Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2014-09-15 and last amended on 2014-08-21. Previous Versions

 In examining a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions, the Minister may examine any information or material filed with the Minister by any person pursuant to Division 5 or section C.08.002, C.08.002.01, C.08.002.1, C.08.003, C.08.005 or C.08.005.1 to establish the safety and effectiveness of the new drug for which the submission or supplement has been filed.

  • SOR/95-411, s. 6;
  • SOR/2001-203, s. 5;
  • SOR/2011-88, s. 14.
  •  (1) Subject to section C.08.004.1, the Minister shall, after completing an examination of a new drug submission or abbreviated new drug submission or a supplement to either submission,

    • (a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

    • (b) if that submission or supplement does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, notify the manufacturer that the submission or supplement does not so comply.

  • (2) Where a new drug submission or abbreviated new drug submission or a supplement to either submission does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, the manufacturer who filed the submission or supplement may amend the submission or supplement by filing additional information or material.

  • (3) Subject to section C.08.004.1, the Minister shall, after completing an examination of any additional information or material filed in respect of a new drug submission or an abbreviated new drug submission or a supplement to either submission,

    • (a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

    • (b) if that submission or supplement does not comply with the requirements of section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, notify the manufacturer that the submission or supplement does not so comply.

  • (4) A notice of compliance issued in respect of a new drug on the basis of information and material contained in a submission filed pursuant to section C.08.002.1 shall state the name of the Canadian reference product referred to in the submission and shall constitute a declaration of equivalence for that new drug.

  • SOR/84-267, ss. 1 to 3;
  • SOR/85-143, s. 3;
  • SOR/86-1009, s. 1;
  • SOR/86-1101, s. 1;
  • SOR/88-42, s. 1;
  • SOR/88-257, s. 1;
  • SOR/95-411, s. 6.
  •  (1) Subject to section C.08.004.1, the Minister shall, after completing an examination of an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission,

    • (a) if that submission or supplement complies with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

    • (b) if that submission or supplement does not comply with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, notify the manufacturer that the submission or supplement does not so comply.

  • (2) Where an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission does not comply with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, the manufacturer who filed the submission or supplement may amend the submission or supplement by filing additional information or material.

  • (3) Subject to section C.08.004.1, the Minister shall, after completing an examination of any additional information or material filed in respect of an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission,

    • (a) if that submission or supplement complies with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

    • (b) if that submission or supplement does not comply with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, notify the manufacturer that the submission or supplement does not so comply.

  • (4) A notice of compliance issued in respect of a new drug for extraordinary use on the basis of information and material contained in a submission filed pursuant to section C.08.002.1 shall state the name of the Canadian reference product referred to in the submission and shall constitute a declaration of equivalence for that new drug.

  • SOR/2011-88, s. 15.