How is “similarity” to an authorised product defined?
That has been clarified by the Court for the benefit of patients as well as national public health authorities. In particular, the product imported in parallel (i.e. after a first marketing authorisation has been granted by the Member State of destination) does not have to be identical in all respects to the product already marketed by the manufacturer but it should at least have been manufactured according to the same formulation and using the same active ingredients.
