CMC Data definition

CMC Data means any and all information contained in, as well as data supporting, the Chemistry, Manufacturing and Control section of an IND or NDA for the Product, and any similar information or data required with respect to any other Regulatory Approval.

CMC Data means any data included in the CMC portion of a Regulatory Filing or in any supporting development reports thereto, in each case, with respect to any Licensed Product in any country in the world.

CMC Data means the chemistry, manufacturing and controls data required by Applicable Law to be included in a New Drug Application (as defined in the FFDCA and the regulations promulgated thereunder) for a Product or in any other Marketing Authorization outside the United States.

Examples of CMC Data in a sentence

• Criterion Maximum Concentration (CMC) Data considered acceptable for inclusion in Table 1, according to the Guidelines, now includes 46 species of fish, 48 species of invertebrates and 4 species of amphibians.

• The VA SOS staff will also keep data available for easy review by all interested parties on the Clean Water Hub and in the CMC Data Explorer.

• The AO shall effect all insurances and negotiate all claims on the Board’s insurers.

• We used the Contraceptive Method Choice (CMC) Data Set from the UCI repos- itory, which can be downloaded from https://archive.ics.uci.edu/ml/datasets/ Contraceptive+Method+Choice.

• Supplier is obliged to fill the form provided by CMC (Data registration in SENT) and send it at the e-mail address SENT_SCRAP@CMC.COM within the deadline indicated by CMC.

More Definitions of CMC Data

CMC Data means the chemistry, manufacturing and controls data required by Applicable Law to be included in a BLA or NDA for a Licensed Product.

CMC Data means the chemistry, manufacturing and controls data for each Research Product, product Directed to a ROFN Target, Licensed Compound or Licensed Product, as applicable, required by Applicable Law to be included or referenced in, or that otherwise supports, an application for Regulatory Approval.

CMC Data means any data included in the “Chemistry, Manufacturing and Controls” portion of a Regulatory Filing or in any supporting development reports thereto, in each case, with respect to any Product in any country in the world.

CMC Data means the data contained in the chemistry, manufacturing and controls section of a submission for Regulatory Approval of the Product in the Field in the Territory.

CMC Data means those data required by Part 2 of the Annex to Directive 2001/83/EC (including, without limitation, any updates and/or amendments thereto) including the qualitative and quantitative particulars of the constituents, the description of the manufacturing method and the controls and tests carried out at all relevant stages of the manufacturing process.

CMC Data means chemistry, manufacturing and controls data for a pharmaceutical product required by Applicable Law to be included or referenced in, or that otherwise supports a Regulatory Approval.

CMC Data means CMC data, results and reports that are generated with respect to the Product or the Durect Technology to the extent incorporated into or utilized in the Product, and that are Controlled at any time during the Term of this Agreement by a Party, or any Affiliate, subcontractor, agent, sublicensee thereof, or jointly by any of the foregoing.