Replies to post #53320 on Easton Pharmaceuticals, Inc. (EAPH)

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Here is your EXEMPTIONS your 100% sure don't exist. Start reading Table 1 , near the bottom.


Posted 26 August 2015
By Rachelle D'Souza

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Following is a free preview of a Regulatory Focus feature article, normally exclusively available to RAPS members. For information about becoming a member, visit Join RAPS. This article presents an overview of Canada's medical marijuana regulations regarding individual prescription access and compliance measures for licensed producers.

The narcotic marijuana (spelled "marihuana" in most official Canadian government communications) is not an approved drug or medicine in Canada. The Canadian government does not endorse marijuana's use due to its potential for serious public health, safety and security risks. However, because the courts required reasonable access to a legal marijuana source when authorized by a healthcare practitioner, the Canadian government introduced Marihuana for Medical Purposes Regulations (MMPR)1 in June 2013.

MMPR allows Health Canada-licensed commercial industry to produce, sell and distribute dried marijuana under secure and sanitary conditions to Canadians who have been authorized by healthcare professionals to possess dried marijuana for medical purposes.2 The Controlled Drugs and Substances Act (CDSA) prohibits possession, trafficking, import and export and production of controlled substances, including marijuana, unless authorized by these regulations.
Individual Access to Medical Marijuana

When individuals access medical marijuana under MMPR (Figure 1), law enforcement agencies may need proof of their legal possession of dried marijuana. This proof can include the label on the marijuana package containing the individual’s specific client information or a separate document containing the same information in the shipment of marijuana.
Figure 1. Individual Access to Medical Marijuana under MMPR

2015-08-26_RF_fea_DSouza_marijuana_Fig1
Information for Healthcare ProfessionalsAuthorizing Marijuana

While not a product monograph or representation of its conclusions on marijuana, Health Canada has prepared a summary document3 from peer-reviewed literature and international reviews discussing the endocannabinoid system, clinical pharmacology, dosing, potential therapeutic uses, precautions, warnings, overdose and toxicity of cannabis (marijuana) and cannabinoids. The document supports healthcare professionals authorizing individual access to marijuana and is intended to complement other reliable sources of information. Health Canada also has provided healthcare professionals with a sample authorization document to provide to eligible medical marijuana patients.4
Information for Marijuana and other Cannabis Producers

Marijuana and cannabis producers may be individuals or corporations and may conduct activities (Table 1) provided they are licensed (Figure 2) and conduct activities in accordance with their license (MMPR Division 2). However, compliance controls are required to become a licensed producer and subsequently to maintain the license in accordance with MMPR. To illustrate, below are some key controls required for compliance, which is evaluated through the presence of adequate procedures and records in a quality system:

Timely reporting of waste, theft or disappearance of cannabis to the police and Health Canada
Destruction of cannabis per controlled procedures including a witness requirement
Safekeeping measures during transportation
Security measures, e.g., visual monitoring by recording devices, an intrusion detection system or physical barriers to prevent unauthorized access to cannabis areas
Good production practices compliance measures
Packaging, labeling and shipping controls

Table 1. Licensable Activities

Activities


Substances


MMPR Conditions

Possess, Produce, Sell, Provide, Ship, Deliver, Transport, Destroy


Marijuana


- Sale or provision may be to another licensed producer, licensed dealer, Health Canada or a person to whom an exemption relating to the substance has been granted under CDSA Section 56.

- Dried marijuana may be sold or provided to producer’s client or an individual responsible for that client, a hospital employee, if the possession of the dried marijuana is for the purposes of and in connection with their employment, or a person to whom an exemption relating to the dried marijuana has been granted under CDSA Section 56.

- Licensed producers may ship dried marijuana to healthcare practitioners who authorize medical documents.

Possess, Produce, Sell, Provide, Ship, Deliver, Transport, Destroy


Cannabis, Other Than Marijuana


- Substances are solely for the purpose of conducting in vitro testing necessary to determine the percentages of cannabinoids in dried marijuana.
- Sale or provision may be to another licensed producer, licensed dealer, Health Canada or a person to whom an exemption relating to the substance has been granted under CDSA Section 56.