Member state

The EBA observes an increase of high earners in the EU in 2022

Retrieved on: 
Thursday, April 25, 2024
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The EBA observes an increase of high earners in the EU in 2022

Key Points: 
  • The EBA observes an increase of high earners in the EU in 2022
    The European Banking Authority (EBA) published today its Report on high earners for 2022.
  • In 2022, the number of high earners receiving a remuneration of more than EUR 1 million increased by 19.7%, from 1 957 in 2021 to 2 342 in 2022.
  • The EBA will continue to publish data on high earners annually, to closely monitor and evaluate developments in this area.
  • EUR 1 mn to EUR 2 mn)
    Slide 3: Number of high earners (data for 2022) by Member State (EU and EEA) and gender for institutions and investment firms
    Slide 4: Percentage of female high earners for institutions and investment firms (data for 2022)
    Slide 5: Ratio between variable and fixed remuneration of high earners by Member State
    Documents
    Press contacts
    Franca Rosa Congiu

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

Retrieved on: 
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 EBA consults on draft technical standards on own funds requirements and stress testing of issuers under MiCAR

Retrieved on: 
Thursday, November 9, 2023
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08 November 2023

Key Points: 
  • 08 November 2023
    The European Banking Authority (EBA) today a launched two consultations on draft Regulatory Technical Standards (RTS) on own funds requirements and stress testing of issuers under the Markets in Crypto-Assets Regulation (MiCAR) which form part of the prudential package of MiCAR products.
  • The first RTS specify the adjustment of own funds requirements and stress testing of issuers of asset-referenced tokens and e-money tokens.
  • The second RTS specify the procedure and timeframe to adjust its own funds requirements for issuers of significant asset-referenced tokens or of e-money tokens.
  • These consultations, together with other consultations papers published today, form part of the third batch of MiCAR policy products.

AliExpress Signs Product Safety Pledge+ at the European Consumer Summit 2023

Retrieved on: 
Tuesday, March 28, 2023
Safety, Member state, AliExpress, Civil service commission, Commission, Risk management, Canal Safety Gates, Alibaba Group, General Product Safety Regulations 2005, Ali Baba, European Commission, European consumer law, Automotive industry, EU

BRUSSELS, March 28, 2023 /PRNewswire/ -- AliExpress, a global retail online marketplace part of Alibaba Group, today signed the EU's Product Safety Pledge+, a voluntary commitment facilitated by the European Commission on product compliance and safety, during the European Consumer Summit 2023.

Key Points: 
  • Elevating its voluntary commitment on product compliance for a fair, regulated online marketplace
    BRUSSELS, March 28, 2023 /PRNewswire/ -- AliExpress, a global retail online marketplace part of Alibaba Group, today signed the EU's Product Safety Pledge+, a voluntary commitment facilitated by the European Commission on product compliance and safety, during the European Consumer Summit 2023.
  • The Product Safety Pledge+, a voluntary commitment of online platforms with respect to the safety of non-food consumer products, is facilitated by the European Commission and based upon the Product Safety Pledge signed by AliExpress and other key industry players in 2018.
  • Following the signing of the 2018 Product Safety Pledge, the European Commission started to discuss further improvements that could further product safety and offer even more protection for consumers.
  • The Product Safety Pledge+ was finalized in 2023 and signed between the European Commission and 11 online platforms at the European Consumer Summit 2023.

Press release - Protecting the EU’s recovery funds: MEPs on a fact-finding visit to Spain

Retrieved on: 
Monday, February 20, 2023
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Spain was the first EU country to receive a payment of Next Generation EU funds in 2021.

Key Points: 
  • Spain was the first EU country to receive a payment of Next Generation EU funds in 2021.
  • At the invitation of Spanish government members will also visit a project funded under the National Recovery Plan - the National Neurotechnology Centre in Spain.
  • Spain was the first country to receive a payment of EUR 10 billion on the basis of achieved milestones, back in 2021.
  • Journalists need to register by sending an email to [email protected]
    The press conference will be webstreamed on English and in Spanish.

DGAP-News: Deutsche Postbank Funding Trust III announces the Netherlands as its home member state

Retrieved on: 
Monday, August 29, 2022
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Deutsche Postbank Funding Trust III announces that it has notified the Dutch Authority for the Financial Markets that as of 15 July 2022 the Netherlands is its home Member State for purposes of the EU Transparency Directive.

Key Points: 
  • Deutsche Postbank Funding Trust III announces that it has notified the Dutch Authority for the Financial Markets that as of 15 July 2022 the Netherlands is its home Member State for purposes of the EU Transparency Directive.
  • The EU Transparency Directive applies to Deutsche Postbank Funding Trust III as a foreign issuer with securities admitted to listing and to trading on a regulated market in the European Economic Area and the home Member State notification is a consequence thereof.
  • The issuer is solely responsible for the content of this announcement.
  • The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.

GLOBAL POLICY WILL REMOVE HEADACHES FROM INTERNATIONAL TRAVEL

Retrieved on: 
Monday, May 9, 2022
Forum, International Civil Aviation Organization, UN, Policy, Travel, Aviation, Custodian of the Two Holy Mosques, Social media, General Authority of Civil Aviation, Digital health, Confusion, Industry, General assembly, Leadership, GACA, Mark (given name), Solution, Research, General authority, SAR, ICAO, YouGov, Weapon, Airline, Medical device, Satellite navigation device, Kingdom, Member state

RIYADH, Saudi Arabia, May 9, 2022 /PRNewswire/ -- Saudi Arabia's General Authority of Civil Aviation (GACA) has announced the Harmonising Air Travel policy, a framework that will make international travel simpler, easier and more enjoyable by removing the confusion over travel requirements currently discouraging millions of people from booking flights.

Key Points: 
  • Our research shows that many people chose not to travel in 2021 and will not travel in 2022 because of confusing health requirements to get from country to country.
  • We are delighted to launch the Harmonising Air Travel policy, a proposed framework that will unify and strengthen our industry by enabling it to navigate future health crises.
  • The Harmonising Air Travel policy framework demonstrates the leadership role Saudi Arabia is taking to ensure that the sector thrives in the years to come."
  • The Harmonising Air Travel policy white paper was launched at the inaugural Future Aviation Forum in Riyadh.

GLOBAL POLICY WILL REMOVE HEADACHES FROM INTERNATIONAL TRAVEL

Retrieved on: 
Monday, May 9, 2022
Forum, International Civil Aviation Organization, UN, Policy, Travel, Aviation, Custodian of the Two Holy Mosques, Social media, General Authority of Civil Aviation, Digital health, Confusion, Industry, General assembly, Leadership, GACA, Mark (given name), Solution, Research, General authority, SAR, ICAO, YouGov, Weapon, Airline, Medical device, Satellite navigation device, Kingdom, Member state

RIYADH, Saudi Arabia, May 9, 2022 /PRNewswire/ -- Saudi Arabia's General Authority of Civil Aviation (GACA) has announced the Harmonising Air Travel policy, a framework that will make international travel simpler, easier and more enjoyable by removing the confusion over travel requirements currently discouraging millions of people from booking flights.

Key Points: 
  • Our research shows that many people chose not to travel in 2021 and will not travel in 2022 because of confusing health requirements to get from country to country.
  • We are delighted to launch the Harmonising Air Travel policy, a proposed framework that will unify and strengthen our industry by enabling it to navigate future health crises.
  • The Harmonising Air Travel policy framework demonstrates the leadership role Saudi Arabia is taking to ensure that the sector thrives in the years to come."
  • The Harmonising Air Travel policy white paper was launched at the inaugural Future Aviation Forum in Riyadh.

INTERIM REPORT on the draft Council and Commission decision on the conclusion by the European Union and the European Atomic Energy Community of the Partnership and Cooperation Agreement establishing a Partnership between the European Communities and [...]

Retrieved on: 
Wednesday, February 27, 2019
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INTERIM REPORT on the draft Council and Commission decision on the conclusion by the European Union and the European Atomic Energy Community of the Partnership and Cooperation Agreement establishing a Partnership between the European Communities and their Member States, of the one part, and Turkmenistan, of the other part

Key Points: 

INTERIM REPORT on the draft Council and Commission decision on the conclusion by the European Union and the European Atomic Energy Community of the Partnership and Cooperation Agreement establishing a Partnership between the European Communities and their Member States, of the one part, and Turkmenistan, of the other part