Certificates of Supplementary Protection (CSP)

Smart & Biggar

On May 12, 2023, Health Canada announced the fifth version of the Guidance Document: Certificates of Supplementary Protection.

The changes are described as being made to reflect current administrative practices, and to reflect the amended definition for “authorization for sale” in the Certificate of Supplementary Protection Regulations, which carves out, for example, certain limited purpose authorizations including for sale of a drug imported into Canada to address an urgent public health need, including a drug shortage.

Other changes include:

  • Aligning the wording of the definition for “filing date of the submission” with the “Management of Drug Submissions and Applications Guidance Document” (page 8);
  • Requiring that CSP applications be submitted electronically by email unless alternate arrangements are made with OPML (pages 8-9); and
  • Explaining that CSP applicants are expected to have knowledge of the relevant provisions or practices relating to their application for marketing approval in the foreign country as they are responsible for determining the relevant “application for a marketing approval, equivalent to an authorization for sale” and making the appropriate attestation (page 10); and,
  • Clarifying that a side-by-side comparison of the chemical structures is undertaken to confirm whether a medicinal ingredient is an enantiomer, solvate and polymorph, as is done for other variations (page 18).

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