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A-6.001, r. 6.1 - Regulation respecting the fees payable to the Institut national d’excellence en santé et en services sociaux for the scientific evaluation of a drug, stable blood product or technology for listing purposes
Schedule
Disposition versions
SCHEDULE I
(s. 1)
FEES PAYABLE FOR VARIOUS SCIENTIFIC EVALUATIONS
| Scientific evaluation | Fee | |
| Item evaluated | Type of evaluation | |
| New cellular or gene therapy | First evaluation | $100,434 per indication |
| Reevaluation | $66,956 per indication | |
| New drug with a companion diagnostic or new indication for a drug currently listed with a companion diagnostic | First evaluation | $77,001 per indication |
| Reevaluation | $40,173 per indication | |
| New drug or new indication for a currently listed drug or new stable blood product | First evaluation | $66,956 per indication |
| Reevaluation | $40,173 per indication | |
| New cutting-edge therapeutic product | First evaluation | $100,434 per indication |
| New radiopharmaceutical | First evaluation | $100,434 per indication |
| Reevaluation | $40,173 per indication | |
| New medical device directly connected with the administration of a drug | First evaluation | $66,967 per submission |
| Reevaluation | $40,173 per submission | |
| New biosimilar drug | First evaluation | $10,044 per submission |
| Subsequent evaluation (i.e., addition of an indication) | $10,044 per submission | |
| Reevaluation | $5,022 per submission | |
| New strength, new content or new form of a currently listed drug | First evaluation | $10,044 per submission |
| Reevaluation | $5,022 per submission | |
| New nutritional formula or new combination of currently listed drugs or new diagnostic agent of a currently listed non-proprietary name | First evaluation | $6,695 per submission |
| Reevaluation | $3,348 per submission | |
| New dressing | First evaluation | $13,391 per submission |
| Reevaluation | $6,695 per submission | |
| Exemption from the application of the lowest price | Any exemption request | $10,044 per submission |
SCHEDULE I
(s. 1)
FEES PAYABLE FOR VARIOUS SCIENTIFIC EVALUATIONS
| Scientific evaluation | Fee | |
| Item evaluated | Type of evaluation | |
| New cellular or gene therapy | First evaluation | $95,579 per indication |
| Reevaluation | $63,719 per indication | |
| New drug with a companion diagnostic or new indication for a drug currently listed with a companion diagnostic | First evaluation | $73,278 per indication |
| Reevaluation | $38,231 per indication | |
| New drug or new indication for a currently listed drug or new stable blood product | First evaluation | $63,719 per indication |
| Reevaluation | $38,231 per indication | |
| New cutting-edge therapeutic product | First evaluation | $95,579 per indication |
| New radiopharmaceutical | First evaluation | $95,579 per indication |
| Reevaluation | $38,231 per indication | |
| New medical device directly connected with the administration of a drug | First evaluation | $63,730 per submission |
| Reevaluation | $38,231 per submission | |
| New biosimilar drug | First evaluation | $9,558 per submission |
| Subsequent evaluation (i.e., addition of an indication) | $9,558 per submission | |
| Reevaluation | $4,779 per submission | |
| New strength, new content or new form of a currently listed drug | First evaluation | $9,558 per submission |
| Reevaluation | $4,779 per submission | |
| New nutritional formula or new combination of currently listed drugs or new diagnostic agent of a currently listed non-proprietary name | First evaluation | $6,371 per submission |
| Reevaluation | $3,186 per submission | |
| New dressing | First evaluation | $12,744 per submission |
| Reevaluation | $6,371 per submission | |
| Exemption from the application of the lowest price | Any exemption request | $9,558 per submission |
SCHEDULE I
(s. 1)
FEES PAYABLE FOR VARIOUS SCIENTIFIC EVALUATIONS
| Scientific evaluation | Fee | |
| Item evaluated | Type of evaluation | |
| New cellular or gene therapy | First evaluation | $89,796 per indication |
| Reevaluation | $59,864 per indication | |
| New drug with a companion diagnostic or new indication for a drug currently listed with a companion diagnostic | First evaluation | $68,844 per indication |
| Reevaluation | $35,918 per indication | |
| New drug or new indication for a currently listed drug or new stable blood product | First evaluation | $59,864 per indication |
| Reevaluation | $35,918 per indication | |
| New cutting-edge therapeutic product | First evaluation | $89,796 per indication |
| New radiopharmaceutical | First evaluation | $89,796 per indication |
| Reevaluation | $35,918 per indication | |
| New medical device directly connected with the administration of a drug | First evaluation | $59,874 per submission |
| Reevaluation | $35,918 per submission | |
| New biosimilar drug | First evaluation | $8,980 per submission |
| Subsequent evaluation (i.e., addition of an indication) | $8,980 per submission | |
| Reevaluation | $4,490 per submission | |
| New strength, new content or new form of a currently listed drug | First evaluation | $8,980 per submission |
| Reevaluation | $4,490 per submission | |
| New nutritional formula or new combination of currently listed drugs or new diagnostic agent of a currently listed non-proprietary name | First evaluation | $5,986 per submission |
| Reevaluation | $2,993 per submission | |
| New dressing | First evaluation | $11,973 per submission |
| Reevaluation | $5,986 per submission | |
| Exemption from the application of the lowest price | Any exemption request | $8,980 per submission |
SCHEDULE I
(s. 1)
FEES PAYABLE FOR THE DIFFERENT SCIENTIFIC EVALUATIONS
| Scientific Evaluation | Fee | |
| Health technology evaluated | Type of evaluation | |
| New drug or new indication for a currently listed drug | First evaluation | $38,921 per indication |
| Reevaluation | $19,460 per indication | |
| Biosimilar | First evaluation | $7,784 per submission |
| Subsequent evaluation (i.e., addition of an indication) | $7,784 per submission | |
| Reevaluation | $3,892 per submission | |
| Subsequent entry non-biological complex drug | First evaluation | $7,784 per submission |
| Subsequent evaluation (i.e., addition of an indication) | $7,784 per submission | |
| Reevaluation | $3,892 per submission | |
| New strength(s) or new form(s) of a currently listed drug | First evaluation | $3,892 per submission |
| Reevaluation | $1,946 per submission | |
| New nutritional formula, new dressing or new combination of currently listed drugs | First evaluation | $5,189 per submission |
| Reevaluation | $2,595 per submission | |
| Diagnostic agent of a currently listed non-proprietary name | First evaluation | $2,595 per submission |
| Reevaluation | $1,297 per submission | |
| Exemption from the application of the lowest price | Any exemption request | $6,487 per submission |
| New stable blood product | First evaluation | $32,744 per submission |
| Reevaluation | $16,372 per submission | |
SCHEDULE I
(s. 1)
FEES PAYABLE FOR THE DIFFERENT SCIENTIFIC EVALUATIONS
| Scientific Evaluation | Fee | |
| Health technology evaluated | Type of evaluation | |
| New drug or new indication for a currently listed drug | First evaluation | $38,921 per indication |
| Reevaluation | $19,460 per indication | |
| Biosimilar | First evaluation | $7,784 per submission |
| Subsequent evaluation (i.e., addition of an indication) | $7,784 per submission | |
| Reevaluation | $3,892 per submission | |
| Subsequent entry non-biological complex drug | First evaluation | $7,784 per submission |
| Subsequent evaluation (i.e., addition of an indication) | $7,784 per submission | |
| Reevaluation | $3,892 per submission | |
| New strength(s) or new form(s) of a currently listed drug | First evaluation | $3,892 per submission |
| Reevaluation | $1,946 per submission | |
| New nutritional formula, new dressing or new combination of currently listed drugs | First evaluation | $5,189 per submission |
| Reevaluation | $2,595 per submission | |
| Diagnostic agent of a currently listed non-proprietary name | First evaluation | $2,595 per submission |
| Reevaluation | $1,297 per submission | |
| Exemption from the application of the lowest price | Any exemption request | $6,487 per submission |
| New stable blood product | First evaluation | $32,744 per submission |
| Reevaluation | $16,372 per submission | |
