Submissions...

New European legislation has now made the Centralised Procedure available to a wider range of products than before and this will expand still further in May 2008. For new products that are not eligible to use this route there is now an opportunity to use the new Decentralised Procedure, which will enable Companies to bring products to the market more quickly than using the older, more established Mutual Recognition Procedure. Where a Marketing Authorisation has already been granted, however, there is still the opportunity to obtain approval for the product in new countries by using the Mutual Recognition Procedure.

Shore has practical experience of filing applications through all of these procedures, which enables us to offer advice on the most appropriate licensing route for your product, as well as providing practical experience on the compilation of the file itself.