Regulatory Open Forum

Hi!

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! 

Hi!

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!