Emergency Use Authorisation definition

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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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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Examples of Emergency Use Authorisation in a sentence

  • Use Authorisation for the Vaccine, but the Vaccine has not yet been granted Regulatory Approval, Novavax shall meet any requirements attached to the Emergency Use Authorisation.

  • Emergency Use Authorisation A process by which a Stringent Regulatory Authority approves the use of a vaccine under development for use during a public health emergency.

  • However, securing an Emergency Use Authorisation shall not relieve Novavax from the ongoing obligation to secure a Marketing Authorisation in the Territory for the Product with the indication in the Field.

  • Developing the Product 4.1 Novavax shall use Commercially Reasonable Efforts to Develop the Candidate in order to secure a Marketing Authorisation (and, if applicable, an Emergency Use Authorisation) in the Territory for the Product with the indication in the Field in accordance with the Development and Manufacturing Plan, Applicable Law and Applicable Standards.

  • Notwithstanding the foregoing, the Parties recognise that events have progressed, in particular, the development of the Original Vaccine has been successful and an Emergency Use Authorisation from the MHRA under Regulation 174 of the Human Medicines Regulations 2012 has been obtained.

  • The Parties acknowledge and agree that Valneva or the Authority may (but shall be under no obligation to), subject to JSC approval, apply for an Emergency Use Authorisation for the Product with the Licensing Authority for the Territory for use within the Field.


More Definitions of Emergency Use Authorisation

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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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 ▇▇▇ ▇▇▇▇; 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...
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Related to Emergency Use Authorisation

  • Safety Authorisation and “deemed Safety Authorisation” have the meanings given to “safety authorisation” and “deemed safety authorisation” by the Railways and Other Guided Transport Systems (Safety) Regulations 2006;

  • Required Authorisation means any authorisation, consent, declaration, licence, permit, exemption, approval or other document, whether imposed by or arising in connection with any law, regulation, custom, contract, security or otherwise howsoever which must be obtained at any time from any person, Government Entity, central bank or other self-regulating or supra-national authority in order to enable the Borrowers lawfully to borrow the loan or draw any Advance and/or to enable any Security Party lawfully and continuously to continue its corporate existence and/or perform all its obligations whatsoever whensoever arising and/or grant security under the relevant Security Documents and/or to ensure the continuous validity and enforceability thereof;

  • Authorisations means any consent, registration, filing, notarisation, licence, approval, permit, authority or exemption from, by or with any Governmental Authority and all corporate, creditors’, shareholders’ and third-party approvals or consents;

  • 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.