Marketing authorization (refusal of MA, MA issued to a competitor)
Your MA application has been refused ? Wondering about the data that led to the granting of a MA to your competitor ? This MA does not seem to comply with regulatory requirements ?
We will request the elements justifying the administration's decision, assess the relevance of litigation (expected effects, chances of success) and manage the pre-litigation and litigation procedure.
Reimbursement (refusal to reimburse, de-reimbursement)
Reimbursement denied ? Product de-reimbursed ? Reimbursement restriction imposed (prior agreement, prescription restriction, etc.) ?
We will request the elements justifying the administration's decision, assess the relevance of litigation (expected effects, chances of success) and manage the pre-litigation and litigation procedure.
Pricing (initial fixing, price reduction, refusal of request for price increase)
Not satisfied with the price set with or by CEPS ? Price reduction imposed ? Price increased refused ? Concerned about the clawbacks’ mechanism or the amount of the clawbacks ?
We will request the elements justifying the administration's decision, assess the relevance of litigation (expected consequences, chances of success) and manage the pre-litigation and litigation procedure.
We represent you by offering a pragmatic, reactive approach and direct management of your entire file.
Our expertise
- Administrative appeals
- Administrative litigations (ordinary proceedings and suspension summary proceedings)
- Direct management of litigation before the "Conseil d'État"