Novel Product Request Form

 

Background

Per COMAR 14.17.13.12 - A licensed processor may submit a request to the Administration in a manner prescribed by the Administration to approve a novel product. A novel product is defined as a cannabis product that is: 1) not presently authorized in Maryland; and 2) lawfully produced in another jurisdiction. Any “approval” granted by the MCA does not confer the ability to produce this product immediately. Given that the novel product request by nature requires regulatory changes, the product would not be able to be produced until regulatory changes have been duly promulgated.

 

 

Licensee Information

 
 
 

 

Point of Contact

 
 
 
Phone
 

 

Novel Product Information

 
 
 
 
 
 
 
 

 

Current Regulatory Status of Product

 
 
 

 

Regulatory Status Outside of Maryland

 
 
 

 

Rationale for Regulatory Changes and Product Approval

 

Please explain why the product should be permitted under the MCA’s regulatory structure. Please include information on the impacts (positive or negative) this product would have on:


a. Youth use or access;


b. Product potency, intoxication levels, or other product uses;


c. Public safety, including diversion;


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

 
 

 

File Uploads

 

Upload the following documentation is support of this novel product request:

1) SOPs (only required for new novel product requests not previously approved by the MCA)

2) Dosage Form (only required for new novel product requests not previously approved by the MCA)

3) Adverse/Beneficial Health Effects (e.g. adverse event or similar safety reports) (required)

4) Product Photo (required)

5) Evidence of Legalization in Another Jurisdiction (required)

6) Letter(s) of Support from Other Licensed Entities (if applicable)

Drop your files here
 
 
 
 
 

 

Acknowledgement and Attestation

 
 
 
 
mm/dd/yyyy
 

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