Drug Approval definition

Drug Approval means an approval granted by the appropriate Regulatory Authority to market the Product in the Field in any particular jurisdiction in the Licensed Territory.

Drug Approval means an approval granted by the appropriate Regulatory Authority to market a Product in the Field in any particular jurisdiction in the Territory; provided, “Drug Approval” includes any and all marketing authorizations in the EU but excludes any and all Pricing and Reimbursement Approvals.

Drug Approval means an approval granted by the appropriate Regulatory Authority to market a Product in the Field in any particular jurisdiction in the Territory, excluding any required Pricing and Reimbursement Approval.

Examples of Drug Approval in a sentence

• New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino, MD,5th edition, Drugs and the Pharmaceutical Sciences,Vol.190.

• The Party that has filed the Drug Approval Application in such country within the Territory or, if no Drug Approval Application has been filed, the Party which has filed the IND (or foreign equivalent) in such country within the Territory shall provide an appropriate response to such contact after such consultation with the other Party.

• Without limiting the generality of the foregoing, Novartis shall have full control and authority and sole responsibility for (A) making all Regulatory Filings for Licensed Products and filing all Drug Approval Applications and otherwise seeking all Regulatory Approvals regarding such matters and (B) reporting of all Adverse Events to Regulatory Authorities if and to the extent required by Applicable Laws.

• Novartis may dissolve the JDC upon achievement of the first approval of a Drug Approval Application by the applicable Regulatory Authority for any Licensed Product or upon [***].

• Prior to submitting any Drug Approval Application, the Parties, through the JDC, shall consult, cooperate in preparing and mutually agree on such Applications and their content and scope.

More Definitions of Drug Approval

Drug Approval means an approval of a BLA, NDA, or of a MAA, or any corresponding Regulatory Approval for the Commercialization of a pharmaceutical product for a particular indication in any other country or region of the world, including other than the U.S. and the EU /European Economic Area.

Drug Approval means the regulatory approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction, including, for purposes of Regulatory Approval in the US, a New Drug or a Biological License and all supplements filed pursuant to the requirements of the FDA (including all documents, data and other information concerning a Product that are necessary for, or included in, FDA approval to market a Product) and, for purposes of Regulatory Approval in the EU, all and any regulatory approval by the EMEA or any other applicable national regulatory authority.

Drug Approval means an approval granted by the appropriate Regulatory Authority to market a Licensed Product (as the context admits) in the Field of Use in any particular jurisdiction in the Licensed Territory; provided “Drug Approval” includes any and all marketing authorizations, but excludes any and all Pricing Approvals and Reimbursement Approvals.

Drug Approval shall have the meaning ascribed to it in the Mundipharma Collaboration Agreement.

Drug Approval means an approval, authorization or license (including, without limitation, an Investigational New Drug Application (“IND”) authorizing human testing of a drug, New Drug Application, conditional Marketing Authorization Application and Marketing Authorization Application) granted by a Governmental Authorities (including, without limitation, the FDA and the European Commission) to permit the use in human use, sale and marketing of a Product.

Drug Approval means approval of an application for the Regulatory Approval required before commercial sale or use of a Product in a regulatory jurisdiction, including with respect to the U.S. a new drug application (“NDA”), a supplemental new drug application, a prior approval supplement to an NDA, a Pre-market Approval Application, clearance of a Pre-market Notification Submission (510(k)), as applicable, or any amendments thereto submitted to the FDA, and with respect to the EMEA or countries outside the U.S. any foreign equivalents thereof.

Drug Approval. APPLICATION shall mean an application for Marketing Authorization required to be approved before commercial sale or use of a Product as a drug in a country of the Territory.