3.11.2020 |
EN |
Official Journal of the European Union |
C 371/26 |
Action brought on 11 September 2020 — Kedrion v EMA
(Case T-570/20)
(2020/C 371/30)
Language of the case: Italian
Parties
Applicant: Kedrion SpA (Barga, Italy) (represented by: V. Salvatore, lawyer)
Defendant: European Medicines Agency
Form of order sought
The applicant claims that the Court should:
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annul the contested decision; and |
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order the European Medicines Agency to pay the costs incurred by the applicant in the present proceedings. |
Pleas in law and main arguments
The present action has been brought against the decision refusing the applicant’s confirmatory application for access to documents, adopted by the European Medicines Agency under Article 8 of Regulation (EC) No 1049/2001 of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (doc.: EMA/336464/2020) (1). The application concerned documents submitted by a new service provider in respect of the collection and fragmentation of plasma in Italy, provided by Italian centres.
In addition to the reasons for refusing access to the requested documents, which had already been set out in the decision refusing the original application and were reiterated in part in the contested decision, EMA further stated that the refusal to grant access had to be considered justified in view of the fact that the document requested contains information also included in form 3.2.S of the request for marketing authorisation (MA) for a medicinal product as well as information concerning contractual arrangements and agreements between the holder of the PMF (Plasma Master File) and the centres, therefore stressing the need to protect such information in so far as it is classified as commercially sensitive.
In support of the action, the applicant relies on two pleas in law.
1. |
First plea in law, alleging infringement of Article 4(2) of Regulation (EC) No 1049/2001
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2. |
Second plea in law, alleging that the contested decision is unlawful on account of a misuse of powers, a lack of reasoning and illogical and contradictory reasoning.
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