Orders (Information) nº T-783/17 of Tribunal General de la Unión Europea, July 11, 2018

Resolution DateJuly 11, 2018
Issuing OrganizationTribunal General de la Unión Europea
Decision NumberT-783/17

Case T-783/17 R

(published in extract form)

GE Healthcare A/S

v

European Commission

(Application for interim measures - Medicinal products for human use - Directive 2001/83/EC - Suspension of the marketing authorisation for contrast agents containing gadolinium for human use - Application for suspension of operation of a measure - Lack of urgency)

Summary - Order of the President of the General Court, 11 July 2018

  1. Application for interim measures - Suspension of operation of a measure - Conditions for granting - Urgency - Serious and irreparable harm - Financial loss - Commission decision suspending the marketing authorisation for a product - Reliance on the adoption of measures suspending authorisations for the product at issue by third States - Harm not serious in nature

    (Art. 278 TFEU)

  2. Application for interim measures - Suspension of operation of a measure - Interim measures - Conditions for granting - Urgency - Serious and irreparable harm - Financial loss - Serious nature of harm - Assessment in the absence of information concerning the size of the undertaking concerned - Lack of information making it necessary for the judge hearing the application for interim measures to determine the existence of particular circumstances, specific to the case at issue, such as to justify urgency - Harm not serious in nature - Existence of contracts allowing the undertaking to reduce the scale of the harm

    (Arts 278 TFEU and 279 TFEU)

  3. Application for interim measures - Suspension of operation of a measure - Conditions for granting - Urgency - Serious and irreparable harm - Financial loss - Irreparable alteration in market share - Commission decision suspending the marketing authorisation for a product - Reliance on difficulties in participating in tendering processes that require a full range of products in the field in question - Marketing authorisation held by the applicant for another product which may, to a certain extent, be substituted for the product covered by the suspension decision - No urgency

    (Art. 278 TFEU)

  4. As regards an application for suspension of operation of a Commission decision suspending the marketing authorisation for a product, the applicant’s assertion that third States have adopted measures suspending authorisations for the product at issue cannot constitute particular circumstances from which the seriousness of the harm may be inferred. Even if that allegation were to prove to be founded, that would not...

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