C.04.077 A fabricator of B.C.G. vaccine shall keep, at a temperature not exceeding 5.0°C, and for not less than six months,
(a) the culture on glycerine-water potato medium from which the Sauton I and Sauton II subcultures were made, and
(b) not less than six vials of the final product
from each lot thereof.
- SOR/97-12, s. 61.
C.04.078 Every fabricator and packager/labeller of B.C.G. vaccine shall keep, in form satisfactory to the Minister, continuous clinical records of the use of B.C.G. vaccine in humans.
- SOR/97-12, s. 63.
C.04.079 A fabricator of B.C.G. vaccine shall examine pathologically all test animals used and shall immediately report to the Minister any evidence of active, progressive tuberculosis in any such animals.
- SOR/97-12, s. 61.
C.04.080 The expiration date for B.C.G. vaccine shall be not more than
(a) 10 days after harvesting in the case of fluid vaccine;
(b) 12 months after harvesting in the case of freeze dried vaccine stored at a temperature of 4°C or above; or
(c) 20 months after harvesting in the case of freeze dried vaccine stored at a temperature below 4°C.
C.04.081 No person shall sell fluid B.C.G. vaccine that is not packaged in containers sealed by fusion.
C.04.082 No inner label shall be required for fluid B.C.G. vaccine in single-dose containers.
C.04.083 The label of fluid B.C.G. vaccine shall carry, in lieu of the statements provided in paragraphs C.04.054(a) and (b), a statement of
C.04.084 The label of freeze-dried B.C.G. vaccine shall carry, in lieu of the statements provided in paragraphs C.04.054(a) and (b), a statement of
C.04.085 The provisions of subparagraph C.04.019(b)(iv) do not apply to freeze-dried B.C.G. vaccine.
Products Analogous to Bacterial Vaccines
C.04.090 A product analogous to a bacterial vaccine shall be
(a) a bacterial antigen, other than a bacterial vaccine, such as a lysate, or
(b) an extract prepared from a bacterial culture,
and shall conform to the requirements of these Regulations for bacterial vaccines except those of paragraphs (a) and (b) of C.04.054.
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