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

Marginal note:Non-payment of fees

30.64 The Minister may withdraw or withhold a service, the use of a facility, a regulatory process or approval or a product, right or privilege under this Act from any person who fails to pay the fee fixed for it under subsection 30.61(1).

Marginal note:Adjustment of amounts

• 30.65 (1) An order made under subsection 30.61(1) may prescribe rules for the adjustment of the amount of the fee by any amounts or ratios that are referred to in the order, for the period that is specified in the order.

• Marginal note:Notice of adjusted amount

  (2) The amount of a fee that is subject to an adjustment rule remains unadjusted for the specified period unless, before the beginning of that period, the Minister publishes a notice in the Canada Gazette that specifies the adjusted amount and the manner in which it was determined.

Marginal note:Service Fees Act

30.66 The Service Fees Act does not apply to a fee fixed under subsection 30.61(1).

Costs

Marginal note:Recovery

• 30.7 (1) Her Majesty in right of Canada may recover, as a debt due to Her Majesty in right of Canada, any costs incurred by Her Majesty in right of Canada in relation to anything required or authorized under this Act, including the inspection of a place or the analysis, examination, storage, movement, seizure, detention, forfeiture, disposal or release of an article.

• Marginal note:Time limit

  (2) Proceedings to recover a debt due to Her Majesty in right of Canada under subsection (1) shall not be commenced later than five years after the debt became payable.

Marginal note:Certificate of default

• 30.8 (1) Any debt that may be recovered under subsection 30.7(1) in respect of which there is a default of payment, or the part of any such debt that has not been paid, may be certified by the Minister.

• Marginal note:Judgment

  (2) On production to the Federal Court, a certificate made under subsection (1) shall be registered in that Court and, when registered, has the same force and effect, and all proceedings may be taken on the certificate, as if it were a judgment obtained in that Court for a debt of the amount specified in the certificate and all reasonable costs and charges attendant in the registration of the certificate.

Offences and Punishment

Marginal note:Contravention of Act or regulations

31 Subject to sections 31.1, 31.2 and 31.4, every person who contravenes any of the provisions of this Act or of the regulations, or fails to do anything the person was ordered to do by an inspector under section 25 or 27.2, is guilty of an offence and liable

• (a) on summary conviction for a first offence to a fine not exceeding five hundred dollars or to imprisonment for a term not exceeding three months or to both and, for a subsequent offence, to a fine not exceeding one thousand dollars or to imprisonment for a term not exceeding six months or to both; and

• (b) on conviction on indictment to a fine not exceeding five thousand dollars or to imprisonment for a term not exceeding three years or to both.

Marginal note:Offences relating to food

• 31.1 (1) Every person who contravenes any provision of this Act or the regulations, as it relates to food, is guilty of an offence and liable

  • (a) on summary conviction, to a fine not exceeding $50,000 or to imprisonment for a term not exceeding six months or to both; or

  • (b) on conviction by indictment, to a fine not exceeding $250,000 or to imprisonment for a term not exceeding three 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 food;

  • (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;

  • (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.

Marginal note:Offences relating to therapeutic products

• 31.2 (1) Subject to section 31.4, every person who contravenes any 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 by indictment, to a fine not exceeding $5,000,000 or to imprisonment for a term not exceeding two years or to both; and

  • (b) on summary conviction, for a first offence, to a fine not exceeding $250,000 or to imprisonment for a term not exceeding six months or to both and, for a subsequent offence, to a fine not exceeding $500,000 or to imprisonment for a term not exceeding 18 months 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 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;

  • (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:Due diligence

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

Marginal note:Offences — section 21.6 and serious risk

• 31.4 (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

31.5 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.

Marginal note:Parties to offence

31.6 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.

Marginal note:Continuing offence

31.7 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.

Marginal note:Limitation period

• 32 (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.

Marginal note:Venue

33 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.

Marginal note:Want of knowledge

• 34 (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.

Marginal note:Certificate of analyst

• 35 (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.