NEW RULES FOR ADMINISTRATIVE PROCESSING OF DIN SUBMISSIONS COMING MARCH 1, 2018
By: Teri Dickinson, Manager, Regulatory Affairs Group, email
On December 13, 2017 Health Canada published the final Guidance Document outlining the Administrative Processing of Submission and Applications: Human or Disinfectant Drugs.
This document outlines the new restrictive eligibility for the administrative process in which all aspects of the submission and application pertaining to the drug product, except for the manufacturer name and/or product name, must be identical to those previously authorized for that product. These include, but are not limited to, the submission type, all clinical data, chemistry and manufacturing data, product formulation, strength, route of administration, dosage form, authorized indication(s) and condition(s) of use as well as all product labels. Any deviations from the previously approved product will not be acceptable under the administrative pathway.
This new policy comes into effect March 1, 2018.
UPDATE: As of February 9th, 2018, meeting with NNHPD it has been confirmed that hard surface disinfectants will be EXEMPT from this guidance document until April 1, 2019. This will align implementation with cost recovery.