Regulation (EU) No. 305/2011

Report on the risk assessment of N,N-diethyl-2- [[4-(1-methylethoxy)phenyl]methyl]-5-nitro-1Hbenzimidazole- 1-ethanamine (isotonitazene) in accordance with Article 5c of Regulation (EC) No 1920/2006 (as amended)

Retrieved on: 
Friday, November 13, 2020
Benzimidazoles, Designer drugs, Analgesics, Opioids, Isotonitazene, Framework decision, Regulation (EU) No. 305/2011, Drugs, Health care

This publication presents the data and findings of the risk assessment on N,N-diethyl-2-[[4-(1-methylethoxy)phenyl]methyl]-5-nitro-1H-benzimidazole-1- ethanamine (isotonitazene), carried out by the extended Scientific Committee of the EMCDDA on 26 May 2020.

Key Points: 
  • This publication presents the data and findings of the risk assessment on N,N-diethyl-2-[[4-(1-methylethoxy)phenyl]methyl]-5-nitro-1H-benzimidazole-1- ethanamine (isotonitazene), carried out by the extended Scientific Committee of the EMCDDA on 26 May 2020.
  • On the basis of the Risk Assessment Report, on 2 September 2020, the Commission decided that isotonitazene should be included in the definition of 'drug', in the Annex to Framework Decision 2004/757/JHA.
  • Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Commission Delegated Directive (EU) 2020/1687 by 3 June 2021.

Hexagon Interim Report 1 January - 30 September 2020

Retrieved on: 
Wednesday, October 28, 2020
Articles, Stock market, Finance, Organizations, Corporate finance, Investment, Investor relations, Hexagon AB, Market abuse, Abuse, European Union, Regulation (EU) No. 305/2011

Maria Luthstrm, Head of Sustainability and Investor Relations, Hexagon AB, +46 8 601 26 27, [email protected]

Key Points: 
  • Maria Luthstrm, Head of Sustainability and Investor Relations, Hexagon AB, +46 8 601 26 27, [email protected]
    This is information that Hexagon AB is obliged to make public pursuant to the EU Market Abuse Regulation.
  • The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CET on 28October 2020.

Sandvik - Interim Report Third Quarter 2020

Retrieved on: 
Friday, October 16, 2020
European Committee for Standardization, Regulation (EU) No. 305/2011, Abuse

A webcast and teleconference will be held on 16 October 2020 at 13:00 CEST.

Key Points: 
  • A webcast and teleconference will be held on 16 October 2020 at 13:00 CEST.
  • Information is available at home.sandvik/investors
    This information is information that Sandvik AB is obliged to make public pursuant to the EU Market Abuse Regulation.
  • The information was submitted for publication, through the agency of the contact person set out above, at about 11.30 CEST on 16 October 2020.

LimaCorporate Is The First Italian Company To Obtain The EU Quality Certificate Under The MDR

Retrieved on: 
Thursday, July 30, 2020
Medical device, MDR, Regulation (EU) No. 305/2011, Quality management system, Professional certification, Articles, Business

SAN DANIELE DEL FRIULI,Italy, July 30, 2020 /PRNewswire/ --LimaCorporate announces that it is the first Italian company to obtain the EU Quality Management System certificate under the new European Medical Devices Regulation (MDR) from TV SD.

Key Points: 
  • SAN DANIELE DEL FRIULI,Italy, July 30, 2020 /PRNewswire/ --LimaCorporate announces that it is the first Italian company to obtain the EU Quality Management System certificate under the new European Medical Devices Regulation (MDR) from TV SD.
  • In 2015, LimaCorporate formalized the development of a line of customized products - prostheses made for the specific needs and requirements of patients.
  • It is precisely for these custom products that LimaCorporate has received this certification in accordance with the new MDR regulation.
  • Over the years, LimaCorporate has evolved, improved, and validated its quality approach to always be ahead of the curve.

LimaCorporate Is The First Italian Company To Obtain The EU Quality Certificate Under The MDR

Retrieved on: 
Thursday, July 30, 2020
Medical device, MDR, Regulation (EU) No. 305/2011, Quality management system, Professional certification, Articles, Business

SAN DANIELE DEL FRIULI,Italy, July 30, 2020 /PRNewswire/ --LimaCorporate announces that it is the first Italian company to obtain the EU Quality Management System certificate under the new European Medical Devices Regulation (MDR) from TV SD.

Key Points: 
  • SAN DANIELE DEL FRIULI,Italy, July 30, 2020 /PRNewswire/ --LimaCorporate announces that it is the first Italian company to obtain the EU Quality Management System certificate under the new European Medical Devices Regulation (MDR) from TV SD.
  • In 2015, LimaCorporate formalized the development of a line of customized products - prostheses made for the specific needs and requirements of patients.
  • It is precisely for these custom products that LimaCorporate has received this certification in accordance with the new MDR regulation.
  • Over the years, LimaCorporate has evolved, improved, and validated its quality approach to always be ahead of the curve.

Boliden: Q2 Interim Report 2020

Retrieved on: 
Wednesday, July 22, 2020
Boliden, Market abuse, Regulation (EU) No. 305/2011, Financial markets, Social issues, Geography of Sweden

Please find enclosed the full report.

Key Points: 
  • Please find enclosed the full report.
  • The Interim Report will be presented via a webcast/conference call on Wednesday, July 22nd at 09:30 (CET).
  • This information is information that Boliden AB is obliged to make public pursuant to the EU Market Abuse Regulation.
  • The information was submitted for publication, through the agency of Director Investor Relations, at 07.45 CET on the 22ndof July 2020.

ESAs notify the European Commission about the outcome of the review of the PRIIPs key information document

Retrieved on: 
Tuesday, July 21, 2020
European Committee for Standardization, Regulation (EU) No. 305/2011, Corporate law, European Union directives, Eurozone

This follows the ESAs’ consultation paper published on 16 October 2019 on draft regulatory technical standards (RTS) to amend the technical rules on the presentation, content, review and revision of KID (Delegated Regulation (EU) 2017/653). 

Key Points: 

This follows the ESAs’ consultation paper published on 16 October 2019 on draft regulatory technical standards (RTS) to amend the technical rules on the presentation, content, review and revision of KID (Delegated Regulation (EU) 2017/653). 

ESAs notify the European Commission about the outcome of the review of the PRIIPs key information document

Retrieved on: 
Tuesday, July 21, 2020
European Committee for Standardization, Regulation (EU) No. 305/2011, Corporate law, European Union directives, Eurozone

This follows the ESAs’ consultation paper published on 16 October 2019 on draft regulatory technical standards (RTS) to amend the technical rules on the presentation, content, review and revision of KID (Delegated Regulation (EU) 2017/653). 

Key Points: 

This follows the ESAs’ consultation paper published on 16 October 2019 on draft regulatory technical standards (RTS) to amend the technical rules on the presentation, content, review and revision of KID (Delegated Regulation (EU) 2017/653). 

Daily Mail and General Trust plc: Director/PDMR Shareholding

Retrieved on: 
Monday, June 22, 2020
European Committee for Standardization, Regulation (EU) No. 305/2011

Daily Mail and General Trust plc: Director/PDMR Shareholding

Key Points: 
  • Daily Mail and General Trust plc: Director/PDMR Shareholding
    Dissemination of a Regulatory Announcement, transmitted by EQS Group.
  • The issuer is solely responsible for the content of this announcement.
  • The information set out below is provided in accordance with the requirements of Article 19(3) of the EU Market Abuse Regulation No 596/2014.

Immunovia Provides Forth Update During COVID-19 Pandemic

Retrieved on: 
Wednesday, May 27, 2020
European Committee for Standardization, Regulation (EU) No. 305/2011

The file will be available within two hours after the conference has ended.

Key Points: 
  • The file will be available within two hours after the conference has ended.
  • This is information that Immunovia is obliged to make public pursuant to the EU Market Abuse Regulation.
  • The information was submitted for publication, through the agency of the contact person set out above, at 16:00 CET on May 27, 2020.
  • Immunovia Dx Laboratories located in Marlborough, Massachusetts, USA and Lund, Sweden will provide laboratory testing services in two accredited reference laboratories.