Centralized Procedure means the European Community Centralized Procedure for marketing authorization in accordance with Council Regulation EEC (2309-93) or any successor regulations.
Centralized Procedure means the procedure through which a Drug Approval Application filed with the EMA results in a single marketing authorization valid throughout the European Union.
Centralized Procedure means the procedures of the EU for obtaining marketing authorisation for a medicinal product as set forth in Regulation (EC) No 726/2004 of 31 March 2004, as amended from time to time during the Term.
Examples of Centralized Procedure in a sentence
Currently the three main types of procedures recognized for the granting of a marketing authorization and to place a product on the market in Malta are the National Procedures, European Procedures (Mutual Recognition and Decentralized Procedures), and Centralized Procedure.
The Centralized Procedure is optional for products containing a new active substance not yet authorized in the EEA, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the EU.
Amount of PSN Funds Requested • Indicate the exact amount of federal funds being requested.
Theproduct was approved through the Centralized Procedure which enabled marketing of the product in all EU member States.
The National MA is for products not falling within the mandatory scope of the Centralized Procedure.
More Definitions of Centralized Procedure
Centralized Procedure means the procedure for the authorization and supervision of medicinal products for human use set forth in Council Regulation (EEC) No. 2309/93 (the “Regulation”);
Centralized Procedure means, to the extent compulsory or permitted for the Regulatory Approval of a pharmaceutical product in [ * ] any country in the EU, the procedure administrated by the EMA which results in a single Regulatory Approval granted by the European Commission (excluding any pricing or reimbursement approval) that is valid in all countries in the EU and following recognition, [ * ].
Centralized Procedure means, to the extent compulsory or permitted for the Regulatory Approval of a pharmaceutical product in Iceland, Liechtenstein, Norway, or any country in the EU, the procedure administrated by the EMA which results in a single Regulatory Approval granted by the European Commission (excluding any pricing or reimbursement approval) that is valid in all countries in the EU and, following recognition, in Iceland, Liechtenstein and Norway. 1.11 [*]. 1.12 “China” means, for purposes of this Agreement, the People’s Republic of China, including the Hong Kong Special Administrative Region, the Macau Special Administrative Region, and the Taiwan Region. 1.13 “Clinical Supply” means, with respect to the Product, Product intended or used for the purpose of Development or obtaining Regulatory Approval of the Product in accordance with the Global Development Plan. 1.14 “Clinical Supply Agreement” means the Tisotumab Vedotin Clinical Supply Agreement, by and between Genmab and SGI, dated as of March 15, 2018, as amended. 1.15 “Clinical Trial” means a Phase I Clinical Trial, a Phase II Clinical Trial, a Phase III Clinical Trial, a Phase III-B Study, or a Phase IV Study, as the case may be, as such terms are defined in the Collaboration Agreement. For clarity, “Clinical Trials” do not include any investigator-initiated trials or investigator-sponsored research, which shall be considered Medical Affairs Activities. 1.16 “CMC Development” means the Development activities related to the composition, manufacture, and specification of the drug substance and the drug product (including Combination Products in a single formulation) intended to assure the proper identification, quality, purity and strength of the drug, including site transfer (as conducted pursuant to and in accordance with this Agreement), test method development and stability testing, process development, process improvements (i.e., improving product robustness or manufacturing efficiencies), drug substance development, process validation, process scale-up, formulation development, delivery system development, QA and QC development. 1.17 “CMC Development Costs” means, with respect to the Product, the [*] and [*] that are incurred by a Party or any of its Affiliates on or after the Effective Date that are directly attributable or reasonably allocable to CMC Development activities undertaken directly or
Centralized Procedure means submission of an MAA to the EMA using the centralised procedure.
Centralized Procedure means, to the extent compulsory or permitted for the Regulatory Approval of a pharmaceutical product in [ * ] any country in the EU, the procedure administrated by the EMA which results in a single Regulatory Approval granted by the European Commission (excluding any pricing or reimbursement approval) that is valid in all countries in the EU and following recognition, [ * ] .
Centralized Procedure means the procedures of the EU for obtaining marketing authorisation for a medicinal product as set forth in
Centralized Procedure the European Union-wide procedure for receipt of the MA for the Product from the EMA, where there is a single application, a single evaluation and a single authorisation for the Product throughout the European Union.