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Document 62015TJ0718
/
DECISION
- Title
- Judgment of the Court (Fourth Chamber) of 22 January 2020. PTC Therapeutics International Ltd v European Medicines Agency. Appeal — Access to documents of EU institutions, bodies, offices or agencies — Regulation (EC) No 1049/2001 — First indent of Article 4(2) — Exception relating to the protection of commercial interests — Article 4(3) — Protection of the decision-making process — Documents submitted to the European Medicines Agency in the context of a marketing authorisation application for a medicinal product for human use — Decision to grant a third party access to the documents — General presumption of confidentiality — No obligation for an EU institution, body, office or agency to apply a general presumption of confidentiality. Case C-175/18 P.
- ECLI identifier
- ECLI:EU:C:2020:23
- Defendant
- European Medicines Agency
- Judge-Rapporteur
- Vilaras
- Type of procedure
- Action for annulment,Appeal - unfounded
- Complementary documents:
22/01/2020
PROCEEDINGS
- Title
- Opinion of Advocate General Hogan delivered on 11 September 2019. PTC Therapeutics International Ltd v European Medicines Agency. Appeal — Access to documents of EU institutions, bodies, offices or agencies — Regulation (EC) No 1049/2001 — First indent of Article 4(2) — Exception relating to the protection of commercial interests — Article 4(3) — Protection of the decision-making process — Documents submitted to the European Medicines Agency in the context of a marketing authorisation application for a medicinal product for human use — Decision to grant a third party access to the documents — General presumption of confidentiality — No obligation for an EU institution, body, office or agency to apply a general presumption of confidentiality. Case C-175/18 P.
- ECLI identifier
- ECLI:EU:C:2019:709
- Advocate General
- Hogan
11/09/2019
DECISION
- ECLI identifier
- ECLI:EU:T:2018:257
27/04/2018
- Title
- Arrêt du Tribunal (deuxième chambre) du 5 février 2018. PTC Therapeutics International Ltd contre Agence européenne des médicaments. Accès aux documents – Règlement (CE) no 1049/2001 – Document détenu par l’EMA et soumis dans le cadre de la demande d’autorisation de mise sur le marché du médicament Translarna – Décision d’accorder à un tiers l’accès au document – Exception relative à la protection des intérêts commerciaux – Absence de présomption générale de confidentialité. Affaire T-718/15.
- ECLI identifier
- ECLI:EU:T:2018:66
- Applicant
- Particulier
- Defendant
- Agence européenne des médicaments, Institutions et organes de l’UE
- Judge-Rapporteur
- Schalin
- Type of procedure
- Recours en annulation - non fondé
- Complementary documents:
05/02/2018
CASE BROUGHT
- Title
- Affaire T-718/15: Recours introduit le 9 décembre 2015 — PTC Therapeutics International/EMA
15/02/2016