Unlike other regions, in the EU a number of options are available to obtain a marketing authorisation. Centralised at the European Medicines Agency in London or decentralised with the individual competent authorities of the member states, each marketing authorisation application procedure has its pros and cons. And even more, duplicate and parallel import licenses also provide for a not so obvious route to marketing authorisation.
DADA has gained extensive experience in European regulatory affairs and its procedures. We can therefore provide you with independent and optimal advice on the best suitable regulatory strategy on a case-by-case basis, and execute it.