I'm very interested to hear from experts about the following:
My experience with a previous large company was that trademark symbols (TM and R) should not be included within Module 3 (and other CMC regulatory dossiers) but instead a list of names with trademarks was provided e.g. within the cover letter. I understood this was done to maximize re-use of CMC dossier content (for example trademarks might not be relevant to all regions) and that it was not a problem to omit trademark symbols from within the CMC dossier. For example, proprietary reagent names.
What is current "good practice" - for example, Module 3/Module 2.3 for marketing applications used for the USA, EU etc. And is it acceptable to omit trademarks?
Thanks very much, in advance, as I am very keen to understand more and I have yet to find anyone who can advise on this!
This is a question for your legal!
Our policy has always been to use TM and not (R) as TM is more universally applicable, but we have never tried leaving it out completely. I generally have the opposite problem - people using it more than it needs to be.
Agree with the other person that you should probably check with Legal.
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