The Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Law [Mass. Gen. Laws Ch. 111N] and its implementing regulations require pharmaceutical and medical device manufacturers registered with the Massachusetts Department of Public Health ("Department") to renew their registration annually between July 5 and August 31. The Department has extended this year's deadline to October 1, 2020, in response to the COVID-19 pandemic.
Manufacturers must provide certification that they have conducted annual audits to monitor compliance with their code of conduct. In addition, manufacturers must pay a $2,000 renewal fee. Online renewal fees may be paid via credit card or electronic check. According to the E-Licensing FAQ, MasterCard and Visa are accepted. In order to complete a renewal, manufacturers must log in to the Department's E-Licensing website, here. Each manufacturer will need its User ID, Password, Unique ID (CC####), and Renewal ID.
Manufacturers that are unable to use the online registration renewal system may submit a paper Registration Renewal Compliance Filing Form. Payment in the form of a check or a money order must be submitted with paper renewal submissions. Renewal forms and payments should be sent to the following address:
Pharmaceutical Code of Conduct Program
MA Bureau of Health Professions Licensure
239 Causeway St., 5th floor - Suite 500
Boston, MA 02114
For more information on Massachusetts' manufacturer renewal procedures, please visit Massachusetts' Marketing Disclosure and Compliance Program/Code of Conduct sections in the Transparency and Limitations Database.
-------------------------------------------
If you are interested in receiving updates relevant to Life Sciences compliance, please contact us for two weeks of complimentary access to all Porzio Compliance Digest InfoCenters. Topics include US and International transparency, US Enforcement Action, HCP Authorities/Restrictions and Licensing Distribution: Trade and Sample.