European Parliament

Press release - Court of Auditors: European Parliament endorses new Italian member

Retrieved on: 
Wednesday, April 3, 2024
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Court of Auditors: European Parliament endorses new Italian member

Key Points: 
  • Court of Auditors: European Parliament endorses new Italian member
    On Thursday MEPs supported the candidacy of Carlo Alberto Manfredi Selvaggi, nominated by the Italian government, for the EU Court of Auditors (ECA).
  • Background
    Carlo Alberto Manfredi Selvaggi has been serving in the Italian Court of Auditors since 1997, as Substitute Prosecutor General until 2005, and Deputy Prosecutor General until 2021.
  • The mandate of the previous Italian ECA member Mr Pietro Russo expired on 29 February.
  • Under the EU Treaty, each member state can propose its candidate for the European Court of Auditors.

Press release - Human rights breaches in Afghanistan and Venezuela

Retrieved on: 
Wednesday, April 3, 2024
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- MEPs denounce gender persecution and gender apartheid, demanding Taliban must be held accountable for their crimes

Key Points: 
  • - MEPs denounce gender persecution and gender apartheid, demanding Taliban must be held accountable for their crimes
    - Increase sanctions on the regime in Venezuela including Maduro himself
    On Thursday, the European Parliament adopted two resolutions on the respect for human rights in Afghanistan and Venezuela.
  • The repressive environment in Afghanistan, including public executions and violence against women
    MEPs are gravely concerned by the humanitarian and human rights crisis in Afghanistan.
  • Demanding their immediate and unconditional release, Parliament exhorts the regime to cease repressing and attacking civil society and the opposition.
  • They urge the International Criminal Court to include ongoing human rights violations and arbitrary detentions in its investigation into alleged crimes against humanity committed by the Maduro regime.

Press release - First green light to new bill on firms’ impact on human rights and environment

Retrieved on: 
Wednesday, April 3, 2024
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They will also have to adopt complaints mechanisms and engage with individuals and communities adversely affected by their actions.

Key Points: 
  • They will also have to adopt complaints mechanisms and engage with individuals and communities adversely affected by their actions.
  • Member states will designate a supervisory authority in charge of monitoring, investigating and imposing penalties on companies that do not comply.
  • The Commission will establish the European Network of Supervisory Authorities to support cooperation among supervisory bodies.
  • Background
    The Commission proposal introduced on 23 February 2022 is consistent with the European Parliament’s 2021 call for mandatory due diligence legislation.

Press release - Invitation to attend 2024 LUX European Audience Film Award Ceremony on 16 April

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Wednesday, April 3, 2024
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Invitation to attend 2024 LUX European Audience Film Award Ceremony on 16 April

Key Points: 
  • Invitation to attend 2024 LUX European Audience Film Award Ceremony on 16 April
    The winning film of the 2024 LUX Award will be announced in the Brussels Hemicycle, with representatives from the five nominated films and MEPs present.
  • The upcoming ceremony in the European Parliament will bring together MEPs, filmmakers, and citizens to celebrate the winning film selected by both MEPs and the audience.
  • If you wish to attend the ceremony, please register here before 8 April.
  • The LUX European Audience Film Award has been awarded by the European Parliament and the European Film Academy, in partnership with the European Commission and the Europa Cinemas network, since 2020.

Press release - European Parliament Press Kit for the European Council of 21 and 22 March 2024

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Wednesday, April 3, 2024
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In this press kit, you will find a selection of the European Parliament’s press releases reflecting MEPs’ priorities for topics on the summit agenda. Source : © European Union, 2024 - EP

Key Points: 


In this press kit, you will find a selection of the European Parliament’s press releases reflecting MEPs’ priorities for topics on the summit agenda. Source : © European Union, 2024 - EP

Press release - Metsola at the European Council: This election will be the test of our systems

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Wednesday, April 3, 2024
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Delivering on our priorities is the best tool to push against disinformation, said EP President Roberta Metsola at European Council Source : © European Union, 2024 - EP

Key Points: 


Delivering on our priorities is the best tool to push against disinformation, said EP President Roberta Metsola at European Council Source : © European Union, 2024 - EP

Procedural advice for orphan medicinal product designation: Guidance for sponsors

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Wednesday, April 3, 2024
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Frequently asked questions ................................................................... 10

Key Points: 
    • Frequently asked questions ................................................................... 10

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 2/13

      1.

    • This Regulation lays down the procedure for
      the designation of medicinal products as orphan medicinal products and provides incentives for the
      development and placing on the market of designated orphan medicinal products.
    • The Regulation also
      establishes the Committee for Orphan Medicinal Products (COMP) within the European Medicines
      Agency (EMA), which is responsible for examining applications for orphan medicinal product
      designation.
    • As of 28 April 2000, the date this Regulation entered into force, sponsors have been able to
      submit applications for orphan medicinal product designation to the EMA.
    • Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 3/13

      2.

    • Objectives
      In examining an application for orphan medicinal product designation, the COMP will focus on
      determining whether the sponsor has established that the designation criteria are met, i.e.
    • To assist in the development of a policy on orphan medicinal products, an expert network will
      be built up by the Committee, with expert(s) identified as appropriate to be involved in the evaluation
      of applications for orphan medicinal product designation.
    • ?

      The complete application should include:

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 5/13

      Document

      Format

      General administrative and scientific information completed online via the portal.

    • Important:
      In preparing an application for orphan medicinal product designation, sponsors are requested to follow
      the Commission guideline (2022/C 440/02) on the format and content of applications for designation
      as orphan medicinal products.
    • Please refer to the Procedural advice on
      appeal procedure for Orphan Medicinal Product Designation (EMEA/2677/01 Rev.3).
    • The grounds for the

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 9/13

      appeal should be based only on the original information provided in the application for orphan
      designation.

    • ?

      The European Commission will enter the designated medicinal product in the Community Register
      of Orphan Medicinal Products.

    • General advice
      ?

      Full information on the procedure for orphan medicinal products designation is available on the
      EMA orphan designation website.

    • In accordance with Regulation (EC) No 141/2000 of 16 December 1999, the sponsor may submit an
      application for orphan medicinal product designation to the Agency at any stage of development of the

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 10/13

      medicinal product as long as the criteria for designation may be justified.

    • A request for orphan medicinal product designation may be made for
      a new orphan indication for an already authorised medicinal product.
    • Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 11/13

      Which are the sponsor?s options in case of negative outcome for orphan designation?

EudraVigilance registration documents

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Wednesday, April 3, 2024
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Table of contents

Key Points: 
    • Table of contents
      Pre-requisites .............................................................................................. 3
      Registration of the headquarter for Marketing Authorisation Holders
      (MAHs) ........................................................................................................ 3
      Registration of the headquarter for Commercial and Non-commercial
      sponsors ...................................................................................................... 4
      Registration of the headquarter of National Competent Authorities ............ 5

      EudraVigilance registration documents
      EMA/503894/2018

      Page 2/5

      Pre-requisites
      ?

      User registration in the EMA Account Management Portal ? see section 2.1 of the EudraVigilance
      Registration Manual.

    • ?

      Registration of the organisation in the Organisation Management System ? see section 3.3 of the
      EudraVigilance Registration Manual.

    • ?

      Request of the role, as applicable, ?EV MAH EU QPPV? or ?EV NCA Responsible? or ?EV CS/NCS
      Responsible? by the user via the EMA Account Management Portal ? see section 5.2 and Annex
      1 of the EudraVigilance Registration Manual.

    • ?

      Once the role has been requested in the EMA Account Management Portal, a Service Desk ticket
      should be raised to the Registration team, quoting the Request ID number and attaching the
      required documents listed below.

    • Registration of the headquarter for Marketing Authorisation
      Holders (MAHs)
      ?

      A cover letter from the headquarters level of the organisation on a company?s headed paper.

    • EudraVigilance registration documents
      EMA/503894/2018

      Page 3/5

      profile who has completed the courses and is related to the respective organisation.

    • Registration of the headquarter for Commercial and
      Non-commercial sponsors
      ?

      A cover letter from the headquarters level of the organisation on a company?s headed paper.

    • EudraVigilance registration documents
      EMA/503894/2018

      Page 4/5

      Registration of the headquarter of National Competent
      Authorities
      ?

      A cover letter on organisation?s headed paper.

Union procedure on the preparation, conduct and reporting of EU pharmacovigilance inspections

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Wednesday, April 3, 2024
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Union procedure on the preparation, conduct and

Key Points: 
    • Union procedure on the preparation, conduct and
      reporting of EU pharmacovigilance inspections
      Table of contents
      1.
    • Record management and archiving ....................................................................... 12

      References ................................................................................................ 12
      Appendix 1 ?Pharmacovigilance inspection report .................................... 13
      Appendix 2- Inspection overview (IO) ...................................................... 14
      Appendix 3- Pharmacovigilance inspection outcome sharing .................... 15
      Appendix 4- Classification of inspection findings....................................... 16

      Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 2/16

      1.

    • Guidelines on the interpretation of legislative pharmacovigilance
      requirements are published in the adopted good pharmacovigilance practices (GVPs) Module III ?
      pharmacovigilance inspections.
    • Preparation of a risk-based programme for pharmacovigilance inspections is presented in the Union
      procedure on the coordination of EU pharmacovigilance inspections.
    • Scope
      This procedure constitutes a guideline in preparing, conducting and reporting national competent
      authority (NCA) pharmacovigilance inspections and outlines the steps taken of the Committee for
      Medicinal Products for Human Use (CHMP) requested pharmacovigilance inspections.
    • Those are covered under the Union procedure on the
      management of pharmacovigilance inspection findings which may impact the robustness of the benefitrisk profile of the concerned medicinal products.
    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 3/16

      3.

    • Preparation
      Preparation encompasses those activities undertaken after the selection of an MAH, or third party, for
      a pharmacovigilance inspection and prior to inspection conduct.
    • For the selection of involved
      parties for CHMP requested inspections, refer to the Union procedure on the coordination of EU
      pharmacovigilance inspections.
    • Announcement communications could include, for example, the

      Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 4/16

      name of the inspector(s), MAH, the objectives and nature of the inspection (i.e.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 5/16

      ?

      Feedback from other competent authority functions, in particular pharmacovigilance assessors.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 6/16

      ?

      If teleconference(s) are planned during the inspection with experts, assessors, MAH personnel
      located off site etc.

    • ?

      Union procedure on the management of pharmacovigilance inspection findings which may impact
      the robustness of the benefit-risk profile of the concerned medicinal products.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 12/16

      Appendix 1 ?Pharmacovigilance inspection report
      Click here for the template.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 13/16

      Appendix 2- Inspection overview (IO)
      Click here for the template.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 14/16

      Appendix 3- Pharmacovigilance inspection outcome sharing
      Click here for the template.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 16/16

The ECB’s climate and nature plan 2024-2025

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Wednesday, April 3, 2024
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Climate change is increasingly affecting the euro area economy. That is why the ECB is committed to integrating climate change considerations into its activities. On 30 January 2024 the ECB published its climate and nature plan 2024-2025, which identifies three focus areas for its future work: (i) navigating the transition towards a green economy

Key Points: 


Climate change is increasingly affecting the euro area economy. That is why the ECB is committed to integrating climate change considerations into its activities. On 30 January 2024 the ECB published its climate and nature plan 2024-2025, which identifies three focus areas for its future work: (i) navigating the transition towards a green economy