GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — 29
29 (2) Section C.08.003 of the Regulations is amended by adding the following after subsection (3.1): (3.2) A supplement to a submission referred to in subsection (1) for a new drug for human use shall contain (a) if a risk management plan for the new drug has not yet been provided to the Minister and one of the circumstances set out in subparagraphs C.08.002(2)(p)(i) or (ii) is met, a risk management plan for the new drug that meets the requirements set out in C.01.701; or (b) if there is already an existing risk management plan as defined in section C.01.700 and one of the circumstances set out in paragraphs C.01.703(a), (b) or C.01.704(1)(b) is met, an updated risk management plan for the new drug that meets the requirements set out in section C.01.701. (4) Subsection C.08.003(7) of the Regulations is replaced by the following: (7) If, at the time the manufacturer files, for a public health emergency drug, a supplement to the new drug submission referred to in subsection (1), the manufacturer is unable to provide the Minister with information or material that relates to any of the matters referred to in paragraphs (2)(d) to (h), subsection (3.2), paragraph (5)(b) and subsection (6) — and, as applicable, the corresponding material referred to in paragraphs C.08.005.1(1)(b) to (d) — or if any of that information or material is incomplete, the manufacturer shall provide the Minister, at that time, with a plan that specifies how and when they will provide the Minister with the missing information or material.
Food and Drug Regulations — 31
31 The Regulations are amended by adding the following after section C.08.003.1: C.08.003.2 In cases where there are significant uncertainties respecting the evidence of the effectiveness of a new drug that was provided in a new drug submission or supplement to a new drug submission, the Minister may, in examining the submission or supplement, take into account whether terms and conditions that may be imposed or amended under section C.01.014.21 would enable the Minister to obtain additional information respecting the uncertainties if (a) the new drug is intended to diagnose, treat, mitigate or prevent a disease, disorder or abnormal physical state, or symptom of a disease, disorder or abnormal physical state, that poses or may pose a serious risk of injury to human or animal health; and (b) either (i) the recommended purpose and conditions of use of the new drug do not fall within the recommended purposes and conditions of use of any other drug for which a drug identification number has been assigned and not been cancelled, or (ii) the recommended purpose and conditions of use of the new drug do fall within the recommended purposes and conditions of use of any other drug for which a drug identification number has been assigned and has not been cancelled, but the Minister has reasonable grounds to believe that the new drug is significantly more effective or poses a significantly lower risk than the other drug.
Food and Drug Regulations — C.08.003.2
C.08.003.2 In cases where there are significant uncertainties respecting the evidence of the effectiveness of a new drug that was provided in a new drug submission or supplement to a new drug submission, the Minister may, in examining the submission or supplement, take into account whether terms and conditions that may be imposed or amended under section C.01.014.21 would enable the Minister to obtain additional information respecting the uncertainties if (a) the new drug is intended to diagnose, treat, mitigate or prevent a disease, disorder or abnormal physical state, or symptom of a disease, disorder or abnormal physical state, that poses or may pose a serious risk of injury to human or animal health; and (b) either (i) the recommended purpose and conditions of use of the new drug do not fall within the recommended purposes and conditions of use of any other drug for which a drug identification number has been assigned and not been cancelled, or (ii) the recommended purpose and conditions of use of the new drug do fall within the recommended purposes and conditions of use of any other drug for which a drug identification number has been assigned and has not been cancelled, but the Minister has reasonable grounds to believe that the new drug is significantly more effective or poses a significantly lower risk than the other drug.
Food and Drug Regulations — 32
32 The Regulations are amended by adding the following after C.08.003.2: C.08.003.3 For greater certainty, the obligation of the manufacturer to provide a risk management plan referred to in paragraph C.08.002(2)(p), subparagraph C.08.002.01(2)(b)(xi) or paragraph C.08.002.1(2)(a.1) or C.08.003(3.2)(a) or an updated risk management plan referred to in paragraph C.08.003(3.2)(b) may arise at any time before the Minister issues a notice of compliance under section C.08.004 or C.08.004.01 or a notice under paragraph C.08.004(3)(b) or C.08.004.01(3)(b).
Food and Drug Regulations — C.08.003.3
C.08.003.3 For greater certainty, the obligation of the manufacturer to provide a risk management plan referred to in paragraph C.08.002(2)(p), subparagraph C.08.002.01(2)(b)(xi) or paragraph C.08.002.1(2)(a.1) or C.08.003(3.2)(a) or an updated risk management plan referred to in paragraph C.08.003(3.2)(b) may arise at any time before the Minister issues a notice of compliance under section C.08.004 or C.08.004.01 or a notice under paragraph C.08.004(3)(b) or C.08.004.01(3)(b).
Food and Drug Regulations — 45
45 (4) Terms and conditions that have been imposed on a drug identification number and that are in effect immediately before the day on which subsection 7 (4) of these Regulations comes into force remain in effect.
Food and Drug Regulations — 46
46 (1) For the purposes of paragraphs C.01.702(1)(a) and C.08.003(3.2)(a) of the Food and Drug Regulations , a risk management plan for the drug is considered to have not yet been provided in the following cases: (a) where no risk management plan for the drug has been provided before the day on which the obligation to provide such a plan under those Regulations comes into force; and (b) where the most recent risk management plan for the drug was provided before the day set out in paragraph (a) but the Minister does not provide, either by that day or after it, an indication to the manufacturer of the drug that the plan was acceptable. (2) The most recent version of the risk management plan for a drug that has been provided to the Minister before the day on which section 8 of these Regulations comes into force and in respect of which the Minister provided, either by that day or after it, an indication that the plan was acceptable is considered to be the existing risk management plan as defined in section C.01.700 of the Food and Drug Regulations .
Food and Drug Regulations — 237
237 Parts G and J of the Food and Drug Regulations 1 are repealed. 1 C.R.C., c. 870
Food and Drug Regulations — 1
1 The definition Act in section A.01.010 of the Food and Drug Regulations 1 is replaced by the following: 1 C.R.C., c. 870 Act means the Food and Drugs Act ; ( Loi )
Food and Drug Regulations — Food and Drug Regulations
Act means the Food and Drugs Act ; ( Loi )
Food and Drug Regulations — 2
2 The definition nurse practitioner in subsection B.25.019(2) of the Regulations is replaced by the following: nurse practitioner has the same meaning as in subsection 1(1) of the Controlled Substances Regulations . ( infirmier praticien )
Food and Drug Regulations — Food and Drug Regulations
nurse practitioner has the same meaning as in subsection 1(1) of the Controlled Substances Regulations . ( infirmier praticien )
Food and Drug Regulations — 3
3 Subparagraphs C.01.004(1)(b)(i) to (iv) of the Regulations are replaced by the following: (i) in the case of a prescription drug, the symbol “Pr”, which must not appear on the label of any other drug, (ii) in the case of a controlled drug , as defined in subsection 1(1) of the Controlled Substances Regulations , other than one contained in a finished product referred to in section 3 of those Regulations, the following symbol in a clear manner and a conspicuous colour and size, Symbol consisting of a diamond-shaped outline where the longest diagonal is vertical and in which an uppercase letter C is centred. (iii) in the case of a narcotic , as defined in subsection 1(1) of the Controlled Substances Regulations , the symbol “N” in a colour contrasting with the rest of the label or in type not less than half the size of any other letter used on the label, and (iv) in the case of a targeted substance , as defined in subsection 1(1) of the Controlled Substances Regulations , the following symbol in a colour contrasting with the rest of the label or in type not less than half the size of any other letter used on the principal display panel, Image showing the bilingual symbol associated with a targeted substance. Text version below. Symbol consisting of a square outline divided diagonally in half from top left corner to bottom right corner. The top right half has an uppercase letter C inside. The lower left half has an uppercase letter T inside.
Food and Drug Regulations — Food and Drug Regulations
Symbol consisting of a square outline divided diagonally in half from top left corner to bottom right corner. The top right half has an uppercase letter C inside. The lower left half has an uppercase letter T inside.
Food and Drug Regulations — 4
4 Paragraph C.01.028(2)(c) of the Regulations is replaced by the following: (c) a prescription drug or a controlled drug , narcotic or targeted substance , as those terms are defined in subsection 1(1) of the Controlled Substances Regulations , that is required by those Regulations to be sold under a prescription , as defined in that subsection.
Food and Drug Regulations — 5
5 (1) The portion of subsection C.01.031.2(1) of the French version of the Regulations before paragraph (a) is replaced by the following: C.01.031.2 (1) Les articles C.01.029 à C.01.031 ne s’appliquent pas aux drogues suivantes : (2) Paragraph C.01.031.2(1)(a) of the Regulations is replaced by the following: (a) a prescription drug or a controlled drug , narcotic or targeted substance , as those terms are defined in subsection 1(1) of the Controlled Substances Regulations , that is required by those Regulations to be sold under a prescription , as defined in that subsection;
Food and Drug Regulations — C.01.031.2
C.01.031.2 (1) Les articles C.01.029 à C.01.031 ne s’appliquent pas aux drogues suivantes :
Food and Drug Regulations — 6
6 Paragraphs C.01.048(1)(a) to (d) of the Regulations are replaced by the following: (a) a controlled drug or narcotic , as those terms are defined in subsection 1(1) of the Controlled Substances Regulations ; or (b) a prescription drug , as defined in subsection 1(2) of the Cannabis Regulations .
Food and Drug Regulations — 7
7 Paragraph C.01.050(4)(b) of the Regulations is replaced by the following: (b) controlled drugs , narcotics or targeted substances , as those terms are defined in subsection 1(1) of the Controlled Substances Regulations , that are required by those Regulations to be sold under a prescription , as defined in that subsection; and
Food and Drug Regulations — 8
8 (1) Paragraph C.01.061(2)(b) of the English version of the Regulations is replaced by the following: (b) no package contains less than the number of dosage units shown on the label except as provided in the table to this section; and (2) Paragraph C.01.061(2)(c) of the Regulations is replaced by the following: (c) in the case of a controlled drug or narcotic , as those terms are defined in subsection 1(1) of the Controlled Substances Regulations , no package contains more than the number of dosage units shown on the label except as provided in the table to this section.
Food and Drug Regulations — 9
9 (1) Paragraph (a) of the definition wholesaler in subsection C.01A.001(1) of the Regulations is replaced by the following: (a) a drug in dosage form that is listed in Schedule C or D to the Act or a prescription drug; (2) Paragraph (c) of the definition wholesaler in subsection C.01A.001(1) of the Regulations is replaced by the following: (c) a controlled drug or narcotic , as those terms are defined in subsection 1(1) of the Controlled Substances Regulations ; or
Food and Drug Regulations — 10
10 Paragraphs C.01A.004(3)(a) to (c) of the Regulations are replaced by the following: (a) in the case of an activity with respect to a controlled drug or narcotic , as those terms are defined in subsection 1(1) of the Controlled Substances Regulations , a dealer’s licence issued under subsection 12(1) of those Regulations; or (b) in the case of an activity with respect to a drug containing cannabis , as defined in subsection 2(1) of the Cannabis Act , a licence issued under that Act to conduct that activity in accordance with the Cannabis Regulations .
Food and Drug Regulations — 11
11 Subparagraph C.01A.005(1)(j)(i) of the Regulations is replaced by the following: (i) for each drug for which the licence is requested that is a controlled drug or narcotic , as those terms are defined in subsection 1(1) of the Controlled Substance Regulations , or a drug containing cannabis , as defined in subsection 2(1) of the Cannabis Act , and
Food and Drug Regulations — 12
12 Item 6 of Table II to section C.01A.008 of the Regulations is replaced by the following: Item Categories of drugs 6 Prescription drugs, drugs that are controlled drugs or narcotics , as those terms are defined in subsection 1(1) of the Controlled Substances Regulations , and drugs containing cannabis , as defined in subsection 2(1) of the Cannabis Act
Food and Drug Regulations — 13
13 (1) The portion of section C.09.001 of the French version of the Regulations before paragraph (a) is replaced by the following: C.09.001 Le présent titre ne s’applique pas aux drogues suivantes : (2) Paragraphs C.09.001(a) and (b) of the Regulations are replaced by the following: (a) a drug that is required by these Regulations to be sold under a prescription; (b) a drug that is a narcotic , as defined in subsection 1(1) of the Controlled Substances Regulations , and that is required by those Regulations to be sold under a prescription , as defined in that subsection; or (c) a drug that is intended for use exclusively in animals.
Food and Drug Regulations — C.09.001
C.09.001 Le présent titre ne s’applique pas aux drogues suivantes :
Food and Drug Regulations — 1
1 Part III of the schedule to Part J of the Food and Drug Regulations 1 is amended by adding the following: 1 C.R.C., c. 870 Item Column 1 Column 2 Substance Period 1 Spirobrorphine (8-[1-(4-bromophenyl)ethyl]-1-phenyl-1,3,8-triazaspiro[4.5]decan-4-one) and its salts June 5, 2026 to September 30, 2026 2 Spirochlorphine (8-[1-(4-chlorophenyl)ethyl]-1-phenyl-1,3,8-triazaspiro[4.5]decan-4-one) and its salts June 5, 2026 to September 30, 2026
Government Annuities Regulations — 1
1 These Regulations may be cited as the Government Annuities Regulations .
Government Annuities Regulations — 2
2 In these Regulations and in any document or table of rates authorized or approved thereunder, Act means the Government Annuities Act ; ( Loi ) Annuity Table for 1983 means (a) in the case of an individual annuity contract, 1983 Table a published in Transactions of the Society of Actuaries , Vol. XXXIII (1981), at page 708, and (b) in the case of a group annuity contract, 1983 Group Annuity Mortality Tables for Males and Females published in Transactions of the Society of Actuaries , Vol. XXXV (1983), at pages 880 and 881. ( table de rente pour 1983 ) application means a document, approved as to form in accordance with section 6, completed and submitted to the Department or Branch by the intended purchaser of an annuity contract; ( proposition ) Branch means the Annuities Branch of the Department; ( division ) Commission [Repealed, SOR/97-495, s. 1] Department means the Department of Human Resources Development. ( ministère ) Director of Annuities means the officer of the Branch so designated; ( directeur des rentes ) effective date as applicable to an annuity contract, unless otherwise defined therein, means the date on which the first premium payment is made; ( date d’entrée en vigueur ) formal contract means a document, approved as to form and executed in accordance with section 6, issued to a purchaser as evidence of annuity contract entered into under the Act; ( contrat formel ) formal endorsement means an endorsement, written upon or attached to a formal contract before or after issue, with the consent of the contracting parties and executed in accordance with section 6. ( avenant formel ) SOR/97-495, s. 1
Government Annuities Regulations — Government Annuities Regulations
Act means the Government Annuities Act ; ( Loi )
Government Annuities Regulations — (a)
Annuity Table for 1983 means (a) in the case of an individual annuity contract, 1983 Table a published in Transactions of the Society of Actuaries , Vol. XXXIII (1981), at page 708, and (b) in the case of a group annuity contract, 1983 Group Annuity Mortality Tables for Males and Females published in Transactions of the Society of Actuaries , Vol. XXXV (1983), at pages 880 and 881. ( table de rente pour 1983 )
Government Annuities Regulations — Government Annuities Regulations
application means a document, approved as to form in accordance with section 6, completed and submitted to the Department or Branch by the intended purchaser of an annuity contract; ( proposition )
Government Annuities Regulations — Government Annuities Regulations
Branch means the Annuities Branch of the Department; ( division )
Government Annuities Regulations — Government Annuities Regulations
Department means the Department of Human Resources Development. ( ministère )
Government Annuities Regulations — Government Annuities Regulations
Director of Annuities means the officer of the Branch so designated; ( directeur des rentes )
Government Annuities Regulations — Government Annuities Regulations
effective date as applicable to an annuity contract, unless otherwise defined therein, means the date on which the first premium payment is made; ( date d’entrée en vigueur )
Government Annuities Regulations — Government Annuities Regulations
formal contract means a document, approved as to form and executed in accordance with section 6, issued to a purchaser as evidence of annuity contract entered into under the Act; ( contrat formel )
Government Annuities Regulations — Government Annuities Regulations
formal endorsement means an endorsement, written upon or attached to a formal contract before or after issue, with the consent of the contracting parties and executed in accordance with section 6. ( avenant formel )
Government Annuities Regulations — 4
4 (1) The mortality tables to be used in the preparation of tables for determining the values of annuities shall be computed as follows: (a) the basic table shall be the Annuity Table for 1949 (without projection) for males and females published in Transactions of the Society of Actuaries Vol. I, pages 386-389, (b) the mortality rates of the Annuity Table referred to in paragraph (a) shall be modified by Projection Scale C, published in Transactions of the Society of Actuaries Vol. IV, page 272, the rates of decrease for intermediate ages being found by direct interpolation between adjacent quinquennial ages, and (c) the modified mortality rates computed in accordance with paragraphs (a) and (b) shall be used to produce a series of generation mortality tables as set forth herein, except that the mortality rate for any age falling in a calendar year prior to 1950 shall be the mortality rate for that age according to the basic table referred to in paragraph (a), and each table shall apply to annuitants born in the calendar years as follows: Generation Table in which age 65 occurs in the calendar year Applies to annuitants born in the calendar years 1945 1890 and before 1955 1891-1900 1965 1901-1910 1975 1911-1920 1985 1921-1930 1995 1931-1940 2005 1941-1950 2015 1951-1960 2025 1961-1970 (2) In determining the value of an annuity payable in accordance with paragraph 4(b) of the Act, the following modification in the use of the mortality tables computed in accordance with subsection (1) shall apply: (a) where one annuitant is a male and the other is a female the joint annuity required in determining the value of the annuity shall be computed as though the female life belonged to the same generation as the male life, or (b) where both annuitants are of the same sex, the joint annuity required in determining the value of the annuity shall be computed as though both lives belonged to the generation of the older life. (3) In determining the values of annuities purchased by group annuity contracts entered into pursuant to subsection 6(3) of the Act, the mortality rates for a male life shall be taken as the rates for the age one year older than the actual age. (4) [Repealed, SOR/97-495, s. 3] SOR/97-495, s. 3
Government Annuities Regulations — 5
5 (1) Notwithstanding sections 3 and 4, (a) where a person, prior to April 19, 1948, ceased to be employed by an employer who entered into a contract pursuant to subsection 6(3) of the Act, received from the Minister a statement of the annuity payable to him under the contract containing the following words: “This contract witnesseth further that in consideration of the payment of premiums in any other manner than above indicated, such annuity shall be paid at the date of maturity of this contract as such premiums will purchase according to the rates of mortality and interest in effect on the date of inclusion of the annuitant under the Group Annuity Contract, provided, however, that the total annuity payable to the Annuitant hereunder and under any other Canadian Government Annuity Contracts shall not exceed $1,200 per year” or words to the like effect, or (b) where a person was included as an employee under such a contract made prior to April 19, 1948, and the contract or the agreement between the employer and his employees pursuant to which the contract was made included the following provision: “TERMINATION OF EMPLOYMENT” “If for any reason other than his death a member should cease to be employed by the employer before his Normal Retirement Date, the total of the contributions which he has made under the Plan will remain at his credit with the Government, to provide him with an annuity commencing at Normal Retirement Date, or any earlier anniversary thereof.  The member will have the privilege of continuing contributions in order to increase the amount of his annuity” or words to the like effect, and such person purchased or purchases on his own life an annuity with the same day of commencement and duration as that of the annuity payable to him under the contract referred to in paragraph (a), the rate of interest and the mortality table for computing the purchase price of the annuity purchased by that person shall be the rate of interest and the mortality table authorized for use in computing the purchase price of annuities on the date of his inclusion as an employee under the contract referred to in paragraph (a). (2) Subsection (1) applies only if the total annuities payable to a person under the contracts referred to therein would not exceed the maximum amount authorized for payment to any person under the Act at the date of the inclusion of that person as an employee under the contract referred to in paragraph (1)(a).
Government Annuities Regulations — Government Annuities Regulations
“This contract witnesseth further that in consideration of the payment of premiums in any other manner than above indicated, such annuity shall be paid at the date of maturity of this contract as such premiums will purchase according to the rates of mortality and interest in effect on the date of inclusion of the annuitant under the Group Annuity Contract, provided, however, that the total annuity payable to the Annuitant hereunder and under any other Canadian Government Annuity Contracts shall not exceed $1,200 per year”