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Food and Drugs Act (R.S.C., 1985, c. F-27)

Full Document:  

Act current to 2024-03-06 and last amended on 2023-12-22. Previous Versions

PART IIAdministration and Enforcement (continued)

Offences and Punishment (continued)

Marginal note:Due diligence

 Due diligence is a defence in a prosecution for an offence under this Act, other than an offence under section 31.4.

  • 2014, c. 24, s. 9

Marginal note:Offences — section 21.6 and serious risk

  •  (1) A person who contravenes section 21.6, or who knowingly or recklessly causes a serious risk of injury to human health in contravening another provision of this Act or the regulations, as it relates to a therapeutic product, or an order made under any of sections 21.1 to 21.32 is guilty of an offence and liable

    • (a) on conviction on indictment, to a fine the amount of which is at the discretion of the court or to imprisonment for a term not exceeding five years or to both; and

    • (b) on summary conviction, for a first offence, to a fine not exceeding $500,000 or to imprisonment for a term not exceeding 18 months or to both and, for a subsequent offence, to a fine not exceeding $1,000,000 or to imprisonment for a term not exceeding two years or to both.

  • 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;

    • (a.1) section 3.1, 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;

    • (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.

Marginal note:Sentencing considerations

 A court that imposes a sentence for an offence under section 31.2 or 31.4 shall take into account, in addition to any other principles that it is required to consider, the following factors:

  • (a) the harm or risk of harm caused by the commission of the offence; and

  • (b) the vulnerability of consumers of the therapeutic product.

  • 2014, c. 24, s. 9

Marginal note:Parties to offence

 If a person other than an individual commits an offence under section 31.2, or commits an offence under section 31.4 by reason of contravening section 21.6, then any of the person’s directors, officers or agents or mandataries who directs, authorizes, assents to or acquiesces or participates in the commission of the offence is a party to the offence and is liable on conviction to the punishment provided for by this Act, even if the person is not prosecuted for the offence.

  • 2014, c. 24, s. 9

Marginal note:Continuing offence

 If an offence under section 31.2 or 31.4 is committed or continued on more than one day, it constitutes a separate offence for each day on which it is committed or continued.

  • 2014, c. 24, s. 9

Marginal note:Limitation period

  •  (1) A prosecution for a summary conviction offence under this Act may be instituted at any time within two years after the time the subject-matter of the prosecution becomes known to the Minister or, in the case of a contravention of a provision of the Act that relates to food, to the Minister of Agriculture and Agri-Food.

  • Marginal note:Minister’s certificate

    (2) A document purporting to have been issued by the Minister referred to in subsection (1), certifying the day on which the subject-matter of any prosecution became known to the Minister, is admissible in evidence without proof of the signature or official character of the person appearing to have signed the document and is evidence of the matters asserted in it.

  • R.S., 1985, c. F-27, s. 32
  • 1997, c. 6, s. 66

Marginal note:Venue

 A prosecution for a contravention of this Act or the regulations may be instituted, heard, tried or determined in the place in which the offence was committed or the subject-matter of the prosecution arose or in any place in which the accused is apprehended or happens to be.

  • R.S., c. F-27, s. 28

Marginal note:Want of knowledge

  •  (1) Subject to subsection (2), in a prosecution for the sale of any article in contravention of this Act, except Parts III and IV, or of the regulations made under this Part, if the accused proves to the satisfaction of the court or judge that

    • (a) the accused purchased the article from another person in packaged form and sold it in the same package and in the same condition the article was in at the time it was so purchased, and

    • (b) that the accused could not with reasonable diligence have ascertained that the sale of the article would be in contravention of this Act or the regulations,

    the accused shall be acquitted.

  • Marginal note:Notice of reliance on want of knowledge

    (2) Subsection (1) does not apply in any prosecution unless the accused, at least ten days before the day fixed for the trial, has given to the prosecutor notice in writing that the accused intends to avail himself of the provisions of subsection (1) and has disclosed to the prosecutor the name and address of the person from whom the accused purchased the article and the date of purchase.

  • R.S., c. F-27, ss. 29, 39, 46

Marginal note:Certificate of analyst

  •  (1) Subject to this section, in any prosecution for an offence under any of sections 31 to 31.2 and 31.4, a certificate purporting to be signed by an analyst and stating that an article, sample or substance has been submitted to, and analysed or examined by, the analyst and stating the results of the analysis or examination is admissible in evidence and, in the absence of evidence to the contrary, is proof of the statements contained in the certificate without proof of the signature or official character of the person appearing to have signed it.

  • Marginal note:Requiring attendance of analyst

    (2) The party against whom a certificate of an analyst is produced pursuant to subsection (1) may, with leave of the court, require the attendance of the analyst for the purposes of cross-examination.

  • Marginal note:Notice of intention to produce certificate

    (3) No certificate shall be admitted in evidence pursuant to subsection (1) unless, before the trial, the party intending to produce the certificate has given reasonable notice of that intention, together with a copy of the certificate, to the party against whom it is intended to be produced.

  • Marginal note:Proof of service

    (4) For the purposes of this Act, service of any certificate referred to in subsection (1) may be proved by oral evidence given under oath by, or by the affidavit or solemn declaration of, the person claiming to have served it.

  • Marginal note:Attendance for examination

    (5) Notwithstanding subsection (4), the court may require the person who appears to have signed an affidavit or solemn declaration referred to in that subsection to appear before it for examination or cross-examination in respect of the issue of proof of service.

  • R.S., 1985, c. F-27, s. 35
  • R.S., 1985, c. 27 (1st Supp.), s. 192
  • 1996, c. 19, s. 78
  • 2014, c. 24, s. 12

Marginal note:Proof as to manufacturer or packager

  •  (1) In a prosecution for a contravention of this Act or of the regulations made under this Part, proof that a package containing any article to which this Act or the regulations apply bore a name or address purporting to be the name or address of the person by whom it was manufactured or packaged is, in the absence of evidence to the contrary, proof that the article was manufactured or packaged, as the case may be, by the person whose name or address appeared on the package.

  • Marginal note:Offence by employee or agent

    (2) In a prosecution for a contravention described in subsection (1), it is sufficient proof of the offence to establish that it was committed by an employee or agent of the accused whether or not the employee or agent is identified or has been prosecuted for the offence.

  • Marginal note:Certified copies

    (3) In a prosecution for a contravention described in subsection (1), a copy of or extract from a document, including electronic data, that is certified to be a true copy by the inspector who made or took it under paragraph 23(2)(c), (d) or (f), as the case may be, is admissible in evidence and is, in the absence of evidence to the contrary, proof of its contents.

  • Marginal note:Where accused had adulterating substances

    (4) Where a person is prosecuted under this Part for having manufactured an adulterated food or drug for sale, and it is established that the person had in his possession or on his premises any substance the addition of which to that food or drug has been declared by regulation to cause the adulteration of the food or drug, the onus of proving that the food or drug was not adulterated by the addition of that substance lies on the accused.

Exports

Marginal note:Conditions under which exports exempt

  •  (1) This Act does not apply to any packaged food, drug, cosmetic or device if

    • (a) it is manufactured or prepared in Canada;

    • (b) it is intended for export and is not manufactured or prepared for consumption or use in Canada nor sold for consumption or use in Canada;

    • (c) a certificate that the package and its contents do not contravene any known requirement of the law of the country to which it is or is about to be consigned has been issued in respect of the package and its contents in prescribed form and manner; and

    • (d) the packaged food, drug, cosmetic or device meets any other prescribed requirement.

  • Marginal note:Exception — Act

    (1.1) Despite subsection (1),

    • (a) section 4, subsection 5(1) and section 7 apply to any food;

    • (b) section 8, subsection 9(1) and section 11 apply to any drug that is not a natural health product within the meaning of the Natural Health Products Regulations;

    • (c) sections 16 and 18 apply to any cosmetic; and

    • (d) section 19 and subsection 20(1) apply to any device.

  • Marginal note:Exception — regulations

    (1.2) Despite subsection (1), any prescribed provision of the regulations applies to any food, drug, cosmetic or device.

  • Marginal note:Exception — General Council Decision

    (2) Despite subsection (1), this Act applies in respect of any drug or device to be manufactured for the purpose of being exported in accordance with the General Council Decision, as defined in subsection 30(6), and the requirements of the Act and the regulations apply to the drug or device as though it were a drug or device to be manufactured and sold for consumption or use in Canada, unless the regulations provide otherwise.

Marginal note:Conditions under which transhipment exempt

 This Act does not apply to any packaged food, drug, cosmetic or device if

  • (a) it is manufactured or prepared outside Canada;

  • (b) it is imported solely for the purpose of export and is not sold for consumption or use in Canada; and

  • (c) it meets any other prescribed requirement.

  • 2016, c. 9, s. 12

PARTS III AND IV[Repealed, 1996, c. 19, s. 81]

 

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