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Twelve years ago, your company was the first to market a tablet for the treatment of symptoms associated with disease X. However, a generic company,
Twelve years ago, your company was the first to market a tablet for the treatment of symptoms associated with disease X. However, a generic company, your competitor, has now come out with a product with the same formulation. Their tablet is identical in shape (round) and weight to yours. You have decided to change the shape of your tablet to oblong to differentiate your product (composition and weight remains same as before). Provide the assessment change number against the Post-NOC guidance document. What level change is this (I, II, or III)? What are the review timelines associated with Health Canada? What are the costs involved
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