Pharmaceutical and Medical Device Manufacturers must submit first annual Code of Conduct Compliance Filing Form by July 1, 2010Print PDF
This is a reminder. If you are a Pharmaceutical or Medical Device Manufacturer Company (a “PMDMC”) selling your products in Massachusetts, you are likely required to comply with M.G.L. c. 111N, Pharmaceutical and Medical Device Conduct, (“Chapter 111N”) and the regulations found at 105 CMR 970.000.
Among other things, this relatively new law requires that PMDMCs make two annual filings with the Department of Public Health. The PMDMC must file an Code of Conduct Compliance Form certifying the PMDMC’s compliance with Chapter 111N. PMDMCs must also file an annual disclosure report detailing all payments of $50 or more in connection with sales and marketing activities which the PMDMC provides, directly or through its agents, to any hospital, nursing home, pharmacist, health benefit plan administrator, healthcare practitioner or other person who is authorized or licensed by Massachusetts law to prescribe, dispense or purchase prescription drugs or medical devices.
The first annual certification and disclosure reports are due no later than July 1, 2010, less than one week away. This first disclosure report covers sales and marketing activities occurring during the period of July 1, 2009 – December 31, 2009.
A $2000 filing fee must accompany the disclosure report filing. It is important to note that the initial filing fee is due even if you have no disclosable activities to report. The disclosed information will be posted on a publicly available website maintained by the Department of Public Health. There are substantial penalties for a PMDMC that does not file the required annual reports or does not comply with other provisions of Chapter 111N.
Information, including the Compliance Filing Form and format for the disclosure report, can be found at http://www.mass.gov/dph/pharmamed.
If you have any questions about whether Chapter 111N applies to you, or if you need help with your filings, please contact Maria Buckley at 617-439-2709, or your Nutter attorney.
This update is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered as advertising.