The amount of work involved in assessing a product with a completely new chemical entity compared to a product based on a well-established substance (as defined in Article 10a of Directive 2004/27/EC amending Directive 2001/83/EC) differs significantly.
The amount of work involved in assessing a product with a completely new chemical entity compared to a product based on a well-established substance (as defined in Article 10a of Directive 2004/27/EC amending Directive 2001/83/EC) differs significantly.