On December 21, 2022, Health Canada opened a consultation on a proposal to amend the labelling of pharmaceutical drugs for human use guidance document. The amendments that have been proposed were to sections C.01.004(1)(a) and C.01.011 of the Food and Drug Regulations.
What are the Proposed Amendments?
For your convenience, we have outlined the proposed amendments to the regulations:
- 2.1.1 Principal Display Panel
“The standard for the drug product, if any;” will no longer need to be displayed on the principal display panel.
- 3.4.2.1 Proper Name
It will no longer be a requirement to list the standard of manufacture near the proper name of the drug, instead Health Canada proposes leaving it up to the discretion of the sponsor whether or not they “would like to include the standard of manufacture”, but if they do, should still include it in close proximity to the proper name.
- 3.4.3 Standard of Manufacture
Health Canada is proposing removing “Pursuant to subsection C.01.004 (1) of the Regulations” from: Pursuant to subsection C.01.004 (1) of the Regulations, where a standard prescribed by the Regulations exists (see Section 3.4.3.1, “Prescribed Standard”) and it applies to the specific drug product, it shall be included on the principal display (main) panel of the inner and outer labels. Additionally, the proposal changes “it shall be included” to “it may be included” from the above statement.
- 3.4.3.1 Prescribed Standard
It will no longer be required to include on the label the CSD standard, however the drug substance must still conform in all aspects to that standard.
- 3.4.3.3 Manufacturer’s Standard
The proposal removes both references to sections C.01.011 & C.01.011 (4) of the Regulations:
- In accordance with section C.01.011 of the Regulations, no person shall use a manufacturer’s standard for a drug that provides (a) lesser degree of purity than the highest degree of purity, or (b) a greater variation in potency than the least variation of potency, provided for that drug in any publication mentioned in Schedule B to the Act.
- (See section C.01.011 (4) of the Regulations.)
- 3.4.3.5 Placement of Standard on Labelling
The proposal removes “(see subsections 10(1) and (2) of the Act)”, and “this standard” from: Where a standard of manufacture is to be shown on a label (see subsections 10(1) and (2) of the Act), this standard should be declared near the prescribed or proper name of the drug product. The quantitative amounts may be indicated before or after the prescribed or proper name (e.g., Conjugated Estrogen Tablets CSD 1.25 mg, Acetaminophen Tablets USP, 325 mg).
- 3.5.5 Declaration of Medicinal Ingredients
The proposal removes the footnote from “However, when a standard exists for the entire combination, then this standard must normally10 be declared on the main panel of the label” and also changes “must” to “may”.
- 5.4.5 Prescribing Information
The proposal removes “Standard of manufacture where required by the Regulations;” from the prescribing information (or professional information) for new drug products not conforming to the Product Monograph format or not subject to Division 8 of the Regulations.
Who Can Participate?
Anyone. This consultation is open to academics, consumer and patient safety organizations, drug and medical device industry, health system partners, and the general public.
How to Participate?
Submission of comments can be done by downloading this fillable PDF form and sending it to hpfb.engagement-mobilisation.dgpsa@hc-sc.gc.ca
For your convenience, you can access the original version of the guidance document here.
Consultation is closing on March 27, 2023
If you have any questions or concerns about this consultation and how it can impact you or your business, please contact us.
