DRAFT GUIDANCE DOCUMENT

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Health Canada Draft Guidance Document - For comment purposes only Administrative Processing of Submissions and Applications Involving Human or Disinfectants Drugs 809 Draft Date: 2017/02/17 19
Administrative Processing of Submissions and Applications Involving Human or Disinfectants Drugs Health Canada Draft Guidance Document - For comment purposes only 810 811 812 813 814 815 816 817 818 819 820 821 822 823 824 825 826 827 828 829 830 831 832 833 834 835 836 837 838 839 840 841 842 843 844 845 846 847 848 849 850 851 852 853 854 855 856 APPENDIX 1: ADMINISTRATIVE CHANGES - CERTIFICATION FORM Administrative Changes - Certification Form for Human or Disinfectant Drugs Reason for Submission: Manufacturer Name Change Existing DIN(s) must be retained Product Name Change Existing DIN(s) must be retained Manufacturer and Product Name Changes Existing DIN(s) must be retained Changes in Product Ownership Existing DIN(s) must be retained Additional Product name New DIN(s) must be issued Merger/Buyout Existing DIN(s) must be retained Licensing Agreement between two Manufacturers 12 New DIN(s) issued or Existing DIN(s) retained ……………………… …………………….... ……………………… Labelling Update (to match Licensor) Existing DIN(s) must be retained CMC Update (to match Licensor) Existing DIN(s) must be retained I, the undersigned, certify that all aspects of the drug submission or application pertaining to: .................................................................................................................................................................. (Name of Product) submitted by: .................................................................................................................................................................. (Name of Manufacturer) are identical to; ............................................................................................................................ ................................ (Name of product, Name of Manufacturer) [Current DIN(s)] except for name changes to the manufacturer and/or product, and that the product will be manufactured in the same location(s) with identical specifications and procedures. 12 If existing DINs are retained, please clearly list the DINs under this check box. 20 Draft Date: 2017/02/17
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DRAFT GUIDANCE DOCUMENT

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