If the research is also being carried out in other countries of the European Union, an overview of competent authorities to which the protocol has been submitted must be included. Competent Authority Arrangements. Home > List of designated competent authorities under Securitisation Regulation. NSAI provide information and advice, free of charge, to economic operators. An Authorized Representative is the main contact for the European Commission and the National Competent Authorities. Assist the European Commission in monitoring correct application of common aviation safety requirements by EU Member States Cooperate with foreign civil aviation authorities, and regional and international organisations alike, in order to enhance aviation safety in Europe and worldwide. Coronavirus/ COVID-19 Medical devices that are already registered inside the EEA through a European authorized representative do not need an additional registration at MPI and can be sold in Germany! 245 / 274 Fax: (599-717) 2824 Email: [email protected] 2. The competent authorities responsible for the online procedures referred to in paragraph 1 shall, upon an explicit, freely given, specific, informed and unambiguous request of the user concerned, request evidence directly from competent authorities issuing evidence in other Member States through the technical system. (4) If a competent authority removes an ADR entity from the list under paragraph (3) it must, without undue delay, send the revised list to the single point of contact. The European medicines regulatory system is based on a network of regulatory authorities (national competent authorities (NCA)) from the 28 European Union member states, Iceland, Norway and Liechtenstein, the European Commission and the European Medicines Agency (EMA). National Competent Authorities Clinical Trial Contacts Doc id: EMA/438927/ 2008 . For products in transit through the European Union: the name and address are compulsory. EMA is responsible for maintaining a rapid alert list of contact points, which includes national competent authorities in EEA Member States, the European Commission and international partner regulatory authorities and organisations. The List is kept updated on ongoing basis. 19. List of civil aviation authorities A competent authority is a term used in tax treaties to identify the position, person, or body to whom issues can be addressed to ensure a good faith application of a double taxation banks and competent authorities. These operators may also have to comply with rules of the third-country State of Registry (SoR) if this State has not delegated its responsibilities to the European State of the Operator. Authorised Representatives, Importers and Distributors. The more coherent the common approach to the GDPR in various European central banks and competent authorities is, the better their common understanding of and compliance The authorities have communicated that they are working together on different levels (national, European) in order to achieve a Union-wide harmonised implementation of the Commission Notice 2021/C 8/01. 9 See, e.g., Article 6(6) and (7) of SSMR. ICC is the only sailing license approved by United Nations as a legitimate recreational sailing license. List of civil aviation authorities Shipments of “green-listed” non-hazardous wastes within the EU and OECD do not usually require the prior consent of the authorities, but information requirements apply. The competent authorities responsible for the online procedures referred to in paragraph 1 shall, upon an explicit, freely given, specific, informed and unambiguous request of the user concerned, request evidence directly from competent authorities issuing evidence in other Member States through the technical system. 5.1. The European Medical Devices Directive (93/42/EEC) and In-Vitro Diagnostic Devices Directive (98/79/EC) state that medical device manufacturers are legally required to report adverse incidents and Field Safety Corrective Actions (FSCAs) to EU Competent Authorities. As of 21 March 2010, a SingleEEA/EU/EC European Authorised/Authorized Representativemust be designated by a non-EEA manufacturer of medical devices as required by directive 2007/47/EC, are you ready? After the PIP affair involving fraudulent use of non-medical grade silicone breast implants, the European Commission and the EU member States adopted a Joint Plan for Immediate Action under existing Medical Devices Legislation (the so-called “PIP Action Plan”). Macroprudential authority established in accordance with Recommendation ESRB/2011/3. t+43(0)505 4350555- ilon reischl@ e 55-36820 36820 36809 BE +www.afmps.be +3225248 3225248+ greet .musch@fagg be 065 065 065 Tel. In order to qualify for the application of European directive 2013/55/UE, you must meet the following conditions: You gained your qualification in an EEA country. ICC is the only sailing license approved by United Nations as a legitimate recreational sailing license. Implementation of Competent Authority Options and Discretions in the CRD Regulations and CRR 2 List of Abbreviations CP CRD IV Consultation Paper Capital Requirements Directive IV (Directive 2013/36/EU) CRR Capital Requirements Regulation (Regulation (EU) No 575/2013) EBA ECB European Banking Authority European Central Bank EUROPEAN COMMISSION DG Internal Market, Industry, Entrepreneurship and SMEs Consumer, Environmental and Health Technologies Health technology and Cosmetics GUIDELINES ON MEDICAL DEVICES GUIDELINES FOR COMPETENT AUTHORITIES FOR MAKING A VALIDATION/ASSESSMENT OF A CLINICAL INVESTIGATION APPLICATION UNDER DIRECTIVES 93/42/EEC and 90/385/EEC List of competent authorities: EMIR: List of competent authorities: Central Securities Depositories Regulation (CSDR) List of competent authorities: Securitisation Regulation: List of competent authorities: Short selling Regulation (SSR) List of competent authorities: Benchmarks Regulation: List of competent authorities: CRD: List of competent authorities: UCITS Directive The list of participants is provided in Appendix I. This is the process set out in Art 16(2) of the SSR. 4.5. A competent authority must make the consolidated list of ADR entities published by the European Commission— Introduction The purpose of this section is to provide an overview of the role of the competent authority. 10 Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in An International Certificate of Competence (ICC) is a certificate, which may be issued to anyone who has successfully completed certain national boating licenses or has passed an examination to prove the necessary competence for pleasure craft operation. However, if errors are brought to its attention, the Commission undertakes to correct them, if deemed appropriate. Medical Devices. Additionally, a copy of the decision made by foreign MRECs and/or competent authorities must be included, if available. This directory lists the competent national authorities empowered to issue certificates and authorizations for the import and export of narcotic drugs and psychotropic substances, and to regulate or enforce national controls over precursors and essential chemicals. Competent authorities in non-EU/EEA countries. An International Certificate of Competence (ICC) is a certificate, which may be issued to anyone who has successfully completed certain national boating licenses or has passed an examination to prove the necessary competence for pleasure craft operation. List of competent authorities, helpdesks and stakeholders for the implementation of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products HEALTH AND FOOD SAFETY DIRECTORATE GENERAL Food and feed safety, innovation Pesticides and Biocides EUROPEAN COMMISSION The new Regulations also include a broader set of legal mechanisms available to Competent Authorities and the European Commission to act against issues and non-compliances detected on the marketplace. Aug 29, 2002. Founded in 1995, MDSS pioneered European Representation, and is well known and respected with the Competent Authorities. “No more” the EU has said, also in the scope of its single market: we put a consistency mechanism in place and that de facto has an impact on, among others, the role and rules with regards to the data protection authorities and the List of the competent authorities in Member States MEMBER STATES COMPETENT AUTHORITIES CONTACT Kingdom of Denmark Danish Business Authority Helene Bille Albrechtsen +45 35291335 helalb@erst.dk Republic of Estonia Estonian Tax and Customs Board (Eesti Maksu- ja Tolliamet, EMTA) E-mail: emta@emta.ee Address: Lõõtsa 8a, 15176 Tallinn, Estonia The rules on animal transport are not the same in every country, and this makes it important for you to check what rules apply in the country you are going to. DECISION OF THE EUROPEAN BANKING AUTHORITY ON REPORTING BY COMPETENT AUTHORITIES TO THE EBA . banks and competent authorities. On this page you will find links to most authorities responsible for animal transport in European … 3. Association of German Chambers of Commerce and Industry. Countries, eligible to designate organisations for the List, are the EU Members States, Iceland and Norway. European EC Authorized Representative for CE Marking. The applicant may designate a country to act as the Reference Member State (RMS). Register/Notifyyour MD-Medical Devices & IVD-In Vitro Diagnostic Medical Devices with MHRA& other EEA (EU/EFTA) authorities by … EUROPEAN COMMISSION DIRECTORATE-GENERAL CLIMATE ACTION Directorate A – International and Mainstreaming CLIMA.A.2- Climate Finance, Mainstreaming, Montreal Protocol Competent Authorities in Member States Contact points for issues related to F-Gases in Member States Version October 2018 AUSTRIA Mr Paul KRAJNIK Ministry of the Agriculture, Forestry On 17 February 2014 EIOPA published an ERRATA and an Explanatory text to the ERRATA on Guidelines on Submission of Information to National Competent Authorities. Overview list of competent authorities. Competent Authorities are required to maintain a list of OES for their sector or region, and liaise with Competent Authorities covering the same sector in devolved administrations, so that the UK can fulfil its national reporting obligations. Financial Markets Authority.
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