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Guidance documents are meant to provide assistance to industry and health care (a) Inner/Outer Label Mock-ups; (b) Package Insert Mock-Ups; (c) Product . (j. 1) in the case of a new drug for human use, mock-ups of every label to be used in (ii) mock-ups of every label to be used in connection with the new drug.
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Intelligence (pal-paca.org); Computation and Language (pal-paca.org). Cite as: arXiv: [cs. HC ]. (or [cs. HC ] for this version). Health Canada recommends that sponsors file second language documents PM and package insert together as one regulatory transaction, when applicable. They will not be applied retroactively and they will not be applied to submissions in the queue. Note that package inserts could also include wallet cards, tear-off pads and hand-outs directed to the consumer and whose content is Part III of the PM. For products already approved as per the mock-up requirement, sponsors are expected to continue to maintain the compliance of their labels and package insert with PLL principles e. In these instances, sponsors should include a rationale along with their submission for Health Canada's review. Home Smart Home is the magazine that brings you the latest trends in home control solutions and smart devices.
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