02-392-2 Me. Code R. § 12-2

Current through 2024-51, December 18, 2024
Section 392-2-12-2 - Application for Licensure

The manufacturer or wholesaler shall provide the following information on forms supplied by the board, along with such other information as the board may require. Applications will not be considered for approval until they are complete. Incomplete applications will be returned to the applicant.

1. The name, physical address, contact address, telephone number, email address and world wide web address of the wholesaler or manufacturer;
2. All trade or business names used by the wholesaler or manufacturer;
3. The name, address, 24-hour telephone number and email address of a contact person for the facility used by the wholesaler or manufacturer for storing, handling and distributing prescription drugs.
4. Type of ownership or operation (i.e., partnership, corporation, limited liability company or sole proprietorship); and
5. The name(s) of the owner and/or operator of the wholesaler or manufacturer, including:
A. If a partnership, the name, contact address, telephone number and employer identification number of the partnership, and the name and contact address of each partner;
B. If a corporation, the name, contact address, telephone number and employer identification number of the corporation; the name of the parent company, if any; the name, contact address and title of each corporate officer and director; the name and contact address of each shareholder owning 10% or more of the voting stock of the corporation, including over-the-counter stock, unless the stock is traded on a major stock exchange and not over-the-counter; a certificate of existence from the corporation's state of organization and, for corporations not organized under Maine law, a certificate of authority from the Maine Secretary of State if such certificate is required by 13-C M.R.S.A. §1501;
C. If a limited liability company, the name, contact address, employer identification number, telephone number, fax number and email address of the limited liability company; the names and mailing addresses of each member and manager; a certificate of existence from the Maine Secretary of State or, for limited liability companies not organized under Maine law, a certificate of authority or certificate of qualification from the Maine Secretary of State; and the name of the member or manager who will be representing the applicant in matters before the board.
D. If a sole proprietorship, the name, contact address, telephone number and social security number of the sole proprietor and the name of the business entity;
6. The DEA number;
6-A. If the applicant is accredited by VAWD, proof of current accreditation.
7. A list of all jurisdictions in which the manufacturer or wholesaler licensed as of the date of application to the board, along with the license number and license expiration date for each such jurisdiction;
7-A. Disclosure of, and the final disposition document pertaining to, any disciplinary action taken against the manufacturer or wholesaler by a licensing or regulatory authority in any jurisdiction. If the applicant is accredited by VAWD, such disclosure and documentation need only pertain to the period of time subsequent to the wholesaler's initial accreditation or most recent annual renewal of accreditation.
8. A copy of the most recent inspection report from the state in which the manufacturer or wholesaler is located. If a wholesaler is accredited by VAWD, this information need not be provided; and
9. The fee required by Chapter 10 of the rules of the Department of Professional and Financial Regulation, Office of Licensing and Registration, entitled "Establishment of License Fees."

02-392 C.M.R. ch. 2, § 12-2