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Canadian Drug Facts Table & Plain Language Labels

Health Canada’s Plain Language Labelling initiative is well under way for drug products in Canada. Although the program was introduced several years ago, it has only been since June of 2017 that compliant labels were required to accompany all drug applications submitted to Health Canada. The goal of the plain language label (PLL) program is […]

Do I Need a License to Import?

We are often asked whether or not a license is required for health products that are planned for import into Canada.   Health Canada has an easy-to-follow policy on the importation of prescription drugs, over-the-counter drugs and natural health products (dietary supplements). The Guidance Document on the Import Requirements for Health Products under the Food […]

Health Canada Updates Site License Holders List

Two important lists regarding the manufacture and import of natural health products into have been updated on the Health Canada website.   The first list, the Site License Holders List, provides information on those facilities located in Canada that have received approval by Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) for the following […]

Products at the Cosmetic-Drug Interface

There are several product groups on the border-line between cosmetics and drug products in Canada. Understanding which category your product belongs to is the first step in successful marketing your health product or cosmetic to Canadians.   Here’s a few categories of products that sit on the cosmetic-drug borderline in Canada. • Acne products • […]

List of Drugs for an Urgent Public Health Need

Health Canada has just announced which drugs will be included on their initial list of urgently needed medications, known as the List of Drugs for an Urgent Public Health Need. As a result of the new regulations announced this week, provinces and territories are now able to import top-priority medications that are not presently available […]

Attestation Process for (NHP) Product License Applications

The Natural and Non-Prescription Health Products Directorate (NNHPD) has published a handy tool ahead of schedule (dated Winter 2017) to remind applicants about the attestation process for natural health product license applications. The monograph attestation form should be completed for all applications where one or more ingredients is supported by an NHP monograph, otherwise known […]

Drug Establishment License Holders to Import Urgently Needed Drugs

Health Canada’s April 2017 announcement regarding the importation of drugs for urgent public health needs confirmed that the Canadian government is indeed taking steps to respond quickly to a public health crisis. Health Canada plans to achieve this by opening up a new regulatory pathway for importation of products that have not been authorized for […]

Drug Identification Number (DIN) Review – Canada

If you are selling a drug product in Canada you are most likely familiar with the term “DIN” which stands for Drug Identification Number. In order to sell a drug product in Canada and operate in compliance with Health Canada’s Food & Drug Regulations all companies must apply for and receive a DIN for their […]

Changes in Ownership, Mergers & Buyouts – Drug Products

On February 18, 2017 Health Canada released the Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant Drugs for external consultation. This guidance document will ultimately replace the current 1998 Change in Manufacturer’s / Product Name Policy (CMPN). Once finalized, this new draft guidance document would replace the CMPN Policy. […]

GMP Audits for Site Licences in Canada

Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) provided a glimpse of some proposed changes in their Six-Month Calendar of Activities for January-June 2017. The last one on the list, Compliance Monitoring Projects, has to do with on-site auditing of GMP compliance. This one may be of particular interest to those facilities with a […]