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 or a stable blood product

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chapter 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 or a stable blood product
FINANCIAL ADMINISTRATION — FEES PAYABLE — STABLE BLOOD PRODUCT
Financial Administration Act
(chapter A-6.001, s. 83.8).
A-6.001
June 20 2018July 19 2018
1. A manufacturer who asks the Institut national d’excellence en santé et en services sociaux to conduct a scientific evaluation of a drug or a stable blood product shall pay the fees set out in Schedule 1.
These fees vary according to the scientific evaluation that the Institut decides to conduct after receiving the request from the manufacturer.
861-2018O.C. 861-2018, s. 1.
2. As used in this regulation:
scientific evaluation : means a structured evaluation, the objective of which is to guide decision-making, of a health technology that can concern both the direct impact of that technology and its indirect and unintentional consequences;
manufacturer : means a person or group of persons who manufacture, produce, import or sell, under their name or a brand name, drugs or stable blood products;
indication : means the indication for use requested by a manufacturer;
drug : means a product that can be entered on the list of medications referred to in section 60 of An Act respecting prescription drug insurance (chapter A-29.01) or on the lists of medications referred to in section 116 of An Act respecting health services and social services (chapter S-4.2) or in section 150 of An Act respecting health services and social services for Cree Native persons (chapter S-5);
stable blood product : means an acellular component of blood with the storage characteristics of drugs and that is used to treat certain disorders due to an imbalance in the circulatory system or certain specific diseases.
861-2018O.C. 861-2018, s. 2.
3. The fees stipulated in this regulation are non-refundable.
861-2018O.C. 861-2018, s. 3.
4. The fees stipulated in this regulation are indexed in the manner set out in chapter VIII.1 of the Financial Administration Act (chapter A-6.001).
The Minister of Health and Social Services shall publish the result of the indexation in Part 1 of the Gazette officielle du Québec.
861-2018O.C. 861-2018, s. 4.
5. (Omitted).
861-2018O.C. 861-2018, s. 5.
SCHEDULE I
(s. 1)
FEES PAYABLE FOR THE DIFFERENT SCIENTIFIC EVALUATIONS
Scientific EvaluationFee
Health technology evaluatedType of evaluation
New drug or new indication for a currently listed drugFirst evaluation$38,921 per indication
Reevaluation$19,460 per indication
BiosimilarFirst 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 drugFirst 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 drugFirst evaluation$3,892 per submission
Reevaluation$1,946 per submission
New nutritional formula, new dressing or new combination of currently listed drugsFirst evaluation$5,189 per submission
Reevaluation$2,595 per submission
Diagnostic agent of a currently listed non-proprietary nameFirst evaluation$2,595 per submission
Reevaluation$1,297 per submission
Exemption from the application of the lowest priceAny exemption request$6,487 per submission
New stable blood productFirst evaluation$32,744 per submission
Reevaluation$16,372 per submission
861-2018O.C. 861-2018, Sch. I.
REFERENCES
O.C. 861-2018, 2018 G.O. 2, 2774