Tribunal de Justicia de la UE: El Tribunal de Justicia confirma el derecho de acceso a los documentos contenidos en el expediente de una solicitud de autorización de comercialización de medicamentos

Date of article: 22/01/2020

Daily News of: 23/01/2020

Country:  EUROPE

Author: Court of Justice of the European Union

Article language: es

Tribunal de Justicia de la Unión Europea

COMUNICADO DE PRENSA n.º 6/20

Luxemburgo, 22 de enero de 2020

Sentencia en los asuntos C-175/18 P PTC Therapeutics International Ltd/Agencia Europea de Medicamentos (EMA), y C-178/18 P MSD Animal Health Innovation e Intervet International/Agencia Europea de Medicamentos (EMA)

 

El Tribunal de Justicia confirma el derecho de acceso a los documentos contenidos en el expediente de una solicitud de autorización de comercialización de medicamentos

La oposición al acceso debe facilitar explicaciones sobre la naturaleza, el objeto y el alcance de los datos cuya divulgación perjudicaría a los intereses comerciales

 

Comunicado de prensa completo aquí: https://curia.europa.eu/jcms/upload/docs/application/pdf/2020-01/cp200006es.pdf

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Corte di giustizia dell’Unione europea: La Corte conferma il diritto di accesso ai documenti contenuti nel fascicolo di una domanda di autorizzazione all’immissione in commercio dei medicinali

Date of article: 22/01/2020

Daily News of: 23/01/2020

Country:  EUROPE

Author: Court of Justice of the European Union

Article language: it

Corte di giustizia dell’Unione europea

COMUNICATO STAMPA n. 6/20

Lussemburgo, 22 gennaio 2020

Sentenze nelle cause C-175/18PPTC Therapeutics International Ltd/ Agenzia europea per i medicinali (EMA)eC-178/18PMSD Animal Health Innovation eIntervet International/ Agenzia europea per i medicinali (EMA)

La Corte conferma il diritto di accesso ai documenti contenuti nel fascicolo di una domanda di autorizzazione all’immissione in commercio dei medicinali

Un’opposizione all’accesso deve fornire spiegazioni circa la natura, l’oggetto e la portata dei dati la cui divulgazione arrecherebbe pregiudizio agli interessi commerciali

Comunicato stampa completo: https://curia.europa.eu/jcms/upload/docs/application/pdf/2020-01/cp200006it.pdf 

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Gerichtshof der Europäischen Union: Der Gerichtshof bestätigt das Recht auf Zugang zu Dokumenten, die in den Akten zu einem Antrag auf Genehmigung für das Inverkehrbringen von Arzneimitteln enthalten sind

Date of article: 22/01/2020

Daily News of: 23/01/2020

Country:  EUROPE

Author: Court of Justice of the European Union

Article language: de

Gerichtshof der Europäischen Union

PRESSEMITTEILUNG Nr.6/20

Luxemburg, den 22.Januar 2020

Urteil in den RechtssachenC-175/18P, PTC Therapeutics International Ltd/Europäische Arzneimittelagentur (EMA), und C-178/18P, MSD Animal Health Innovation und Intervet International/Europäische Arzneimittelagentur (EMA)

https://curia.europa.eu/jcms/upload/docs/application/pdf/2020-01/cp200006de.pdf

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Updated programme: Artificial intelligence and Human rights - Ombudmanship challenges, roles and tools

Date of article: 22/01/2020

Daily News of: 23/01/2020

Country:  Spain - Catalonia

Author: Regional Ombudsman of Catalonia

Article language: en

ARTIFICIAL INTELLIGENCE AND HUMAN RIGHTS

OMBUDSMANSHIP CHALLENGES, ROLES AND TOOLS

Monday, 2nd March, 2020

15-15.30h Welcome

15.30-16h Opening ceremony

  • Pedro Duque, Minister of Science and Technology
  • Jordi Puigneró, Catalan Government Minister for Digital Policy and Public Administration
  • Peter Tyndall, President of IOI and Ombudsman of the Republic of Ireland
  • Rafael Ribó, European President of IOI and Ombudsman of Catalonia

16-17.30h Facts and limits of the AI

Chairperson: Andreas Pottakis, Greek Ombudsman and Director of IOI

17.30-18h Coffee break

18-19.30h From analogic to digital society

Chairperson: Joana Barbany (Gencat)

  • Barry O’Sullivan, University College Cork (Ireland), European AI Association, European Commission High-Level Expert Group on AI
  • José María Lassalle
  • Daniel Innerarity
  • Renata Ávila

Tuesday, 3rd March, 2020

9-13.30h Rights, challenges, fundamental questions. International institutions and definitions

9-11h   I. Rights, challenges: Sectorial approach

Chairperson: Laia Bonet, Barcelona City Hall Councillor

  • Cybersecurity: Ángel Gómez de Ágreda
  • Health and databases research: Josep M. Argimón
  • Social programs and non-discrimination: Liliana Arroyo
  • Bioethics: Itziar de Lecuona

11-11.30h Coffee break

11.30 – 13.30h   II. Rights, challenges: International treaties and definitions

Chairperson: Miquel Molina, deputy director of La Vanguardia

  • Martha Stickings, Fundamental Rights Agency (FRA)
  • Geraldine Mattioli-zeltner, ECHR, Coe
  • CAHAI, COE
  • PACE, COE
  • EU Ombudsman

13.30-14.30h Lunch break

14.30-16.30h Roles, challenges and opportunities for the ombudsmen

Chairperson: Joan Manuel del Pozo, Girona University Ombudsman

  • Carles Ramió
  • Rob Behrens, UK Parliamentary and Health Service Ombudsman
  • Elisabet Rynning, Swedish Parliamentary Chief Ombudsman
  • Ulle Madise, Ombudsman of Estonia
  • Quirine Eijkman, Commissioner and Vice President of the Netherlands Institute of Human Rights

16.30-17h Coffee break

17-17.30h Conclusions and tools

  • Ulises Cortes
  • Catherine De Bruecker, Belgian Federal Ombudsman, IOI Europe Vice President

17.30-18h Closing ceremony

Registration form 

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Cour de justice del’Union européenne : La Cour confirme le droit d’accès aux documents contenus dans le dossier d’une demande d’autorisation de mise sur le marché des médicaments

Date of article: 23/01/2020

Daily News of: 22/01/2020

Country:  EUROPE

Author: Court of Justice of the European Union

Article language: fr

La Cour confirme le droit d’accès aux documents contenus dans le dossier d’une demande d’autorisation de mise sur le marché des médicaments

Une opposition à un tel accès doit fournir des explications sur la nature, l’objet et la portée des données dont la divulgation porterait atteinte aux intérêts commerciaux

 

COMMUNIQUE DE PRESSE n° 6/20 :

 

https://curia.europa.eu/jcms/upload/docs/application/pdf/2020-01/cp200006fr.pdf

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