Completing and submitting Form 1: Medicine Identification Sheet

Completing and submitting Form 1: Medicine Identification Sheet - Transcript

Slide 1

  • The following instructional video will provide patentees with the correct method for filing out and filing a Form 1: Medicine Identification Sheet.

Slide 2

  • A new Form 1 must be submitted either seven days after the date of the issuance of the first Notice of Compliance, or seven days after the date of first sale in Canada, whichever comes first.
  • An amended Form 1 must be submitted within 30 days of any modification of information. This could be the addition of a date of first sale, a date of Notice of Compliance, changes to patent information, change of address of patentee, or change of patentee.

Slide 3

  • At the top of Form 1 there is the option of selecting either an Original filing or an Amendment to an Original filing. Only one box, either Original or Amendment, should be checked.
  • An Original Form 1 is to be submitted when it is the first time the information is being filed to the PMPRB. An amended Form 1 would be filed when a Form 1 has previously been submitted and the patentee is making any changes to the existing information. If the submission is an amendment, please note which Blocks are being amended.

Slide 4

  • Block 1 includes the Brand Name registered with Health Canada, the generic name and the therapeutic use that has been approved by Health Canada. Please do not add any lines to the therapeutic use area. If the description is longer than the lines provided, it is possible to continue typing in the lines after the text no longer appears on the screen. The PMPRB’s system will still recognize the information.

Slide 5

  • The second section of Block 1 includes three check boxes, only one of which may be checked. Human Prescription, Human Over the Counter or Veterinary.

Slide 6

  • Block 2 consists of information about the patentee. Include the patentee’s name and address and identify if the patentee filing is the patent holder or the person entitled to the benefits of a patent or to exercise any rights in relation to a patent. If a patentee is both the patent holder for one patent and the person entitled to the benefits of a patent for another patent, please only check patent holder. Only one box may be checked.

Slide 7

  • Block 3 is the date of the first Notice of Compliance issued by Health Canada for the drug product. If a Notice of Compliance has not yet been issued, please leave this box blank. There are also boxes to check if the product is being sold under the Special Access Programme or if it is a Clinical Trial Application or Investigational New Drug.

Slide 8

  • Block 4 is information about the drug product. Please include the DIN, Dosage Form and Strength per Unit as reported to Health Canada. All information in Block 4, except the DIN field, should be filled out even if a Notice of Compliance and DIN have not been granted. If the drug product has been sold, please include the date of first sale in Block 5. If the product is not yet on the market, please leave Block 5 blank.
  • Block 6 includes two check boxes to indicate whether a product monograph or information similar to that contained in a product monograph has been included with Form 1. A product monograph or information similar to that contained in a product monograph is required for all new Form 1s or if there are any changes that have been made to the document.

Slide 9

  • Block 7 includes information regarding the patents that pertain to the drug product. The patent number must be numeric only. If the patent has been granted, please include the date it was granted and the patent expiration date. If the patent has not yet been granted, please only include an expiration date.

Slide 10

  • Determining when a patent expires depends on whether it was filed before or after October 1, 1989.
  • If a patent was filed on or after October 1, 1989, it expires 20 years after the filing date.
  • If a patent was filed before October 1, 1989, it expires 17 years from the date on which the patent was issued.

Slide 11

  • Block 8 of Form 1 must be signed by a duly authorized person for the reporting patentee. It must include the name, title, company name, date and contact information for this individual.
  • If the patentee does not want to include an electronic signature, they may print Form 1, sign it and scan it as a PDF. If a signed PDF is sent, the unsigned version of Form 1 in Excel format must also be submitted.

Slide 12

  • A few tips to keep in mind when filing a Form 1:
  • All filings must be sent to the Compliance email address shown on the screen. Filings sent to any other address will not be accepted.
  • Never comment directly on the forms. Any comments or concerns should be included in the patentee’s email submission or in a letter.
  • Form 1 must be filed using the most recent version of the template available on the PMPRB website. Any older versions will not be accepted.
  • Filings must be submitted to the PMPRB in Excel format. A signed PDF version may be submitted in addition to the Excel version.
  • Do not modify the template. This includes adding extra boxes for patents or lines for therapeutic use. Form 1 submissions that use modified templates will be rejected by the PMPRB’s electronic verification system and patentees will be notified of the issue.

Slide 13

  • Questions about completing or submitting Form 1 can be directed to the PMPRB at the Compliance e-mail address on the screen.
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