Regulatory Activities definition

Regulatory Activities means all activities relating to the obtaining and maintaining of any Regulatory Approval with respect to a Licensed Product, including without limitation, the preparation and filing of Regulatory Filings and interacting with Regulatory Authorities with respect to such Regulatory Filings.

Regulatory Activities means any and all actions reasonably necessary or required to obtain or maintain the Regulatory Approvals, including, without limitation, the design and conduct of clinical trials as necessary.

Regulatory Activities has the meaning set forth in Section 2.2.

Examples of Regulatory Activities in a sentence

• Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities Preferred Terms.

• Descriptive summaries (frequencies and percentages) for ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities Preferred Terms.

• Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities Preferred Terms, for Completed and Discontinued sets.

• Unsolicited adverse events and medical history terms will be coded from the verbatim description (Investigator term) using the Medical Dictionary for Regulatory Activities (MedDRA).

• FOR FURTHER INFORMATION CONTACT: Requests for additional information or a copy of an agency’s submission may be obtained by contacting: OCC: Xxxxxx Xxxxxxx, OCC Clearance Officer, or Xxxxxxx Xxxxx, (202) 874– 5090, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 000 X Xxxxxx, XX, Xxxxxxxxxx, XX 00000.

More Definitions of Regulatory Activities

Regulatory Activities means any regulatory activities directed towards compiling, filing and obtaining any Regulatory Approval for a Licensed Product in the Partner Territory including completion of any sample testing required by Regulatory Authorities for a Licensed Product in the Partner Territory.

Regulatory Activities mean any one or more of the regulatory activities to be performed by Hana, its Licensees, Sublicensees, or their respective Representatives in pursuit of the Development of each Product, including writing, translation, compilation, notification, submission, filing, defense, maintenance and renewal of Regulatory Approvals and payment of fees associated therewith, and meeting with Regulatory Authorities.

Regulatory Activities means all regulatory activities (such as filing, pricing, reimbursement, inspection by Regulatory Authorities) in order to obtain and to maintain Product Approval(s) for the Product in the Territory.

Regulatory Activities means all activities, other than Development and Commercialization activities, that are reasonably necessary in order to obtain and maintain Regulatory Approval of Product in the Field in the Territory, including but not limited to (a) the preparation, filing, and maintenance of Regulatory Materials, including the filing of annual updates, and (b) the conduct of post-marketing Studies.

Regulatory Activities means with respect to a Product, Elected Additional Products or New Presentation: (a) the preparation, review and filing of any and all Regulatory Filings; (b) maintaining contact and communication with the Regulatory Authorities; and (c) otherwise complying with all requirements of a Sponsor and applicable Laws. For the avoidance of doubt, Regulatory Activities include any NPS Program activities and compassionate use program activity.

Regulatory Activities means with respect to the Licensed Product in the Territory: (a) the preparation, review, filing and maintenance of any and all Regulatory Filings; (b) maintaining contact and communication with KFDA, MHW, HIRA and/or all other applicable Governmental Bodies; and (c) otherwise complying with all requirements of a holder of any Regulatory Approval and applicable Law.

Regulatory Activities has the meaning set forth in Section 7.3(b).