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TGA shelves biosimilar and generic transparency measures
In late 2020, following almost 18 months of public and industry consultations conducted by the Therapeutic Goods Administration (TGA).
Global | Publication | July 6, 2018
Welcome to Essential Corporate News, our weekly news service covering the latest developments in the UK corporate world.
On June 29, 2018 the Financial Services and Markets Act 2000 (Prospectus and Markets in Financial Instruments) Regulations 2018 were published. The Regulations make amendments to the Financial Services and Markets Act 2000 (FSMA) in order to implement part of Regulation (EU) No 2017/1129 of the European Parliament and of the Council of 30 June 2017 (Prospectus Regulation)and come into force on July 21, 2018.
The Regulations amend:
Section 86(1)(e) FSMA (Exempt offers to the public), by increasing the threshold for offers to the public that are exempt from the obligation to publish a prospectus from EUR 100,000 to EUR 8 million, and
The Regulations also make other minor amendments to FSMA, and to other primary and secondary legislation, in relation to MiFID II.
On July 4, 2018 the London Stock Exchange (LSE) published feedback on AIM Notice 51 and confirmed the changes to the AIM Rules for Nominated Advisers.
The LSE has mostly implemented the amendments proposed in AIM Notice 51, save that:
Eligibility criteria - The new Rule 2 criteria for seeking approval as a Nominated Adviser (Nomad) have been amended to remove the proposed requirement for the entity to provide evidence that it has implemented adequate risk management systems. It is noted that Nomads are already obliged to have proper procedures pursuant to Rule 23, and an applicant will be required to demonstrate that it can comply with Rules 23 to 25 when seeking approval as a Nomad.
The LSE does not intend to review existing Nomads against the new amended criteria, as they should already be meeting them through their existing authorisations. It only proposes that eligibility be reviewed if an issue is identified as part of its supervisory work or relevant information is brought to its attention which would bring into question a Nomad’s ability to comply.The LSE notes that, in relation to Rule 3, while it has decided to go ahead with its proposal to have discretion to decline an application if it "considers that an applicant, any shareholder of the applicant, or any officer of the applicant might be detrimental to the reputation and/or integrity of AIM”, when considering whether a shareholder may be so detrimental, it will consider the non-exhaustive matters listed in Rule 3.
Other minor drafting and consequential amendments have also been made. The new rules will come into effect on July 30, 2018.
The LSE has also announced that it will issue a consultation on changes to the AIM Disciplinary Procedures and Appeals Handbook in Q3 2018.
(AIM Notice 52, AIM Rules for Nominated Advisers – 04.07.2018)
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In late 2020, following almost 18 months of public and industry consultations conducted by the Therapeutic Goods Administration (TGA).
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The Government of Ontario recently introduced the Strengthening Cyber Security and Building Trust in the Public Sector Act, 2024 (Bill 194) seeking to strengthen cybersecurity programs in the public sector and provide the groundwork for the responsible use of artificial intelligence (AI) among various public sector entities.
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On May 24 the Labour Party published an update to its proposals on employment law in “Labour’s Plan to Make Work Pay: Delivering A New Deal for Working People” (the Plan). Our review of the proposals included in the Green Paper which was initially published in 2021 can be found here. Should they win the election, the Labour Party has stated that it will introduce an Employment Bill within the first 100 days of being in power which will cover many of these issues.
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