European Union: Small Molecules Products

Since 1998 companies who intend to market a product in the European Union in more than one Member State have the choice to use the most suitable procedure for a new molecular entity. New small molecules can go either the central or the mutual recognition way.

Each procedure carries both advantages and disadvantages. The wrong choice can be costly and time-consuming and lead to sub-optimal performance of the company.

It is our aim to help companies define the right regulatory pathway by taking into consideration issues like: