Notice

April 2, 2012
Our file number: 12-104793-842

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Re: Revisions made to guidance documents and forms for drugs and medical devices to show the annual 2% increase in fees as per the Fees in Respect of Drugs and Medical Devices Regulations as well as other minor revisions to improve clarity of the Guidance Document - Fees for the Review of Drug Submissions and Applications.

Health Canada would like to inform sponsors that the following documents have been revised to reflect fees that are current as of April 1, 2012. Health Canada has also made minor revisions to improve clarity in the Guidance Document - Fees for the Review of Drug Submissions and Applications. These are shown in the Document Change Log in that document. Notice of the increase in fees was published in Canada Gazette, Part I on Saturday, Febraury 18, 2012.

• Updated Drugs Documents:
  • Drug Submission/Application Fee Form
  • Guidance Document - Fees for the Review of Drug Submissions and Applications
• Updated Medical Devices Documents:
  • How to Complete the Application for a New Medical Device Licence
  • New Class III Medical Device Licence Application Form
  • New Class IV Medical Device Application Form
  • Class III Medical Device Licence Amendment Application Form
  • Class IV Medical Device Licence Amendment Application Form
  • Guidance Document - Fees for the Review of Medical Device Licence Applications
  • Guidance Document - Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices

Should you have any questions or comments regarding the content of this Notice, please contact:

• Bureau of Policy, Science and International Programs
  Therapeutic Products Directorate
  Health Canada
  Holland Cross, Tower B, 2nd Floor
  1600 Scott Street
  Address Locator 3102C1
  Ottawa, Ontario
  K1A 0K9
• Telephone: 613-948-4623
  Fax: 613-941-1812
  E-Mail: policy_bureau_enquiries@hc-sc.gc.ca