The Company does not undertake to update any forward-looking information, except as, and to the extent required by, applicable securities laws. This news release contains information about potential sales revenue from supply agreements, which may be considered as disclosure of financial outlook under applicable securities laws.
Such information is subject to the same assumptions, risk factors, limitations, and qualifications as set forth in the above paragraph. Specifically, estimated sales revenue which may be derived from supply contracts has been calculated based on current wholesale prices and assume, among other things, that the Company will be able to find buyers for its products. Financial outlook contained in this news release was made by management as of the date of this news release and was provided for the purpose of providing readers with an understanding of the potential revenue which may be derived from supply agreement recently entered into by the Company, and are not an estimate of profitability or any other measure of financial performance.
Readers are cautioned that the financial outlook contained in this document should not be used for purposes other than for which it is disclosed herein. The CSE has neither approved nor disapproved the contents of this press release. However, Health Canada's SAP allows practitioners to request access to drugs that are not available in Canada for the emergency treatment of patients with serious or life-threatening conditions who have exhausted other treatment options.
Due to regulatory changes made in , restricted drugs have not been made available through the SAP. Since then, clinical trials have been the only avenue by which the sale of a restricted drug could be authorized for patient treatment. While clinical trials remain the best mechanism to authorize the sale of drugs, there are barriers to patient participation including geography or lack of clinical trial recruitment.
Yet, there has been ongoing scientific research into the efficacy and safety of certain restricted drugs. In response, Health Canada has today announced a reversal of the regulatory changes made in to Part C of the Food and Drug Regulations and has restored potential access to restricted drugs through the SAP.
The regulatory amendments will allow physicians to request patient access to psychoactive substances, like psilocybin and MDMA, for psychedelic-assisted therapy. However, a rejection of an application in another jurisdiction may adversely affect an approval in Canada. Much of the information required for Health Canada submissions is the same as that of an EU technical file or US k , so having these could potentially reduce preparation time.
Do foreign manufacturers need in-country representation in Canada? In-country representation is not required by Health Canada for medical devices. Foreign manufacturers may submit device registration applications and hold the registration. Please add emergobyul. Skip to main content. Which medical devices require a Canada Medical Device Licence?
What are the QMS requirements for each licence type?
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