Notice - Prescription Drug List (PDL): Hydroquinone
August 29, 2017
Our file number: 17-109315-912
The purpose of this Notice of Intent to Amend is to notify that Health Canada will add certain hydroquinone products to the Prescription Drug List (PDL). Only the Human part of the PDL is to be revised. Health Canada has conducted a scientific review of hydroquinone against the criteria in section C.01.040.3 of the Food and Drug Regulations. The new listing, which remains unchanged from what was proposed in the February 1, 2017 Notice of Consultation, is:
- Drugs containing any of the following: Hydroquinone or its derivatives
- Qualifier: When sold in a concentration greater than 2% in preparations for topical use on the skin.
- Effective Date: 12 months from date of this Notice
The proposal to amend the PDL in relation to hydroquinone was communicated through a Notice of Consultation posted on Health Canada's website on February 1, 2017. The 75 day consultation period ended on April 17, 2017.
Two comments opposing the change and one comment supporting it were received on this consultation.
A scientific assessment of hydroquinone was conducted by Environment and Climate Change Canada (previously Environment Canada) and a screening assessment of hydroquinone was conducted by Health Canada's Healthy Environments and Consumer Safety Branch as part of the Chemicals Management Plan. As a result, hydroquinone was added to Schedule 1 of the Canadian Environmental Protection Act (CEPA 1999) due to health concerns assessed through the Chemicals Management Plan. In addition, following an assessment of hydroquinone at a concentration greater than 2% in products for topical use on the skin against the criteria listed in section C.01.040.3 of the Food and Drugs Regulations, it was determined that practitioner supervision is necessary to mitigate the risks. The present amendment is also consistent with regulations from several international governments and agencies (United States Food and Drug Administration, Australia's Therapeutic Goods Administration, and the South African Health Products Regulatory Agency).
Hydroquinone will be excluded from the Natural Health Products Regulations at a concentration of greater than 2% in products for topical use on the skin once added to the Prescription Drug List. This revision will come into effect 12 months from the date of this Notice through a Notice of Amendment posted on the Health Canada website.
Health Canada will communicate with the Market Authorization Holders (MAH) that are impacted by the above-noted change.
MAHs that currently hold a Natural Product Number (NPN) but wish to retain their current formulation for a product containing hydroquinone at a concentration greater than 2% for topical use on skin should make a submission to the Therapeutic Products Directorate to obtain a Drug Identification Number (DIN) under the Food and Drug Regulations in order to obtain a valid market authorization.
MAHs can alternatively reformulate their product(s) to decrease the hydroquinone concentration in their products to 2% or below, by applying for an NPN under the Natural Health Products Regulations (NHPR).
MAHs currently holding DIN(s) or NPN(s) for products containing hydroquinone at a concentration greater than 2% that do not wish to maintain market authorization may apply for discontinuation of these products.
For all questions regarding the submission process for DINs, please refer to the guidelines and forms on the Health Canada website, or contact the Bureau of Gastroenterology and Infectious Diseases within TPD at email@example.com for further guidance on how to file a drug submission.
For all questions regarding the application process for natural health products, please refer to the Management of product licence application for natural health products guideline, or contact NNHPD at firstname.lastname@example.org.
Once the Notice of Amendment is posted in August 2018, the PDL will be revised and all products containing greater than 2% hydroquinone in preparations for topical use on the skin may only be sold if they have been issued a DIN and if they are sold pursuant to a prescription.
Once the PDL is revised, companies wishing to conduct licensable activities (e.g., fabricate, package / label, test, import) for products containing greater than 2% hydroquinone will be required to hold a Drug Establishment Licence (DEL) and meet all applicable requirements under the Food and Drug Regulations. DEL applications are subject to fees and a performance standard of 250 days on average. For more information related to DEL requirements, please refer to the Health Canada website or contact DEL_questions_LEPPP@hc-sc.gc.ca.
Should you have any questions on this update to the Prescription Drug List, please contact:
Prescription Drug Status Committee
Holland Cross, Tower B, 2nd Floor
1600 Scott Street
Address Locator 3102C3
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