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 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 (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 směrnice 2001/83/ES (nebo právních předpisů, které tyto nahrazují);2 „Zařízení“ znamená všechna zařízení využívaná při Výrobě Přípravku, který má být dodán podle této Smlouvy o dodávkách;
Sample 1
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;
Sample 1Sample 2
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);
Sample 1Sample 2

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
Sample 1

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.

  • EU Data Protection Law means (i) prior to 25 May 2018, Directive 95/46/EC of the European Parliament and of the Council on the protection of individuals with regard to the processing of Personal Data and on the free movement of such data ("Directive") and on and after 25 May 2018, Regulation 2016/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of Personal Data and on the free movement of such data (General Data Protection Regulation) ("GDPR"); and (ii) Directive 2002/58/EC concerning the processing of Personal Data and the protection of privacy in the electronic communications sector and applicable national implementations of it (as may be amended, superseded or replaced).

  • Controlled Substances Act means the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), as amended from time to time, and any successor statute.

  • Emergency Action means any emergency action for locational or system-wide capacity shortages that either utilizes pre-emergency mandatory load management reductions or other emergency capacity, or initiates a more severe action including, but not limited to, a Voltage Reduction Warning, Voltage Reduction Action, Manual Load Dump Warning, or Manual Load Dump Action.