In May of 2019, Health Canada announced a “Notice of Consultation on the Prescription Drug List: Vitamin D”. This notice opened up to public consultation the proposal to amend the Prescription Drug List (PDL) qualifier for Vitamin D to allow non-prescription status to products containing up to 2,500 International Units (IU)/day for oral use.
Following the consultation, which concluded on July 22, 2019, Health Canada published the “Notice of Intent to Amend the Prescription Drug List” on August 19, 2020. This amendment will bring the original non-prescription status qualifier limit of 1000 IU/day to 2500 IU/day, as discussed above.
This amendment will take effect on February 24, 2021.
What does this mean?
Normally, any submissions with vitamin D levels higher than 1,000 IU per dosage are regulated according to the Food and Drug Regulations. However, once the PDL listing for Vitamin D has been amended, authorizations can be made by submitting a product licence application to the NNHPD.
dicentra can assist with the compilation of high-quality submissions through the interpretation of the evidence to support the safety and efficacy of your products.