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Cannabis Compounds: Prescription Drugs?

By: Paula Stanley, Manager Environmental Health & Safety, email

On July 11, 2018, Health Canada announced that it will add phytocannabinoids to the human and veterinary prescription drug list when the Cannabis Act comes into force this October 2018. This means that drugs produced by or found in cannabis plants or that are duplicates of phytocannabinoids will be listed on the prescription drug list.

This is a significant departure for Canada; in the past medical cannabis or its related substances were not considered to be a “drug”. This amendment opens the possibility for cannabis-based products to be assigned a DIN (drug identification number) and potentially be covered under health insurance plans.

As such, when a drug is accepted in the market and listed on the prescription drug list, the requirements for licensing and production change. There are required submissions for prescription drugs and drug production facilities including GMP’s (Good manufacturing practices) and quality & risk control with repeatable results.

DIN issuance is based on registration and thorough reviews of scientific requirements. This represents an additional layer of complication bringing products to market.  Dell Tech consultants have decades of experience executing DIN registrations for our global network of clients.

For more information on DIN Registrations, GMP Compliance, or Quality & Risk Control, contact Dell Tech today.


Dell Tech has provided professional, confidential consulting services to the chemical specialty industry in Canada, USA, Europe and Asia for the last 35 years. Contact us today for more information.

www.delltech.com

 

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