It comes into force just in time prior to the expiry of the data exclusivity periods of the first centrally approved reference products. For abridged applications on these products the new legislation will no longer force generic companies to follow the centralised authorisation route as well. After the Review generic companies will be allowed to choose a decentralised or a centralised MAP when reference is made to a centrally approved RP.

Furthermore a new condition has been added to the legislative texts as an opportunity for all kinds of medicinal products to have access to the centralised authorisation route, which is in case the drug concerned is considered to be of added value for the patient on Community level. In this case a generic product can in theory also be approved centrally in case the corresponding originator was approved nationally.

On the other hand a new kind of marketing authorisation procedure, the decentralised procedure (DCP) will be implemented in November 2005: This procedure shall replace the current mutual recognition procedure (MRP) in cases where an authorisation in more than one member state shall be obtained and no authorisation within the EU does yet exist. This marketing authorisation procedure shall be more successful than the current MRP due to an involvement of the concerned member states from the beginning of the procedure and an accelerated evaluation timetable. However the generic industry currently has some questions regarding this new marketing authorisation procedure and asks for further detailed guidance concerning the concrete tasks of all parties involved.

An evaluation of these three registration routes cannot be done on a general basis. The final submission-strategy of a generic company will depend on various factors, which will be a case-by-case decision depending on the commercial perspective of the company, the characteristics of the reference product concerned, the expected generic competition on the market, the market exclusivity periods and further aspects.