Financial Services and Markets Authority (Belgium)

EBA and ESMA consult on two sets of joint guidelines under MiCA

Retrieved on: 
Thursday, November 9, 2023

EBA and ESMA consult on two sets of joint guidelines under MiCA

Key Points: 
  • EBA and ESMA consult on two sets of joint guidelines under MiCA
    The European Banking Authority (EBA) and the European Securities and Markets Authority (ESMA) today published a Consultation Paper on two draft Joint Guidelines covering suitability assessment of members of the management body, and suitability of shareholders and members with qualifying holdings of issuers of asset referenced tokens (ARTs) and of crypto-asset service provider (CASPs).
  • Consultation process
    Comments to this consultation can be sent to the EBA by clicking on the "send your comments" button on the consultation page.
  • The EBA will inform ESMA of all the comments received.
  • All received contributions will be published at the end of the consultation, unless requested otherwise.

Government of Jamaica Announces Acceptance of Offers to Tender for Cash its 7.625% Notes due 2025, 9.250% Notes due 2025, and 6.750% Notes due 2028

Retrieved on: 
Tuesday, October 31, 2023

(212) 430-3774, or toll free (855) 654-2014) Attention: Corporate Actions, or from any of the Dealer Managers.

Key Points: 
  • (212) 430-3774, or toll free (855) 654-2014) Attention: Corporate Actions, or from any of the Dealer Managers.
  • The distribution of materials relating to the Invitation and the transactions contemplated thereby, may be restricted by law in certain jurisdictions.
  • The Invitation and any of the transactions contemplated thereby are void in all jurisdictions where they are prohibited.
  • This announcement is not an invitation for offers to purchase for cash or a solicitation of invitations for offers to purchase for cash any Old Notes.

The EBA responds to the European Commission’s Call for Advice on significance criteria and supervisory fees under the Markets in Crypto-Assets Regulation

Retrieved on: 
Friday, September 29, 2023

The EBA proposes a set of core and ancillary indicators for each significance criterion within the scope of the Call for Advice: financial sector interconnectedness, and activities on an international scale.

Key Points: 
  • The EBA proposes a set of core and ancillary indicators for each significance criterion within the scope of the Call for Advice: financial sector interconnectedness, and activities on an international scale.
  • all types of transactions, or transactions where the token is used as means of exchange) and take account of data availabilities.
  • Regulation (EU) 2023/1114 on Markets in Crypto-assets (MiCAR) establishes a regime for the regulation and supervision of crypto-asset issuance and crypto-asset service provision in the European Union (EU).
  • Supervision tasks are conferred on the EBA for ARTs and EMTs that are determined by the EBA to be significant.

National regulators strengthen their supervision of the compliance function

Retrieved on: 
Thursday, July 13, 2023

National regulators strengthen their supervision of the compliance function

Key Points: 
  • National regulators strengthen their supervision of the compliance function
    The European Securities and Markets Authority (ESMA), the EU’s financial markets regulator and supervisor, has today published its follow-up report to the peer review on certain aspects of the compliance function under MiFID I.
  • The report shows that, overall, the National Competent Authorities (NCAs) assessed improved their practices following the 2017 peer reviews findings and recommendations.
  • Two NCAs, CySEC and CBI, are encouraged to continue this process in the following manner:
    - CySEC should consolidate its supervisory approach to ensure ongoing supervisory focus on firms’ compliance function
    - CBI should structurally integrate all elements of the ESMA Guidelines on the compliance function under MiFID into its supervisory approach and increase its controls on the compliance function of non-banking investment for firms.
  • Next steps
    As the compliance function remains a key element to promote sound and compliant behaviour by firms, all NCAs should continue monitoring the effective application of the Guidelines and the effectiveness of the supervisory practices implemented, taking supervisory action when needed.

EBA publishes validation requirements on initial margin models

Retrieved on: 
Friday, July 7, 2023

06 July 2023

Key Points: 
  • 06 July 2023
    The European Banking Authority (EBA) published today its final draft Regulatory Technical Standards (RTS) on Initial Margin Model Validation (IMMV) under the European Markets Infrastructure Regulation (EMIR).
  • These draft RTS set out the supervisory procedures to ensure the prudent use of initial margin models for OTC derivatives.
  • The requirements set out in the RTS envisage a phased-in implementation of the supervisory requirements to ensure a smooth model validation process.
  • Jointly with the RTS, the EBA published an Opinion on IMMV, calling on co-legislators and the European Commission to consider the establishment of a centralised validation function at the EBA to ease the coordination issues linked to the validation of IM models that have industry-wide application.

Novavax's Nuvaxovid™ Receives Full Marketing Authorization in the EU for the Prevention of COVID

Retrieved on: 
Thursday, July 6, 2023

Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .

Key Points: 
  • Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

Novavax's Nuvaxovid™ Receives Full Marketing Authorization in the EU for the Prevention of COVID

Retrieved on: 
Thursday, July 6, 2023

Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .

Key Points: 
  • Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

LIBERTY GLOBAL ANNOUNCES PUBLICATION OF PROSPECTUS AND RESPONSE MEMORANDUM RELATED TO ITS BID FOR SHARES IN TELENET IT DOESN’T ALREADY OWN

Retrieved on: 
Wednesday, June 7, 2023

Liberty Global plc (“Liberty Global”) (NASDAQ: LBTYA, LBTYB and LBTYK) announces today the publication of the prospectus related to the voluntary and conditional public takeover bid by its indirect wholly-owned subsidiary, Liberty Global Belgium Holding B.V. (Liberty Global Belgium Holding) for all the shares of Telenet Group Holding NV (Telenet) that Liberty Global Belgium Holding does not already own or that are not held by Telenet (the Offer).

Key Points: 
  • Liberty Global plc (“Liberty Global”) (NASDAQ: LBTYA, LBTYB and LBTYK) announces today the publication of the prospectus related to the voluntary and conditional public takeover bid by its indirect wholly-owned subsidiary, Liberty Global Belgium Holding B.V. (Liberty Global Belgium Holding) for all the shares of Telenet Group Holding NV (Telenet) that Liberty Global Belgium Holding does not already own or that are not held by Telenet (the Offer).
  • In conjunction with the prospectus, the Board of Directors of Telenet has prepared a response memorandum in which it sets out its recommendation of the Offer.
  • Both the prospectus and the response memorandum have been approved by the Financial Services and Markets Authority in Belgium (FSMA).
  • Mike Fries, CEO, Liberty Global, commented: “We are pleased to announce the approval of our Offer prospectus.

Transparency Notifications from Shareholders

Retrieved on: 
Monday, May 15, 2023

(1) The total number of outstanding shares of the Company mentioned in the relevant transparency notifications amounts to 28,050,888, each share giving right to one (1) vote (being 28,050,888 voting rights in total).

Key Points: 
  • (1) The total number of outstanding shares of the Company mentioned in the relevant transparency notifications amounts to 28,050,888, each share giving right to one (1) vote (being 28,050,888 voting rights in total).
  • The notification specifies furthermore that PMV is controlled by Het Vlaams Gewest and that Het Vlaams Gewest is not controlled.
  • The notification furthermore specifies that Optiverder is 100% owned by Mr. C.A.C.M.
  • To access copies of the aforementioned transparency notifications, reference is made to Sequana Medical's website ( https://www.sequanamedical.com/investors/shareholder-information/ ).

MDxHealth Shareholder Transparency Declaration

Retrieved on: 
Friday, April 7, 2023

IRVINE, CA, and HERSTAL, BELGIUM – April 7, 2023 – MDxHealth SA (Nasdaq and Euronext Brussels: MDXH) (the "Company" or "mdxhealth"), a commercial-stage precision diagnostics company, announces today in accordance with Article 14 of the Belgian Act of May 2, 2007 on the disclosure of important participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions (the "Belgian Transparency Act"), that it received the following notification.

Key Points: 
  • IRVINE, CA, and HERSTAL, BELGIUM – April 7, 2023 – MDxHealth SA (Nasdaq and Euronext Brussels: MDXH) (the "Company" or "mdxhealth"), a commercial-stage precision diagnostics company, announces today in accordance with Article 14 of the Belgian Act of May 2, 2007 on the disclosure of important participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions (the "Belgian Transparency Act"), that it received the following notification.
  • The Company was notified that the number of shares with respect to which Valiance Asset Management Limited can exercise voting rights passively crossed below the threshold of 10% of the outstanding shares and voting rights of mdxhealth on February 7, 2023.
  • Notably, it follows from the notification by Valiance Asset Management Limited, who notified alone, that an aggregate of 20,931,094 shares of mdxhealth, representing 7.96% of the 262,880,936 outstanding shares and voting rights of mdxhealth, is held through the following entities: Valiance Holdings Limited, being a Guernsey company within the Valiance corporate structure; Valiance Life Sciences Growth Investment Fund SICAV-SIF, being a Luxembourg fund with multiple external investors; and TopMDx Ltd, being an exempted closed-ended fund registered in British Virgin Islands with multiple external investors.
  • The notification also stated that the investment manager, Valiance Asset Management Limited, which is not a controlled entity, can exercise the voting rights at its discretion for each of these 3 entities.