Regulatory Filing

Regulatory Filing. Any regulatory filings or correspondence necessary to procure or maintain any Governmental Approvals in the Territory for the Fentanyl Product, including any supplements or amendments thereto

Regulatory Filing. Means an application for medical or scientific approval to sell an Extracellular Product in a country.

Regulatory Filing. Means any form or other statement required to be filed with any Regulatory Agency.

Regulatory Filing. Means, collectively: (a) all INDs, Approval Applications, establishment license applications, Drug Master Files, applications for designation as an "Orphan Product(s)" under the Orphan Drug Act, for "Fast Track" status under Section 506 of the FDCA (21 U.S.C. § 356) or for a Special Protocol Assessment under Section 505(b)(4)(B) and (C) of the FDCA (21 U.S.C. § 355(b)(4)(B)) and all other similar filings (including counterparts of any of the foregoing in any country or region); (b) any... applications for Marketing Approval or Pricing Approval and other applications, filings, dossiers or similar documents submitted to a Regulatory Authority in any country or region for the purpose of obtaining Marketing Approval or Pricing Approval from that Regulatory Authority; (c) any Patent-related filings with any Regulatory Authority; (d) all supplements and amendments to any of the foregoing; (e) all documents referenced in the complete regulatory chronology for each Marketing Approval; (f) foreign equivalents of any of the foregoing; and (g) all data and other information contained in, and correspondence with any Regulatory Authority relating to, any of the foregoing. View More

Regulatory Filing. Means all applications, filings, dossiers and the like submitted to a Regulatory Authority in the Territory for the purpose of obtaining a Regulatory Approval from such Regulatory Authority.

Regulatory Filing. Shall mean any New Drug Application or Abbreviated New Drug Application, or any other application, notification or submission made to or with the FDA for Regulatory Approval of a product, together with all amendments and supplements to any of the foregoing.