Budget Implementation Act, 2019, No. 1 (S.C. 2019, c. 29)

171 The Act is amended by adding the following after section 27.2:

• 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;