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.