Protecting the Public Since 1885 | [email protected]Fax (612)617-2262 | 2829 University Ave. SE, Suite 530 | Minneapolis, MN 55414 Medical Gas Manufacturer Renewal Application - Instructions For Resident and Non-Resident Applicants Medical Gas Manufacturer license renewal payment is due June 1, 2020 this year, and licenses expire June 30, 2020 this year only. Subsequent renewal cycles will revert to the established June 1 through May 31 of each year. Renewal fees Follow the instructions under "New Legislation (April 2020 Revision)" below for the correct renewal fee. Renewals received past the license expiration date must pay a late fee in addition to the renewal fee. Late fees are assessed at half of the renewal fee. Note that this year license expiration dates were extended to June 30, 2020. Licenses are mailed to the facility’s physical address. Renewal applications, supporting documentation, and correct payment must be received as a complete packet by the Board prior to the expiration date to avoid late fees. Any check received without an application will be returned immediately. All fees are non-refundable. State of Minnesota Tax ID: 4405717, Federal ID: 41-6007162. Mail the completed renewal form, documents, and payment to Minnesota Board of Pharmacy, 2829 University Ave. SE, Suite #530, Minneapolis, MN 55414-3251. Checks should be payable to the Minnesota Board of Pharmacy. All payments are non- refundable. New Legislation - April 2020 Revision On March 28, 2020, Governor Tim Walz signed a COVID-19 bill into law which does the following: For medical gas (MG) manufacturers it changes the law so that: • If a company has only one facility that requires a MG manufacturer license, that facility will pay a fee of $5,260. • If a company has more than one facility that requires a MG manufacturer license: • One facility must pay a $5,260 fee*; and • Each additional facility must pay a $260 fee. * When applying to renew, the company should designate the facility that will pay the $5,260 fee. Please also note the following clarifications: • A facility with a MG manufacturer license can manufacture, distribute at wholesale, and dispense patient specific medical gases using only a MG manufacturer license – a separate MG wholesaler license for the same facility is not required, even if the facility sells medical gases at wholesale that are manufactured by another MG manufacturer. • A facility with a MG distributor registration can only dispense legend medical gases to patients. Checklist for All Applicants All applicants are required to complete and submit the following information with the renewal: √ Application. Complete the application in its entirety and submit with original signatures and all documents. Do not leave blanks. If an item or question is not applicable, indicate N/A. √ FDA Registration. Provide proof of current FDA Drug Establishment Registration. You must have an FDA registration or we will not issue or renew a license. A printout of your current FDA registration showing the expiration date from the FDA clearing house is acceptable. √ Submit detailed information if you have had any products seized or recalled since June 1 of last year. √ Workman Compensation Requirements (RESIDENTS ONLY). Minnesota Statute 176.182 requires the applicant to provide acceptable proof of compliance with the workers’ compensation coverage provisions before the Board of Pharmacy shall issue a license. √ Current Home State License (NON-RESIDENTS ONLY). A copy of your current license/registration from the state your facility is located, or a letter from your home state explaining that your state does not require a license. 03/20 1/4
Fax (612)617-2262 | 2829 University Ave. SE, Suite 530 | Minneapolis, MN 55414
Protecting the Public Since 1885 |
mn.gov/boards/pharmacy
Medical Gas Manufacturer Renewal Application - InstructionsFor Resident and Non-Resident ApplicantsMedical Gas Manufacturer license renewal payment is due June 1, 2020 this year, and licenses expire June 30, 2020 this year only. Subsequent renewal cycles will revert to the established June 1 through May 31 of each year. Renewal fees
Follow the instructions under "New Legislation (April 2020 Revision)" below for the correct renewal fee. Renewals received past the license expiration date must pay a late fee in addition to the renewal fee. Late fees are assessed at half of the renewal fee. Note that this year license expiration dates were extended to June 30, 2020.
Licenses are mailed to the facility’s physical address. Renewal applications, supporting documentation, and correct paymentmust be received as a complete packet by the Board prior to the expiration date to avoid late fees. Any check received without an application will be returned immediately. All fees are non-refundable. State of Minnesota Tax ID: 4405717, Federal ID: 41-6007162.
Mail the completed renewal form, documents, and payment to Minnesota Board of Pharmacy, 2829 University Ave. SE, Suite #530, Minneapolis, MN 55414-3251. Checks should be payable to the Minnesota Board of Pharmacy. All payments are non-refundable.
New Legislation - April 2020 RevisionOn March 28, 2020, Governor Tim Walz signed a COVID-19 bill into law which does the following:
For medical gas (MG) manufacturers it changes the law so that:• If a company has only one facility that requires a MG manufacturer license, that facility will pay a fee of $5,260.• If a company has more than one facility that requires a MG manufacturer license:
• One facility must pay a $5,260 fee*; and• Each additional facility must pay a $260 fee.
* When applying to renew, the company should designate the facility that will pay the $5,260 fee.
Please also note the following clarifications:
• A facility with a MG manufacturer license can manufacture, distribute at wholesale, and dispense patient specificmedical gases using only a MG manufacturer license – a separate MG wholesaler license for the same facility isnot required, even if the facility sells medical gases at wholesale that are manufactured by another MGmanufacturer.
• A facility with a MG distributor registration can only dispense legend medical gases to patients.
Checklist for All Applicants All applicants are required to complete and submit the following information with the renewal:
√ Application. Complete the application in its entirety and submit with original signatures and all documents. Do notleave blanks. If an item or question is not applicable, indicate N/A.
√ FDA Registration. Provide proof of current FDA Drug Establishment Registration. You must have an FDA registration
or we will not issue or renew a license. A printout of your current FDA registration showing the expiration date from
the FDA clearing house is acceptable.
√ Submit detailed information if you have had any products seized or recalled since June 1 of last year.
√ Workman Compensation Requirements (RESIDENTS ONLY). Minnesota Statute 176.182 requires the applicant toprovide acceptable proof of compliance with the workers’ compensation coverage provisions before the Board ofPharmacy shall issue a license.
√ Current Home State License (NON-RESIDENTS ONLY). A copy of your current license/registration from the stateyour facility is located, or a letter from your home state explaining that your state does not require a license.
Fax (612)617-2262 | 2829 University Ave. SE, Suite 530 | Minneapolis, MN 55414
Protecting the Public Since 1885 |
mn.gov/boards/pharmacy
Ownership Change A change of ownership should not be reported on this renewal form. A change of ownership requires a change of ownership application to be submitted to the Board 60 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.
• Any change in business structure, i.e., sole proprietorship to L.L.C. or Inc., etc.• Sale to another individual;• Incorporation (from sole owner to corporation, from partnership to corporation);• A major stock change (cumulative 20% or more of the stock changes hands since the original license issued);• The addition of one or more partners to a partnership;• One partner buying out the other partner.
Facility Relocation A facility that has relocated should not be reported on this renewal form. A facility that has relocated must send in a new application for a relocation. 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. The application is available on the Board’s website. A new license is issued upon approval, and a fee is charged.
Name Change Notification A facility that has had a name change should not be reported on this renewal form. A name change notification form can be found on the Board’s website. Name changes should be submitted 30 days prior to the change for facilities located in Minnesota. Non-resident facilities will need to 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.
Email AlertThe Board will no longer mail renewal forms or reminders. Reminders will be emailed, and renewal forms will be found on our website. Please make sure to put the email address you wish future communication and reminders sent to in the email address box underneath the mailing address for the facility.
Officer FormsOfficer Change Form is available to report a change in officers. Officer changes should be reported to the Board within 30 days of change.
Fax (612)617-2262 | 2829 University Ave. SE, Suite 530 | Minneapolis, MN 55414
Protecting the Public Since 1885 |
mn.gov/boards/pharmacy
Medical Gas Manufacturer Renewal Application – Resident and Non-Resident
Renewal Fees (Annual fee range prior to 6/30/20 is $260 to $5,260 based on criteria below. After that date, from $390 to $7,890.)
Manufacturer Name MN License Number Expiration Date of
Current License Check if this is the only MG MF owned
Minnesota Tax ID Federal Tax ID FDA Registration Labeler Code
Hours of Operation Monday Tuesday Wednesday Thursday Friday Saturday Sunday No change in hours
Individual Completing Application Must be authorized to discuss application materials.
Ownership Contact Information Person authorized to speak on behalf of the owner.
Name Name Phone
Email
Phone
Email
Facility Contact Information Contact Name Phone Email
Medical gas manufacturers that own more than one facility are only subject to one $5,260 fee. If this applies, list the Minnesota license numbers of all facilities under one ownership and indicate which facility will pay the $5, 260 fee. All other facilities listed on the line below must renew separately and pay the appropriate fee.
Fax (612)617-2262 | 2829 University Ave. SE, Suite 530 | Minneapolis, MN 55414
Protecting the Public Since 1885 |
mn.gov/boards/pharmacy
On behalf of each individual owner, shareholder, partner, or corporate applicant, answer the following.
Yes No
Has the applicant been convicted, or plead guilty to a felony in any court? If yes, provide a copy of each n self-explanation.ncourt order along with a writte
Has the applicant applied for a license to operate a wholesaler/manufacturer in this state or any other state?
If yes, was the application denied by the Board of Pharmacy? If it was denied, attach a sheet with the reason it was denied unless it has been previously disclosed to the Board.
If a license was granted, was it later suspended, revoked, placed on probation, or subject to any Board or court issued orders, warnings, or reprimands? If yes, provide copies of all related, relevant documents.
Insurance Coverage for Facilities Residing in Minnesota Minnesota Statute 176.182 requires the applicant to provide acceptable proof of compliance with the workers’ compensation coverage provisions before the Board of Pharmacy shall issue a license. If your facility is not located in the state of Minnesota, do not complete this section. If your facility is in Minnesota, please check the appropriate box below.
This facility does not employ anyone and therefore, will not supply workers’ compensation coverage documents.This facility is self-insured and has attached a Certificate of Exemption.This facility has paid, or compensated employees and has attached a Certificate of Insurance. This facility has paid, or compensated employees and is supplying the insurance company information:
Insurance Co. Name Policy Number Policy Expiration Date Address Phone Number
AcknowledgmentThe data you supply on this form will be used to assess your qualifications for renewal. You are not legally required to provide this data, but we will not be able to grant the renewal without it. This data will constitute a public record if and when the renewal is granted and, at that time, copies may be issued to anyone.
I have read the above statement and agree to supply the data on this form with full knowledge of the information provided to that statement. In addition, I, the undersigned, do hereby certify that all of the information contained in this renewal application is true and correct, and that the firm will be operated in compliance with all applicable laws and regulations.
__________________________ Date
_________________________________________
_____________________________________________ Signature of Applicant
