European Network About the European Network The European Medicines Agency (EMA) in Amsterdam is the scientific coordinative body for marketing authorisation and safety of medicinal products in Europe. [...] Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HaDEA. Neither the European Union nor the [...] provided by EU pharmaceutical legislation . Together with the member states and the European Commission as partners in a European network, the EMA fulfils the following tasks: Provide independent, science-based

European guidelines For the implementation of the Regulation (EU) 2019/6, the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) has set up an area where numerous

Authorisation In the European Union, new pharmaceutical specialities are increasingly not authorised in each individual member state, but simultaneously for all member states via the European Medicines Agency [...] issues a positive opinion, the European Commission in Brussels issues the final notification of authorisation, which is legally binding for all member states of the European Economic Area (27 EU countries [...] countries + Norway + Iceland + Liechtenstein). The decision of the European Commission and the European Public Assessment Report (EPAR) are publicly available. All centrally authorised products are listed in

portal of the European Union Information for patients from the EMA - European Medicines Agency European Patients Forum EUPATI - European Patients Academy on Therapeutic Innovations EFA - European Federation [...] portal of the European Union Information on actions and decisions at European level to protect the health of Europeans. healthcare sector Information for patients from the EMA - European Medicines Agency [...] to contact them directly. EPF EUPATI - European Patients Academy on Therapeutic Innovations Patient training - the ABC of drug development EUPATI - the European Patients' Academy on Therapeutic Innovation

essential part of the tasks of the European Medicines Agency (EMA). Austria is just as affected by the decisions taken at European level as all other member states of the European Economic Area. The safety measures

to the provisions of the current Best Practice Guidelines jointly developed by the European Commission and the European Directorate for the Quality of Medicines and Health Care of the Council of Europe [...] centers Haemovigilance (notification of adverse reactions and events) The role of the European Commission The European Commission helps to address the risks of using blood and blood products (e.g. transmission [...] Federal Office for Safety in Health Care (BASG) in the context of tissue safety The role of the European Commission Legal basis of blood safety For blood and blood products for transfusion: Austrian Medicines

Register The European Union Clinical Trials Register provides protocol and result searches for: clinical trials on medicinal products that are conducted in the European Union (EU) and the European Economic [...] Area (EEA) clinical trials on medicinal products conducted outside the EU / EEA that are linked to European paediatric-medicinal product development The information contained in the EU Clinical Trials Register

1394/2007 of the European Parliament and of the Council. The role of the Federal Office for Safety in Health Care (BASG) in the context of tissue safety Contact person of the European Commission (Competent [...] ents Tissue vigilance (notification of adverse reactions or events) The role of the European Commission The European Commission helps address the risks of using cells and tissues (e.g. transmission of [...] granted. The register is maintained through the European Coding Platform. EU Tissue Establishment compendium It is an IT platform provided by the European Commission. The EU compendium of tissue establishments

Eudralex Vol.10 - EU Commission Guidance on Clinical Trials Information from the European Medicines Agency (EMA) The European Medicines Agency (EMA) manages the central submission portal for clinical trials [...] Regulation (CTR) became applicable in the EU. Further information can be found on the websites of the European Medicines Agency (EMA) and CTIS . On 29 February 2024, the EMA and member states will offer an CTIS [...] the BASG fee schedule for the current fees. Information and training material Information from the European Commission The basis for clinical trials with medicinal products is the Regulation (EU) 536/2014

for innovation, interdisciplinarity, and excellence . European We live and promote the European idea. We actively participate in shaping the European regulatory environment, thereby contributing to safeguarding [...] evaluation are the AVG § 7 and the "European Medicines Agency policy on the handling of competing interests of scientific committees' members and experts" of the European Medicines Agency; the evaluation [...] digitalisation Establish BASG as central data hub and platform for Austria Implement national and European requirements promptly Use new opportunities of digitalisation for support Evaluating and using