Regulatory Package definition

Regulatory Package means all of Insmed’s intellectual property relating to Masoprocal, including without limitation, all of the masoprocal-related pre-clinical and clinical research dossier associated with the Endocrine IND and modifications, variations, amendments and any regulatory documents filed with the FDA or any other regulatory agency associated with the Endocrine IND, as set forth on Exhibit A attached.
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Regulatory Package means, with respect to each Oncology Product, all INDs and other regulatory applications submitted to any Agency, Product Approvals, pre-clinical and clinical data and information, regulatory materials, drug dossiers, master files (including Drug Master Files, as defined in 21 C.F.R. 314.420 (or any non-United States equivalent thereof)), and any other reports, records regulatory correspondence and other materials
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Regulatory Package means, with respect to each Otezla Product, all INDs and other regulatory applications submitted to any Agency, Product Approvals, pre-clinical and
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Examples of Regulatory Package in a sentence

  • Further, this policy provides various reliefs which the Company may provide to the eligible borrowers pursuant to the COVID-19 - Regulatory Package as released by the RBI vide Guidelines no.

  • The Reserve Bank of India (RBI) has issued guidelines relating to COVID-19 Regulatory Package dated March 27, 2020 and April 17, 2020 and in accordance therewith, the Company have provided a moratorium of three months on the payment of all principal amounts and/or interest, as applicable, falling due between March 1, 2020 and May 31, 2020 to all eligible borrowers classified as standard, even if the said amounts were overdue on February 29, 2020.

  • Similarly in respect of working capital facilities sanctioned in the form of cash credit/overdraft (“CC/OD”), the Regulatory Package permitted the recovery of interest applied during the period from March 1, 2020 upto May 31, 2020 to be deferred (‘deferment period’).

  • In respect of accounts where moratorium benefit was granted, the staging of those accounts as at September 30, 2020 is based on the days past due status considering the benefit of moratorium period in accordance with the COVID-19 Regulatory Package announced by the RBI vide aforesaid notifications.

  • RBI/2019-20/186 DOR.No.BP.BC.47/21.04.048/2019-20 dated March 27, 2020 and COVID-19 - Regulatory Package as released by the RBI vide Guidelines no.

  • Regulatory Package for New Source Performance Standards and III(d) Guidelines for Municipal Solid Waste Air Emissions.

  • In the Audit Report under “ Emphasis of Matter” attention is drawn to Note No. 2 to the Statement, which explains the staging of accounts to whom moratorium benefit was extended in accordance with the Reserve Bank of India COVID-19 Regulatory Package.

  • In respect of accounts which were granted moratorium in terms of the Covid19 Regulatory Package, the asset classification for the period from March 1, 2020 to August 31, 2020 shall be governed in terms of the circular DOR.No.BP.BC.63/21.04.048/2019-20 dated April 17, 2020, read with circular DOR.No.BP.BC.71/21.04.048/2019-20 dated May 23, 2020.

  • We also held discussions with the management of the Bank on high risk industry sectors and measures taken by the management to monitor to such assets.We read the RBI Annual Financial Inspection report for the financial year ended 31 March 2019 and other communication with the regulators.With respect to those borrowers to whom a moratorium was granted in accordance with the Regulatory Package, on a sample basis, we tested that such moratorium was granted in accordance with the board approved policy.

  • This evaluation proposed a change to the Decommissioning Plan to reduce the scopes of the radioactive effluent controls and the radiological environmental monitoring programs.


More Definitions of Regulatory Package

Regulatory Package means all of the investigational new drug applications and amendments for acute infectious diarrhea, pediatric diarrhea, and HIV-related diarrhea filed with the FDA (according to FDA standards) with respect to crofelemer. All future filings submitted to the FDA and/or the EMEA, or the applicable regulatory agency in the Reserved Territory, including NDAs, with respect to Licensed Product(s) will be considered part of the Regulatory Package.
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Regulatory Package means the entire documentary apparatus composed of the Code of Ethics, the Code of Conduct and the Corporate Governance Model adopted by INSO S.p.A.
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Regulatory Package means the entire documentary apparatus consisting
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Related to Regulatory Package

  • Instructional material means instructional content that is provided to a student, regardless of its format, including printed or representational materials, audio-visual materials, and materials in electronic or digital formats (such as materials accessible through the Internet). The term does not include academic tests or academic assessments.

  • Regulatory Authority means any federal, national, multinational, state, county, city, provincial, or local regulatory agency, department, bureau or other governmental entity with authority over the marketing, commercialization, manufacture or sale of a pharmaceutical product in the Territory, including the FDA in the United States and the EMA in the EU.

  • FDA means the United States Food and Drug Administration or any successor entity thereto.

  • Labeling means all labels and other written, printed, or graphic matter on an article or any of its