Regulation .12 Novel Product Requests.

In this regulation, “novel product” means a cannabis product that is:

(1)

Not presently authorized in Maryland; and

(2)

Lawfully produced in another jurisdiction.

A licensed processor may submit a request to the Administration in a manner prescribed by the Administration to approve a novel product.

A valid novel product request shall include:

(1)

A detailed product description;

(2)

An explanation of how the product deviates from current regulations;

(3)

Evidence that the same product type is permitted in at least one other state’s regulated cannabis market; and

(4)

Health and safety information, including but not limited to:

(a)

Available information or studies regarding any beneficial or adverse effects from the use of the product; and

(b)

Packaging and labeling strategies to minimize risk to patients, consumers, and children.

The Administration may:

(1)

Make its own determination to approve or deny the request; or

(2)

Defer the request to the Public Health Advisory Council.

The Administration reserves the right to make a final determination on the request