Aprobación Condicional definition

Aprobación Condicional significa una autorización condicional de comercialización del Producto, otorgada por el INVIMA- Instituto Nacional de Vigilancia de Medicamentos y Alimentos, que permite poner el Producto en el mercado, en Colombia.
Aprobación Condicional significa una autorización condicional para la comercialización del Producto, otorgada por (a) por (i) la Administración de Alimentos y Medicamentos de los Estados Unidos (“FDA”), incluyendo inicialmente bajo la autorización de uso de emergencia u otra forma de aprobación regulatoria para el Producto (“Aprobación Condicional de la FDA”), o (ii) la Comisión Europea (“Aprobación Condicional de la EC”), y (b) el Instituto de Salud Pública, que permite poner el Producto en el xxxxxxx, en Chile.

Related to Aprobación Condicional

  • Abnormal Market Conditions means conditions contrary to Normal Markets Conditions e.g. when there is low liquidity in the market or rapid price movements in the market or Price Gaps.

  • Pretreatment wash primer means the first coat applied to bare metal if solvent-based primers will be applied. This coating:

  • Barrier Event means that R (final) is lower than the Barrier.

  • ICAO means the International Civil Aviation Organisation;

  • Regulatory Capital Treatment Event means the Corporation’s reasonable determination that as a result of any (i) amendment to, or change (including any announced prospective change) in, the laws or regulations of the United States or any political subdivision of or in the United States that is enacted or becomes effective after the initial issuance of any shares of Series N Preferred Stock; (ii) proposed change in those laws or regulations that is announced or becomes effective after the initial issuance of any shares of Series N Preferred Stock; or (iii) official administrative decision or judicial decision or administrative action or other official pronouncement interpreting or applying those laws or regulations that is announced after the initial issuance of any shares of Series N Preferred Stock, there is more than an insubstantial risk that the Corporation will not be entitled to treat the full liquidation preference amount of all shares of Series N Preferred Stock then outstanding as Tier 1 capital (or its equivalent) for purposes of the capital adequacy guidelines or regulations of the appropriate federal banking agency, as then in effect and applicable, for as long as any share of Series N Preferred Stock is outstanding.

  • DAS means the State of Oregon acting through its Department of Administrative Services.

  • SORA means, in respect of any Singapore Business Day “i”, a reference rate equal to the daily Singapore Overnight Rate Average published by the Monetary Authority of Singapore (or a successor administrator), as the administrator of the benchmark, on the Monetary Authority of Singapore’s website currently at http://www.mas.gov.sg, or any successor website officially designated by the Monetary Authority of Singapore (or as published by its authorised distributors) (the “Relevant Screen Page”) on the Singapore Business Day immediately following such Singapore Business Day “i”;

  • Anaerobic digestion ’ means a controlled process involving microbial decomposition of organic matter in the absence of oxygen ;

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • POPIA means the Protection of Personal Information Act 4 of 2013;

  • Primer means a coating labeled and formulated for application to a substrate to provide a firm bond between the substrate and subsequent coats.

  • Para means a Para of this Agreement;

  • Pattern of racketeering activity means the planned, ongoing, continuous or repeated participation or involvement in any offence referred to in Schedule 1 and includes at least two offences referred to in Schedule 1, of which one of the offences occurred after the commencement of this Act and the last offence occurred within 10 years (excluding any period of imprisonment) after the commission of such prior offence referred to in Schedule 1;

  • DEL means the Department of Early Learning of the State of Washington; any division, section, office, unit or other entity of DEL; or any of the officers or other officials lawfully representing DEL.

  • COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.

  • AV means (in each case as at the last Valuation Date) such proportion of the Asset Value of the General Long Portfolio as is equal to the proportion that the Notes of the relevant General Long Series represent of the General Long Outstanding Note Liability as determined by the Administration Agent (or such other person as may be responsible for calculating the Asset Value with respect to the Notes in accordance with the Agency Agreement) in accordance with clause 17 of the Agency Agreement and in consultation with the Portfolio Manager, adjusted, in consultation with the Portfolio Manager, to account fully for any losses, expenses and costs to the Issuer of unwinding any underlying or related hedging and funding arrangements; and

  • Step Down Conditions As of any Distribution Date on which any decrease in any Senior Prepayment Percentage may apply, (i) the outstanding Principal Balance of all Mortgage Loans 60 days or more Delinquent (including Mortgage Loans in REO and foreclosure), averaged over the preceding six month period, as a percentage of the aggregate of the Class Certificate Principal Balances of the Classes of Subordinate Certificates on such Distribution Date, does not equal or exceed 50% and (ii) cumulative Realized Losses with respect to all of the Mortgage Loans do not exceed: · for any Distribution Date on or after the seventh anniversary until the eighth anniversary of the first Distribution Date, 30% of the aggregate Certificate Principal Balance of the Subordinate Certificates as of the Closing Date, · for any Distribution Date on or after the eighth anniversary until the ninth anniversary of the first Distribution Date, 35% of the aggregate Certificate Principal Balance of the Subordinate Certificates as of the Closing Date, · for any Distribution Date on or after the ninth anniversary until the tenth anniversary of the first Distribution Date, 40% of the aggregate Certificate Principal Balance of the Subordinate Certificates as of the Closing Date, · for any Distribution Date on or after the tenth anniversary until the eleventh anniversary of the first Distribution Date, 45% of the aggregate Certificate Principal Balance of the Subordinate Certificates as of the Closing Date, and · for any Distribution Date on or after the eleventh anniversary of the first Distribution Date, 50% of the aggregate Certificate Principal Balance of the Subordinate Certificates as of the Closing Date.

  • Banquet Event Order or “BEO” means a written order issued by the Contractor to the Judicial Council that confirms the Judicial Council’s specific instructions and orders with respect to the Program on any one or more of the following, but does not alter any of the Agreement’s terms and conditions: (i) meeting and/or function room(s) and set-up requirements and/or rental charges; (ii) meal menus and prices and set-up requirements; and/or (iii) audio-visual equipment and set-up requirements and/or rental charges. BEO’s will be approved and signed by the Judicial Council’s representative, as set forth in Exhibit B.

  • Automated external defibrillator means a defibrillator device to which all of the following apply:

  • Handgun means a firearm of any description, loaded or unloaded, from which any shot, bullet, or other missile can be discharged by an action of an explosive where the length of the barrel, not including any revolving, detachable, or magazine breech, does not exceed 12 inches; provided, however, that the term "handgun" shall not include a gun which discharges a single shot of .46 centimeters or less in diameter.

  • FOISA means the Freedom of Information (Scotland) Xxx 0000 and any subordinate legislation made under this Act from time to time or any superseding or amending enactments or regulations, together with any guidance and/or codes of practice issued by the Information Commissioner, the Scottish Information Commissioner and/or any relevant government department in relation to such legislation.

  • ni means, for any RFR Banking Day "i", the number of calendar days from, and including, that RFR Banking Day "i" up to, but excluding, the following RFR Banking Day;

  • Elder abuse (OAA) means abuse, neglect, or exploitation of an older individual (elder) including the willful:

  • Capital Treatment Event means the receipt by the Company and the Trust of an opinion of counsel experienced in such matters to the effect that, as a result of the occurrence of any amendment to, or change (including any announced prospective change) in, the laws, rules or regulations of the United States or any political subdivision thereof or therein, or as the result of any official or administrative pronouncement or action or decision interpreting or applying such laws, rules or regulations, which amendment or change is effective or which pronouncement, action or decision is announced on or after the date of original issuance of the Debentures, there is more than an insubstantial risk that the Company will not, within 90 days of the date of such opinion, be entitled to treat an amount equal to the aggregate liquidation amount of the Capital Securities as “Tier 1 Capital” (or its then equivalent) for purposes of the capital adequacy guidelines of the Federal Reserve, as then in effect and applicable to the Company (or if the Company is not a bank holding company, such guidelines applied to the Company as if the Company were subject to such guidelines); provided, however, that the inability of the Company to treat all or any portion of the liquidation amount of the Capital Securities as Tier l Capital shall not constitute the basis for a Capital Treatment Event, if such inability results from the Company having cumulative preferred stock, minority interests in consolidated subsidiaries, or any other class of security or interest which the Federal Reserve or OTS, as applicable, may now or hereafter accord Tier 1 Capital treatment in excess of the amount which may now or hereafter qualify for treatment as Tier 1 Capital under applicable capital adequacy guidelines; provided further, however, that the distribution of Debentures in connection with the liquidation of the Trust shall not in and of itself constitute a Capital Treatment Event unless such liquidation shall have occurred in connection with a Tax Event or an Investment Company Event.

  • Distribution Conditions means, with respect to any Restricted Payment or Restricted Junior Debt Prepayment, the following:

  • CON means a certificate of need or other license or permit issued by a state health facilities planning board or similar agency or body required for the construction, expansion, or investment in a health facility.