Originally published June 24, 2010
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.
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.