Initial Registration as a Manufacturer for Pharmaceutical Code of Conduct

Manufacturers of pharmaceuticals and medical devices are required to register with Department of Public Health. Learn how to register for the first time.

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Registration requirements

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

The Massachusetts Pharmaceutical Code of Conduct (PCOC) program utilizes an online portal for registration and renewals. In order to use the system, all users will need to first create an account on our Health Professions Licensing System. Please see the Creating an Account section of our user guide for information on how to get started.

After an account has been created, you will need to apply for a Pharmaceutical Code of Conduct Registration:

  1. Click “View Other Types” under the Other License and Registration Types section:
    View Other Types Image
  2. Navigate to the “Pharmaceutical and Medical Device Manufacturer Code of Conduct” registration and click “View More”
    Pharmaceutical and Medical Device Manufacturer Code of Conduct Image
  3. Under Pharmaceutical Code of Conduct Registration click “Start Application”.
  4. Continue through the application following the instructions on each page and completing the required fields. You will be prompted to pay the $2,000 registration fee to complete the application.
  5. PCOC staff will review the submitted application and once approved an email will be sent with the company’s registration number in the format of CC####.

Reporting requirements

Learn about basic terms, requirements, restrictions, and disclosure on our page Pharmaceutical Code of Conduct Requirements.

 

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