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

Updated to 19 July 2018

This document has official status.

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 Act

(chapter A-6.001, s. 83.8).

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.

O.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.

O.C. 861-2018, s. 2.

3. The fees stipulated in this regulation are non-refundable.

O.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.

O.C. 861-2018, s. 4.

5. (Omitted).

O.C. 861-2018, s. 5.

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

O.C. 861-2018, Sch. I.

REFERENCES

O.C. 861-2018, 2018 G.O. 2, 2774