ABSTRACT
As explained in Chapter 4, in January 1995 there were three key developments: CPMP opinions in both mutual recognition and concertation/centralised procedures became binding on Member States; the EMEA was established to administer the new procedures, with expert advice from the CPMP; and strict timetables for product assessment were introduced. These changes signalled the latest and most important stage in the introduction of an ‘efficiency regime’ for pharmaceuticals in Europe. In January 1998, the parallel national application route disappeared, making it no longer possible to market a drug in more than one EU country via the national licensing authorities, apart from generics and herbal products (European Commission 1997).
