DRAFT GUIDANCE DOCUMENT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Health Canada Draft Guidance Document - For comment purposes only Administrative Processing of Submissions and Applications Involving Human or Disinfectants Drugs 653 654 655 656 657 658 659 660 661 662 663 664 665 666 667 668 669 670 671 672 673 674 675 676 677 678 679 680 681 682 683 684 685 686 687 688 689 690 691 692 693 2.6 Labelling For manufacturers who are transitioning products due to new business arrangements, Health Canada expects that there is a 6 month phase-in period to replace the original product labels with new product labels. With the coming into force on June 13, 2015 of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use), for prescription products and products administered or obtained through a health professional for human use, all manufacturers are required to file mock-ups of their inner and outer labels and packaging in both English and French as part of their submission package at the time of filing. Where a sponsor is requesting a product name change, unless the change fits the exemptions set out in the Frequently Asked Questions - Guidance document for Industry - Review of Drug Brand Names, the submission should be filed as a Labelling Only submission and should include evidence supporting the product name(s) submitted along with the appropriate fee. Manufacturers will still be required to certify that all aspects of the drug submission or application pertaining to their product remain the same as was previously authorized. However, they will also be required to certify that the new labels and packaging are similar to those initially approved with respect to location and size of the text and graphics (including logos). Manufacturers who wish to change the location and/or size of text and/graphics are required to file a Labelling Only submission with the appropriate fees. Manufacturers are also required to file the Mock-up Labels and Packages Certification Form with their submission package which includes an attestation to the accuracy of translation. For additional information about changes resulting from the Plain Language Labelling amendments, consult the Guidance Document: Questions and Answers on Plain Language Labelling. 2.7 Fees For information on issues related to drug submission/application evaluation fees and annual authority to sell fees, refer to current versions of the Guidance Document: Fees for the Review of Drug Submissions and Applications, How to Pay Fees to the Health Products and Food Branch, and the Guidance Document: Fees for the Right to Sell Drugs. For fee reduction information refer to the Guidance Document: Fees for the Right to Sell Drugs and the Right to Sell Drug Fee Remission Request and Attestation Form. Draft Date: 2017/02/17 15
Administrative Processing of Submissions and Applications Involving Human or Disinfectants Drugs Health Canada Draft Guidance Document - For comment purposes only 694 695 696 697 698 699 700 701 702 703 704 705 706 707 708 709 710 711 712 713 714 715 716 717 718 719 720 721 722 723 724 725 726 727 728 729 730 731 732 733 734 735 3. CONTACT INFORMATION Questions or comments related to this guidance document should be directed to: Health Canada Office of Submissions and Intellectual Property Health Products and Food Branch Therapeutic Products Directorate Address Locator: 0201D 101 promenade Tunney's Pasture Driveway Ottawa Ontario K1A 0K9 Canada Email: OSIP-BPPI@hc-sc.gc.ca Fax number: 613-946-5610 or 613- 941-0825 4. REFERENCES Submission/Application Related Documents: Blank Certified Product Information Document (Schedule D Drugs) (CPID (Schedule D Drugs)) Template in the CTD Format (http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applicdemande/guides/qualit/prod/tech-doc-biologic/ctd_cpid-dcip_schd-ann-eng.php) Drug Submission Application (3011) Form (http://www.hc-sc.gc.ca/dhpmps/alt_formats/pdf/prodpharma/applic-demande/form/hc3011_sc3011-eng.pdf) Guidance Document: Fees for the Review of Drug Submissions and Applications (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/fee_frais_guide-eng.php) Guidance Document: Fees for the Right to Sell Drugs (http://www.hc-sc.gc.ca/dhpmps/prodpharma/fees-frais/right_sell_guid_droit_vendre-eng.php) Guidance Document: Post-Drug Identification Number (DIN) Changes (http://www.hcsc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/change_din-eng.php) Guidance Document: Patented Medicines (Notice of Compliance) Regulations (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guideld/patmedbrev/pmreg3_mbreg3-eng.php) 16 Draft Date: 2017/02/17
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