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

Section 2 Disposition versions

2021-06-24

2. As used in this Regulation,

“scientific evaluation” means the structured evaluation of a drug, stable blood product or technology that can concern both its direct effects and its indirect and unintentional consequences, with the objective of guiding decision-making;

“manufacturer” means a person or group of persons that manufactures, produces, imports or sells a drug, stable blood product or technology, under its own name or under a brand name;

“nutritional formula” means a therapeutic nutritional product;

“indication” means an 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 the Act respecting prescription drug insurance (chapter A-29.01), the list of medicines referred to in section 116 of the Act respecting health services and social services (chapter S-4.2), or the list of medications referred to in section 150 of the Act respecting health services and social services for Cree Native persons (chapter S-5), which is not otherwise contemplated by this Regulation;

“biosimilar drug” means a biologic drug introduced onto the Canadian market that is highly similar to a biologic drug already marketed in Canada and whose efficacy and safety do not diverge significantly from the reference biologic drug for the same indications;

“dressing” means a medical instrument used to treat wounds for an indication recognized on the lists of medications;

“radiopharmaceutical” means a radioactive product used to diagnose or treat a disease;

“stable blood product” means an acellular component of blood with the storage characteristics of drugs that is used to treat certain disorders due to an imbalance in the circulatory system or certain specific diseases and that can be entered on the Québec list of blood system products that may be distributed by Héma-Québec;

“cutting-edge therapeutic product” means a health product that is so new, complex and distinct that the current legislation is not able to take it into account, but that may still be entered on the list of medications referred to in section 60 of the Act respecting prescription drug insurance (chapter A-29.01), the list of medicines referred to in section 116 of the Act respecting health services and social services (chapter S-4.2), or the list of medications referred to in section 150 of the Act respecting health services and social services for Cree Native persons (chapter S-5);

“companion diagnostic” means a diagnostic test, a pharmacogenetic test or a therapeutic monitoring test designed to select only the patients for whom a treatment is likely to be beneficial among all the patients diagnosed with a given condition, based on their results for the predictive marker identified by the test;

“cellular or gene therapy” means a therapy to transfer living cells to a patient or to modify a patient’s genetic materials in order to treat or heal a condition.

O.C. 861-2018, s. 2; O.C. 770-2021, s. 3.

2018-07-19

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.

Not in force

In force: 2018-07-19

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.