Germany Regulatory Health Authority

Listing Websites about Germany Regulatory Health Authority

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BfArM - Homepage

(9 days ago) WebEurope and International. The BfArM is the largest drug approval authority in Europe. Experts contribute their knowledge to the scientific committees of the European Medicines Agency ( EMA ), among others. Throughout the EU and internationally, BfArM makes a significant contribution to the supply of safe and effective medicines. Read more.

https://www.bfarm.de/EN/Home/_node.html

Category:  Medicine Show Health

Homepage [www.zlg.de]

(2 days ago) WebCentral Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices. Bodies. Notified Bodies. Contact. Do you have questions? Heinrich-Böll-Ring 10 · 53119 Bonn · Germany · Tel.: +49 228 97794-0 · Fax: +49 228 97794-44 · zlg(at)zlg.nrw.de

https://www.zlg.de/en/

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Federal Institute for Drugs and Medical Devices (BfArM)

(7 days ago) WebThe Federal Institute for Drugs and Medical Devices is an independent specialised federal higher authority within the portfolio of the Federal Ministry of Health. Roughly 1,000 employees – including physicians, pharmacists, chemists, biologists, lawyers, engineers, technical assistants and administrative staff – work at the Federal

https://www.bundesgesundheitsministerium.de/en/en/ministry/authorities-within-the-remit/federal-institute-for-drugs-and-medical-devices-b

Category:  Medical Show Health

Homepage European Medicines Agency

(7 days ago) WebOnline. European Medicines Agency, Amsterdam, the Netherlands. Live broadcast. Start date: 30 May 2024, 09:00 (CEST) End date: 30 May 2024, 16:30 (CEST) 03 Jun 2024.

https://www.ema.europa.eu/en/homepage

Category:  Medicine Show Health

Federal Ministry of Health

(7 days ago) WebIn a Joint Declaration of Intent, Germany and Ukraine have agreed to strengthen their cooperation in the field of healthcare and public health. If we achieve a breakthrough in digitalisation, it will change practical …

https://www.bundesgesundheitsministerium.de/en/index.html

Category:  Health Show Health

The Federal Ministry of Health BMG

(7 days ago) WebThe Federal Ministry of Health is responsible for a variety of policy areas, whereby its activities focus predominantly on the drafting of bills, ordinances and administrative regulations. Moreover, by means of prevention campaigns, the Federal Ministry of Health seeks to improve the population's health. All in all, the sphere of …

https://www.bundesgesundheitsministerium.de/en/ministry/the-federal-ministry-of-health/

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Regulation - Paul-Ehrlich-Institut - PEI

(3 days ago) WebRegulation. Regulation. Navigation. Advice; Clinical Trials; Marketing Authorisation (Human) Marketing Authorisation (Veterinary) Approvals; The Paul-Ehrlich-Institut is an Agency of the German Federal Ministry of Health. Its research and control activities promote the quality, efficacy and safety of biological medicinal products.

https://www.pei.de/EN/regulation/regulation-node.html

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CoR - Germany Public health - europa.eu

(6 days ago) WebSets the general framework for the organisation and performance of the health sector. Concurrent legislative power for measures to combat human and animal diseases which pose a danger to the public, pharmacies, medicines, medical products, drugs, narcotics and poisons (Article 74 BL) Health education and information fulfilled by the federal

https://portal.cor.europa.eu/divisionpowers/Pages/Germany-Public-health.aspx

Category:  Medical,  Medicine Show Health

Digital Health Laws and Regulations Germany 2024

(5 days ago) Web2.1 What are the core healthcare regulatory schemes related to digital health in your jurisdiction? Digital health products, including medical apps, often qualify as medical devices or in vitro diagnostics and, therefore, fall within the scope of the MDR and Regulation (EU) 2017/746 on in vitro diagnostics (“IVDR”). As EU regulations, the MDR …

https://iclg.com/practice-areas/digital-health-laws-and-regulations/germany

Category:  Medical Show Health

Medical Device Regulations in Germany - Operon Strategist

(7 days ago) WebThe regulatory authority responsible for medical device oversight in Germany is The Federal Institute for Drugs and Medical Devices (in German: Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM). The German Institute of Medical Documentation and Information (DIMDI), an authority within the German Federal …

https://operonstrategist.com/medical-device-regulations-in-germany/

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Healthcare regulations in Germany: What to expect - Infopulse SCM

(9 days ago) WebLearn about the BSI Act, PDSG, SGB V, and many others to know what the healthcare sector should expect in 2022. The healthcare sector in Germany has been facing regulatory strengthening since the pandemic, and authorities are pushing to ensure that all assets are maximum secured. Critical infrastructures are susceptible to malicious

https://compliance-aspekte.de/en/blog/healthcare-regulations-germany/

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Current legislation – The German Patient Data Protection Act (PDSG)

(Just Now) WebThe focus was on the organization of the digitalization of medical and nursing care in Germany. On 3 July 2020, the Bundestag adopted the Federal Government's draft of the Patient Data Protection Act (PDSG) in its third reading. After the Bundesrat had also approved the law on 18 September 2020, it is to enter into force shortly.

https://www.goerg.de/en/insights/publications/21-09-2020/current-legislation-the-german-patient-data-protection-act-pdsg

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Regulatory Services in Germany - Freyr Solutions

(1 days ago) WebKeeping abreast with region-specific legislation and Regulatory guidelines. Freyr provides market assessment, dossier preparation & submission, product registration & license management services in Germany as per BfArM for Pharmaceuticals /medicinal products, Medical Devices, Cosmetics, Healthcare & Biologics companies.

https://www.freyrsolutions.com/regulatory-services-in-germany

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Germany - Arazy Group

(3 days ago) WebREGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Germany, devices are regulated by the The Federal Institute for Drugs and Medical Devices (BfArM) and The German Institute of Medical Documentation and Information (DIMDI), an authority within the German Federal Ministry of Health. …

https://arazygroup.com/ivd-medical-device-registration-germany/

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BfArM - Medical devices

(Just Now) WebThe tasks of BfArM in the field of medical devices result in particular from the Medical Device Regulation ( MDR) ( EU) 2017/745, the Medical Device Law Implementation Act, the “Medizinprodukterecht-Durchführungsgesetz” ( MPDG ), the Medical Devices Act “Medizinproduktegesetz” ( MPG) and the further implementing legal …

https://www.bfarm.de/EN/Medical-devices/_node.html

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Four arrested in sprawling European sting on malware network

(5 days ago) WebGreece's data protection authority has fined the interior ministry 400,000 euros ($434,880) for leaking the email addresses of thousands of expatriate voters in June 2023. May 28, 2024

https://www.reuters.com/technology/cybersecurity/four-arrested-sprawling-european-sting-malware-network-2024-05-30/

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BfArM - Medicinal products information

(7 days ago) WebThe BfArM provides information on medicinal products for healthcare professionals and consumers. The Public Assessement Reports state the background for scientific evaluations, discussions, and decisions regarding a medicinal product. Product informations containing Package Leaflet and Summary of Product Characteristics which ensure …

https://www.bfarm.de/EN/Medicinal-products/Information-on-medicinal-products/_node.html

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Defense Federal Acquisition Regulation Supplement: Procurement

(Just Now) WebExecutive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).

https://www.federalregister.gov/documents/2024/05/30/2024-11518/defense-federal-acquisition-regulation-supplement-procurement-technical-assistance-program-dfars

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BfArM - Clinical trials

(9 days ago) WebClinical Trials Information System - CTIS Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC will alter many aspects of the authorisation procedure of clinical trials on medicinal products.With the entry into force of the EU …

https://www.bfarm.de/EN/Medicinal-products/Clinical-trials/_node.html

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