New format for electronic submission
Final filing requirements have been published in the April 2015 issue of the NEWSletter and will be incorporated into the yearly update of the Compendium of Policies, Guidelines and Procedures (Guidelines) in June 2015. For submission deadlines, please see the HDAP schedule.
New requirements for electronic submissions
- One CD or memory stick must be filed within the HDAP submission deadlines
- The CD or memory stick should be labelled according to the following naming convention: [Name of drug under review]
- All documents must be provided in a single PDF document that is unlocked, searchable, and printable to enable users to extract information
- The PDF document should be labelled according to the following naming convention: [Name of drug under review] Patentee Submission for the [Date of HDAP meeting] HDAP Meeting (e.g., Drug XX Patentee Submission for the May 4, 2015 HDAP Meeting)
- Documents that have been merged into one PDF should be labelled and organized as indicated below. They must also appear in the following order and format in the PDF Bookmarks:
A. Cover Letter
B. Proposal of the Patentee – refer to Schedule 1 of the Guidelines for details on the required contents of the proposal. Do not include any price justification or pricing details; if this information is included, the submission will be returned to the patentee.
C. References – please do not provide duplicate references or references that are not included in your submission. For the naming of articles/references, please minimize the characters used.
1. Smith 2014
2. (Company Name) Study
a. Clinical Trial
b. Relevant Findings
Do not include the Product Monograph or Form 1. See Patented Medicines Regulations and HDAP schedule for the timelines for submission of Form 1 and the Product Monograph.
- CDs or memory sticks should be mailed or couriered to:
Regulatory Affairs and Outreach Branch
Patented Medicine Prices Review Board
Box L40, 333 Laurier Avenue West, Suite 1400
Ottawa, Ontario K1P 1C1
Questions or comments regarding HDAP submissions can be directed to Amber MacPherson, Regulatory Affairs and Outreach Branch.