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Division of
Professional Regulation

Manufacturer License



When to Apply

Manufacturers are facilities that manufacture or package drugs, toilet preparations, dentifrices, or cosmetics in Delaware.

Submit an application for a Pharmacy-Manufacturer license when:

  • applying for an initial license.
  • re-applying when a previous Delaware license has lapsed and is no longer renewable.
  • you need to report that your Delaware-licensed manufacturer:
    • changes ownership (controlling interest), or
    • relocates.

A Pharmacy-Manufacturer permit terminates automatically when the controlling interest in the facility changes, the facility’s legal existence ends, or the business ceases to operate.


Information on How to Apply for a License in DELPROS

All applications are submitted our online system DELPROS. We no longer accept paper applications.


PRIOR TO APPLYING

In order to apply for a license or submit a service request, you must first have a DELPROS user account.  To LOG IN or CREATE a DELPROS (Delaware Professional Regulation Online Services) user account:

  1. Go to: https://delpros.delaware.gov/OH_HomePage.
  2. Click GO on the Apply/Manage a License and Service Requests tile.
  3. If you do not have a DELPROS user account, click the REGISTER button on the left side of page for NEW USERS.
  4. If you already have a DELPROS user account, enter your email address and password on the right side for EXISTING USERS and click the LOGIN button.

DELPROS allows you to save your incomplete application and return to it later to finish the process. You only have six (6) months to submit your application once you begin.

  • If you do not submit your application within six months of starting it, you will be required to restart the entire online application again.

You may check the status of your application online throughout the entire application process by using the “View Application Status” feature in DELPROS on your e-License dashboard.


KNOW YOUR REQUIREMENTS AND COLLECT YOUR DOCUMENTS

  1. Know the requirements for the license you are pursuing.
  2. Request and gather all documents required to upload on the Attachments page. All information and forms are located on your profession’s webpages.


ATTACHING AND ACKNOWLEDGING DOCUMENTS

On the ATTACHMENTS page of your application, you may be instructed to:

  • either “attach” or “upload” the required document(s) directly to your application. This means you will find the document(s) saved on your computer or device and upload it to your application.
  • click “acknowledge.”  This means you will either have to mail the documents yourself or request the “third-party” mail the document(s) directly to the Board office.
    • Examples of “third-party forms” are transcripts from schools, employment verifications from a supervisor, and license verifications from another state.
  • Forms requiring a supervisor signature, seal, or notary may have to be MAILED to the Board office directly UNLESS the document specifically indicates to UPLOAD the document.

The requirements for this license type are provided in the following section(s).


Requirements

In addition to submitting the application and fee in DELPROS, you must submit:

  • The results of last GMP inspection if the firm is registered with the Food and Drug Administration or Drug Enforcement Administration.
  • A Manufacturer Permit–Information about Ownership forms for all of the following:
    • Designated Representative (DR) or most senior person responsible for facility operations, purchasing, and inventory control
    • Supervisor of the DR or most senior person responsible for facility operations, purchasing and inventory control
    • If the distributor is not a publicly held company, all principals and owners who directly or indirectly own more than 10% interest in the company
  • Each person who is required to complete a Manufacturer Permit – Information_About_Ownership form must also complete a Criminal History Record Check Authorizationform to request State of Delaware and Federal Bureau of Investigation criminal background checks.


Inspection Requirement

In addition to meeting the requirements above, the facility must be inspected before opening. A representative of the manufacturer must notify the Board office when the facility is ready for inspection. When the facility passes the final inspection, the Board office will issue the license.


Reporting a Manufacturer Name Change

If the facility’s name changes, but there is no change in ownership nor in location, submit a Name Change Service Request in DELPROS. The license number will not change. When completed, you will be notified and you may print the updated license.


Controlled Substances Registration

IMPORTANT: The facility also manufacturers controlled substances, you must submit a separate Controlled Substances – Facility application in the DELPROS online portal.

 


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