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

Marginal note:Power to require assessment

21.31 Subject to the regulations, the Minister may order the holder of a therapeutic product authorization to conduct an assessment of the therapeutic product to which the authorization relates and provide the Minister with the results of the assessment.

Marginal note:Power to require tests, studies, etc.

21.32 Subject to the regulations, the Minister may, for the purpose of obtaining additional information about a therapeutic product’s effects on health or safety, order the holder of a therapeutic product authorization to

• (a) compile information, conduct tests or studies or monitor experience in respect of the therapeutic product; and

• (b) provide the Minister with the information or the results of the tests, studies or monitoring.

Marginal note:Statutory Instruments Act

• 21.4 (1) For greater certainty, orders made under any of sections 21.1 to 21.32 are not statutory instruments within the meaning of the Statutory Instruments Act.

• Marginal note:Availability of orders

  (2) The Minister shall ensure that any order made under any of sections 21.1 to 21.32 is publicly available.

Marginal note:Injunction

• 21.5 (1) If, on the application of the Minister, it appears to a court of competent jurisdiction that a person has done, is about to do or is likely to do anything that constitutes or is directed toward the commission of an offence under this Act in respect of a therapeutic product, the court may issue an injunction ordering the person, who is to be named in the application, to

  • (a) refrain from doing anything that it appears to the court may constitute or be directed toward the commission of the offence; or

  • (b) do anything that it appears to the court may prevent the commission of the offence.

• Marginal note:Notice

  (2) No injunction is to be issued under subsection (1) unless 48 hours’ notice is served on the party or parties who are named in the application or unless the urgency of the situation is such that service of notice would not be in the public interest.

Marginal note:False or misleading information — therapeutic products

21.6 No person shall knowingly make a false or misleading statement to the Minister  —  or knowingly provide him or her with false or misleading information  —  in connection with any matter under this Act concerning a therapeutic product.

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: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.

Marginal note:Health care institutions to provide information

21.8 A prescribed health care institution shall provide the Minister, within the prescribed time and in the prescribed manner, with prescribed information that is in its control about a serious adverse drug reaction that involves a therapeutic product or a medical device incident that involves a therapeutic product.

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).

PART IIAdministration and Enforcement

Inspection, Seizure and Forfeiture

Marginal note:Inspectors

• 22 (1) For the purposes of the administration and enforcement of this Act, the Minister may designate individuals or classes of individuals as inspectors to exercise powers or perform duties or functions in relation to any matter referred to in the designation.

• Marginal note:Certificate to be produced

  (2) An inspector shall be given a certificate in a form established by the Minister or the President of the Canadian Food Inspection Agency attesting to the inspector’s designation and, on entering any place pursuant to subsection 23(1), an inspector shall, if so required, produce the certificate to the person in charge of that place.

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:Means of telecommunication

  (12) An application for a warrant under subsection (10) may be submitted, and the warrant may be issued, by a means of telecommunication and section 487.1 of the Criminal Code applies for those purposes 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.