Orders (Information) nº T-235/15 of The General Court, September 01, 2015

• Resolution Date: September 01, 2015
• Issuing Organization: The General Court
• Decision Number: T-235/15

Case T-235/15 R

(publication by extracts)

Pari Pharma GmbH

v

European Medicines Agency (EMA)

(Application for interim measures - Access to documents - Regulation (EC) No 1049/2001 - Documents held by the EMA concerning information submitted by an undertaking as part of its application for authorisation to place a medicinal product on the market - Decision to grant a third party access to the documents - Application for suspension of operation of a measure - Urgency - Prima facie case - Weighing up of interests)

Summary - Order of the President of the General Court, 1 September 2015

1. Application for interim measures - Suspension of operation of a measure - Conditions for granting - Prima facie case - Prima facie examination of the pleas in law put forward in support of the main action - Jurisdiction of the court hearing the application for interim relief - Limits - Action against a decision of the EMA granting a third party access to information submitted by an undertaking in the context of its application for authorisation to market a medicinal product - Plea revealing the existence of complex legal questions - Plea not prima facie lacking in foundation

   (Art. 278 TFEU; Rules of Procedure of the General Court, Art. 156(3); European Parliament and Council Regulation No 1049/2001)

2. Application for interim measures - Suspension of operation of a measure - Conditions for granting - Balancing of all the interests involved - Suspension of operation of a decision of the EMA granting a third party access to information submitted by an undertaking in the context of its application for authorisation to market a medicinal product - Need to maintain the effectiveness of the decision of the General Court in the action in the main proceedings

   (Arts 15(3) TFEU and 278 TFEU; Charter of Fundamental Rights of the European Union, Art. 47; Rules of Procedure of the General Court, Art. 156(3); European Parliament and Council Regulation No 1049/2001)

3. Application for interim measures - Suspension of operation of a measure - Interim measures - Conditions for granting - Serious and irreparable damage - Damage resulting from the disclosure of allegedly confidential information - Assessment of the seriousness of the damage by the court hearing the application for interim measures

   (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the General Court, Art. 156(3))

4. Application for interim measures - Suspension of operation of a measure - Conditions for granting - Urgency - Serious and irreparable damage - Financial loss - Assessment in accordance with the circumstances of the case - Damage linked to the disclosure of information covered by business secrecy - Criteria for assessment - Importance of the information for the undertaking concerned and usefulness of it for other undertakings

   (Art. 278 TFEU; Rules of Procedure of the General Court, Art. 156(3); European Parliament and Council Regulation No 1049/2001, Art. 6(1))

5. Application for interim measures - Suspension of operation of a measure - Interim measures - Conditions for granting - Urgency - Assessment in litigation on the protection of confidential information - Serious and irreparable damage - Sufficient where probability of that damage is shown

   (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the General Court, Art. 156(3))

6. Application for interim measures - Suspension of operation of a measure - Interim measures - Conditions for granting - Urgency - Serious and irreparable damage - Decision of the EMA granting a third party access to information submitted by an undertaking in the context of its application for authorisation to market a medicinal product - No jurisdiction for the court hearing the application for interim relief to authorise partial access

   (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the General Court,...