1.

Notifying Member: CANADA

If applicable, name of local government involved (Articles 3.2 and 7.2):

2.

Agency responsible:

Health Canada

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:

4.

Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)

5.

Details of notified document(s) (title, number of pages and languages, means of access): Notice of Consultation: Adding melatonin for sleep-related use in the pediatric population to the Prescription Drug List; (4 page(s), in English), (4 page(s), in French)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

https://www.canada.ca/en/health-canada/programs/consultation-adding-melatonin-sleep-related-use-pediatric-population-prescription-drug-list.html

6.

Description of content: The purpose of this Notice of Consultation is to provide an opportunity for the public and other interested stakeholders to comment on the proposal to revise the listing for "Melatonin or its salts" on the human use part of the Prescription Drug List (PDL). Specifically, the proposal is to broaden the qualifier to capture all sleep-related uses in the pediatric population (i.e., all children and adolescents under 18 years of age).

7.

Objective and rationale, including the nature of urgent problems where applicable: For the protection of human health or safety, and to broaden the qualifier to capture all sleep-related uses in the pediatric population (i.e., all children and adolescents under 18 years of age).

8.

Relevant documents:

Health Canada website: https://www.canada.ca/en/health-canada/programs/consultation-adding-melatonin-sleep-related-use-pediatric-population-prescription-drug-list.html, the notice of consultation, posted 16 September 2025, (available in English and French)

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Provision of comments

Final date for comments: 30 December 2025

[ ] 60 days from notification

Contact details of agency or authority designated to handle comments regarding the notification:

Canada's Notification Authority and Enquiry Point

Global Affairs Canada

Technical Barriers and Regulations Division

111 Sussex Drive

Ottawa, ON K1A 0G2

Canada

Telephone: (343)203-4273

Fax: (613)943-0346

Email: enquirypoint@international.gc.ca