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clock Created with Sketch. 04/02/21
18:27
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Originally posted by Joannie:
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I have been having connection problems with my internet. Anyway here is the reply. I would be interested in comments, to me it appears dose 150mg is not yet available, but lower doses are? Thank you for contacting Little Green Pharma. Re: Down-scheduling of low-dose Cannabidiol (CBD) Following the TGA's recent decision regarding the down-scheduling of low-dose Cannabidiol (CBD), from February 2021, products registered as S3 medications on the Australian Register of Therapeutic Goods (ARTG) will be able to be sold over the counter (OTC). There are currently no TGA approved products on the ARTG that meet the Schedule 3 criteria and at this stage it is unlikely that OTC supply of S3 CBD products will be available before 2022. The change in scheduling will apply to registered CBD products with a maximum recommended daily dose of 150mg in packs containing 30 days or less supply, and where CBD comprises at least 98% of the total cannabinoid content in the preparation. Other CBD products will continue to be available as Schedule 4 or 8 (depending on other cannabinoid content totals, including - but not limited to - THC) and can be accessed via the Special Access Scheme. Sponsoring companies can now lodge an application to the TGA for inclusion of Schedule 3 CBD preparations on the ARTG. The current registration pathway for Schedule 3 requires efficacy data, which helps support further clinical research in the area of low-dose CBD medicines. This may, however, be challenging to produce at a low dose. Little Green Pharma, the first company to grow and manufacture Australian medicinal cannabis, will continue to assess its registration options for an eligible CBD product, including a formulation of its current LGP Classic CBD50 and LGP Classic 1:100 cannabis oil medicines. Our CBD product, LGP Classic CBD50, continues to be available via the TGA SAS B or Authorised Prescriber pathway and LGP Classic 1:100 will be released shortly. Please don't hesitate to contact our team if we can assist further. Kind regards, Natalie Little Green Pharma
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Ok, so my understanding is:
