Here's a section under Canada's FDA regulations, t
Post# of 56324
Posted On: 10/09/2014 11:24:07 AM
Here's a section under Canada's FDA regulations, the MMPR regulations refer to the FDA. Not sure if this applies but it sounds like testing of a drug is required if you DON'T have a license. Not trying to stir the pot here, just trying to make sense of the delay.
C.02.019. (1) A packager/labeller of a drug, a distributor referred to in paragraph C.01A.003(b) and an importer of a drug other than an active ingredient shall perform the finished product testing on a sample of the drug that is taken either
(a) after receipt of each lot or batch of the drug on their premises in Canada; or
(b) before receipt of each lot or batch of the drug on their premises in Canada if the following conditions are met:
(i) the packager/labeller, distributor or importer
(A) has evidence satisfactory to the Director to demonstrate that drugs sold to them by the vendor of that lot or batch are consistently manufactured in accordance with and consistently comply with the specifications for those drugs, and
(
undertakes periodic complete confirmatory testing, with a frequency satisfactory to the Director, and
(ii) the drug has not been transported or stored under conditions that may affect its compliance with the specifications for that drug.
(2) If the packager/labeller, distributor or importer receives a lot or batch of a drug on their premises in Canada the useful life of which is more than 30 days, the lot or batch shall be tested for identity and the packager/labeller shall confirm the identity after the lot or batch is packaged/labelled.
(3) Subsections (1) and (2) do not apply to a distributor if the drug is fabricated, packaged/labelled and tested in Canada by a person who holds an establishment licence that authorizes that activity.
(4) Subsections (1) and (2) do not apply to a distributor or importer if the drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building and both of the following requirements are met:
(a) the address of the building is set out in their establishment licence; and
(b) they retain a copy of the batch certificate for each lot or batch of the drug that they receive.
C.02.019. (1) A packager/labeller of a drug, a distributor referred to in paragraph C.01A.003(b) and an importer of a drug other than an active ingredient shall perform the finished product testing on a sample of the drug that is taken either
(a) after receipt of each lot or batch of the drug on their premises in Canada; or
(b) before receipt of each lot or batch of the drug on their premises in Canada if the following conditions are met:
(i) the packager/labeller, distributor or importer
(A) has evidence satisfactory to the Director to demonstrate that drugs sold to them by the vendor of that lot or batch are consistently manufactured in accordance with and consistently comply with the specifications for those drugs, and
(
undertakes periodic complete confirmatory testing, with a frequency satisfactory to the Director, and (ii) the drug has not been transported or stored under conditions that may affect its compliance with the specifications for that drug.
(2) If the packager/labeller, distributor or importer receives a lot or batch of a drug on their premises in Canada the useful life of which is more than 30 days, the lot or batch shall be tested for identity and the packager/labeller shall confirm the identity after the lot or batch is packaged/labelled.
(3) Subsections (1) and (2) do not apply to a distributor if the drug is fabricated, packaged/labelled and tested in Canada by a person who holds an establishment licence that authorizes that activity.
(4) Subsections (1) and (2) do not apply to a distributor or importer if the drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building and both of the following requirements are met:
(a) the address of the building is set out in their establishment licence; and
(b) they retain a copy of the batch certificate for each lot or batch of the drug that they receive.
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