C.04.125. No person shall sell poliomyelitis vaccine unless it has been tested by an acceptable method for potency and safety and when so tested it shall be safe and of acceptable potency.
C.04.126. The outer label shall carry a statement of any antibiotic present in the vaccine.
C.04.127. The expiration date of the poliomyelitis vaccine shall be not later than 12 months after the date of the last satisfactory potency test unless evidence, satisfactory to the Director, is presented that a longer period is appropriate.
- SOR/85-715, s. 6.
Poliovirus Vaccine, Live, Oral
C.04.128. Poliovirus Vaccine, Live, Oral or Poliovirus Vaccine, Live, Oral (Naming the strains) shall be prepared from living poliomyelitis virus types I, II and III that
(a) have been obtained directly from a source acceptable to the Director;
(b) are shown to be genetically stable by an acceptable method;
(c) are shown to be non-pathogenic when given orally to humans;
(d) are proved to be capable of multiplying in the human alimentary tract and of producing type specific neutralizing antibodies when administered orally; and
(e) have a history of successful use in the production of polio-virus vaccine, live, oral.
C.04.129. Poliovirus vaccine, live, oral, shall be fabricated, packaged/labelled and tested in premises separated from buildings where other products are fabricated, packaged/labelled or tested, and from buildings where control tests involving the use of cell lines or virus strains not employed in the fabrication, packaging/labelling and testing of poliovirus vaccine, live, oral, are carried out.
- SOR/97-12, s. 45.
C.04.130. No fabricator shall permit the introduction of any bacterial or viral cultures other than those used in the manufacture of poliovirus vaccine, live, oral on any premises that are used for the manufacture of poliovirus vaccine, live, oral.
- SOR/97-12, s. 61.
C.04.131. Notwithstanding sections C.04.129 and C.04.130, a fabricator may manufacture other drugs in an area in which polio-virus vaccine, live, oral is manufactured at times when that vaccine is not being manufactured, if
(a) both prior to and following each manufacture the area is cleaned and disinfected by methods acceptable to the Director; and
(b) the fabricator has received written permission from the Director to carry out such manufacture.
- SOR/97-12, s. 61.
C.04.132. Poliovirus vaccine, live, oral shall be prepared only
(a) in a tissue culture,
(b) in a medium, and
(c) by methods
acceptable to the Director.
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