Drugs - SNI Inc.

02 Jun 2026

Health Canada Melatonin Update: Pediatric Use to Become Prescription-Only

DrugsFood and Drug Regulations, health canada, Melatonin, natural health products, NHP compliance, Pediatric Melatonin, Pediatric Sleep Products, Prescription Drug List, regulatory affairs Canada

Health Canada has announced an amendment to the human use section of the Prescription Drug List for “melatonin or its salts.” Effective June 2, 2026, melatonin products sold for sleep-related use in children and adolescents under 18 years of age will be classified as prescription drugs under the Food and Drug…

04 Sep 2025

Health Canada Adds New Ingredients to the Prescription Drug List

Canadian Drug Regulationsartesunate, benzoyl peroxide, canadian regulations, crovalimab, health canada, osilodrostat, PDL update, Pharmaceutical compliance, Prescription Drug List, prescription drugs, quizartinib, Regulatory Affairs

Health Canada has announced updates to the Prescription Drug List (PDL) that affect both human and veterinary drugs. This amendment introduces four new medicinal ingredients that now require a prescription and revises the conditions under which benzoyl peroxide is considered prescription-only for human use. These changes are effective immediately as…

20 May 2025

April 2025 Additions to Health Canada’s Prescription Drug List (PDL): What You Need to Know

Canadian Drug Regulationsdrug regulation, efanesoctocog alfa, fecal microbiota, health canada, inavolisib, loncastuximab tesirine, PDL, Prescription Drug List, retifanlimab, rozanolixizumab, sipavibart, tofersen, vaborbactam

When most people think about prescription drugs, they may not consider the regulatory framework that determines which medicines are available only by prescription. But in Canada, this distinction is critically important and tightly governed by Health Canada through its Prescription Drug List (PDL). In a recent regulatory update published on…

15 May 2025

How to License a Sunscreen Product in Canada — Step-by-Step for NHPs and NPDs

Canadian Drug Regulations, Natural Health Products (NHPs)Canadian Cosmetic Regulations, Canadian Sunscreen Compliance, Health Canada Licensing, Health Canada Regulations, NHP vs NPD Sunscreens, SPF Claims Canada, Sunscreen Approval Canada, Sunscreen Import Requirements, Sunscreen Labelling Requirements, Sunscreen Licensing, Sunscreen Product Licensing

Sunscreen is more than a summertime staple; it's a frontline defence against premature aging, sunburn, and skin cancer. As consumer awareness around sun protection continues to grow, so does the demand for innovative, high-quality sunscreen products. But behind every tube on a drugstore shelf lies a rigorous regulatory journey. In…

13 May 2025

How to Get a Drug Identification Number (DIN) in Canada — A Guide for Importers and Manufacturers

Canadian Drug RegulationsCanadian drug regulations, DIN application process, DIN Canada, Drug Identification Number, drug import Canada, drug labelling Canada, GMP compliance Canada, Health Canada DEL, Health Canada drug approval, how to get a DIN, pharmaceutical compliance Canada, sell drugs in Canada

Entering the Canadian pharmaceutical market requires more than just a good product—it requires regulatory approval. If you’re planning to sell prescription drugs, over-the-counter medications, medicated shampoos, or sunscreens in Canada, you’ll need a Drug Identification Number (DIN) issued by Health Canada. The DIN is not just a tracking number; it’s…

08 May 2025

Understanding Sunscreen Licensing in Canada — Regulatory Pathways and Health Canada’s Role

Canadian Drug Regulations, Natural Health Products (NHPs)Canadian Sunscreen Compliance, Health Canada Regulations, NHP vs NPD Sunscreens, Sunscreen Approval Canada, Sunscreen Licensing

Over the years, research has consistently highlighted just how important sunscreen is in a daily skincare routine. Some people were ahead of the curve, protecting their skin from harmful UV rays long before sunscreen became a non-negotiable part of everyone’s morning regimen. But what many don’t realize is that bringing…

15 Jan 2024

Crossing the border out of the USA– regulatory considerations and possible funding support

Food and Beverage, International Trade, Market Entry Support, U.S. Drug Regulations, U.S. Food Regulationsborder crossing, exporting products, FAS, Food Export Midwest, Food Export Northeast, Foreign Agricultural Services, Regulatory Affairs, Southern US Trade Association, SUSTA, USDA, use border

Our team at SNI has helped countless clients successfully export their products from the US market into other countries. When it comes time to evaluate the potential export of your products, we are here to help! Our team has expert knowledge on product classification, formulation considerations, and all aspects of…

05 Jul 2023

UPDATES: Natural Health Product Plain Language Labelling

Canadian Drug Regulations, Canadian Food Regulations, Drugs, Food and Beverage, Natural Health Products (NHPs), NHP Regulationscanadian drug facts table, consumer safety, drug facts, health canada, medicinal ingredients, natural health products, NHP, non-prescription drugs, NPDs, PFT, Plain Language Labelling, PLL, product facts table, product license

We mentioned in September that there are changes in the near future regarding labelling of natural health products in Canada, and with an implementation date of June 21, 2025, we are revisiting the requirements to help the industry prepare. For products already on the market, or those which will have…

29 Jun 2023

Health Canada’s Proposal for NHP Cost Recovery Causes Waves

Canadian Drug Regulations, Drugs, Natural Health Products (NHPs), NHP Quality Assurance, NHP RegulationsAnnual Establishment Licensing Fees, Authority to Sell Drug Fees, consumer safety, DIN applications, Drug Evaluation Fees, HEAL Committee, health canada, medicinal ingredients, natural health products, NHP, NHP Product License, non-prescription drugs, NPDs, PFT, PLA, Plain Language Labelling, PLL, product facts table, product license

The Canadian regulations for Natural Health Products (NHPs) came into force in 2004, and for nearly 20 years, Canadians have been able to shop with confidence for products displaying either a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the product label. These products must be approved by…

22 Mar 2023

Reminder: We’re Here to Support Your U.S. Regulatory Needs

Drugs, Food and Beverage, Market Entry Support, Medical Devices, U.S. Drug Regulations, U.S. Food Regulations, U.S. Medical Device Regulationsdietary supplement, dietary supplements, FDA, Food Labeling, food labelling, Food Packaging, NDA Notifications, Packaging Compliance, Pharmaceutical compliance, U.S food labelling requirements, U.S. food labels, U.S. Regulatory Services

Despite sharing a border, Canada and the U.S. have completely separate (and quite different!) regulations for products like foods and dietary supplements. And while you might know us for our Canadian services thanks to our robust client base, we want to remind you that SNI is here to support your…