Primary and secondary legislation

Clinical Trials Information System Webinar: Last Year of Transition, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 March 2024, 13:00 (CET) to 25 March 2024, 17:30 (CET)

Retrieved on: 
Sunday, March 10, 2024
EMA, Primary and secondary legislation, Location, Clinical trial, Vimeo, European Medicines Agency, SME, CTR

Since 31 January 2023, it is mandatory for sponsors to submit all initial clinical trial applications via CTIS.

Key Points: 
  • Since 31 January 2023, it is mandatory for sponsors to submit all initial clinical trial applications via CTIS.
  • In less than a year, from 31 January 2025 onwards sponsors will need to comply with their obligations under the CTR and its Delegated Acts.
  • This EMA-hosted webinar is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations.
  • Attendees are invited to fill out a short feedback survey via Slido that will be available after the event.

Carbon intensity regulation to make or break global low-carbon hydrogen market

Retrieved on: 
Thursday, February 15, 2024
Hydrogen, Inflation, Primary and secondary legislation, GWE, Ammonia, Electrolysis, Transport, Carbon, CO2, Electricity, Economics, Treasury, Natural gas

However, the variability of renewables means that multiple electrolytic hydrogen projects are planning grid connection to maximise the utilisation of electrolysers and lower hydrogen unit costs.

Key Points: 
  • However, the variability of renewables means that multiple electrolytic hydrogen projects are planning grid connection to maximise the utilisation of electrolysers and lower hydrogen unit costs.
  • However, if the availability of renewable power is limited, there is a high risk that green hydrogen projects will need to connect to grids with very high carbon intensity, stated the report.
  • However, capturing more than 60% of the carbon dioxide from hydrogen production is costly and has yet to be proven at scale.
  • Green hydrogen with 20% grid supply and blue hydrogen with 60% capture do not make the cut in the EU or Japan.

ACT EU Training for non-commercial sponsors: Transitioning trials to the CTR (CTIS) , Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 9 February 2024, 10:00 (CET) to 9 February 2024, 13:00 (CET)

Retrieved on: 
Sunday, February 4, 2024
Primary and secondary legislation, CTIS, Clinical trial, EMA, CTR, European Economic Area, Location, Vaccine

Moreover, the event will provide useful training in preparing new clinical trials following the Clinical Trial Regulation (CTR).

Key Points: 
  • Moreover, the event will provide useful training in preparing new clinical trials following the Clinical Trial Regulation (CTR).
  • Sponsors, therefore, need to transition any trials that will continue after 30 January 2025 from the Clinical Trials Directive to the legal framework of the CTR.
  • During the event, representatives from the Member States and EMA will provide guidance and resources to support non-commercial sponsors in transitioning their trials to the Clinical Trials Information System (CTIS).
  • Please subscribe to the clinical trials newsletter for updates on the availability of video recordings for EMA events related to clinical trials.

Advent Technologies Participates in the 2nd European Electrolyser Summit

Retrieved on: 
Tuesday, June 27, 2023
Technology, Manufacturing, Other Energy, Telecommunications, Other Defense, Defense, Alternative Energy, Environment, Energy, Engineering, Hardware, Hydrogen, European Commissioner for Internal Market, Partnership, French-Soviet Joint Declaration of June 30, 1966, Civil service commission, Jorgo Chatzimarkakis, ADN, Multimedia, REPowerEU, Primary and secondary legislation, Renewable Energy Directive 2018, Green, European Commissioner, European single market, Advent, Joint, European Commission, Joint Declaration, Renewable energy, EU, Additionality

Advent Technologies Holdings, Inc. (NASDAQ: ADN) ("Advent" or the "Company"), an innovation-driven leader in the fuel cell and hydrogen technology sectors, participated in the 2nd European Electrolyser Summit held in Brussels on June 26.

Key Points: 
  • Advent Technologies Holdings, Inc. (NASDAQ: ADN) ("Advent" or the "Company"), an innovation-driven leader in the fuel cell and hydrogen technology sectors, participated in the 2nd European Electrolyser Summit held in Brussels on June 26.
  • Dr. Vasilis Gregoriou, Advent’s Chairman and CEO, joined a group of 30 CEOs representing the European electrolyser manufacturing sector in a meeting with European Commissioner Thierry Breton.
  • This partnership, established in September 2022 following the 1st Electrolyser Summit, witnessed the signing of the Joint Declaration by 20 industry leaders, including Advent, and Commissioner Breton.
  • Following the 2nd European Electrolyser Summit, the industry remains steadfast in its commitment to achieving the ambitious goals set out in the REPowerEU communication.

RECOMMENDATION FOR SECOND READING on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council establishing the Connecting Europe Facility and repealing Regulations (EU) No 1316/20[...]

Retrieved on: 
Tuesday, July 6, 2021
Euro, European Union, European Parliament, European Union (Approval of Treaty Amendment Decision) Act, Treaties of the European Union, Treaty on the Functioning of the European Union, European Committee of the Regions, Primary and secondary legislation, European Union legislative procedure

on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council establishing the Connecting Europe Facility and repealing Regulations (EU) No 1316/2013 and (EU) No 283/2014

Key Points: 
  • on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council establishing the Connecting Europe Facility and repealing Regulations (EU) No 1316/2013 and (EU) No 283/2014

    (06115/2/2021 C90214/2021 2018/0228(COD))

    (Ordinary legislative procedure: second reading)

    The European Parliament,

    having regard to the Council position at first reading (06115/2/2021 C90214/2021),

    having regard to the opinion of the European Economic and Social Committee of 19 September 2018[1]

    having regard to the opinion of the Committee of the Regions of 10 October 2018[2],

    having regard to its position at first reading[3] on the Commission proposal to Parliament and the Council (COM(2018)0438),

    having regard to Article294(7) of the Treaty on the Functioning of the European Union,

    having regard to the provisional agreement approved by the committees responsible under Rule 74(4) of its Rules of Procedure,

    having regard to Rule67 of its Rules of Procedure,

    having regard to the recommendation for second reading of the Committee on Industry, Research and Energy and the Committee on Transport and Tourism (A9-0219/2021),

    1.Approves the Council position at first reading;

    2.Notes that the act is adopted in accordance with the Council position;

    3.Instructs its President to sign the act with the President of the Council, in accordance with Article297(1) of the Treaty on the Functioning of the European Union;

    4.Instructs its Secretary-General to sign the act, once it has been verified that all the procedures have been duly completed, and, in agreement with the Secretary-General of the Council, to arrange for its publication in the Official Journal of the European Union;

    5.Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Grand Committee scrutiny of secondary legislation resumes

Retrieved on: 
Thursday, September 3, 2020
United Kingdom administrative law, Delegated legislation, Statutory law, Statutory instrument, Primary and secondary legislation, Brexit, Law, Politics of the European Union, Scottish statutory instrument

Hybrid proceedings for Grand Committee will see members taking part either online or in person in a committee room re-designed to minimise COVID risk.

Key Points: 
  • Hybrid proceedings for Grand Committee will see members taking part either online or in person in a committee room re-designed to minimise COVID risk.
  • This change will increase the amount of time available for scrutiny of secondary legislation in the House of Lords.
  • Secondary legislation under scrutiny this week includes orders, rules and regulations relating to Brexit, investigatory powers, regulations on COVID-19 and the Human Rights Act 1998.
  • Secondary legislation is the regulations, orders or rules, generally known as statutory instruments (SIs), used to fill in the details of Acts of Parliament (primary legislation).

Lords debates secondary legislation

Retrieved on: 
Friday, July 24, 2020
United Kingdom administrative law, Statutory law, Delegated legislation, Statutory instrument, Primary and secondary legislation, Law, Coming into force, Public law, Scottish statutory instrument

The House of Lords examinesfour statutory instruments (SIs), the regulations, orders or rules, used to fill in the details of Acts of Parliament, on Friday 24 July.

Key Points: 
  • The House of Lords examinesfour statutory instruments (SIs), the regulations, orders or rules, used to fill in the details of Acts of Parliament, on Friday 24 July.
  • Secondary legislation is the regulations, orders or rules, generally known as statutory instruments (SIs), used to fill in the details of Acts of Parliament (primary legislation).
  • SIs provide many of the practical measures that enable the law to operate in daily life and to be enforced.
  • certain functions of local and public authorities to be carried out by the Barnsley, Doncaster, Rotherham and Sheffield Combined Authority (SCRCA) and those only to be carried out by the Mayor of the SCRCA
    insolvency moratoriumfor private registered providers of social housing.

Committee recommends further scrutiny of two statutory instruments

Retrieved on: 
Thursday, July 16, 2020
United Kingdom administrative law, Westminster system, Statutory law, Legislatures, Statutory instrument, Delegated Legislation Committee, Delegated legislation, Political systems, Law, Policy debate, Primary and secondary legislation, Debate

The report details ten proposed negative instruments laid by the Government and recommends upgrading two instruments to the affirmative procedure which requires further debate in Delegated Legislation Committee or the Commons Chamber.

Key Points: 
  • The report details ten proposed negative instruments laid by the Government and recommends upgrading two instruments to the affirmative procedure which requires further debate in Delegated Legislation Committee or the Commons Chamber.
  • These are:
    The Government can reject or accept recommendations made by the Committee but must provide a written statement if it chooses to reject the recommendation to make a statutory instrument affirmative.
  • Click here to read more about the role of the Committee.
  • You can find proposed negative instruments, and follow their scrutiny journey, using the Parliamentary Statutory Instruments tracker .

Committee recommends further scrutiny of two statutory instruments

Retrieved on: 
Thursday, July 16, 2020
United Kingdom administrative law, Westminster system, Statutory law, Legislatures, Statutory instrument, Delegated Legislation Committee, Delegated legislation, Political systems, Law, Policy debate, Primary and secondary legislation, Debate

The report details ten proposed negative instruments laid by the Government and recommends upgrading two instruments to the affirmative procedure which requires further debate in Delegated Legislation Committee or the Commons Chamber.

Key Points: 
  • The report details ten proposed negative instruments laid by the Government and recommends upgrading two instruments to the affirmative procedure which requires further debate in Delegated Legislation Committee or the Commons Chamber.
  • These are:
    The Government can reject or accept recommendations made by the Committee but must provide a written statement if it chooses to reject the recommendation to make a statutory instrument affirmative.
  • Click here to read more about the role of the Committee.
  • You can find proposed negative instruments, and follow their scrutiny journey, using the Parliamentary Statutory Instruments tracker .

Committee recommends further scrutiny of two statutory instruments

Retrieved on: 
Thursday, July 16, 2020
United Kingdom administrative law, Westminster system, Statutory law, Legislatures, Statutory instrument, Delegated Legislation Committee, Delegated legislation, Political systems, Law, Policy debate, Primary and secondary legislation, Debate

The report details ten proposed negative instruments laid by the Government and recommends upgrading two instruments to the affirmative procedure which requires further debate in Delegated Legislation Committee or the Commons Chamber.

Key Points: 
  • The report details ten proposed negative instruments laid by the Government and recommends upgrading two instruments to the affirmative procedure which requires further debate in Delegated Legislation Committee or the Commons Chamber.
  • These are:
    The Government can reject or accept recommendations made by the Committee but must provide a written statement if it chooses to reject the recommendation to make a statutory instrument affirmative.
  • Click here to read more about the role of the Committee.
  • You can find proposed negative instruments, and follow their scrutiny journey, using the Parliamentary Statutory Instruments tracker .