Brilitas Pharmaceuticals EU OÜ
Budget
€25 — €0
EP Access
1
accredited persons
Staff
1
1 FTE
EU Grants
€1,700
Mission & Goals
- Serving as an authorized representative for medical and pharmaceutical enterprises, advocating for the collective interests of patients across EU member states, and of EU and non-EU manufacturers, and championing the propagation of EU culture and policies across the globe. - Facilitating the provision of EU Services for medicines, medical devices, in-vitro diagnostic medical devices, supplements and cosmetics, veterinary medicinal products 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 and Pharmacovigilance, maintaining a vigilant and responsive system, and fostering close collaboration with governmental bodies and Health Agencies in the respective localities.
EU Legislative Interests
- 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.
Communication Activities
Joining NIF 158th NDA Plenary meeting - European Food Safety Authority (EFSA) EMA multi-stakeholder workshop on qualification of novel methodologies, European Medicines Agency, 17 - 18/04/2023 Policy 0070 on publication of clinical data for medicinal products for human use, European Medicines Agency, 16/05/2023 Implementation of the outcome of the signal management process by MAHs according to Article 81(2) of Regulation (EU) 2019/6, European Medicines Agency, 25/04/2023 Public consultation concerning the revision of the transparency rules of the Clinical Trials Information System (CTIS), the IT platform supporting the implementation of the Clinical Trials Regulation (EU) No 536/2014 (CTR), European Medicines Agency, 28/06/2023 Webinar via Webex on CE marking for companies working in the MedTech area, Medicines Agency, 24/05/2023 Multi-stakeholder platform kick-off hybrid workshop, European Medicines Agency, 22-23/06/2023 Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use, European Medicines Agency, 26-27/06/2023 ACT EU workshop on Clinical Trial Methodology Guidance workshop, European Medicines Agency, 16/11/2023 ACT EU Clinical Trial Data Analytics hybrid workshop, European Medicines Agency, 25-26/01/2024 Workshops on Union Product Database (UPD) and Antimicrobial Sales and Use (ASU) Platform data quality, European Medicines Agency, 29/11/2023 Orphan Medicines Development – ask the European Regulator, European Medicines Agency, 29/02/2024 Transitioning clinical trials in the CTR (CTIS), European Medicines Agency, 09/02/2024 Quality Innovation Group - Listen and Learn Focus Group hybrid meeting, European Medicines Agency, 4-5/06/2024 Advancing Regulatory Science Research, European Medicines Agency, 18/11/2024 European Antibiotic Awareness Day and World AMR Awareness Week 2024, European Medicines Agency, 18/11/2024 UPD refresher webinar for marketing authorisation holders on volume of sales submission, European Medicines Agency, 5/12/2024 Improving efficiency of approval process for new medicines in the EU, European Medicines Agency, 05/12/2024 ACT EU consultation on clinical trials training needs for academia and SMEs, European Medicines Agency, 14/01/2025 158th Open Plenary Meeting of the Nutrition, Novel Foods, and Food Allergens (NDA) Panel, European Food Safety Authority, 07/05/2025 Webinar on the Open MCRA tool for prospective cumulative risk assessment, European Food Safety Authority, 26/05/2025 A call for expressions of interest in joining EFSA’s new stakeholder community on applications for food and feed products, European Food Safety Authority, 2025 Review of Guidance document for risk assessment of nanomaterials and materials containing nanoparticles in the food chain, and a new Guidance document for the risk assessment of feed additives containing nanoparticles produced by EFSA’s FEEDAP Panel, European Food Safety Authority, 2025 EFSA's Chemical Risk Assessment project, European Food Safety Authority, 2025 Pre-Submission support for Novel Food SMEs, European Food Safety Authority, 2025 Public consultation on Scoping paper on the update of EFSA’s guidance on risk assessment of nanomaterials and materials containing small/nano particles in the food chain, European Food Safety Authority, 2025 Integration of New Approach Methodologies in Chemical Risk Assessment: case studies addressing nanoplastics in food (NAMs4Nanoplastics), European Food Safety Authority, 2025
Interests Represented
Promotes their own interests or the collective interests of their members
Member Of
European Medicines Agency European Food Safety Authority European Database on Medical Devices (EUDAMED) European Cosmetic Products Notification Portal (CPNP) European Parliament
Organisation Members
Authorized representative at EUDAMED (European Database on Medical Devices) https://ec.europa.eu/tools/eudamed/#/screen/search-eo/27cdd0a1-9e50-4df7-96d8-8ce6e3053b6c Registered European Importer at EUDAMED https://ec.europa.eu/tools/eudamed/#/screen/search-eo/c8ecd367-5337-4d77-8352-d4d2a2864330 Registered by the European Medicines Agency (EMA) https://fmapps.ema.europa.eu/SME/search_detail.php?_pKID=6706
Commissioner Meetings
No recorded meetings with EU commissioners.