Registration application

Request for registration

In order to register a drug product under the List of Medications covered by the basic prescription drug insurance plan or the List of Medications — Institutions of the Régie de l'assurance maladie du Québec, manufacturers must put in a request.

To see a list of deadlines for requests for registration under the next updates, go to the List update schedule. The deadlines for the receipt of requests for registration for multisource medications are also indicated.

Putting together a file

You must refer to the checklist to find out the required documents according to the type of submission. For a detailed description of the required items, please consult “Guidance Document for Submitting a Request to INESSS”.  The forms and template letters are also available.

Please make sure that you use the most recent versions of these documents, available here.

 

  • Checklist 1
    New innovative drug or new indication – With a Health Canada notice of compliance
  • Checklist 2
    New innovative drug or new indication – Health Canada notice of compliance pending
  • Checklist 3
    New innovative drug that is a combination of drugs (each of which is listed) – With a Health Canada notice of compliance
  • Checklist 4
    New pharmaceutical form or new strength of a listed drug
  • Checklist 5
    New biosimilar drug or new indication
  • Checklist 6_Multisource
    New multisource drug (generic drug or natural health product)
  • Checklist 7
    New diagnostic agent with a listed generic name
  • Checklist 8
    New nutritional formula with a listed generic name
  • Checklist 9
    New package size of a diagnostic agent or nutritional formula
  • Checklist 10
    New dressing with a listed generic name
  • Checklist 11
    New size or new form of dressing
  • Checklist 12
    First request: New biosimilar drug or new indication – Health Canada notice of compliance pending
  • Checklist 13
    Exemption from the application of the lowest price
  • Checklist A
    New innovative drug, new indication, or new innovative drug that is a combination of drugs (each of which is listed) – With a Health Canada notice of compliance
  • Checklist B
    New pharmaceutical form or new strength of a listed drug
  • Checklist C
    New diagnostic agent or new nutritional formula with a listed generic name
  • Drug Listing request
    Drug Listing Request
  • Form
    Summary Submission Description
  • Letter
    Certificate of availability of a product for which a listing request is being submitted
  • Letter
    Request to withdraw a submission
  • Letter
    Authorization to share the information contained in the listing request

Guide et informations supplémentaires pour remplir la demande

Subscribe to our newsletter now

Subscription