Budget Implementation Act, 2019, No. 1 (S.C. 2019, c. 29)
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Assented to 2019-06-21
PART 4Various Measures (continued)
DIVISION 9Regulatory Modernization (continued)
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
- 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
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.
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