Health Canada

The purpose of this Notice of Amendment is to notify about the additions of Alpelisib, Baloxavir marboxil, Betula verrucosa (white birch), Brolucizumab, Cabotegravir, Caplacizumab, Ciclesonide, Darolutamide, Entrectinib, Fremanezumab, Glasdegib, Isatuximab, Siponimod, Tenapanor, Tetracosactide...

This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to Section C.08.004 of the Food and Drug Regulations. In the absence of a guidance specific to Quality changes to drugs which were approved through a Drug Identification Application...

This guidance document combines and supercedes the policy and guidance documents for Notices of Compliance with Conditions (NOC/c) dated June 12, 2007. The revisions to this document incorporate the provision for the filing of Abbreviated New Drug Submissions (ANDSs) or Supplement to an...

The Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) were introduced originally by Industry Canada under the Patent Act. The PM(NOC) Regulations intersect with drug approval under the Food and Drugs Act and Division 8 of the Food and Drug Regulations.

Notice of Compliance with Conditions - Qualifying Notice.

Notice of Compliance with Conditions - Qualifying Notice.

Notice of Compliance with Conditions - Qualifying Notice

Notice of Compliance with Conditions - Qualifying Notice

Notice of Compliance with Conditions - Qualifying Notice

Notice of Compliance with Conditions - Qualifying Notice.

Notice of Compliance with Conditions - Qualifying Notice

The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will switch certain uses of Esomeprazole to nonprescription status for human use by modifying the Human Prescription Drug List (PDL).

The purpose of this Notice of Amendment is to announce the revised listing for hydrocortisone on the Prescription Drug List (PDL).

The purpose of this Notice of Amendment is to notify about the addition of hydroquinone or its derivatives to the Prescription Drug List (PDL) for human use when sold in concentrations greater than 2% in topical products.

The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will switch certain uses of Ibuprofen to nonprescription status for human use by modifying the Human Prescription Drug List (PDL). The Veterinary List will remain unchanged.

The purpose of this Notice of Amendment is to notify that Health Canada has revised the listing for levonorgestrel on the Prescription Drug List (PDL). Only the Human part of the PDL was revised; the listing for Veterinary use will remain unchanged.

The purpose of this Notice of Amendment is to announce the revised listing for lovastatin on the Prescription Drug List (PDL). As stated in the Notice of Intent to Amend, posted June 4, 2014, the revision will allow lovastatin to be marketed as a nonprescription product. Only the Human part of...

The purpose of this Notice of Amendment is to notify that Health Canada has revised the listing for Adrenocortical hormones on the Prescription Drug List (PDL) to allow the nonprescription use of Mometasone furoate for the conditions listed below. Only the Human part of the PDL was revised.

The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will switch certain uses of Polymyxin B to prescription status for veterinary use by adding it to the Veterinary Prescription Drug List (PDL).

The purpose of this Notice of Amendment is to announce the revised listing for Adrenocortical hormones to allow the nonprescription use of triamcinolone acetonide for the conditions listed below. Only the Human part of the PDL has been revised.