Proposed Amendments to Regulations under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee ActPublished on November 26, 2018
Author: Bhavesh Patel, C. Chem. Natco Pharma (Canada) Inc.
The Ministry of Health & Long-Term Care recently announced proposed amendments to the regulatory scheme affecting private label drug products.
Private label drug products are drug products that bear the trademark or branding of a wholesaler or pharmacy chain but are manufactured by an unrelated manufacturer. In essence, the wholesaler or pharmacy chain pharmacy purchases the drug product from the manufacturer then sells the products under its own trademark.
Under the current regulatory scheme, private label products are not eligible for designation as listed drug products under the Ontario Drug Benefits Act and are therefore ineligible for public funding under the Ontario Drug Benefit Program. Similarly, private label products are not eligible for designation as an interchangeable product under the Drug Interchangeability and Dispensing Fee Act. As a result, pharmacists cannot easily dispense private label products to private and cash paying clients.
The proposed regulatory amendments will revoke the above restrictions. Ontario is currently the only Canadian jurisdiction with such restrictions. The proposed amendments would align Ontario's position on private label products with the other provinces and territories. The proposed amendments will also lessen the regulatory burden for private label companies by removing the requirement for the private label manufacturer to fabricate the drug, in whole or in part.
A summary and draft of the proposed amendments to the regulations are available on the Regulatory Registry website at: https://www.ontariocanada.com/registry/view.do?postingId=27986&language=en
Interested parties are invited to provide written comments on the proposed changes to the regulations as part of the review. The Ministry will consider comments received on or before November 27, 2018 at midnight EST. Please be advised that submissions received after this date may not be considered.
Thank you for reading Regulated Affairs, the CAPRA Blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Feel free to share our blog posts and join us on social media.
Pragmatic Clinical Trials: Testing Treatments in the Real-World
What is a Pragmatic Clinical Trial? Clinical trials can be designed to be either pragmatic or explanatory. Explanatory trials are designed to find out whether a treatment...
The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use – June 28, 2022
The FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862)....