| | | |
| | | Exceptions and limitations |
|
| “5. | Cell, tissue or gene therapy product |
|
| (1) | “Cell, tissue or gene therapy product” means any substance that — |
|
| |
| | (a) | is intended for use by and in humans for a therapeutic, preventive, palliative or diagnostic purpose, including any of the following purposes: |
|
| |
| | (i) | for preventing, diagnosing, treating, curing or alleviating any disease, disorder, injury, ailment, handicap or abnormal physical or mental state, or any symptom thereof; |
|
| |
| | (ii) | for replacing, repairing, regenerating or reconstructing any anatomy, or for modifying or replacing any physiological process; |
|
| |
| | (iii) | for regulating, repairing, replacing, adding or deleting a genetic sequence or modifying genetic material; |
|
| |
| | (iv) | for supporting or sustaining life; |
|
| |
| | (b) | has as a constituent any of the following substances or combination of substances: |
|
| |
| | (i) | viable or non‑viable human cells or tissues; |
|
| |
| | (ii) | viable animal cells or tissues; |
|
| |
| | (iii) | recombinant nucleic acids, where the effect of the recombinant nucleic acid relates directly to the recombinant nucleic acid sequence that it contains or to the product of the genetic expression of its sequence; |
|
| |
| | (c) | achieves its primary intended action by pharmacological, immunological, physiological, metabolic or physical means, leading to its use for a therapeutic, preventive, palliative or diagnostic purpose; and |
|
| |
| | (d) | is not any of the following: |
|
| |
| | (i) | a recombinant vaccine for a preventive purpose; |
|
| |
| | (ii) | an in‑vitro diagnostic product; |
|
| |
| | (iii) | bone marrow, peripheral blood or umbilical or placental cord blood from a human that is minimally manipulated and intended for homologous use; |
|
| |
| | (iv) | cells and tissues obtained from a patient that are minimally manipulated and re‑implanted for homologous use into the same patient during the same surgical procedure; |
|
| |
| | (v) | organs and tissues that are minimally manipulated and intended for transplant; |
|
| |
| | (vi) | reproductive cells (sperm, eggs) and embryos intended for assisted reproduction; |
|
| |
| | (vii) | whole blood and any blood component that is minimally manipulated and intended for treating blood loss or blood disorders. |
|
| |
| | (2) | For the purposes of paragraph (1) — |
|
| |
| | “homologous use” means the use of a cell, tissue or gene therapy product to repair, reconstruct, replace or supplement the cells or tissue of an individual (called the recipient) if the cell, tissue or gene therapy product performs the same basic function or functions in the recipient as the original cells or tissue in the donor in the same anatomical or histological environment; |
| |
| | “minimally manipulated”, in relation to a cell or tissue (but not a gene), means processing the cell or tissue by way of any process so that the biological characteristics or functions of the cell or the structural properties of the tissue (as the case may be) are not altered, such as by — |
| |
| | | |
| | | |
| | | |
| | | |
| | (e) | soaking in an antibiotic or antimicrobial solution; |
|
| |
| | (f) | sterilization or irradiation; |
|
| |
| | (g) | cell separation, concentration or purification; |
|
| |
| | | |
| | | |
| | | |
| | | |
| | | |