Those familiar with the Site Licensing renewal process know that SL renewals must be filed 30 days before the expiry date of the licence. Failure to meet the deadline will […] Read More >>
Health Canada has released Batch 4b for consultation, marking another significant step in its Natural Health Products (NHP) monograph revision process. This ongoing initiative by the Natural and Non-Prescription Health […] Read More >>
Health Canada has opened a consultation to update its 2015 Good Manufacturing Practices (GMP) guide for Natural Health Products (NHPs). This effort is aimed at refining the existing guidelines, making […] Read More >>
Ashwagandha root extract is a well-known adaptogen, recognized for its potential to reduce stress, improve energy levels, and support overall well-being. While it is widely used in the Natural Health […] Read More >>
Health Canada has recently launched a significant update to streamline the submission process for medical devices. The Medical Devices Directorate (MDD) is now offering the Regulatory Enrolment Process (REP) as […] Read More >>
Cosmetics are currently regulated in Canada through Health Canada’s Cosmetic Regulations (which falls under the Food and Drugs Act). Under Sections 30 and 31 of the Cosmetic Regulations, it is […] Read More >>
Health Canada continues its progress in revising the monographs for natural health products (NHPs), with the release of Batch 4a for consultation. This is part of the ongoing effort by […] Read More >>
A Quality Management System (QMS) is a structured framework that organizations use to ensure their products or services consistently meet customer expectations and regulatory requirements. Its purpose is to ensure […] Read More >>
On July 3, 2024, Health Canada officially permitted the use of Veterinary Health Products (VHPs) via the in-feed route of administration. This significant regulatory update opens new opportunities for maintaining […] Read More >>
On May 17, 2024, Health Canada published the Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine. This order introduces specific condition-of-sale regulations for natural […] Read More >>
Health Canada continues its commitment to updating and revising its monographs, releasing Batch 3 for consultation. This represents another crucial step in ensuring the accuracy and applicability of information provided […] Read More >>
On April 24, 2024, Health Canada published amendments to the Cosmetics Regulations in Canada. These amendments, detailed in the Cosmetic Regulations under the Food and Drugs Act, signify important changes […] Read More >>
On May 12, 2023, Health Canada alerted industry of a proposal to introduce cost recovery fees for Natural Health Products (NHPs). This proposal, initially released for consultation from May 12 […] Read More >>
In Canada, infant formulas and human milk fortifiers are regulated under the Food and Drug Regulations, Part B, Division 25 (B.25.019). Health Canada defines infant foods as food to be […] Read More >>
Health Canada’s ongoing efforts to update and revise its monographs continue with the release of Batch 2 for consultation. This marks another significant step in ensuring the accuracy and relevance […] Read More >>
A Natural Product Number (NPN) is an 8-digit number issued to a Natural Health Product (NHP), after an assessment, indicating its approval by Health Canada’s Natural and Non-Prescription Health Products […] Read More >>
The Canadian Food and Drug Regulations (FDR) have established regulations for Food for Special Dietary use (FSDU) as well as food for infants, covered under Divisions 24 and 25 of […] Read More >>
On Thursday, September 21, 2023, representatives from dicentra attended the CHFA Now’s Regulatory Forum in Toronto in order to stay informed and be able to provide our clients, prospects, and […] Read More >>
In the ever-evolving landscape of regulatory compliance for the natural health product (NHP) industry in Canada, recent developments such as Bill C-47 (refresher here) and the NHP GMP Inspection Program […] Read More >>
Definition of a Pregnancy Test A urine pregnancy test device is an In-Vitro Diagnostic (IVD) hormonal assay that measures the beta (β) subunit of Human Chorionic Gonadotrophin (hCG) levels in […] Read More >>
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