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Top News In மருந்து ஒழுங்குமுறைகள் Today - Breaking & Trending Today

Canadian companies send psilocybin package to Health Canada for pre-clinical trial application

The initial trial would focus on dosage before expanding into psilocybin treatments for a variety of health conditions.
“This is another important step for our commitment to the development of naturally sourced, evidence-based product formulations,” said Optimi chairman of the board JJ Wilson.
The information package included the investigational product’s chemical constituents, genotype, and formulation as well as procedures and processes to produce a consistent dosage from psilocybe mushrooms.
Optimi will retain 100 per cent ownership of the resulting all-natural psilocybin capsule and full intellectual property rights to its use, according to the release.
“Numinus is pleased to partner with Optimi on this important work and provide the expertise, licensed facility and specialized equipment required to quickly develop, formulate and rigorously test products derived from natural psilocybe sources and prepare them for Health Canada submissions and approvals, ....

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Federal Court Of Appeal Affirms Minister's Decision That CSP Eligibility Requires Claim For Active Ingredients And Excludes Formulations Claims - Intellectual Property

Patent Act, R.S.C. 1985, c.P-4 (the

Patent Act ) followed as a consequence of
Canada s commitment to the Canada-European Union Comprehensive
Economic and Trade Agreement ( CETA ). Part of that
agreement required Canada to implement a CSP regime permitting
patent holders to receive up to two years of additional patent
protection for approved medicines, to compensate them for time
spent in research and development of drugs containing patented
medicinal ingredients, and for regulatory delays in obtaining
marketing approval.
To be CSP eligible, a patent must meet a number of requirements,
including that it pertains in the prescribed manner to a ....

Canada Health , European Union , Health Canada , European Court , Federal Court , Supplementary Protection Regulations , Supplementary Protection , Patent Act , Canada European Union Comprehensive , Trade Agreement , Canadian Statement , Drug Regulations , Viiv Healthcare , Canadian Courts , கனடா ஆரோக்கியம் , ஐரோப்பிய தொழிற்சங்கம் , ஆரோக்கியம் கனடா , ஐரோப்பிய நீதிமன்றம் , கூட்டாட்சியின் நீதிமன்றம் , துணை ப்ரொடெக்ஶந் ஒழுங்குமுறைகள் , துணை ப்ரொடெக்ஶந் , காப்புரிமை நாடகம் , கனடா ஐரோப்பிய தொழிற்சங்கம் விரிவான , மருந்து ஒழுங்குமுறைகள் , கனடியன் நீதிமன்றங்கள் ,

Federal Court of Appeal finds Minister of Health's refusal to grant a CSP for SHINGRIX is reasonable | Smart & Biggar

To embed, copy and paste the code into your website or blog:
In the first appellate decision relating to Certificates of Supplementary Protection (CSPs), the Federal Court of Appeal has allowed the appeal of the Minister of Health (the Minister), setting aside the lower court judgment.
In a unanimous decision released on April 14, 2021, the Federal Court of Appeal in
Canada (Health) v Glaxosmithkline Biologicals S.A., 2021 FCA 71 found that the Federal Court (see article here) did not correctly apply the applicable standard of review.
The Decision Under Review
The Minister had found that
SHRINGIX contained only one medicinal ingredient a Varicella Zoster Virus (VZV) gE antigen, and that the adjuvant in SHINGRIX was not a medicinal ingredient. ....

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Proposed amendments to the Patented Medicines (Notice of Compliance) Regulations would expand definition of "claim for the medicinal ingredient" | Smart & Biggar

On April 24, 2021, proposed
The proposed PMNOC amendments relate to the 2019 proposed
Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (proposed FDR amendments)(previously reported here), which would allow a generic manufacturer to file an abbreviated new drug submission for a different salt form of the medicinal ingredient in the Canadian reference product. The proposed FDR amendments have not yet been finalized.
The objective of the proposed PMNOC amendments is to make patents with claims related to a different salt form of an approved medicinal ingredient eligible for inclusion on the Patent Register by extending the definition of “claim for the medicinal ingredient” to a claim for certain variations, such as a salt: ....

Regulations Amending , Patented Medicines , Drug Regulations , Improving Access , Patent Register , காப்புரிமை பெற்றது மருந்துகள் , மருந்து ஒழுங்குமுறைகள் , மேம்படுத்துகிறது நுழைவு , காப்புரிமை பதிவு ,

Optimi Health Receives Health Canada NPN Product Licenses in Preparation for Q2 Sales Launch

VANCOUVER, British Columbia, March 16, 2021 (GLOBE NEWSWIRE)
Optimi Health Corp. (CSE: OPTI) (“Optimi” or the “Company”), developers of a vertically integrated functional mushroom brand focused on the health and wellness sector, is pleased to announce it has received product licensing paving the way for the commencement of nutraceutical marketing and sales in Q2, 2021.
Optimi Health is developing an innovative pipeline of functional, medicinal, and nutraceutical mushroom brands encompassing natural health products to proposed, future psychedelic formulations. In preparation for the public sales launch of its nutraceutical brand lineup, the Company applied for and has now received NPN licenses for six products. These include five singular mushroom strain capsules (Reishi, Chaga, Turkey Tail, Lions Mane and Cordyceps) and one proprietary Optimi formulated mixed blend capsule. To sell natural health products in Canada, companies must obtain a product license call ....

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