know that our country is stronger — and our government more effective — when decision-makers reflect Canada’s diversity. The Government of Canada has implemented an appointment process that is transparent and merit-based, strives for gender parity, and ensures that Indigenous peoples and minority groups are properly represented in positions of leadership. We continue to search for Canadians who reflect the values that we all embrace: inclusion, honesty, fiscal prudence, and generosity of spirit. Together, we will build a government as diverse as Canada.
We are equally committed to providing a healthy workplace that supports one’s dignity, self-esteem and the ability to work to one’s full potential. With this in mind, all appointees will be expected to take steps to promote and maintain a healthy, respectful and harassment-free work environment.
The Government of Canada is currently seeking applications from diverse and talented Canadians from across the country who are interested in the following positions.
Current opportunities
The following opportunities for appointments to Governor in Council positions are currently open for applications. Every opportunity is open for a minimum of two weeks from the date of posting on the Governor in Council appointments website.
| Position | Organization | Closing date |
|---|---|---|
| Director | Bank of Canada | |
| Chairperson | Canada Deposit Insurance Corporation | |
| Chairperson | Canada Industrial Relations Board | |
| Vice-Chairperson | Canada Industrial Relations Board | |
| Chairperson | Canada Infrastructure Bank | |
| Director | Canada Lands Company Limited | |
| Chief Executive Officer | Canadian Accessibility Standards Development Organization | |
| Director | Canadian Air Transport Security Authority | |
| Director | Canadian Energy Regulator | |
| Assistant Chief Commissioner | Canadian Grain Commission | |
| Chief Commissioner | Canadian Human Rights Commission | |
| Permanent Member | Canadian Nuclear Safety Commission | |
| Director | Canadian Race Relations Foundation | |
| Director | Canadian Tourism Commission | |
| President | Canadian Tourism Commission | |
| Chairperson | Civilian Review and Complaints Commission for the Royal Canadian Mounted Police |
|
| Vice-Chairperson | Civilian Review and Complaints Commission for the Royal Canadian Mounted Police |
|
| Member | Copyright Board | |
| Director | Defence Construction (1951) Limited | |
| Member | Employment Insurance Board of Appeal | December 16, 2024 |
| Regional Coordinator | Employment Insurance Board of Appeal | December 16, 2024 |
| President | Export Development Canada | |
| Vice-Chairperson | Federal Public Sector Labour Relations and Employment Board | |
| Director (Federal) | Halifax Port Authority | |
| Member | Historic Sites and Monuments Board of Canada | |
| Member | National Seniors Council | |
| Member | Natural Sciences and Engineering Research Council | |
| Member | Net-Zero Advisory Body | |
| Commissioner of Official Languages | Office of the Commissioner of Official Languages | |
| Deputy Director of Public Prosecutions | Office of the Director of Public Prosecutions | |
| Ombudsperson for the Department of National Defence and the Canadian Forces | Office of the Ombudsperson for the Department of National Defence and the Canadian Forces | |
| Senate Ethics Officer | Office of the Senate Ethics Officer | |
| Member | Payments in Lieu of Taxes Dispute Advisory Panel | |
| Principal | Royal Military College of Canada | |
| Director | Sept-Îles Port Authority | |
| Administrator | Ship-source Oil Pollution Fund and Fund for Railway Accidents Involving Designated Goods | |
| Chief Statistician | Statistics Canada | |
| Co-chair | Sustainable Jobs Partnership Council | |
| Member | Sustainable Jobs Partnership Council | |
| Chairperson | The Jacques-Cartier and Champlain Bridge Inc. | |
| Secretary | The National Battlefields Commission | |
| Chairperson | VIA Rail Canada Inc. | |
| Chairperson | Windsor-Detroit Bridge Authority |
GLOBAL AFFAIRS CANADA
Consultations on a possible free trade agreement with the Philippines
Promoting trade and investment with Indo-Pacific markets like the Philippines is a priority for the Government of Canada. The Government’s trade policy and inclusive approach to trade is one that puts the interests of Canadians and opportunities for the middle class, youth, and traditionally underrepresented groups front and centre.
To this end, the Government of Canada is soliciting the views of Canadians on possible free trade agreement negotiations with the Philippines. As steps are taken to ensure that more Canadians have access to the benefits and opportunities that flow from international trade, traditionally underrepresented groups, such as women, small and medium-sized enterprises, Indigenous Peoples, persons with disabilities, youth, 2SLGBTQI+, and racialized communities are encouraged to provide their input.
Background
Canada’s commercial relations with the Philippines
The year 2024 marks the 75th anniversary of Canada’s strong and friendly diplomatic relations with the Philippines. Canada and the Philippines have a growing trade and investment relationship. In 2023, bilateral merchandise trade totalled $3.4 billion, with Canadian exports to the Philippine market amounting to $1.24 billion. The stock of Canadian direct investment in the Philippines was $983 million in 2022.
The Philippines is the second-largest market in Southeast Asia and one of the fastest growing economies in the region, with the Asia Development Bank forecasting 6.2% gross domestic product (GDP) growth in 2025. It is currently Canada’s 27th largest export market.
Renewal of exploratory discussions towards a potential Canada-Philippines Free Trade Agreement
On December 5, 2024, Canada and the Philippines agreed to renew exploratory discussions towards a potential bilateral free trade agreement. In addition, Global Affairs Canada is launching public consultations and inviting Canadians to submit their views, reflections, and priorities with respect to enhanced trade and investment with the Philippines. Submissions received from these consultations will help define Canada’s interests in and approach to any potential free trade agreement negotiations with the Philippines.
Submission guidelines
More information on the Government’s consultations on a potential free trade agreement with the Philippines can be found on the Consulting with Canadians web page.
All interested parties are invited to submit their views by March 7, 2025. Please be advised that any information received as a result of this consultation will be considered public information unless explicitly requested otherwise. Please read the privacy notice statement carefully prior to sending a written submission.
Submissions should include the following:
- the contributor’s name and address and, if applicable, the name of the contributor’s organization, institution or business;
- the specific issues being addressed; and
- where possible, precise information on the rationale for the positions taken, including any significant impact they may have on Canada’s domestic or international interests.
Contributions can be sent to
Canada-Philippines FTA Consultations
Global Affairs Canada
Indo-Pacific Trade Policy Division
125 Sussex Drive
Ottawa, Ontario
K1N 0G2
Email: Philippines-Consultations@international.gc.ca
Submissions by interested parties
The following are examples of areas where the Government would appreciate receiving views from Canadians:
Trade and investment interests
- Goods of export or import interest (identified by HS/Tariff codes) that would benefit from the expedited or phased-in removal of tariffs and other barriers, as well as any import sensitivities;
- Origin procedures to administer the rules of origin, including any customs processes that may have an impact on accessing preferential tariff treatment;
- Non-tariff barriers (such as import licensing, administration of tariff-rate quotas, taxes, lack of transparency), technical barriers to trade (including technical regulations, standards or conformity assessment procedures), and sanitary and phytosanitary measures;
- Investment barriers, including restrictions imposed on foreign ownership or entry to market, questions of transparency of regulation, and performance requirements;
- Interests related to trade in services, specifically identification of sectors and activities of export interest for Canadian service providers, market access barriers and domestic regulatory measures that either restrict or affect the ability to conduct business or deliver services in the Philippines;
- Temporary entry of business people from Canada into the Philippines and from the Philippines into Canada, including impediments to obtain a work permit to work in the other market on a temporary basis, such as the application of economic needs tests or numerical restrictions;
- Priority government procurement markets for Canadian suppliers in the Philippines, including at the central, regional and local levels; also, the goods, services, and construction services that Canadian suppliers are interested in selling to those government organizations, as well as barriers faced when selling or attempting to sell to the Government of the Philippines and to lower levels of government;
- Any issues affecting business practices when interacting with state-owned enterprises;
- Rules of origin, for specific products or sectors (identified by HS/Tariff codes), that would be required to benefit from preferential tariff treatment;
- Border and customs issues that have an impact on the movement of commercial goods into and out of the Philippines;
- Trade facilitation issues (e.g. impediments related to import procedures);
- Electronic commerce (e.g. any restrictive measures faced by Canadian suppliers of digital products and services in the Philippines, such as requirements for data localization);
- Intellectual property (IP), including any issues with the Philippines’ domestic IP framework (e.g. laws, regulations, policies or procedures) for the administration, protection, and enforcement of IP rights, or other measures that may result in discrimination against foreign IP, such as perceived requirements for the involuntary transfer of IP including the disclosure of trade secrets;
- Competition policy matters, including competition law enforcement or other measures affecting competition in the Philippines;
- Preferred approach to trade remedies to be applied to trade between Canada and the Philippines;
- Any incidents of unfair business practices;
- Development of small and medium-sized enterprises;
- Support and advancement of traditionally underrepresented groups in trade, including women and Indigenous Peoples; and promotion of environmental protection and conservation; and
- Opportunities to advance transparency, anti-corruption and responsible business conduct, and to promote and protect good governance, the rule of law, human rights and labour rights.