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;
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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

  • 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.

  • 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.

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

  • Recently, the DCGI had granted Emergency Use Authorisation (EUA) to the foreign Covid-19 vaccine man-ufacturer.Similarly, Zydus Cadila’s DNA vaccine may get the approval from the drug regu- lator soon.

  • Abbbott has received USFDA Emergency Use Authorization to launch 5-min COVID-19 testAbbott on last Saturday announced it has received the United States Food and Drug Administration's Emergency Use Authorisation (EUA) for its rapid, portable, point-of-care molecular test for the detection of novel coronavirus (COVID-19).

  • On 2 September 2020, the Company’s wholly owned subsidiary, TBG Taiwan has received an Emergency Use Authorisation (EUA) from the United States Food and Drug Administration (FDA) for its TBG SARS-CoV-2IgG / IgM Rapid Test Kit.

  • In the coming weeks, the Company will submit to the US FDA a regulatory submission for Emergency Use Authorisation, incorporating data from both the US and non-US Phase III clinical trial programme and emerging real-world data.

  • As previously announced, Dotz has applied for a US FDA Emergency Use Authorisation for its Dotz Test Kits, following a successful blind clinical trial of the nasopharyngeal swab Dotz Test Kits on 73 subjects in the US1.

  • The investigational anti-spike neutralising monoclonal antibody (mAb) therapy Bamlanivimab (LY-CoV555) has been granted Emergency Use Authorisation (EUA) by the FDA on November 202054 for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.

  • Presumably this question has been prompted by misinformation about the Centers for Disease Control’s (CDC) decision to withdraw the FDA Emergency Use Authorisation for a PCR test it developed early in the pandemic.


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 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...
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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, with respect to a country, region or other jurisdiction in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations, or authorisations of any Regulatory Authority necessary to commercially distribute, sell, or market Product in such country or other jurisdiction, including, where applicable, (a) pre- and post-approval regulatory approvals (including any prerequisite manufacturing approval or authorisation related thereto), and (b) approval of Product labelling.

  • Service Authorization means that Open Ecosystem Partner needs to meet specific qualification requirements for the products included in a “Service” Product Family that Open Ecosystem Partner wants to promote and offer Services for as set out in detail in the Open Ecosystem Program Guide.

  • Environmental, Health or Safety Requirements of Law means all Requirements of Law derived from or relating to foreign, federal, state and local laws or regulations relating to or addressing pollution or protection of the environment, or protection of worker health or safety, including, but not limited to, the Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. § 9601 et seq., the Occupational Safety and Health Act of 1970, 29 U.S.C. § 651 et seq., and the Resource Conservation and Recovery Act of 1976, 42 U.S.C. § 6901 et seq., in each case including any amendments thereto, any successor statutes, and any regulations or guidance promulgated thereunder, and any state or local equivalent thereof.

  • Federal work authorization program means any of the electronic verification of work authorization programs operated by the United States Department of Homeland Security or any equivalent federal work authorization program operated by the United States Department of Homeland Security to verify information of newly hired employees, pursuant to the Immigration Reform and Control Act of 1986 (IRCA), D.L. 99-603.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Required Governmental Approvals means the Company Required Governmental Approvals and the Parent Required Governmental Approvals.

  • Client Money Rules means the Securities and Futures (Client Money) Rules (Chapter 571I of the Laws of Hong Kong) made by the SFC under section 149 of the Securities and Futures Ordinance as amended from time to time;

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • European Data Protection Laws means data protection laws applicable in Europe, including: (i) 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"); (ii) Directive 2002/58/EC concerning the processing of personal data and the protection of privacy in the electronic communications sector; and (iii) applicable national implementations of (i) and (ii); or (iii) GDPR as it forms parts of the United Kingdom domestic law by virtue of Section 3 of the European Union (Withdrawal) Act 2018 ("UK GDPR"); and (iv) Swiss Federal Data Protection Act on 19 June 1992 and its Ordinance ("Swiss DPA"); in each case, as may be amended, superseded or replaced.

  • 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;

  • Central Contractor Registration (CCR) database means the primary Government repository for Contractor information required for the conduct of business with the Government.

  • Data Protection Laws and Regulations means all laws and regulations, including laws and regulations of the European Union, the European Economic Area and their member states, Switzerland and the United Kingdom, applicable to the Processing of Personal Data under the Agreement.

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

  • Explosives or munitions emergency response means all immediate response activities by an explosives and munitions emergency response specialist to control, mitigate, or eliminate the actual or potential threat encountered during an explosives or munitions emergency. An explosives or munitions emergency response may include in-place render-safe procedures, treatment or destruction of the explosives or munitions and/or transporting those items to another location to be rendered safe, treated, or destroyed. Any reasonable delay in the completion of an explosives or munitions emergency response caused by a necessary, unforeseen, or uncontrollable circumstance will not terminate the explosives or munitions emergency. Explosives and munitions emergency responses can occur on either public or private lands and are not limited to responses at RCRA facilities.

  • 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).

  • Emergency worker means any person who is registered with a local emergency management organization or the department and holds an identification card issued by the local emergency management director or the department for the purpose of engaging in authorized emergency management activities or is an employee of the state of Washington or any political subdivision thereof who is called upon to perform emergency management activities.

  • European Data Protection Law means the GDPR and any data protection law of a European Member State and Switzerland, including local legislation implementing the requirements of the GDPR, including subordinate legislation, in each case as amended from time to time;

  • Environmental, Health, and Safety Requirements means all federal, state, local and foreign statutes, regulations, and ordinances concerning public health and safety, worker health and safety, and pollution or protection of the environment, including without limitation all those relating to the presence, use, production, generation, handling, transportation, treatment, storage, disposal, distribution, labeling, testing, processing, discharge, release, threatened release, control, or cleanup of any hazardous materials, substances or wastes, as such requirements are enacted and in effect on or prior to the Closing Date.

  • 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.

  • 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.

  • Accessibility Standards means accessibility standards and specifications for Texas agency and institution of higher education websites and EIR set forth in 1 TAC Chapter 206 and/or Chapter 213.

  • Flood Insurance Regulations means (a) the National Flood Insurance Act of 1968 as now or hereafter in effect or any successor statute thereto, (b) the Flood Disaster Protection Act of 1973 as now or hereafter in effect or any successor statute thereto, (c) the National Flood Insurance Reform Act of 1994 (amending 42 USC § 4001, et seq.), as the same may be amended or recodified from time to time, and (d) the Flood Insurance Reform Act of 2004 and any regulations promulgated thereunder.