|
New! Renewals
for these tasks are accessible through the Michigan Business One Stop portal.
A. NAME OF PERMIT OR APPROVAL:
Manufacturer/Wholesaler License
B. STATUTORY AUTHORITY:
Public Act 368 of
1978, as amended; Article 7 titled Controlled Substances; Parts 71-75
C. APPLICABLE REGULATION:
Administrative
Rules of the Board of Pharmacy
D. SUMMARY OF PERMIT/APPROVAL PROCESS:
1. Applicability
Manufacturers or wholesale distributors of any prescription drug doing
business in the State of Michigan, whether or
not located in the State of Michigan,
are required to possess a valid Manufacturer/Wholesaler License issued by the
Michigan Department of Licensing and Regulatory Affairs, Bureau of Health Professions. If a
manufacturer/wholesaler's license lapses, a re-licensure
application (included on the Manufacturer/Wholesaler License Application) must
be submitted. If a manufacturer/wholesaler is transferred, changes location,
has a partner or stockholder change or a name change, the
Manufacturer/Wholesaler License Application must be submitted.
2. Pre-Application Requirements
Manufacturer/wholesalers that are operating as a partnership or corporation
must have been previously approved by the Department of Licensing and Regulatory Affairs' Corporation Division. If the manufacturer/wholesaler is
operating under an assumed name, the assumed name must be registered with the
appropriate County
Clerk's Office.
3. Application Submission
Requirements
Manufacturer/Wholesaler
License Application and supporting documents listed in instructions.
4. Procedures and Time-Frame for
Obtaining Permit or Approval
A Manufacturer/Wholesaler License Application and any required supporting
documents will be reviewed for completeness. The review process normally takes
up to 8 weeks.
5. Operational Requirements
Manufacturer/Wholesaler Licenses must be renewed every 2 years.
6. Fees
New Manufacturer/Wholesaler License - $85.00
Manufacturer/Wholesaler Relicensure -
$105.00
Manufacturer/Wholesaler Transfer - $85.00
Manufacturer/Wholesaler Change of Location - $65.00
Manufacturer/Wholesaler Miscellaneous Change (Partner or Shareholder
Change) - No Fee
Manufacturer/Wholesaler Miscellaneous Change (Name Change Fee) -
$10.00 for each new license issued (reissuance of license(s) not required).
7. Appeal Process
If the decision is made to deny a Manufacturer/Wholesaler License, a Notice
of Intent to Deny Licensure is issued. The applicant would then be entitled to
an administrative hearing and the Administrative Law Examiner's Proposal for
Decision would be reviewed by the Board of Pharmacy for review and disposition.
8. Public Input Opportunities
If changes to the Board of Pharmacy's administrative rules have been
approved by the Board of Pharmacy, a public hearing would be conducted for
public comment and public comments could also be submitted via email. The
proposed changes would also be available on the Bureau of Health Professions'
website at www.michigan.gov/healthlicense.
E. Contact Information:
Contact
Us
Creation/Revision Date: September 8, 2010
|
