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Food and Drug Regulations

Version of section C.02.017 from 2006-03-22 to 2018-04-03:

  •  (1) The examination or testing referred to in section C.02.016 shall be performed on a sample taken

    • (a) after receipt of each lot or batch of packaging material on the premises of the person who packages a drug; or

    • (b) subject to subsection (2), before receipt of each lot or batch of packaging material on the premises of the person who packages a drug, if

      • (i) that person

        • (A) has evidence satisfactory to the Director to demonstrate that packaging materials sold to him by the vendor of that lot or batch of packaging material are consistently manufactured in accordance with and consistently comply with the specifications for those packaging materials, and

        • (B) undertakes periodic complete confirmatory examination or testing with a frequency satisfactory to the Director,

      • (ii) the packaging material has not been transported or stored under conditions that may affect its compliance with the specifications for that packaging material.

  • (2) After a lot or batch of packaging material is received on the premises of the person who packages a drug,

    • (a) the lot or batch of the packaging material shall be examined or tested for identity; and

    • (b) the labels shall be examined or tested in order to ensure that they comply with the specifications for those labels.

  • SOR/82-524, s. 3
  • SOR/89-174, ss. 2(F), 8(F)
  • SOR/97-12, s. 56(F)
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