by Kristian Snyders | Wed, Aug, 2020 | Health Authority, Initiatives
Canada’s first Product Monograph in the XML PM format was submitted to Health Canada on August 17. i4i worked closely with the Market Authorization Holder to finalize the XML PM included in their eCTD submission. This submission marks the first XML PM received for an...
by Jonathan Meaney | Wed, Jun, 2019 | Health Authority
Health Canada is transitioning from unstructured product monographs to structured product monographs (SPMs) for drug labeling. The move will affect human drug labeling, product monographs, and electronic submission. Veterinary drugs, over the counter drugs, natural...