Regulatory Submissions definition

Regulatory Submissions means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

Regulatory Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining Regulatory Approval.

Examples of Regulatory Submissions in a sentence

• Please submit these labeling electronically according to the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.

• For more information about submitting promotional materials in eCTD format, see the draft guidance for industry Providing Regulatory Submissions in Electronic and Non-Electronic Format-Promotional Labeling and Advertising Materials for Human Prescription Drugs.3 You must submit final promotional materials and Prescribing Information, accompanied by a Form FDA 2253, at the time of initial dissemination or publication[21 CFR 314.81(b)(3)(i)].

• For more information about submitting promotional materials in eCTD format, see the draft guidance for industry Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs.3 As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the Prescribing Information, at the time of initial dissemination or publication, accompanied by a Form FDA 2253.

• For more information about submitting promotional materials in eCTD format, see the draft guidance for industry Providing Regulatory Submissions in Electronic and Non- Electronic Format-Promotional Labeling and Advertising Materials for Human Prescription Drugs.

• For information about submitting promotional materials, see the final guidance for industry Providing Regulatory Submissions in Electronic and Non- Electronic Format-Promotional Labeling and Advertising Materials for Human Prescription Drugs.3 You must submit final promotional materials and Prescribing Information, accompanied by a Form FDA 2253, at the time of initial dissemination or publication[21 CFR 314.81(b)(3)(i)].

More Definitions of Regulatory Submissions

Regulatory Submissions means applications for Regulatory Approval, notification and other submissions made to or with a Regulatory Authority that are necessary or reasonably desirable to Develop, Manufacture or Commercialize a Product in the Field in one or more of the countries in the Territory, whether obtained before or after a Regulatory Approval in such countries. Regulatory Submissions include, without limitation, investigational new drug applications and new drug applications, and amendments and supplements to any of the foregoing and their foreign counterparts, applications for pricing and reimbursement approvals, and all proposed labels, labeling, package inserts, monographs and packaging for a Product in a particular jurisdiction.

Regulatory Submissions means applications for Regulatory Approval, notification and other submissions made to or with a Regulatory Authority that are necessary or reasonably desirable to Develop, Manufacture or Commercialize a Product in the Field in a particular country, whether obtained before or after Regulatory Approval in the country. Regulatory Submissions include, without limitation, investigational new drug applications and NDAs, and amendments and supplements to any of the foregoing and their foreign counterparts, applications for pricing and reimbursement approvals, and all proposed labels, labeling, package inserts, monographs and packaging for a Product in a particular country.

Regulatory Submissions means applications for Regulatory Approval, notification and other submissions made to or with a Regulatory Authority that are necessary or reasonably desirable to Develop, Manufacture or Commercialize a Collaboration Product in the Field in a particular country, whether obtained before or after a Regulatory Approval in the country. Regulatory Submissions include, without limitation, investigational new drug applications and NDAs, and amendments and supplements to any of the foregoing and their foreign counterparts, applications for pricing and reimbursement approvals, and all proposed labels, labeling, package inserts, monographs and packaging for a Collaboration Product in a particular country.

Regulatory Submissions means all applications, approvals, licenses, notifications, registrations, submissions and authorizations made to a Regulatory Authority in connection with the development, manufacture or commercialization of a medical device product, including any marketing and reimbursements.

Regulatory Submissions means any filing, application, or submission with any Regulatory Authority in support of the Development, Manufacture, Commercialization, or other Exploitation of a pharmaceutical or biologic product (including to obtain or maintain Regulatory Approval from that Regulatory Authority), and all written or electronic correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences, or discussions with the relevant Regulatory Authority. Regulatory Submissions include all INDs, BLAs, and other applications for Regulatory Approval and their equivalents.

Regulatory Submissions means all applications, notifications, and submissions made to a Regulatory Authority (including any attachment or supplement thereto) to obtain Regulatory Approval in connection with the development, manufacture or commercialization of the Product, and all Information contained therein (but excludes IceCure Information, IceCure Patents, and Inventions).

Regulatory Submissions has the meaning set forth in Section 2.5.