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Brilitas Pharmaceuticals EU OÜ

Acronym: Brilitas EU

General Information

Identification Code: 413055049244-08
Website: [object Object]
Entity Form: osaühing
Registration Category: Companies & groups
Registration Date: 2/25/2023
Last Update: 6/24/2024
EP Accredited Number: 0

Mission & Interests

Goals: - Serving as an authorized representative for medical and pharmaceutical enterprises, advocating for the collective interests of patients across both EU member states and non-EU manufacturers, and championing the propagation of EU culture and policies across the globe. - Facilitating the provision of EU Registration Services for medicines, medical devices, in-vitro diagnostic medical devices, supplements and cosmetics and other industrial products to EU and non-EU manufacturers, including preclinical and clinical research support, marketing authorization registration, CE Mark certification issuance, import-export operations, warehousing, distribution, tendering processes, and the establishment of an extensive Agency & Partner Network. - Implementing Post-Market Surveillance, maintaining a vigilant and responsive system, and fostering close collaboration with governmental bodies and Health Agencies in the respective localities.
Interests Represented: Promotes their own interests or the collective interests of their members
Interests:
  • Agriculture and rural development
  • Banking and financial services
  • Borders and security
  • Budget
  • Business and industry
  • Climate action
  • Communication
  • Competition
  • Consumers
  • Culture
  • Culture and media
  • Customs
  • Digital economy and society
  • Economy, finance and the euro
  • Education and training
  • Employment and social affairs
  • Energy
  • Enlargement
  • Environment
  • European neighbourhood policy
  • External relations
  • Food safety
  • Foreign affairs and security policy
  • Fraud prevention
  • Humanitarian aid and civil protection
  • Institutional affairs
  • International co-operation and development
  • Justice and fundamental rights
  • Maritime affairs and fisheries
  • Migration and asylum
  • Public health
  • Regional policy
  • Research and innovation
  • Single market
  • Sport
  • Taxation
  • Trade
  • Trans-European Networks
  • Transport
  • Youth
Levels of Interest:
  • national
  • sub-national
  • european
  • global

Activities

Main EU Legislative Proposals: - Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements; Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU; - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC; - Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety; - Regulation (EU) 2021/947 of the European Parliament and of the Council of 9 June 2021 establishing the Neighbourhood, Development and International Cooperation Instrument – Global Europe, amending and repealing Decision No 466/2014/EU of the European Parliament and of the Council and repealing Regulation (EU) 2017/1601 of the European Parliament and of the Council and Council Regulation (EC, Euratom) No 480/2009.
Inter-institutional or Unofficial Groupings: N/A

Head Office

Address: Pärnu 110Kesklinna linnaosa, Harju maakond
Post Code: 11313
City: Tallinn
Country: ESTONIA
Phone: [object Object]

EU Office

Address: Pärnu 110Kesklinna linnaosa, Harju maakond
Post Code: 11313
City: Tallinn
Country: ESTONIA
Phone: [object Object]

Financial Data

New Organisation: false
Closed Year: [object Object]
Current Year: [object Object]

Membership Information

Members10 Percent: 0
Members25 Percent: 0
Members50 Percent: 0
Members75 Percent: 0
Members: 1
Members F T E: 1

Structure

Structure Type: Structure
Is Member Of: Authorized representative at EUDAMED (European Database on Medical Devices) https://ec.europa.eu/tools/eudamed/#/screen/search-eo/27cdd0a1-9e50-4df7-96d8-8ce6e3053b6c European Importer at EUDAMED https://ec.europa.eu/tools/eudamed/#/screen/search-eo/c8ecd367-5337-4d77-8352-d4d2a2864330 SME registered by the European Medicines Agency (EMA) https://fmapps.ema.europa.eu/SME/search_detail.php?_pKID=6706
Organisation Members: European Medicines Agency European Food Safety Authority European Database on Medical Devices (EUDAMED) European Cosmetic Products Notification Portal (CPNP)