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 (continued)
Marginal note:R.S., c. 31 (1st Supp.), ss. 11(1) and (2); R.S., c. 27 (3rd Supp.), s. 2
170 Section 23 of the Act is replaced by the following:
Marginal note:Provision of documents, information or samples
22.1 (1) An inspector may, for a purpose related to verifying compliance or preventing non-compliance with the provisions of this Act or the regulations, order a person to provide, on or before the date and time specified by the inspector and at the place and in the manner specified by the inspector, any document, information or sample specified by the inspector.
Marginal note:Duty to provide
(2) A person that is ordered by an inspector to provide a document, information or a sample shall do so on or before the date and time, and at the place and in the manner, specified by the inspector.
Marginal note:Powers of inspectors
23 (1) Subject to subsection (9), an inspector may, for a purpose related to verifying compliance or preventing non-compliance with the provisions of this Act or the regulations, enter any place, including a conveyance, in which they believe on reasonable grounds
(a) an activity that may be regulated under this Act is being conducted;
(b) any article to which this Act or the regulations apply is located; or
(c) an activity could be conducted under an authorization, including a licence, for which an application is under consideration by the Minister.
Marginal note:Other powers
(2) The inspector may, in the place entered under subsection (1),
(a) examine any article to which this Act or the regulations apply or anything that the inspector believes on reasonable grounds is used or is capable of being used for an activity regulated under this Act;
(b) open and examine any receptacle or package that the inspector believes on reasonable grounds contains any article to which this Act or the regulations apply;
(c) examine — and make copies of or take extracts from — any record, report, electronic data or other document that is found at the place and that the inspector believes on reasonable grounds includes information relevant to the administration of this Act or the regulations;
(d) cause to be reproduced any electronic data referred to in paragraph (c);
(e) use, or cause to be used, any computer system or telecommunication system at the place;
(f) examine — and reproduce or cause to be reproduced — any electronic data that is contained in or available to a system referred to in paragraph (e) and that the inspector believes on reasonable grounds includes information relevant to the administration of this Act or the regulations;
(g) remove, for examination or copying, any copies made or extracts taken under paragraph (c), (d) or (f);
(h) test anything that the inspector believes on reasonable grounds is an article to which this Act or the regulations apply;
(i) take samples of any food, drug, cosmetic, device or anything used for an activity regulated under this Act;
(j) take photographs and make recordings and sketches;
(k) remove anything from the place for the purpose of examination, conducting tests or taking samples; and
(l) seize and detain for the time that may be necessary any article that the inspector believes on reasonable grounds is an article by means of, or in relation to which, any provision of this Act or the regulations has been contravened.
Marginal note:Means of telecommunication
(3) For the purposes of subsection (1), an inspector is considered to have entered a place when they access it remotely by a means of telecommunication.
Marginal note:Limitation — access by means of telecommunication
(4) An inspector who enters remotely, by a means of telecommunication, a place that is not accessible to the public shall do so with the knowledge of the owner or person in charge of the place and only for the period necessary for the purpose referred to in subsection (1).
Marginal note:Stopping or moving conveyance
(5) For the purpose of entering a conveyance, an inspector may order the owner or person having possession, care or control of the conveyance to stop it or move it.
Marginal note:Duty to comply
(6) An owner or person who, under subsection (5), is ordered to stop or move a conveyance shall stop or move it.
Marginal note:Individual accompanying inspector
(7) An inspector may be accompanied by any other individual that the inspector believes is necessary to help them exercise their powers or perform their duties or functions under this section.
Marginal note:Entering private property
(8) An inspector and any individual accompanying them may enter and pass through private property, other than a dwelling-house on that property, in order to gain entry to a place referred to in subsection (1). For greater certainty, they are not liable for doing so.
Marginal note:Warrant to enter dwelling-house
(9) In the case of a dwelling-house, an inspector may enter it only with the consent of the occupant or under the authority of a warrant issued under subsection (10).
Marginal note:Authority to issue warrant
(10) A justice of the peace may, on ex parte application, issue a warrant authorizing the inspector named in it to enter a dwelling-house, subject to any conditions specified in the warrant, if the justice is satisfied by information on oath that
(a) the dwelling-house is a place referred to in subsection (1);
(b) entry to the dwelling-house is necessary for a purpose referred to in that subsection; and
(c) entry to the dwelling-house has been refused or there are reasonable grounds to believe that it will be refused.
Marginal note:Use of force
(11) In executing a warrant issued under subsection (10), an inspector shall not use force unless they are accompanied by a peace officer and the use of force is specifically authorized in the warrant.
Marginal note:Telewarrant
(12) If an inspector believes that it would not be practical to appear personally to make an application for a warrant under subsection (10), a warrant may be issued by telephone or other means of telecommunication on information on oath submitted by telephone or other means of telecommunication and section 487.1 of the Criminal Code applies for that purpose with any necessary modifications.
Marginal note:Assistance to inspector
(13) The owner or other person in charge of a place entered by an inspector under subsection (1) and every individual found there shall
(a) give the inspector all reasonable assistance; and
(b) provide the inspector with any information that the inspector may reasonably require, including information that is necessary to establish their identity to the inspector’s satisfaction.
Marginal note:Definition of article to which this Act or the regulations apply
(14) In subsections (1) and (2), article to which this Act or the regulations apply includes
(a) any food, drug, cosmetic or device;
(b) anything used for an activity regulated under this Act; and
(c) any record, report, electronic data or other document — including any labelling or advertising material — relating to the administration of this Act or the regulations.
171 The Act is amended by adding the following after section 27.2:
Preventive and Remedial Measures
Marginal note:Measures
27.3 (1) If the Minister has reasonable grounds to believe that a person has contravened, or is likely to contravene, this Act or the regulations, the Minister may order the person to take any measures that the Minister considers necessary to remedy the contravention or prevent it.
Marginal note:Duty to take measures
(2) A person that is ordered to take measures shall take them.
172 (1) Subsection 30(1) of the Act is amended by adding the following after paragraph (a):
(a.1) respecting consultations in respect of orders referred to in section 2.4;
(2) Subsection 30(1) of the Act is amended by adding the following after paragraph (b):
(b.1) respecting the conduct of clinical trials;
(b.2) respecting the issuance of authorizations referred to in section 3.1 and the amendment, suspension and revocation of those authorizations;
(b.3) authorizing the Minister to impose terms and conditions on authorizations referred to in section 3.1, including existing authorizations, and to amend those terms and conditions;
(b.4) requiring the Minister to ensure that decisions with regard to the issuance, amendment, suspension and revocation of authorizations referred to in section 3.1, and to the imposition and amendment of terms and conditions referred to in paragraph (b.3), along with the reasons for those decisions, are publicly available;
(b.5) requiring holders of an authorization referred to in section 3.1, or former holders of such an authorization, to provide the Minister, after the clinical trial to which the authorization relates is completed or discontinued or, if the authorization is suspended or revoked, after the suspension or revocation, with safety information that the holders or former holders receive or become aware of about the drug, device or food for a special dietary purpose that is or was the subject of the clinical trial;
Marginal note:2016, c. 9, s. 8(2)
(3) Paragraph 30(1)(f) of the Act is replaced by the following:
(f) requiring persons that sell food, drugs, cosmetics or devices, or persons that import them solely for the purpose of export, to maintain any records, reports, electronic data or other documents that the Governor in Council considers necessary for the purposes of this Act;
(4) Paragraph 30(1)(m) of the Act is replaced by the following:
(m) adding anything to any of the schedules, other than to Schedule A or G, in the interest of, or for the prevention of injury to, the health of the purchaser or consumer, or deleting anything from any of the schedules, other than from Schedule A or G;
Marginal note:2014, c. 24, s. 6(1)
(5) Paragraph 30(1.2)(b.1) of the Act is replaced by the following:
(b.1) requiring the Minister to ensure that decisions with regard to the issuance, amendment, suspension and revocation of authorizations referred to in paragraph (a), and to the imposition and amendment of terms and conditions in respect of those authorizations, along with the reasons for those decisions, are publicly available;
(b.2) specifying provisions of the regulations that are excluded from the exemption provided for in section 21.94 or 21.96;
Marginal note:2014, c. 24, s. 6(1)
(6) Paragraph 30(1.2)(c) of the French version of the Act is replaced by the following:
c) enjoignant au titulaire d’une autorisation relative à un produit thérapeutique permettant l’importation ou la vente d’un tel produit pour un essai clinique ou pour un essai expérimental sur des sujets humains, ou à l’ancien titulaire d’une telle autorisation, de fournir au ministre, après la fin ou la cessation de l’essai — ou, si l’autorisation est suspendue ou révoquée, après cette suspension ou révocation —, les renseignements sur la sécurité de ce produit dont il a reçu communication ou a connaissance;
(7) Paragraph 30(1.2)(c) of the Act is replaced by the following:
(c) requiring holders of a therapeutic product authorization that authorizes the import or sale of a therapeutic product for a clinical trial, or former holders of such an authorization, to provide the Minister, after the trial is completed or discontinued, or, if the authorization is suspended or revoked, after the suspension or revocation, with safety information that the holders or former holders receive or become aware of about the therapeutic product;
Marginal note:2014, c. 24, s. 6(1)
(8) Paragraph 30(1.2)(c.1) of the Act is repealed.
Marginal note:2014, c. 24, s. 6(1)
(9) The portion of paragraph 30(1.2)(d) of the French version of the Act before subparagraph (i) is replaced by the following:
d) enjoignant au titulaire d’une autorisation relative à un produit thérapeutique de fournir au ministre les renseignements dont il a reçu communication ou a connaissance concernant tout risque grave de préjudice à la santé humaine et se rapportant à la sécurité de ce produit, à savoir ceux qui concernent :
Marginal note:2014, c. 24, s. 6(5)
(10) The portion of subsection 30(2) of the French version of the Act before paragraph (a) is replaced by the following:
Marginal note:Règlements relatifs aux drogues fabriquées à l’étranger
(2) Sans que soit limité le pouvoir conféré par les autres paragraphes du présent article, le gouverneur en conseil peut, par règlement, selon qu’il l’estime nécessaire pour la protection du public à l’égard de la sécurité et de la qualité d’une drogue ou catégorie de drogues fabriquée à l’extérieur du pays, régir, réglementer ou interdire :
173 (1) Section 31.1 of the Act is renumbered as subsection 31.1(1) and is amended by adding the following:
Marginal note:Clarification
(2) For greater certainty, subsection (1) applies in respect of the following provisions of this Act:
(a) section 3, if the contravention of that section involves food;
(b) subsection 22.1(2), if the contravention of that subsection involves any document or information that relates to food or a sample that is or relates to food;
(c) subsection 23(6), if the contravention of that subsection involves a conveyance in respect of which an inspector is exercising powers or performing duties or functions in relation to food;
(d) subsection 23(13), if the contravention of that subsection involves a place in which an inspector is exercising powers or performing duties or functions in relation to food;
(e) subsection 24(1), if the contravention of that subsection involves the obstruction or hindering of — or the making of a false or misleading statement to — an inspector who is carrying out duties or functions in relation to food;
(f) subsection 24(2), if the contravention of that subsection involves anything seized that is or relates to food; and
(g) subsection 27.3(2), if the contravention of that subsection involves measures that were ordered to be taken in relation to food.
(2) Subsection 31.1(2) of the Act is amended by adding the following after paragraph (a):
(a.1) section 3.1 or 3.3, if the contravention of that section involves a clinical trial that relates to food;
(a.2) section 3.2, if the contravention of that section involves the terms and conditions of an authorization that authorizes the conduct of a clinical trial that relates to food;
174 (1) Section 31.2 of the Act is renumbered as subsection 31.2(1) and is amended by adding the following:
Marginal note:Clarification
(2) For greater certainty, subsection (1) applies in respect of the following provisions of this Act:
(a) section 3, if the contravention of that section involves a therapeutic product;
(b) subsection 22.1(2), if the contravention of that subsection involves any document or information that relates to a therapeutic product or a sample that is or relates to a therapeutic product;
(c) subsection 23(6), if the contravention of that subsection involves a conveyance in respect of which an inspector is exercising powers or performing duties or functions in relation to a therapeutic product;
(d) subsection 23(13), if the contravention of that subsection involves a place in which an inspector is exercising powers or performing duties or functions in relation to a therapeutic product;
(e) subsection 24(1), if the contravention of that subsection involves the obstruction or hindering of — or the making of a false or misleading statement to — an inspector who is carrying out duties or functions in relation to a therapeutic product;
(f) subsection 24(2), if the contravention of that subsection involves anything seized that is or relates to a therapeutic product; and
(g) subsection 27.3(2), if the contravention of that subsection involves measures that were ordered to be taken in relation to a therapeutic product.
(2) Subsection 31.2(2) of the Act is amended by adding the following after paragraph (a):
(a.1) section 3.1 or 3.3, if the contravention of that section involves a clinical trial that relates to a therapeutic product;
(a.2) section 3.2, if the contravention of that section involves the terms and conditions of an authorization that authorizes the conduct of a clinical trial that relates to a therapeutic product;
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