Edible Cannabis Product Exemption Application

Background

10.62.37.21

.21 Medical Cannabis Products and Components Not Subject to This Chapter.

C. The Commission may approve a request to exempt a dosage form from Regulations .01—.19 under the following conditions if the licensed processor submits:

(1) A completed application in a form prescribed by the Commission;

(2) Standard operating procedures for all aspects of the receipt, processing, storage, packaging, labeling, handling, tracking, and shipping of products in the dosage form;

(3) The dosage form is recognized by the United States Pharmacopeia, the National Formulary, or the Food and Drug Administration; and

(4) The licensed processor is certified by an accredited third-party certification body in an alternative pharmaceutical or dietary supplement certification approved by the Commission.

Licensees seeking an edible cannabis product exemption under COMAR 10.62.37.21 need to follow this process for each product they wish to be exempt from the edibles dosage limits.

License Information

Name of Licensee

Legal Name *

Trade Name (D/B/A) (Put N/A if Not Applicable) *

MCA License #

Point of Contact

Point of Contact Name

Point of Contact Email Address

Point of Contact Primary Phone Number

Exemption Request

You may list up to ten (10) items for exemption per application.

Must include the METRC item name (same name to be used in METRC), dosage form, and proposed amount of THC per dose.

Enter METRC item name, dosage form, and proposed amount of THC per dose. Remove Field

Add Item

Documentation of Dosage Form

Upload documentation demonstrating that the proposed dosage form is recognized by the U.S. Pharmacopeia, the National Formulary, or the Food and Drug Administration.

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Standard Operating Procedures

Upload Standard Operating Procedures (SOPs) for all aspects of the receipt, processing, storage, packaging, labeling, handling, tracking, and shipping of products in the proposed dosage form.

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Upload File(s) detailing a complete ingredient list for the proposed dosage form.

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Packaging and Labeling

Upload images of the product packaging, including any product labeling. Include multiple images to ensure all sides of the packaging are displayed.

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Product Images

Upload images of the product in the proposed dosage form.

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cGMP Certification

Has your cGMP previously been approved by MCA?

Yes

cGMP Vendor Name

Certificate Number

Upload a copy of the cGMP certification issued to the licensee.

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cGMP Support Documentation (Please upload your facility's cGMP final audit, corrective action plan, and the certification body's accreditation certificate)

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Attestation

I attest that the information reported on this form is accurate and complete as of this date: (Click on the box to select a date from the calendar)

Contact Email Address (confirmation email sent to this address)

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First Name

Last Name

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Draw Type

I hereby confirm the following: I am a representative of the named Licensee and I am authorized to submit this Edible Cannabis Product Exemption Application Form to the Maryland Cannabis Administration.