Updated: Notice - Notification of Safety Labelling Changes to the Product Monographs of Pharmaceutical Drug Products
Our file number: 20-102628-584
March 23, 2020
Subject - Notification of Safety Labelling Changes to the Product Monographs of Pharmaceutical Drug Products
On February 21, 2013, Health Canada implemented a process that informed generic drug sponsors of safety labelling changes to the Product Monographs (PM) of brand name pharmaceutical drugs.
Further to the new Fees in Respect of Drugs and Medical Devices Order, effective April 1, 2020, Notifiable Changes will no longer exist for safety and efficacy changes to pharmaceutical drug products for human use. Health Canada will continue to post a monthly table on the Department website which reflects updated and/or new safety information in PMs of brand name pharmaceutical drug products (those regulated under Division 8 of the Food and Drug Regulations only). This table will identify the section of the PM that was updated pursuant to a Supplement to an (Abbreviated) New Drug Submission (S(A)NDS).
The issuance of this table is aimed to inform generic drug sponsors about new safety information for pharmaceutical drug products so that they can update their PMs for health care professionals and Canadians. The table will also address Departmental commitments following the Auditor General's audit report: Regulating Pharmaceutical Drugs - Health Canada, related to improving transparency and timeliness with respect to drug safety.
Note that all sponsors are required under the Food and Drug Regulations to ensure drug product labelling, including the PM, is up to date and supports safe conditions of use. The table will provide generic drug sponsors with the necessary information about their Canadian Reference Products' (CRP) labelling to facilitate corresponding updates to generic PMs. Generic drug sponsors are reminded of their obligations to update their PM to ensure consistency with that of the CRP; they are encouraged to review the table and submit to Health Canada according to the suggested timeline. Further instructions for generic drug sponsors can be found below.
The table can be found on the Health Canada website. To access up-to-date Health Canada approved information on drugs marketed in Canada, you can perform a search of the Drug Product Database online. When required, Health Canada will continue to communicate new safety information to Canadians by various means including: issuing warnings, advisories, and PM updates.
Information on Filing Safety updates for Generic Sponsors
Sponsors of authorized generic products are expected to file S(A)NDSs to update their labelling within 30 days of the posting date of the table describing the safety labelling change(s) for the CRP. Generic sponsors may also wish to include non-safety updates to the labelling to be in line with the CRP, which may not be summarised in the above-mentioned table.
Drug Identification Number (DIN) Assigned/ Non-Marketed / Dormant Products
Generic sponsors are also expected to file safety updates according to the above timeline if their products have a DIN assigned but are not currently marketed in Canada or if the assigned DINs are dormant.
Products on Intellectual Property (IP) Hold
Sponsors of generic products on IP hold are also expected to file safety updates according to the above timeline, however in certain cases it may be acceptable to delay filing until closer to the date of issuance of the Notice of Compliance.
Please note that while this posting is intended to replace direct generic sponsor labelling request notifications, in some cases, Health Canada may still contact generic sponsors directly to request labelling updates. Submissions should be prepared in the usual manner as per the Management of Drug Submissions and Applications and Post-Notice of Compliance Changes Guidance Documents.
Sponsors should include a Sponsor Attestation with their submission, certifying that the submitted PM is updated to be consistent with the most recent PM of the CRP. Attestation forms can be found on the Health Canada website and should be used for all S(A)NDSs for generic products where a PM update is proposed.
The appropriate submission class for filing should be determined by referencing the Guidance Document: Fees for the Review of Human Drug and Disinfectant Submissions and Applications and will be confirmed by Health Canada at the time of screening.
Questions or concerns related to this Notice should be directed to the Regulatory Project Management Division:
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