At a Glance Vanessa’s Law, formally known as the Protecting Canadians from Unsafe Drugs Act, strengthened Health Canada’s authority to identify and respond to safety risks associated with therapeutic products […] Read More >>
At a Glance Stability testing is the process of evaluating how the quality of a dietary supplement or Natural Health Product (NHP) changes over time under defined storage conditions. The […] Read More >>
At a Glance Health Canada has released a draft Quality of Natural Health Products Guide for consultation, proposing the most significant update to NHP quality guidance since the finalized Good […] Read More >>
Abstract Good Manufacturing Practices are fundamental to product quality in both the Canadian Natural Health Product and U.S. dietary supplement industries. However, the requirements are not interchangeable. In the United […] Read More >>
Abstract Introduction Health Canada’s Red Tape Reduction Initiative for Natural Health Products represents the latest step in the modernization of Canada’s NHP regulatory framework. The proposed amendments are intended to […] 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 >>
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 >>
Health Canada’s Natural Non-Prescription Health Products Directorate (NNHPD) recently announced that beginning at the end of October, they will begin consulting on monograph revisions. This initiative is geared toward enhancing […] 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 >>
On June 22, 2023, Bill C-47 received Royal Assent, introducing amendments to the Food and Drugs Act (FDA) concerning Natural Health Products (NHPs). These amendments extend the enforcement power of […] Read More >>
On May 12, 2023, Health Canada alerted industry of a new proposal to introduce cost recovery fees for Natural Health Product (NHP) regulatory activities in Canada. The proposal, open for […] Read More >>
As of March 21, 2023, the Natural and Non-prescription Health Product Directorate (NNHPD) began applying new refusal criteria against Site Licence (SL) and Foreign Site Reference Number (FSRN) submissions, as […] Read More >>
On July 20, 2022, Health Canada published amendments to the Food and Drug Regulations (FDR), introducing new regulations for supplemented foods as a category. These new regulations continue to protect […] Read More >>
New labelling requirements announced by Health Canada in Canada Gazette, Part II, Volume 156, Number 14 titled “Regulations Amending the Natural Health Products Regulations” have come into effect as of […] Read More >>
Health Canada has recently notified the industry that TMAL (Temporary Marketing Authorization Letter) holders for supplemented foods (and caffeinated energy drinks) which are set to expire on December 31, 2021, […] Read More >>
If you are currently using a COVID-19 Site Licence to manufacture, package, label, or import alcohol-based hand sanitizers, your licence will expire September 30, 2021. Background In August of 2020, […] Read More >>
A “Brand Name” is defined as the name under which your NHP (Natural Health Product) is registered or sold. Selecting a “Brand Name” for your NHP is an important part […] Read More >>
With the recent announcement that Coronovirus has gone pandemic, consumers are flooding supermarkets, and preparing for indeterminate periods of self-isolation. All the while the marketplace is reeling, seeing demand for […] Read More >>
Companies following the media coverage surrounding Coronavirus may be interested to know that their Broad Spectrum viricides could be eligible to be used as an Expected Claim related to Emerging […] Read More >>
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