Learn about SVHC reporting requirements and comply with the Waste Framework Directive A document providing guidance on the scientific or regulatory aspects of development medicines and applications for marketing authorisation. Although guidelines are not legally binding, applicants need to provide justification any deviations. For more information can be found under Scientific guidelines. Guideline | European Medicines Agency
European guidelines Guidelines are non-binding documents which aim to facilitate the implementation of European directives. There are different types of guidelines, such as practical guidelines from the European Commission setting out best practice for the prevention of risks, Council Recommendations, European Commission Communications, EU Social partners agreements, and others The European Union sets legislation in the form of Directives, based on the legal foundation established in Article 153 of the Treaty on the Functioning of the European Union. EU legislature has established a system of basic principles of safety management, which must be transposed into national law by the Member States. Thus the principles are applicable in all establishments in the European Union Commission Directive (EU) 2017/1572 (for linguistic versions, click here) of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives. The Agency strongly encourages applicants and marketing authorisation holders to follow these guidelines A regulation is a binding legislative act. It must be applied in its entirety across the EU. For example, when the EU wanted to make sure that there are common safeguards on goods imported from outside the EU, the Council adopted a regulation. Directives. A directive is a legislative act that sets out a goal that all EU countries must achieve. However, it is up to the individual countries to devise their own laws on how to reach these goals. One example is th
, proprietary and confidentiality and on disclosure frequency; Implementing Technical Standards on disclosure and reporting of MREL and TLAC; Implementing Technical Standards on disclosure of indicators of global systemic importance by G-SII Browse through the current guidelines published on the website: Summary of The International Guidelines For Groin Hernia Management Guidelines on prevention and treatment of Parastomal Hernias 2019 Guidelines for primary ventral hernias We hope you enjoy reading Guidelines on soft tissues and visceral sarcomas, bone sarcomas and GIST developed in collaboration with the European Reference Networks Supportive and Palliative Care Supportive and palliative care are areas of high importance in oncology and ESMO published Clinical Practice Guidelines on the management of a variety of issue 2019 update of the European AIDS Clinical Society Guidelines for treatment of people living with HIV version 10.0. Ryom L, Cotter A, De Miguel R, Béguelin C, Podlekareva D, Arribas JR, Marzolini C, Mallon P, Rauch A, Kirk O, Molina JM, Guaraldi G, Winston A, Bhagani S, Cinque P, Kowalska JD, Collins S, Battegay M; EACS Governing Board. HIV Med. 2020 Sep 3. doi: 10.1111/hiv.12878. Online ahead.
the obligation under Directive 2010/75/EU (22) to use the best available techniques ('BAT') and ensure that emission levels of pollutants are not higher than they would be when applying BAT; for the cases where emission levels associated with the BAT have been defined in implementing acts adopted under Directive 2010/75/EU, those levels will be applicable for the purpose of these Guidelines; where those levels are expressed as a range, the limit where the BAT is first achieved will be. . The human-centric approach to AI strives to ensure that human values are central to the wa Guidelines for Examination - This area contains legal texts from the EPO, including the European Patent Convention, Ancillary regulations to the EPC, National law relating to the EPC, Guidelines for Examination, and much more EU GMP Annex 15: Qualification and Validation - ECA Academy. The following guideline can be ordered through the address listed in the Source/Publisher-category. In cases in which you can order through the Internet we have established a hyperlink
Interim guidance on the benefits of full vaccination against COVID-19 for transmission and implications for non-pharmaceutical interventions. Technical report - 21 Apr 2021. Publication. Reinfection with SARS-CoV-2: implementation of a surveillance case definition within the EU/EEA. Technical report - 8 Apr 2021 European Guidelines (4th Edition) In 2006 the European Commission, in cooperation with EUREF, EBCN and EUSOMA, published the 4th edition of the European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis. These guidelines aim to raise quality standards by bringing together at EU level the best examples from regional and national breast cancer screening programmes over. Re-open EU also provides information on the various restrictions in place, including on quarantine and testing requirements for travelers and mobile coronavirus contact tracing and warning apps. This should help you plan your travel in Europe, while staying safe and healthy. The European Union is making major efforts to overcome this pandemic. EU law and other public EU documents, authentic electronic Official Journal of the EU - in 24 languages. Direct access to the Official Journal of the EU; European Parliament. European Parliament register of documents; Agendas, minutes, reports of proceedings, legislative texts, resolutions, etc. European Council. European Council conclusion
The European Resuscitation Council Guidelines for Resuscitation provide specific instructions for how resuscitation should be practiced and take into account ease of teaching and learning, as well as the science. They were developed by Europeans and have been specifically written with European practice in mind. 2021 Guidelines . Download the full PDF version as they are published in. European Standards. A standard (French: norme, German: Norm) is a document that provides rules, guidelines or characteristics for activities or their results, for common and repeated use. Standards are created by bringing together all interested parties including manufacturers, users, consumers and regulators of a particular material, product. ESGE guidelines represent a consensus of best practice based on the available evidence at the time of preparation. They may not apply in all situations and should be interpreted in the light of specific clinical situations and resource availability. Recently published ESGE Guidelines. Diagnosis and management of acute lower gastrointestinal bleeding: European Society of Gastrointestinal.
ESC-Guidelines. An dieser Stelle finden Sie Leitlinien der European Society of Cardiology (ESC), auf welche u.a. die Kommentare und Stellungnahmen der Deutschen Gesellschaft für Kardiologie - Herz- und Kreislaufforschung e.V. Bezug nehmen Benefits of ESAIC Guidelines Committee activities. To make available a European guideline to be used by individual ESAIC members and adopted, with any desired modifications, by national societies of anaesthesiology for their own national use, if they so wish. Harmonisation of clinical management of anaesthesiology, perioperative medicine and. European Thyroid Association Guidelines for Ultrasound Malignancy Risk Stratification of Thyroid Nodules in Adults: The EU-TIRADS Eur Thyroid J. 2017 Sep;6(5):225-237. doi: 10.1159/000478927. Epub 2017 Aug 8. Authors Gilles Russ 1. They are used by policy makers in the EU and its Member States to issue recommendations on nutrient intake to consumers. DRVs are also used as the basis for information on food labels and for establishing dietary guidelines. Such guidelines can help consumers make healthy dietary choices. DRVs are intended for healthy people. Those who suffer from diseases may have different needs. Health. PDF. ESVS / SVS / WFVS Global Vascular Guidelines : Management of Chronic Limb-Threatening Ischemia (June 2019) PDF. Position paper on Aortic Arch Surgery : ESVS/EACTS (February 2019) PDF. Management of Abdominal Aorto-iliac Artery Aneurysms (January 2019) PDF. Vascular Access: 2018 Clinical Practice Guidelines (June 2018) PDF
Guidance on safety data sheets Description: This guidance provides information on issues to consider when compiling a Safety Data Sheet (an SDS), details of the requirements for information to be included within each Section of an SDS - in particular detailing the changes arising from the different revisions of Annex II of REACH and transition periods for implementation of these changes In order to look for a study, click on Home & Search. Users are reminded that phase 1 trials, conducted solely in adults and which are not part of an agreed PIP, are not public in the EU CTR. Please refer to European Guidance 2008/C 168/02 Art. 3 para 2 European S3-Guidelines on the systemic treatment of psoriasis vulgaris. D Pathirana, AD Ormerod, P Saiag, C Smith, PI Spuls, A Nast, J Barker, JD Bos, G-R Burmester, S Chimenti, L Dubertret, B Eberlein, R Erdmann, J Ferguson, G Girolomoni, P Gisondi, A Giunta, C Griffiths, H Hönigsmann, M Hussain, R Jobling, S-L Karvonen, L Kemeny, I Kopp, C Leonardi, M Maccarone, A Menter, U Mrowietz, L.
CO EUR 5 CONCL 2 . COVER NOTE . From: General Secretariat of the Council To: Delegations Subject: Special meeting of the European Council (Art. 50) (29 April 2017) - Guidelines . Delegations will find attached the guidelines adopted by the European Council. 1. at the above meeting, following the United Kingdom's notification under Article 50 TEU. 1 Following the notification under Article 50. It has been drafted by 21 ECCO members from 13 European countries. Although this is the first ECCO consensus guideline that primarily addresses EIMs, it is partly derived from, updates, and replaces previous ECCO consensus advice on EIMs, contained within the consensus guidelines for Crohn's disease1 [CD] and ulcerative colitis2 [UC]
EDQM closure Monday 24 May 2021. Due to a public holiday in Alsace, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Monday 24 May 2021. Adoption of the revised General Notices chapter. At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of. Guidelines 01/2020 on processing personal data in the context of connected vehicles and mobility related application ESC Clinical Practice Guidelines aim to present all the relevant evidence to help physicians weigh the benefits and risks of a particular diagnostic or therapeutic procedure on Arterial Hypertension. They should be essential in everyday clinical decision making In 2008, the European Parliament was one of the first international organisations to adopt multilingual guidelines on gender-neutral language. I am pleased that, since then, many other institutions and organisations have adopted similar guidance. On the occasion of the 10 year anniversary of the guidelines, and in order to reflect linguistic and cultural developments, the High-Level Group on.
Europa Web Guide. The Europa Web Guide is the official rulebook for the European Commission's web presence, covering editorial, legal, technical, visual and contractual aspects. All European Commission web sites must observe the rules and guidelines it contains. Web practitioners are invited to observe its contents and keep abreast of updates Anhang 1 zum EU-GMP Leitfaden Entwurf 2020 GMP SUCHMASCHINE Suche im Bereich GMP Navigator Seminare/Webinare On-Demand Training Guidelines News & Presse Tagungsmappe European standards and guidelines for quality assurance in higher education 56 . Part 1: Standards and guidelines for internal quality assurance 57 . Part 2: Standards and guidelines for external quality assurance 67 . Part 3: Standards and guidelines for quality assurance agencies 73 . III. Annex : Summary list of standards 78 . 5 Standards und Leitlinien für die Qualitätssicherung im. The European Securities and Markets Authority (ESMA) has published its final Guidelines on Alternative Performance Measures (APMs) for listed issuers. An APM is a financial measure of historical or future financial performance, financial position, or cash flows, other than a financial measure defined or specified in the applicable financial.
ECCO Guidelines. The work on guidelines resulted in a number of consensus conferences requiring more dedicated organisational work in that area and more planning for the future. Since the initiation of the first project in 2006, the ECCO Guidelines have become standard references for IBD management in Europe and around the world Draft Ethics guidelines for trustworthy AI. This working document constitutes a draft of the AI Ethics Guidelines presented by the European Commission's High-Level Expert Group on Artificial Intelligence (AI HLEG). After its presentation on 18 December 2018, a consultation process was launched with the aim to collect feedback on the draft
2015 ESC Guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC) Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM Decision 2013/63/EU adopting guidelines for the implementation of specific conditions for health claims; Regulation 432/2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health; Regulation 1169/2011 on the provision of food information to consumers ; EU Register of Nutrition and. Guidelines - 23 March 2018 1. The European Council welcomes the agreement reached by the negotiators on parts of the legal text of the Withdrawal Agreement covering citizens' rights, the financial settlement, a number of other withdrawal issues and the transition. The European Council recalls that other issues still require agreement and negotiations can only progress as long as all. European guidelines on breast cancer screening and diagnosis. The recommendations included in the guidelines are developed starting from relevant healthcare questions that below are grouped into main topics. Each topic includes one or more recommendations presented in a question and answer format. Breast cancer screening . Breast cancer screening. Screening ages and frequencies.
ICH Official web site : ICH Hom Guidelines under Article 17 and 18(4) of Directive (EU) 2015/849 on simplified and enhanced customer due diligence and the factors credit and financial institutions should consider when assessing the ML/TF risk associated with individual business relationships and occasiona company or its agent in compliance with European legislation and guidelines in order to seek a marketing authorisation or any amendments thereof. An eCTDapplication may comprise a number of regulatory activities. In the EU an eCTD application may comprise several dosage forms and strengths, all under one invented product name. This is understood to be equivalent to a Global Marketing. The General Data Protection Regulation (EU) 2016/679 (GDPR) is a regulation in EU law on data protection and privacy in the European Union (EU) and the European Economic Area (EEA). It also addresses the transfer of personal data outside the EU and EEA areas. The GDPR's primary aim is to give individuals control over their personal data and to simplify the regulatory environment for.
European Union - Interinstitutional Style Guide - Uniform stylistic rules and conventions (publishing, copyright, manuscripts, proofreading, States/countries, languages, currencies, punctuation, upper case and lower case, abbreviations, acronyms The European Guidelines for Digital Youth Work have been designed to clearly define Digital Youth Work, its impact and the value of youth work as an important educational practice which can empower young people in a digitalising society. The guidelines give practical and ethical guidance to youth workers, managers and organisations. They also include a [
Effa guidance document on the ec regulation on flavourings updated july 2019. 1.93 MB. Attachment ix commission guidance notes on the classification of a flavouring substance with modifying properties and a flavour enhancer. 0.06 MB. Effa guidance document attachment x on flavourings with modifying properties fmps. 0.05 MB Guidelines. Since the data protection implications of some functions common to all EU institutions, bodies and agencies are similar, we publish guidelines on specific subjects, such as recruitment, appraisals, use of IT equipment in the workplace and disciplinary procedures. These consolidate our guidance from our prior check Opinions. European guidelines for validating non-formal and informal learning. COVID-19 and hard copy dissemination - Due to the pandemic, Cedefop has decided to suspend distribution of all hard copy publications and flyers for as long as special measures are enforced by Member States. We encourage you to visit our website, where all published titles are. We report the fourth update of European Guidelines for the Management of RDS by a European panel of experienced neonatologists and an expert perinatal obstetrician based on available literature up to the end of 2018. Optimising outcome for babies with RDS includes prediction of risk of preterm delivery, need for appropriate maternal transfer to a perinatal centre and timely use of antenatal. The European legislator established therefore a classification concept which is essentially based on potential hazards related to the use and possible failure of devices taking account of technology used and of health policy considerations. This approach in turn allows the use of a small set of criteria that can be combined in various ways: duration of contact with the body, degree of.
EUIPO is the European Union Intellectual Property Office responsible for managing the EU trade mark and the registered Community design. We also work with the IP offices of the EU Member States and international partners to offer a similar registration experience for trade marks and designs across Europe and the world Providing the community with up-to-date guidelines is one of the core activities of the EANM under the lead of its Committees. Browse this section for the most recent EANM-led and EANM-endorsed publications. Questions or comments related to the EANM guidelines are welcome any time via email@example.com The European AI Alliance is an online forum with over 4000 members representing academia, business and industry, civil society, EU citizens and policymakers. The members of the AI Alliance offered detailed feedback for the Ethics Guidelines for Trustworthy AI. Moreover, a set of materials such as policy documents, academic papers and discussions published on the forum, helped define the other.
About our Guidelines. The European Society of Endocrinology is a focal point for endocrinology and hormone research in Europe. We collaborate with national and specialty societies, and champion endocrinology at a pan-European level. The Society will also consider endorsement requests for other organisations guidelines. Read more. European Society of Endocrinology Clinical Practice Guideline. Welcome to the European Commission's Health Promotion and Disease Prevention Knowledge Gateway a reference point for public health policy makers. You will find reliable, independent and up-to date information on topics related to the promotion of health and the prevention of non-communicable diseases.; It provides short, impactful and concise briefs for each topic, focusing on the aspects most. EU Regulation . View publications . Guidelines . View publications . Policy Positions Cosmetic Product Claims & Advertising: Compendium of applicable legislation, self-regulation, best practices and guidance Download Read online. July 02, 2020; CE Statistics 2019 Public price 25,00€ Member price FREE; Order. June 10, 2020; Cosmetics Europe Activity Report 2019 Download Read online. Stay.
Welcome to gdpr-info.eu. Here you can find the official PDF of the Regulation (EU) 2016/679 (General Data Protection Regulation) in the current version of the OJ L 119, 04.05.2016; cor. OJ L 127, 23.5.2018 as a neatly arranged website. All Articles of the GDPR are linked with suitable recitals. The European Data Protection Regulation is applicable as of May 25th, 2018 in all member states to. The official website of the European Patent Office (EPO). Find information on applying and searching for patents, legal issues on patents, patent grants, rules and regulations about European and international patent applications. Explore engineering careers and apply for jobs in engineering
The EU Harmonised technical eCTD guidance version 4.0 ; eCTD validation criteria v7.1 and Release notes - 02.03.2018. Entered into force on 1st of September 2018. Variations in eCTD format Q&A document covering practical issues for variations in eCTD format; Validation criteria Q&A 06.04.2017 ; The CMDh Best Practise Guide for use of eCTD in MRP/DCP (April 2020) Updated; Q&A on how to handle. European emission standards are vehicle emission standards for exhaust emissions of new vehicles sold in the European Union and EEA member states. The standards are defined in a series of European Union directives staging the progressive introduction of increasingly stringent standards. Details of Euro 7, the final standard, will be announced in 2021 and probably come into force in 2025. Rechtswirkung. Im Gegensatz zu EU-Verordnungen sind EU-Richtlinien nicht unmittelbar wirksam und verbindlich, sondern sie müssen durch nationale Rechtsakte umgesetzt werden, um wirksam zu werden. Es bleibt den einzelnen Mitgliedstaaten überlassen, wie sie die Richtlinien umsetzen. Sie haben also bei der Umsetzung der Richtlinie einen gewissen Spielraum
It should include guidance about email security, passwords, two-factor authentication, device encryption, A list of many of the EU member states supervisory authorities can be found here. The GDPR does not specify whom you should notify if you are not an EU-based organization. For those in English-speaking non-EU countries, you may find it easiest to notify the Office of the Data. Introduction to European Braille Guidance Royal National Institute of Blind People (RNIB) and the European Blind Union (EBU), who previously hosted this information, have helped us develop the European Braille Guidance area of our website to continue to provide access to the EBU recommended Braille code and practical guidance for implementing Pharmaceutical Braille in Europe Guidance; About Us; News. 2020 enforcement data reveals increasing number of hand sanitiser imports violating EU chemical safety laws. 09/06/2021. Brussels, 9 June 2021 - According to Cefic's analysis of data reported through the EU's 'Safety Gate', 2020 saw a steep increase in hand sanitiser imports not compliant with the EU chemicals safety rules. These products are either not. The European Hematology Association promotes excellence in patient care, research, and education in hematology. We serve medical professionals, researchers, and scientists with an active interest in hematology. We are proud to be the largest European-based organization connecting hematologists worldwide to support career development and. This clinical guideline provides recommendations on the diagnostic approach for endometriosis, including the symptoms predictive of endometriosis, the utility of medical technologies and of clinical examination for diagnosis. Treatments for endometriosis, as medical treatment, non-pharmacological treatment as well as surgery, are discussed for both relief of painful symptoms and for. When processing personal data, EU institutions and bodies (EUIs) must comply with specific data protection rules. Depending on their role, their obligations differ. The following guidelines provide explanation and practical advice to EU institutions and bodies on how to comply with Regulation (EU) 2018/1725 ('the Regulation')