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Manufacturer


Forms

Manufacturer Renewal Application
Medical Gas Manufacturer Renewal Application
- for Medical Gas Manufacturers
Application for a New Manufacturer License
Officer Reporting Form
Officer Change Form
License Closure Form
  • Submit this form 14 days prior the date the facility closes or surrenders their license to conduct business in the state of Minnesota.
Change of Ownership Form
A change of ownership requires a change of ownership application to be submitted to the Board 30 days prior to the effective date of the change. The application is available on the Board’s website. A new license is not issued for the change and there is not a fee.
The following are some examples of ownership changes that require you to report a change of ownership.
  • Sale to another individual;
  • Incorporation (from sole owner to corporation, from partnership to corporation);
  • Major stock change (if 20% or more of the stock changes hands since the incorporation);
  • Sole owner to partnership;
  • Change from limited liability corporation to corporation;
  • The addition of one or more partners to a partnership; or
  • One partner buying out the other partner.
Name Change Form
  • Name changes should be submitted 30 days prior to the change for facilities located in Minnesota. Non-resident facilities must report the name change of the facility on the notification form and include the license issued by the home state regulatory agency showing the new facility name.
Relocation Form
  • A relocation application and required documents must be submitted to the Board 30 days prior the relocation date for facilities located in Minnesota. Non-resident facilities must apply for a new license after your home state regulatory agency has issued a license, showing the new address, and an inspection has been conducted of the new location. A new license is issued upon approval, and a fee is charged.

Fee Increases Effective July 1, 2019

Legislation enacted during the 2019 Regular and Special Sessions contained many provisions that will have an impact on the Board’s licensees and registrants. The increase affects all licensees of the Board of Pharmacy. We have an updated Fee Chart on the License and Registration home page that summarizes all fee increases with the exception of the opioid product registration fees. In addition, the application and renewal registration fees for most drug manufacturers, medical gas manufacturers, drug wholesalers, and medical gas wholesalers, and medical gas distributors will increase to at least $5,260 effective July 1, 2019. The Board believes that the Legislature may reconsider the increase in fees for medical gas manufacturers, wholesalers, and distributors during the 2020 Session.
  • All drug and medical gas wholesalers: $5,260
  • Drug manufacturers (except for opioid manufacturers) and medical gas manufacturers: $5,260
  • Medical gas distributors: $5,260
  • Opioid drug manufacturers: $55,260 (Reduced to $5,260 if the sunset provision kicks in).
  • Opioid manufacturers with sales within Minnesota of over 2,000,000 units per year will also have to pay an annual opiate product registration fee of $250,000.

License Renewal

Manufacturer/Outsourcing license renewal payment is due May 1 of each year, and licenses expire May 31 of each year. Licensure as a manufacturer is required for all parties involved in the manufacturing of a drug product. This includes but is not limited to virtual manufacturers, contract manufacturers, re-packagers, and labelers. The exception is if the manufacturer is located outside of the United States or its territories.

Currently, the renewal process is not an online process. All renewal applications must be completed and mailed or delivered to the Board address on the form with all required documents, payments, and signatures. Incomplete applications or applications missing payment will be returned to the sender.

Renewal Fees
  • A Non-Opiate Manufacturer renewal fee is $5,260, if submitted before the expiration date of the license. Renewal fee plus late fee is $7,890 if the license has expired.
  • An Opiate Manufacturer renewal fee is $55,260, if submitted before the expiration date of the license. Renewal fee plus late fee is $82,890 if the license has expired.
  • Opiate manufacturers that own more than one facility are only subject to one $55,260 fee. If this applies, you must list the license numbers of all facilities on the renewal form and indicate which facility will pay the $55,260. The rest of the facilities under the same ownership must renew separately and pay the $5,260 renewal fee. Licenses are mailed to the facility’s physical address.
  • Renewal applications, supporting documentation, and correct payment must be received by the Board prior to the expiration date to avoid late fees. All fees are non-refundable.
Mail the completed renewal form, documents, and payment: Minnesota Board of Pharmacy, 2829 University Ave. SE, Suite #530, Minneapolis, MN 55414-3251. Check should be payable to the Minnesota Board of Pharmacy. All payments are non-refundable.

Renewal Application. Review all instructions carefully and submit the application, payment, and supporting documents together. The board will return incomplete applications and payment received without applications immediately.

Allow a minimum of 10 business days for the board to process a COMPLETED renewal application. Once processed, allow 7-10 business days for the new license certificate to arrive at the facility location. All renewal applications received after the license expires must submit the additional late fee.

General Information

Do drug manufacturers also need to be licensed as drug wholesalers?

No, not if they only engage in the wholesale distribution of their own drug products. Manufacturers who distribute the drugs of other manufacturers do need to be licensed as drug wholesalers. Any manufacturer that only distributes its own products and that still also holds a drug wholesaler license can drop the wholesaler license (or simply not renew it when it is up for renewal in May 2020).

Laws and Rules Regarding Manufacturers:
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