Emergency Use Authorisation definition

Emergency Use Authorisation means a risk-based procedure developed by a Stringent Regulatory Authority to approve the use of a vaccine under development for use during a public health emergency;
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Emergency Use Authorisation means any emergency use approval issued pursuant to Regulation 174 of the Human Medicines Regulations 2012 (or any replacement or superseding legislation);
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Emergency Use Authorisation means any emergency use approval issued pursuant to legislation implementing Article 5(2) of Directive 2001/83/EC in the Territory (or any replacement or superseding legislation);1 “Facilities” means each and all of the facilities used in respect of the Manufacturing of the Product to be supplied pursuant to this Supply Agreement; klinické a regulační činnosti týkající se Přípravku (včetně podávání dokumentace k příslušným Regulačním orgánům na podporu těchto předklinických a klinických činností a za účelem získání Regulačního schválení), včetně provádění klinických studií nezbytných pro stanovení úhrady a včetně klinických zkoušek poté, co Přípravek obdrží Regulační schválení, za účelem (a) zachování platnosti stávajícího Regulačního schválení; nebo (b) přeměny podmíněného schválení (např. schválení Evropskou komisí podle čl. 14a nařízení (ES) č. 726/2004, které umožňuje uvedení Přípravku na trh na daném Území) na nepodmíněné Regulační schválení, je-li to nezbytné; „Strana zpřístupňující informace“ má význam uvedený v odst. 15.1.2; „Dokumentace“ má význam uvedený v odst. 5.5; „Darovat“ má význam uvedený v odst. 0; „Dávka“ znamená tři sta (300) miligramů podaných ve formě směsi dvou druhů dlouhodobě působících protilátek (LAAB), tixagevimabu (AZD8895) a cilgavimabu (AZD1061), každý po sto padesáti (150) miligramech. „Datum účinnosti“ znamená datum, k němuž je tato Smlouva o dodávkách podepsána oběma Smluvními stranami; „EMA“ znamená Evropskou agenturu pro léčivé přípravky; „Dodávka na základě schválení pro podmínečné použití“ znamená jakoukoli dodávku Přípravku podle této Smlouvy o dodávkách na základě Schválení pro podmínečné použití; „Schválení pro podmínečné použití“ znamená schválení pro podmínečné použití vydané podle právních předpisů, jimiž se na Území provádí čl. 5 odst. 2
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Examples of Emergency Use Authorisation in a sentence

  • On 12 June 2020, TBG Taiwan has received an Emergency Use Authorisation (EUA) from the United States Food and Drug Administration (FDA) for its ExProbeTM SARS-CoV-2 Testing Kit.

  • TBG Taiwan has received US FDA Emergency Use Authorisation (EUA) for its COVID-19 nucleic acid test kits.

  • The proposed development would not raise other material concerns regarding residential amenity.• Section 16.28 of the development relates to new off licences and so is not applicable in this instance.

  • Strategic risk is the risk of losses as a result of strategic/management decisions or business choices.

  • On 29 July 2020, TBG Taiwan received an Emergency Use Authorisation (EUA) from the Taiwan Ministry of Health and Welfare (“MOHW”) for its ExProbeTM SARS-CoV-2 Testing Kit.

  • The first three COVID-19 vaccines to receive Emergency Use Authorisation (EUA) from the United States Food and Drug Administration (US FDA), thePfizer-BioNTech® COVID-19 vaccine (BNT162b2), the Moderna® COVID-19 vaccine (mRNA-1273) and the Johnson & Johnson® vaccine (JNJ-78436735), reported good vaccine efficacy at 95%, 94.1% and 66.9%, respectively.4-6 However, patients on immunosuppressive therapy were excluded from all three trials.

  • EUA Hydroxychloroquine sulfate Health Care Provider Fact Sheet - Emergency Use Authorisation (EUA).

  • As such the following milestones have been set for FY2021: • US FDA Emergency Use Authorisation (EUA) for the EasyScreen™ SARS-CoV-2 Detection Kit• First North American contracts• FDA submission for the EasyScreen™ Enteric Protozoan Detection Kit• CE-IVD and TGA registration for EasyScreen™ STI / Genital Pathogen Detection Kits• CE-IVD and TGA registration for EasyScreen™ Flavivirus / Alphavirus Detection Kits• Commence development of new instrumentation.

  • Two vaccines have been approved for Emergency Use Authorisation by the DCGI.

  • All outreach information was made available online and in both English and Spanish.


More Definitions of Emergency Use Authorisation

Emergency Use Authorisation means any emergency use approval issued pursuant to Regulation 174 of the Human Medicines Regulations 2012 (or any replacement or superseding legislation); "Facilities" means each and all of the facilities used in respect of the Manufacturing of the Product, including those identified in Schedule 2; "Field" means the vaccination against SARS-CoV-2; "Force Majeure" means any events beyond a Party's reasonable control, subject to that Party having taken all reasonable steps (both anticipatory and reactionary) to avoid or mitigate such risks, such as labour disturbances or labour disputes of any kind, accidents, failure of any governmental approval required for full performance, civil disorders or commotions, war, acts of terrorism, acts of God, pandemics other than the SARS-CoV- 2 Pandemic, energy or other conservation measures, explosions, failure of utilities, mechanical breakdowns, material shortages, default of suppliers or subcontractors, theft, or other occurrences. For the avoidance of doubt, (i) the withdrawal of the UK from the European Union and any related circumstances, events, changes or requirements; and (ii) the pandemic declared in respect of SARS-CoV-2; shall not be deemed an event of Force Majeure (the "SARS-CoV-2 Pandemic"); "Fraud" any offence under Applicable Laws creating offences in respect of fraudulent acts, including any fraudulent acts in relation to this Agreement, or defrauding, attempting to defraud or conspiring to defraud the Crown; "Fujifilm" means Fujifilm Diosynth Biotechnologies UK Limited having its facilities at Billingham, Teesside, UK; "Funding Entity(ies)" means each of (i) The Coalition for Epidemic Preparedness Innovations and (ii) the U.S. Government; "GDPR" means the General Data Protection Regulation (Regulation (EU) 2016/679); "General Anti-Abuse Rule" means: (i) the legislation in Part 5 of the Finance Xxx 0000; and (ii) any future legislation introduced into Parliament to counteract tax advantages arising from abusive arrangements to avoid national insurance contributions; "Governmental Authority" means any government, supra-national, regional, regulatory or administrative body, authority, board, commission or agency, including any corresponding foreign agency or any instrumentality or officer acting in an official capacity of any of the foregoing, including any court, tribunal or judicial or arbitral body, or any committee exercising any executive, legislative, regulatory or administrative functions of govern...
Sample 1
Emergency Use Authorisation means any emergency use approval issued pursuant to legislation implementing Article 5(2) of Directive 2001/83/EC in the Territory (or any replacement or superseding legislation);1
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Related to Emergency Use Authorisation

  • Authorisation means an authorisation, consent, approval, resolution, licence, exemption, filing, notarisation or registration.

  • Marketing Authorisation means any approval (including all applicable pricing and governmental reimbursement approvals) required from the FDA or relevant Competent Authority to market and sell a Product in a particular country.

  • Client Money Rules means the rules specified in paragraph 18(2)(j) of the Law which provides for the Provision of Investment Services, the Exercise of Investment Activities, the Operation of Regulated Markets and other related matters and the Directives and Circulars issued pursuant to this paragraph, as amended from time to time by CYSEC.

  • European Data Protection Laws means the EU General Data Protection Regulation 2016/679 (“GDPR”) and data protection laws of the European Economic Area (“EEA”) and their member states and the FADP.

  • EU Data Protection Laws means EU Directive 95/46/EC, as transposed into domestic legislation of each Member State and as amended, replaced or superseded from time to time, including by the GDPR and laws implementing or supplementing the GDPR;

  • Clean air standards, as used in this clause, means:

  • Emergency work means any urgent measures which in the opinion of the Engineer-in-Charge become necessary during the progress of the work to obviate any risk of accident or failure or which become necessary for security.