# COMAR Title 14 — Independent Agencies

## Subtitle 17 — Maryland Cannabis Administration

### Chapter 13 — Cannabis Products

#### Regulation .12 Novel Product Requests.

*COMAR 14.17.13.12*

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

  (1) Not presently authorized in Maryland; and

  (2) Lawfully produced in another jurisdiction.

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

C. 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.

D. 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.

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