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Order of the General Court (Second Chamber) of 8 March 2012. # Octapharma Pharmazeutika Produktionsgesellschaft mbH v European Medicines Agency (EMA). # Medicinal products for human use - Changes to a plasma master file (PMF) - Fees payable to the EMA - Act with adverse effects - Measure merely confirmatory - Manifest inadmissibility. # Case T-573/10.
ECLI:EU:T:2012:114
62010TO0573
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(Case T‑573/10)
Medicinal products for human use — Changes to a plasma master file (PMF) — Fees payable to the EMA — Act with adverse effects — Measure merely confirmatory — Manifest inadmissibility
4. Actions for annulment — Action against a decision confirming an earlier decision not challenged within the time limits — Inadmissibility — Meaning of confirmatory decision — Decision recalling the legal basis of an earlier decision and reacting to a new argument submitted well after the expiry of the time limit for bringing an action against the earlier decision — Included (Art. 263 TFEU) (see paras 54-60)
Re:
APPLICATION for annulment of the letter of 21 October 2010 (EMA/643425/2010) by which the European Medicines Agency (EMA) refused to repay to the applicant the sum of EUR 180 700 corresponding to the difference between, on the one hand, the sum the applicant paid to it in respect of fees for the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products and, on the other hand, the sum which the applicant maintains it should have paid.
Operative part
1.The action is dismissed.
2.Octapharma Pharmazeutika Produktionsgesellschaft mbH is ordered to pay the costs.