Regulation (European Union)

EQS-News: Multitude SE: The Extraordinary General Meeting of Multitude SE Approved The Transfer Of The Company’s Registered Office From Finland To Malta

Retrieved on:

Wednesday, April 10, 2024

Transfer, EUR, WKN, Regulation (European Union), Fintech, Malta Stock Exchange, EFI, Statute, CSD, Malta Business Registry, Register, Security (finance)

Additionally, the Extraordinary General Meeting approved certain other related proposals.

Key Points:

Additionally, the Extraordinary General Meeting approved certain other related proposals.
For the purposes of the Transfer, the Board of Directors had approved a Transfer Proposal (“Transfer Proposal”) in accordance with Article 8 (2) of the SE Regulation.
Multitude’s Extraordinary General Meeting approved the Transfer Proposal (including, without limitation the New M&A), and resolved on the Transfer in accordance with the Transfer Proposal.
The Extraordinary General Meeting resolved to appoint PricewaterhouseCoopers Malta as the auditor of the Company upon the registration of the Company with the Malta Business Registry.

Aquaporin publishes prospectus and initiates rights issue

Retrieved on:

Friday, April 5, 2024

Rights issue, Exercise, Prospectus, Nasdaq Copenhagen, Spar Nord, Water quality, AN, Regulation (European Union), NOT, Subscription business model, Finance Secretary (India), Senior, Offering, Executive, DKK, Water, Security (finance)

COPENHAGEN, Denmark, April 5, 2024 /PRNewswire/ -- Aquaporin A/S ("Aquaporin" or the "Company") (CSE: AQP) today announces that its board of directors (the "Board of Directors") has resolved to initiate a rights issue with pre-emptive subscription rights (the "Pre-emptive Rights") for the Company's existing shareholders allowing for subscription of up to 14,594,872 new shares with a nominal value of DKK 1 each (the "New Shares") at a subscription price of DKK 14 per New Share (the "Subscription Price") (the "Offering" or the "Rights Issue").

Key Points:

: DK28315694
COPENHAGEN, Denmark, April 5, 2024 /PRNewswire/ -- Aquaporin A/S ("Aquaporin" or the "Company") (CSE: AQP) today announces that its board of directors (the "Board of Directors") has resolved to initiate a rights issue with pre-emptive subscription rights (the "Pre-emptive Rights") for the Company's existing shareholders allowing for subscription of up to 14,594,872 new shares with a nominal value of DKK 1 each (the "New Shares") at a subscription price of DKK 14 per New Share (the "Subscription Price") (the "Offering" or the "Rights Issue").
A prospectus regarding the Offering (the "Prospectus") is, subject to certain restrictions, available at the Company's website: https://investors.aquaporin.com/investors/default.aspx .
Trades of Pre-emptive Rights executed during the Rights Trading Period will, however, not be affected.
Consequently, investors who have acquired Pre-emptive Rights will incur a loss corresponding to the purchase price of the Pre-emptive Rights and any transaction costs.

Notice of the Annual General Meeting of Kamux Corporation

Retrieved on:

Wednesday, March 27, 2024

Instructions for advance voting are presented in part C of this notice to the Annual General Meeting.

Key Points:

Instructions for advance voting are presented in part C of this notice to the Annual General Meeting.
Shareholders who are registered in the company's shareholders' register maintained by Euroclear Finland Oy on the record date of the Annual General Meeting and who have registered for the Annual General Meeting, may follow the Annual General Meeting through a webcast.
Changes in shareholdings after the record date for the Annual General Meeting do not affect the right to attend the Annual General Meeting or the number of votes of the shareholder.
Changes in the shareholding after the record date for the Annual General Meeting do not affect the right to attend the Annual General Meeting or the number of votes of the shareholder.

The Eurosystem Integrated Reporting Framework ‒ an overview

Retrieved on:

Friday, April 5, 2024

The Eurosystem Integrated

Key Points:

The Eurosystem Integrated
Reporting Framework ? an overview
1
Background
European Union (EU) banks face a whole range of data reporting obligations,
including for statistical, resolution and prudential information.
Existing ECB statistical regulations specify the information that must be reported, but
not how the actual reporting process is to be carried out.
The Eurosystem Integrated Reporting Framework ? an overview
1

submitted by reporting agents to NCBs.
This arrangement dates back to when the ECB was set up in 1998 and was justified
at the time, as it meant that statistical reporting could be founded on well-established
national reporting frameworks.
Figure 1
Current Eurosystem approach to collecting statistical information from banks
Banks

NCBs

ECB

Transformations by banks

Transformations by NCBs
Country A

BSI & MIR

Integrated approach
?

SHS

Country B

Operational
systems

Monetary data

b.o.p., i.i.p &
sector accounts

Credit register
Sector accounts

AnaCredit
b.o.p.
Under the new paradigm, cross-border banks could unify the
technical specifications of their reporting for all their European entities.
2
The scope of the IReF
The IReF seeks to integrate existing ESCB statistical data requirements for banks as
far as possible into a single, standardised reporting framework applicable across the
euro area.
The feasibility of aligning the IReF
more closely with the Financial Reporting (FINREP) requirements applicable at solo
level11 is also being assessed.
Some NCBs have
developed an integrated reporting framework for investment funds (covering both
MMFs and non-MMFs).
The Eurosystem reviewed the results of the CBA to identify optimal features for
banks, the Eurosystem and its users.
This time frame will give reporting agents and the Eurosystem enough lead time to
prepare the legal and technical framework without unduly delaying the expected
reduction in the reporting burden.
16
See ?On a Feasibility Study of an Integrated Reporting System under Article 430c CRR?, EBA, 2021;
and ?The EBA?s feasibility study on integrated reporting system provides a long-term vision for
increasing efficiencies and reducing reporting costs?, EBA, December 2021.
The Eurosystem is already cooperating closely with the banking industry to optimise
reporting and reduce the overall reporting burden via the Banks? Integrated Reporting
Dictionary (BIRD).19 BIRD offers a redundancy-free source (i.e.
The IReF describes statistical requirements in a redundancy-free layer
and will represent future statistical reporting obligations issued by the ECB and
applicable to Eurosystem banks.
Data quality should increase and costs decrease, as the BIRD input layer would
provide a comprehensive and flexible tool to support data reporting.

Procedural advice for orphan medicinal product designation: Guidance for sponsors

Retrieved on:

Wednesday, April 3, 2024

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

Retrieved on:

Wednesday, April 3, 2024

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.

Questions and answers on the European Union framework for (traditional) herbal medicinal products, including those from a ‘non-European’ tradition

Retrieved on:

Sunday, March 10, 2024

Well, DER, Fungus, Capsule, TUR, Interest, Animal, Part, Exercise, Database, Viral, Hepatitis, Powder, Collection, Directive, Union, Nutrient, DSM-IV codes, Volume, CTD, Legislation, Literature, Fermentation, Diabetes, Pharmacopoeia, Inhalation, Committee, Monograph, NTA, WEU, DCP, AIDS, See, Mineral, Marketing, Safety, Plant, MRA, Autoimmunity, Directive 2001/83/EC, GMP, Documentation, Seed, Heart failure, Distillation, CHMP, MRP, European Medicines Agency, Guideline, Disorder, Mutual, Convention, State, Tablet, Community, Clinical trial, Rapporteur, European Commission, Woman, Medication package insert, Vitamin, Quality, Authority, GACP, SAWP, Pharmacovigilance, Civil service commission, HMPS, Science, Health, Bibliography, Section 4, Infection, Kampo, Commission, Abbreviation, Pathology, Prescription, Human, Medication, Reproduction, EMA, NCA, Chapter One, EDQM, TAM, European Pharmacopoeia, European Economic Area, Food, Regulation (European Union), COM, TCM, Administration, Mutual recognition, Procedure, Medicine, Herbal, Answer, Q&A, HIV, EudraLex, Cancer, Public, Medicinal plants

1

Key Points:

1
Committee on Herbal Medicinal Products (HMPC)
Questions & Answers on the European Union framework
for (traditional) herbal medicinal products, including those
from a ?non-European? tradition

Table of Content
1.
European Pharmacopoeia
SAWP

Scientific Advice Working Party

SmPC

Summary of Product Characteristics

THMP

Traditional Herbal Medicinal Product

TUR

Traditional Use Registration

WEU

Well-Established Use

Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Terminology of herbal medicinal products (Q&A 1-4)
Question 1
What are herbal substances, herbal preparations, and herbal medicinal products?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Question 4
Are food supplements regulated under the European Union (EU) pharmaceutical legislation
for (traditional) herbal medicinal products ((T)HMPs)?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Regulation of herbal medicinal products in the European Union (Q&A 511)
Question 5
Where to find the pharmaceutical legislation and dossier requirements for herbal medicinal
products (HMPs), including traditional herbal medicinal products (THMPs), in the European
Union (EU)?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
These countries have,
through the EEA agreement, adopted the complete Union acquis on medicinal products and are
consequently parties to the Union procedures.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Specific provisions for traditional herbal medicinal products (Q&A 1221)
Question 12
Which indications can be granted for traditional herbal medicinal products (THMPs)?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Nov. 2023
Answer 17
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Question 29
Does the Committee on Herbal Medicinal Products (HMPC) hold a specific database on
(registered) authorised (traditional) herbal medicinal products ((T)HMPs)?
Discussion with Member States intended to be
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.

LG UNVEILS BRAND-NEW DUALCOOL AIR CONDITIONER AT MCE 2024 IN MILAN

Retrieved on:

Thursday, March 7, 2024

SEOUL, South Korea, March 7, 2024 /PRNewswire/ -- LG Electronics (LG) is revealing its efficient, new DUALCOOL™ residential air conditioner at MCE 2024 – one of Europe's biggest heating, ventilation and air conditioning (HVAC) exhibitions – in Milan, Italy, from March 12-15. Leveraging LG's latest air conditioning technologies, including the comfort-enhancing Soft Air™ function, the new DUALCOOL provides a year-round pleasant indoor environment.

Key Points:

Latest DUALCOOL Model Boasts Sophisticated Design, Company's DUAL Vane System, and the Comfort-Enhancing Soft Air Feature
SEOUL, South Korea, March 7, 2024 /PRNewswire/ -- LG Electronics (LG) is revealing its efficient, new DUALCOOL™ residential air conditioner at MCE 2024 – one of Europe's biggest heating, ventilation and air conditioning (HVAC) exhibitions – in Milan, Italy, from March 12-15.
With its sophisticated 'interior fit' design and refined matte finish, the latest LG DUALCOOL air conditioner is a stylish addition to the home.
Incorporating the innovative DUAL Vane™ system, the LG DUALCOOL air conditioner sends warm or cool air in multiple directions to deliver fast, effective temperature control.
The new LG DUALCOOL air conditioner is set to launch in Italy on April, with availability in other EU countries.

EQS-News: NOTICE TO CONVENE MULTITUDE SE’S EXTRAORDINARY GENERAL MEETING OF SHAREHOLDERS

Retrieved on:

Wednesday, February 14, 2024

Notice is given to the shareholders of Multitude SE (Company) that the Extraordinary General Meeting of the Company is to be held on 21 March 2024 at 10:00 a.m. (EET / Finnish time).

Key Points:

Notice is given to the shareholders of Multitude SE (Company) that the Extraordinary General Meeting of the Company is to be held on 21 March 2024 at 10:00 a.m. (EET / Finnish time).
Shareholders may participate in the General Meeting of Shareholders and exercise their rights at the meeting by way of proxy representation.
A remote connection to the General Meeting will be arranged via an online meeting platform, which includes a video and audio connection to the General Meeting.
On the date of this notice to the Extraordinary General Meeting of Shareholders, dated 14 February 2024, the total number of shares in Multitude SE is 21,723,960 and each of these shares carries one vote.

Ouinex Secures VASP Registration from Polish Regulator KNF Paving the Way for European Expansion

Retrieved on:

Wednesday, January 31, 2024

Crypto, Contract for difference, Growth, VASP, KNF, Regulation (European Union), FX, Sale, Cryptocurrency

Ouinex , a secure, high-speed digital asset trading platform, is thrilled to announce that it has successfully obtained Virtual Asset Service Provider (VASP) registration from the Polish Financial Supervision Authority (KNF).

Key Points:

Ouinex , a secure, high-speed digital asset trading platform, is thrilled to announce that it has successfully obtained Virtual Asset Service Provider (VASP) registration from the Polish Financial Supervision Authority (KNF).
This significant milestone opens the door for Ouinex to extend its services within the European market, setting the stage for further growth and innovation.
The approval from the KNF comes at a pivotal moment for Ouinex, aligning with the company's strategic vision of establishing a robust European presence.
This achievement not only signifies regulatory recognition, but also underscores Ouinex's commitment to compliance and adherence to the highest industry standards.