Manufacturers of pharmaceuticals and medical devices are required to register with Department of Public Health. Learn how to register for the first time.
Guide Initial Registration as a Manufacturer for Pharmaceutical Code of Conduct
Table of Contents
The Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct statute and the Department of Public Health implementing regulation (105 CMR 970.000) requires that a Pharmaceutical and Medical Device Manufacturer:
- Must register with DPH when the company first becomes subject to regulation ($2,000.00 fee required)
- Renew their registration annually ($2,000.00 fee required)
- Annually submit a disclosure report (covering the period Jan 1 – Dec 31) to the Department of Public Health detailing all payments made to covered recipients.
- The disclosure report includes activity for an entire calendar year, and is required to be submitted to the department by July 1st of the following year.
Late initial registration: If your company did not register the year it became subject to regulation, you must retroactively submit an Initial Registration form as soon as possible and include the $2,000.00 fee.
How to register
Initial registration must be submitted by mail.
Download and complete the Pharmaceutical Code of Conduct - Manufacturer Initial Registration Form PDF | (Accessible version)
- Contact info
- Manufacturer name and address
- Contact name, phone, and email
- Compliance Officer name, phone, email, and address
- Attestation and signature
- Sign that you're in compliance with 105 CMR 970
- The Pharmaceutical Code of Conduct - manufacturer registration fee is $2,000. Pay by check, made payable to the Commonwealth of Massachusetts.
Submit by mail
Mail your completed form and fee to:
Pharmaceutical Code of Conduct Program
MA Bureau of Health Professions Licensure
239 Causeway St.
5th floor, Suite 500
Boston, MA 02114
As soon as you are registered you will receive a Unique ID CC#### from Department of Public Health.