The quick and easy answer is yes. There is no provision in the regulations for allowing the assessment to cover anything other than the original formulation that has been assessed.
The original EU regulations have nothing at all to say about it. The UK regulations are a bit more expressive, insofar as they say that
“The PIF should be a ‘living document’ and should be updated as necessary. For instance, it should be updated when changes are made to the CPSR, such as the addition of new test data. If a product is significantly different from a same name product previously placed on the market, an update might not be sufficient and the Responsible Person will have to consider creating a new PIF.”
This is unusually casual language for a regulation and refers to the PIF rather than the CPSR, but it does suggest a level of flexibility.
If I have complete responsibility for the product, the approach I take is that I don’t alter the report to reflect minor changes that I can easily justify as having no effect on the safety of the final product. If I think I would struggle to defend a change, I get the product reassessed.
But if the product is someone else’s, or if it is being distributed by another party, so it wouldn’t be me that was the point of contact if something went wrong I’d play safe and reassess any change.
