CHMP Opinion definition

CHMP Opinion means a decision by the CHMP on [***].

Examples of CHMP Opinion in a sentence

  • A CHMP Opinion is not given on the first two categories listed in this section, therefore in centralised procedure applicants should indicate only third and/or fourth category, if applicable.

  • A CHMP Opinion is not given on these sub-categories, therefore applicants should not fill in this section for applications in centralised procedure.

  • The scientific conclusions of the CHMP Opinion of 17 December 2009 were revised accordingly.

  • It is concluded that the risk evaluation is sufficiently meeting the requirements as described in Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products.

  • Any divergent positions of the CHMP members are also attached to the final CHMP Opinion.

  • Relevant EMA and CMDh guidanceAssessment report Procedure under Article 5(3) of Regulation EC (No) 726/2004 Nitrosamine impuritiesin human medicinal products- EMA/369136/2020Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in humanmedicinal products - EMA/409815/2020CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl.

  • Bioequivalence vis-à-vis a valid EU reference medicinal product has been established for marketing authorisation applications listed in Annex Ia of the CHMP Opinion.

  • When divergent positions have been expressed, they will be referenced in the CHMP Opinion.

  • For centrally authorised medicinal products, the appropriate point in time for dissemination of a DHPC is usually once the CHMP Opinion has been adopted.

  • Pre-Filled Dual-Chamber Syringe for Abilify Maintena® (aripiprazole) Prolonged-Release Suspension for Injection, Used in the Treatment of Schizophrenia, Receives Positive CHMP Opinion (Approval in EU), Business Wire, Mar.

Related to CHMP Opinion

  • Second opinion means an opportunity or requirement to obtain a clinical evaluation by a provider other than the one originally making a recommendation for a proposed health service to assess the clinical necessity and appropriateness of the initial proposed health service.

  • Favorable Opinion of Bond Counsel means an opinion of Bond Counsel addressed to the Issuer and the Trustee to the effect that the action proposed to be taken is authorized or permitted by the laws of the Commonwealth and this Indenture and will not, in and of itself, adversely affect any exclusion of interest on the Bonds from gross income of the owners thereof for federal income tax purposes.

  • REMIC Opinion An Independent Opinion of Counsel, to the effect that the proposed action described therein would not, under the REMIC Provisions, (i) cause any REMIC created hereunder to fail to qualify as a REMIC while any regular interest in such REMIC is outstanding, (ii) result in a tax on prohibited transactions with respect to any REMIC created hereunder or (iii) constitute a taxable contribution to any REMIC created hereunder after the Startup Day.

  • Opinion means an opinion from Company’s independent legal counsel, in the form attached as Exhibit E or in such other form agreed upon by the parties, to be delivered in connection with the Commitment Closing and any Tranche Closing.

  • Tax Opinion means, with respect to any action, an Opinion of Counsel to the effect that, for federal income tax purposes, (a) such action will not cause the Notes of any outstanding class of Notes that were characterized as debt at the time of their issuance to be characterized as other than debt, (b) such action will not cause the Trust to be deemed to be an association (or publicly traded partnership) taxable as a corporation and (c) such action will not cause or constitute an event in which gain or loss would be recognized by any Holder.

  • Opinion of Bond Counsel means a written opinion of Bond Counsel.

  • Tax Opinions mean certain Tax opinions and supporting memoranda rendered by Bxxxxxxxx to RemainCo or any of its Affiliates in connection with the Plan of Separation.

  • Fairness Opinion has the meaning set forth in Section 4.22.

  • Legal Opinion means any legal opinion delivered to the Agent under Clause 4.1 (Initial conditions precedent) or Clause 29 (Changes to the Obligors).

  • Benefit Plan Opinion With respect to any Certificate presented for registration in the name of any Person, an Opinion of Counsel acceptable to and in form and substance satisfactory to the Trustee and the Company to the effect that the purchase or holding of such Certificate is permissible under applicable law, will not constitute or result in a non-exempt prohibited transaction under Section 406 of ERISA or Section 4975 of the Code, and will not subject the Trust, the Trustee, the Delaware Trustee, the Master Servicer or the Company to any obligation or liability (including obligations or liabilities under Section 406 of ERISA or Section 4975 of the Code) in addition to those undertaken in this Agreement, which Opinion of Counsel shall not be an expense of the Trust, the Trustee, the Delaware Trustee, the Master Servicer or the Company.

  • Nondisqualification Opinion An Opinion of Counsel, prepared at the Trust’s expense and payable from the Collection Account, that a contemplated action will not cause (i) either the Lower-Tier REMIC or the Upper-Tier REMIC to fail to qualify as a REMIC or (ii) a “prohibited transaction” or “prohibited contributions” tax to be imposed on either the Lower-Tier REMIC or the Upper-Tier REMIC at any time that any Certificates are outstanding.

  • Withdrawal Opinion of Counsel has the meaning assigned to such term in Section 11.1(b).

  • Fairness Opinions means the opinions of the Financial Advisors to the effect that, as of the date of such opinion and based upon and subject to the assumptions, procedures, factors, limitations and qualifications set forth therein, the Consideration to be received by the Company Shareholders under the Arrangement is fair, from a financial point of view, to such Company Shareholders.

  • Actuarial opinion means the opinion of an appointed actuary regarding the adequacy of the reserves and related actuarial items based on an asset adequacy analysis in accordance with subrule 5.34(6) and with applicable actuarial standards.

  • Issuer Tax Opinion means with respect to any action, an Opinion of Counsel to the effect that, for federal income tax purposes and subject to customary assumptions and qualifications for opinions of this type, (a) such action will not adversely affect the tax characterization as debt of any Notes that were characterized as debt at the time of their issuance, and (b) following such action neither the Issuer nor the Titling Trust will be treated as an association (or publicly traded partnership) taxable as a corporation.

  • Opinion of Counsel means a written opinion from legal counsel who is acceptable to the Trustee. The counsel may be an employee of or counsel to the Company or the Trustee.

  • No Recognition Opinion means an opinion of a nationally recognized independent tax counsel (reasonably acceptable to the Issuer Trustees) experienced in such matters, which opinion may rely on published revenue rulings of the Internal Revenue Service, to the effect that the Holders of the Securities will not recognize any income, gain or loss for United States Federal income tax purposes as a result of the liquidation of the Trust and the distribution of the Securities to the holders of the Preferred Securities.

  • Bond Counsel means an attorney or firm of attorneys of nationally recognized standing on the subject of municipal bonds satisfactory to the Director.

  • Debt-For-Tax Opinion means an Opinion of Counsel, of nationally recognized tax counsel, delivered to the Depositor and the Indenture Trustee stating that the Notes specified therein will be debt for United States federal income tax purposes.

  • Supplemental Ruling means (i) any ruling (other than the Ruling) issued by the IRS in connection with a Distribution, and (ii) any similar ruling issued by any other Taxing Authority addressing the application of a provision of the laws of another jurisdiction to a Distribution.

  • Non-Consolidation Opinion means that certain substantive non-consolidation opinion delivered to Lender in connection with the closing of the Loan.

  • Insolvency Opinion means that certain non-consolidation opinion letter dated the date hereof delivered by Xxxxxx Xxxxxxxx Xxxxx & Xxxxxxxx LLP in connection with the Loan.

  • Tax Counsel shall have the meaning set forth in Section 6.2 hereof.

  • Opinion of Independent Counsel means a written opinion of legal counsel issued by someone who is not an employee or consultant of Parent, the Company or any Guarantor and who shall be acceptable to the Trustee.

  • Initial Certificate Transfer Opinion means an opinion rendered by nationally recognized tax counsel (i) upon the initial transfer by the Depositor of a Certificate that results in the Issuer being treated as a partnership for United States federal income tax purposes and (ii) while any Note retained by the Issuer or a Person that is considered the same Person as the Issuer for United States federal income tax purposes is outstanding that (x) such Note will be debt for United States federal income tax purposes or (y) the transfer by the Depositor of such Certificate will not cause the Issuer to be treated as an association or publicly traded partnership taxable as a corporation.

  • Tax Opinions/Rulings means (i) any Ruling and (ii) any opinion of a Tax Advisor relating to the Transactions, including those issued on the Distribution Date or to allow a party to take actions otherwise prohibited under Section 4.03(a) of this Agreement.