Generic drug authorisation challenge too late, High Court rules 

A challenge to a marketing authorisation for a generic drug to treat osteoarthritis in dogs was brought outside the applicable time limits, a High Court judge has ruled. 
Mr Justice Garrett Simons said it seemed his preliminary finding means the judicial review challenge must be dismissed but he deferred a final decision on that issue for a week to allow the sides make submissions. 
 
Arthopharm (Europe) Limited sought judicial review against the Health Products Regulatory Authority over a marketing authorisation granted by that body on July 20th, 2018, to Chantelle Pharmaceuticals Manufacturing Ltd for a generic product known as Osteopen 100mg/ml Solution for injection for dogs. 
 
Arthopharm, which has been authorised since 1991 to market Carthophen Vet 100mg/ml Solution for Injection, used to treat osteoarthritis and related musculoskeletal disorders in dogs, challenged the Osteopen authorisation on several grounds. 
 
Three-month limit 
As a result of case management of the proceedings, a number of issues were identified on which preliminary rulings were sought. In a judgment on Tuesday, Mr Justice Simons ruled the proceedings were brought outside the relevant three-month limit for judicial review. He found the relevant date for calculation of the three-month limit was July 23rd, 2018, when the decision to grant the marketing authorisation to Chantelle was posted on the HPRA website. 
 
These proceedings, initiated on December 20th, 2018, were outside the three-month limit, he held. 
 
He also ruled Arthopharm had failed to demonstrate “good and sufficient” reason to extend the time for bringing the proceedings. He rejected arguments otherwise, including that Arthopharm was entitled to await receipt of analysis of a sample of the generic product before taking its case. 
 
While he considered his findings meant the judicial review proceedings should be dismissed “in their entirety”, that was subject to arguments concerning whether the authority had made a “fresh” decision which meant the three-month time limit only began to run from March 2019, he said. He will hear the sides on that issue next week before finalising his decision. 
 
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