Minnesota Department of Health Medical Marijuana Manufacturer Cannabis Manufacturer Questions and Answers Update September 25, 2014

The Minnesota Department of Health has again published updates to the Medical Cannabis Manufacturer Questions and Answers portion of its webpage. Below is a summary of the answers:Medical-Marijuana

  • The Minnesota Department of Health states that the area regarding approved laboratories “will continue to be developed.”
  • Minnesota Statutes Section 13.37, subdivision 1(a) states that security information is government data, the disclosure of which would be likely to substantially jeopardize the security of information, possessions, individuals or property against theft, tampering, improper use, attempted escape, illegal disclosure, trespass, or physical injury. The security information requested in the application would seem to encompass Section 13.37’s definition. Financial information, however, would be less likely to fit under this definition. Applicants are free to explain why certain data should be classified as security data.
  • Minnesota Department of Health reiterated that health practitioners who issue certifications to patients cannot have a financial interest in a manufacturer, but a healthcare professional does not certifying patient conditions can have a financial interest in a medical marijuana manufacturer.
  • Minnesota Department of Health has requested information about product packaging, therefore the department will evaluate and applications information regarding appropriate packaging materials.
  • Actual experience in implementing operational protocols, which is requested on pages 22 through 23 of the application, will be rated higher than theoretical knowledge. There are not “good manufacturing practices” regulations applicable to the production of medical marijuana and therefore good manufacturing practices will not be weighed in the selection process.
  • The Minnesota Department of Health will evaluate a manufacturer’s ability to educate patients regarding medical cannabis. Section B, subsection 3, item C of the application requests information about an applicant’s anticipated outreach about medical cannabis to patients and caregivers.
  • If a manufacturer has a letter of support for medical cannabis facility from a city or municipality it should be included in their application. The city or municipality wants to provide general interests in hosting a perspective manufacturer they should send a letter to health.cannabis.RFA@state.mn.us.
  • The Notice of Proper Manufacturing Facility Zoning Form on page 12 of the application is not required for distribution locations.
  • Compilation conducted consistent with the standards SSAW No. 10 with regards to the requirement that the financial commitment by an owner/investor be accompanied by a letter certified by CPA verifying that the commitment by each owner/potential owner does not exceed 50% of their net wealth is sufficient.
  • Minnesota Department of Health is not able to meet with prospective manufacturers to address any concerns prior to submitting the application. (Potential manufacturers submitted a question requesting to meet with the Department of Health to discuss the fact that they believe that the cost of production of marijuana oil is too expensive for patients).
  • The department cannot direct manufacturers to make specific cannabinoids but the department believes that a manufacturer’s ability to grow medical cannabis to help a range of conditions is a part of the manufacturers duties.
  • There have been multiple questions regarding the source of seeds, but the Department of Health deferred on the question because the Minnesota statute does not address the sourcing of plants and seeds.