In case C-36/03 The Queen, on the application of Approved Prescription Services Ltd v Licensing Authority; Eli Lilly & Co. Ltd the European Court of Justice ruled earlier today on the circumstances in which an applicant for a certificate of approval of a medical product can rely on the fact that that product is essentially similar to an earlier product where that earlier product is a new pharmaceutical form of an even earlier product, from the point of view of being able to rely on earlier test data in support of the safety of its own product. In this case APS wanted to market a liquid form of fluoxetine which was similar to Eli Lilly's Prozac liquid product, which was a different pharmaceutical form of Eli Lilly's still earlier Prozac capsules.
The IPKat sees this ruling as reducing the red tape that makes it difficult to bring generic and equivalent products to the market. Merpel wonders how much Prozac Eli Lilly and other grug originators will need to take in order to keep cheerful after this ruling.
Prozac: the official story here and here
Prozac: the other side here and here
Prozac and mussels here
Thursday, 9 December 2004
Posted by Jeremy at 19:09:00