Own Brand Labelling (OBL) Agreement

somashekar

Super Moderator
Staff member
Super Moderator
#1
Hi, I am in the process of drafting an OBL (or PLM) agreement with the OEM covering both MDD and Health Canada requirements. Would appreciate if I can get as much points. This concerns MDD Class IIB / CMDR Class III devices.
Somashekar
INDIA:thanx:
 

somashekar

Super Moderator
Staff member
Super Moderator
#4
Re: OBL Agreement

Which side of the agreement will you be on?
Fortunately (or otherwise) I am in the corporate and both the OEM and the PLM are associate companies of the corporation doing business as seperate cost centers located in different countries. OEM designs and manufactures and PLM distributes across the globe.
Somashekar...
 

Roland Cooke

Quite Involved in Discussions
#5
Re: OBL Agreement

Actually that sounds kinda neat, hopefully you have some control over the process!

My first piece of advice is, as always, to keep the financial agreement completely separate from the technical/regulatory one.

Then make a list of everything that occurs / could occur in the process. That will include design, outsourced production, inhouse production, artwork creation, translations, regulatory compliance, third-party registrar involvement, complaint handling, communication, and control of change. The list goes on as you can imagine.

From the list determine who will be doing the activity, and who will be responsible for the activity (not necesarily the same thing).

The PLM (or possibly Corporate) should have final regulatory responsibility over everything.
 
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