Budget Implementation Act, 2019, No. 1 (S.C. 2019, c. 29)
Full Document:
- HTMLFull Document: Budget Implementation Act, 2019, No. 1 (Accessibility Buttons available) |
- PDFFull Document: Budget Implementation Act, 2019, No. 1 [3167 KB]
Assented to 2019-06-21
PART 4Various Measures (continued)
DIVISION 9Regulatory Modernization (continued)
SUBDIVISION BR.S., c. E-4Electricity and Gas Inspection Act
162 The Electricity and Gas Inspection Act is amended by adding the following after section 28:
Marginal note:Ministerial regulations
28.1 (1) Despite anything in the Weights and Measures Act, the Minister may make regulations prescribing units of measurement for electricity and gas sales in addition to the units specified in section 3.
Marginal note:Expiry
(2) A regulation made under subsection (1) ceases to have effect on the earliest of
(a) the day on which a regulation made under paragraph 28(1)(b) that has the same effect as the regulation comes into force,
(b) the third anniversary of the day on which the regulation made under subsection (1) comes into force, or
(c) the day on which it is repealed.
SUBDIVISION CR.S., c. F-27Food and Drugs Act
Amendments to the Act
Marginal note:R.S., c. 27 (1st Supp.), s. 191; 2014, c. 24, s. 2(3)
163 (1) The definitions sell and therapeutic product authorization in section 2 of the Food and Drugs Act are replaced by the following:
- sell
sell includes
(a) offer for sale, expose for sale or have in possession for sale — or distribute to one or more persons, whether or not the distribution is made for consideration, and
(b) lease, offer for lease, expose for lease or have in possession for lease; (vente)
- therapeutic product authorization
therapeutic product authorization means
(a) an authorization, including a licence, that authorizes, as the case may be, the import, sale, advertisement, manufacture, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product and that is issued under subsection 21.92(1) or the regulations, or
(b) an authorization, including a licence, that would fall within paragraph (a) if the authorization were not suspended; (autorisation relative à un produit thérapeutique)
(2) The definition therapeutic product authorization in section 2 of the Act is replaced by the following:
- therapeutic product authorization
therapeutic product authorization means
(a) an authorization, including a licence, that
(i) authorizes the conduct of a clinical trial in respect of a therapeutic product and is issued under the regulations, or
(ii) authorizes, as the case may be, the import, sale, advertisement, manufacture, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product and is issued under subsection 21.92(1) or the regulations, or
(b) an authorization, including a licence, that would fall within paragraph (a) if the authorization were not suspended; (autorisation relative à un produit thérapeutique)
(3) Section 2 of the Act is amended by adding the following in alphabetical order:
- advanced therapeutic product
advanced therapeutic product means a therapeutic product that is described in Schedule G or that belongs to a class of therapeutic products that is described in that Schedule; (produit thérapeutique innovant)
(4) Section 2 of the Act is amended by adding the following in alphabetical order:
- clinical trial
clinical trial means a study, involving human subjects, for the purpose of discovering or verifying the effects of a drug, a device or a food for a special dietary purpose; (essai clinique)
- food for a special dietary purpose
food for a special dietary purpose means a food that has been specially processed or formulated
(a) to meet the particular requirements of an individual in whom a physical or physiological condition exists as a result of a disease, disorder or abnormal physical state, or
(b) to be the sole or primary source of nutrition for an individual; (aliment à des fins diététiques spéciales)
164 The Act is amended by adding the following after section 2.3:
Marginal note:Classification — thing
2.4 (1) If the Minister believes that a thing falls within two or more of the definitions food, drug, cosmetic and device in section 2, the Minister may, by order, add a description of the thing to a single part of Schedule A that corresponds to one of the definitions in which the thing is believed to fall.
Marginal note:Classification — class of things
(2) If the Minister believes that every thing in a class of things falls within the same two or more definitions food, drug, cosmetic and device in section 2, the Minister may, by order, add a description of the class to a single part of Schedule A that corresponds to one of the definitions in which the things in the class are believed to fall.
Marginal note:Factors
(3) Before adding a description of a thing or a class of things to a part of Schedule A, the Minister shall consider the following factors:
(a) the risk of injury that the thing or things present to human health;
(b) the protection and promotion of health;
(c) the possibility of a person being deceived or misled;
(d) the purposes for which the thing or things are sold, represented or used and the history of use of the thing or things;
(e) the treatment of similar things that have been regulated as foods, drugs, cosmetics or devices under this Act; and
(f) the prescribed factors, if any.
Marginal note:Effect of addition
(4) A thing that either is described in or belongs to a class of things that is described in
(a) Part 1 of Schedule A falls within the definition food in section 2 and does not fall within any of the other definitions referred to in subsections (1) and (2);
(b) Part 2 of Schedule A falls within the definition drug in section 2 and does not fall within any of the other definitions referred to in subsections (1) and (2);
(c) Part 3 of Schedule A falls within the definition cosmetic in section 2 and does not fall within any of the other definitions referred to in subsections (1) and (2); and
(d) Part 4 of Schedule A falls within the definition device in section 2 and does not fall within any of the other definitions referred to in subsections (1) and (2).
Marginal note:Deletion from Schedule A
(5) The Minister may, by order, delete the description of a thing or a class of things from Schedule A.
Marginal note:Interpretation — definitions food, drug, cosmetic and device
(6) For greater certainty, the definitions food, drug, cosmetic and device in section 2 are subject to subsection (4).
Marginal note:1993, c. 34, s. 72(F)
165 Subsections 3(1) and (2) of the Act are replaced by the following:
Marginal note:Prohibited advertising
3 (1) No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1.
Marginal note:Prohibited sales
(2) No person shall sell any food, drug, cosmetic or device if
(a) it is represented by label as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1; or
(b) the person advertises it to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1.
166 The Act is amended by adding the following after section 3:
Marginal note:Prohibition — clinical trials
3.1 No person shall conduct a clinical trial in respect of a drug, device or prescribed food for a special dietary purpose unless the person holds an authorization issued under the regulations that authorizes the conduct of the clinical trial.
Marginal note:Terms and conditions — clinical trial authorizations
3.2 The holder of an authorization referred to in section 3.1 shall comply with any terms and conditions of the authorization that are imposed by the Minister under regulations made under paragraph 30(1)(b.3).
Marginal note:Duty to publicize clinical trial information
3.3 The holder of an authorization referred to in section 3.1 shall ensure that prescribed information concerning the clinical trial is made public within the prescribed time and in the prescribed manner.
Marginal note:2014, c. 24, s. 3
167 Section 21.7 of the Act is replaced by the following:
Marginal note:Terms and conditions of authorizations
21.7 The holder of a therapeutic product authorization shall comply with any terms and conditions of the authorization that are imposed by the Minister under subsection 21.92(3) or under regulations made under paragraph 30(1.2)(b).
Marginal note:2014, c. 24, s. 3
168 (1) Section 21.71 of the French version of the Act is replaced by the following:
Marginal note:Essais cliniques ou expérimentaux
21.71 Le titulaire d’une autorisation relative à un produit thérapeutique visée à l’alinéa 30(1.2)c) veille à rendre publics, selon les modalités réglementaires — de temps ou autres —, les renseignements réglementaires concernant les essais cliniques ou expérimentaux.
(2) Section 21.71 of the Act is replaced by the following:
Marginal note:Duty to publicize clinical trial information
21.71 The holder of a therapeutic product authorization referred to in paragraph 30(1.2)(c) shall ensure that prescribed information concerning the clinical trial is made public within the prescribed time and in the prescribed manner.
169 The Act is amended by adding the following after section 21.8:
Advanced Therapeutic Products
Marginal note:Prohibited activities
21.9 (1) No person shall import, sell, advertise, manufacture, prepare, preserve, package, label, store or test an advanced therapeutic product unless the person
(a) holds a licence in respect of that product that was issued under subsection 21.92(1) and that authorizes the activity in question;
(b) is authorized under an order made under subsection 21.95(1) to conduct the activity in question in respect of the product; or
(c) conducts the activity in question in accordance with the regulations.
Marginal note:Clarification
(2) For greater certainty, the prohibition applies in respect of an activity regardless of whether the activity is conducted for the purpose of the sale or use of the advanced therapeutic product.
Marginal note:Additions to Schedule G
21.91 (1) For the purpose of preventing injury to health or preventing a person from being deceived or misled, the Minister may, by order, add a description of a therapeutic product or a class of therapeutic products to Schedule G if the Minister believes that the therapeutic product or products represent an emerging or innovative technological, scientific or medical development.
Marginal note:Factors
(2) Before adding a description of a therapeutic product or a class of therapeutic products to Schedule G, the Minister shall consider the following factors:
(a) the degree of uncertainty respecting the risks and benefits associated with the therapeutic product or products and the measures that are available to adequately manage and control those risks;
(b) the extent to which the therapeutic product or products are different from therapeutic products for which therapeutic product authorizations have been issued under the regulations;
(c) the extent to which existing legal frameworks are adequate to prevent injury to health or to prevent persons from being deceived or misled; and
(d) the prescribed factors, if any.
Marginal note:Deletion from Schedule G
(3) The Minister may, by order, delete the description of a therapeutic product or a class of therapeutic products from Schedule G.
Marginal note:Advanced therapeutic product licence
21.92 (1) Subject to the regulations, the Minister may, on application, issue or amend an advanced therapeutic product licence that authorizes a person to import, sell, advertise, manufacture, prepare, preserve, package, label, store or test an advanced therapeutic product if the Minister believes that the applicant has provided sufficient evidence to support the conclusion that
(a) the benefits associated with the product outweigh the risks; and
(b) the risks associated with the product and the activity will be adequately managed and controlled.
Marginal note:Application
(2) An application for an advanced therapeutic product licence, or for its amendment, shall be filed with the Minister in the form and manner specified by the Minister and shall set out the information required by the Minister as well as any prescribed information.
Marginal note:Terms and conditions
(3) The Minister may impose terms and conditions on an advanced therapeutic product licence, including an existing licence, or amend them.
Marginal note:Suspension and revocation
21.93 (1) Subject to the regulations, the Minister may suspend or revoke an advanced therapeutic product licence, in whole or in part, if
(a) the Minister believes that the risks that are associated with the advanced therapeutic product outweigh the benefits;
(b) the Minister believes that the risks associated with the product or any authorized activity are not being adequately managed or controlled;
(c) in the case of a suspension, any prescribed circumstance exists; or
(d) in the case of a revocation, any prescribed circumstance exists.
Marginal note:Suspension without prior notice
(2) If the Minister believes that an immediate suspension is necessary to prevent injury to health, the Minister may suspend an advanced therapeutic product licence, in whole or in part, without prior notice to its holder and regardless of whether any of the circumstances referred to in subsection (1) exists.
Marginal note:Exemption
21.94 The holder of an advanced therapeutic product licence is, in respect of the activities authorized under the licence, exempt from the provisions of the regulations other than any provisions that are specified in regulations made under paragraph 30(1.2)(b.2).
Marginal note:Order — advanced therapeutic products
21.95 (1) The Minister may make an order, with or without terms and conditions, that authorizes any person within a class of persons that is specified in the order to import, sell, advertise, manufacture, prepare, preserve, package, label, store or test an advanced therapeutic product.
Marginal note:Additional content
(2) The Minister may, in the order,
(a) specify provisions of the regulations that are excluded from the scope of the exemption provided for in section 21.96; and
(b) establish classes and distinguish among those classes.
Marginal note:Compliance with terms and conditions
(3) A person that conducts an activity under the order shall comply with any applicable terms and conditions.
Marginal note:Exemption
21.96 A person that conducts an activity under an order made under subsection 21.95(1) is, in respect of the activity, exempt from the provisions of the regulations other than any provisions that are specified in the order or in regulations made under paragraph 30(1.2)(b.2).
Page Details
- Date modified: