NZ company - tissue repair product, page-25

Timber 7 there are an array of options available in the system should there be a disagreement of what ruling it
should be under. There was no disagreement it seems. So I point out the following,

It is very obvious to a lay person with a minimum of research to conclude that this product was under rule 13.
Because it has an ancillary factor, growth factors.
Yet somehow the company with all its expertise and consultants think it should be rule 8.
Then the Notified Body with all its expertise also comes to the conclusion it is under rule 8.
How can that be?
Why can that be?
Answer. Because if you can slip it through under rule 8 there is no EMA interference like we have experienced.
Then at the late stage the BSI brass who have to sign off on it see its not quite right. The MHRA concluded the same, and the EMA decided it was so far removed from a rule 8 they called it a medicine.