Important Message from the Director General of the NNHPD – Notice to Stakeholders: Non-prescription Drugs Label

Posted Date: 18-November-2025

Bulletin 10: Natural Health Products Labelling Regulations Compliance Extension

 

Following discussions at the October 9, 2025, Multilateral Stakeholder meeting on Natural Health Products (NHPs) and Non-prescription Drugs (NPDs), the Natural and Non-prescription Health Products Directorate (NNHPD) has implemented new efficiencies in NPD label review to better align oversight with risk, reduce administrative burden, and streamline processes as part of the government’s red tape review initiatives. Key changes include for Administrative Applications, where full mock-up label reviews will be discontinued for submissions only involving changes in company/manufacturer name or product ownership, focusing instead on verifying the implementation of the proposed change; however, other administrative submissions may still undergo a cursory review for continued licensor compliance. For Post DIN Change (PDC) Applications, products that have already undergone a Plain Language Labelling (PLL) review will no longer receive a full mock-up label review, only a verification of the change, though a full PLL review will be conducted if the product has not had one yet. Finally, General Label Review Efficiencies include placing the onus on the sponsor to ensure the correctness of non-medicinal ingredient (NMI) composition and no longer confirming if ingredient quantities add up to 100%. Furthermore, labels will now be reviewed in only one language (English or French), with the sponsor responsible for accurate translation, and formatting will not be reviewed unless it is clearly incorrect or illegible. These updates are intended to maintain high standards while improving efficiency and clarity for both stakeholders and the NNHPD.

 

CA has asked how these details will be formally communicated on Health Canada’s website and have advanced questions to be included in the formal communication.