Regulatory Procedures definition
Examples of Regulatory Procedures in a sentence
The Required PRC Regulatory Procedures shall have been completed and obtained.
Relevant sections of the FDA Investigations Operations Manual, the FDA Regulatory Procedures Manual, the FDA Compliance Policy Guidance Manual, the FDA Compliance Program Guidance Manual, and other FDA guidances.
The parties shall work in good faith to finalize and mutually agree upon the Regulatory Procedures Protocol and the final agreed version thereof shall become part of and be incorporated into this Agreement on or before the Date of First Delivery.
Any such written assignment and/or delegation shall expressly refer to this Agreement, specify the particular rights, duties, obligations, responsibilities, or benefits so assigned and/or delegated, and shall not be effective unless approved by the Town in accordance with Section 1.3 of the Regulatory Procedures.
If the Required PRC Regulatory Procedures are not completed within 60 days of the execution of this Subscription Agreement (or such longer period as may be agreed between the parties), either party shall have the right to terminate this Subscription Agreement with notice to the other party, and upon such termination, the Purchaser shall have no further obligations hereunder.
The subdivision improvement agreement required pursuant to Section 5.3.A of the Regulatory Procedures shall be substantially in the form and substance attached hereto as Exhibit B attached hereto and incorporated herein by this reference, subject to any revisions or other modifications mutually approved by the parties thereto (the “SIA”).
Developer may submit for the Town’s review and written approval, in accordance with Section 1.3 of the Regulatory Procedures, a request for Model Home building permits showing the site designated for the location of the Model Homes, together with contemplated parking, security, customer control fencing, and sufficient information regarding utility services to the Model Homes, and may obtain a traffic variance, if required.
The proposal to simplify the ex-post reviews of existing regulations would not have an effect on Croatia’s score in the Complexity of Regulatory Procedures low-level indicator, as this indicator only captures whether such ex-post assessments are undertaken.
U.S. FDA: • Title 21, Code of Federal Regulations, Part 7, Enforcement Policy – Recalls (Including Product Corrections) – Guidelines on Policy, Procedures, and Industry Responsibilities • Regulatory Procedures Manual, Ch. 7, Recall and Emergency Procedures ▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/ora/compliance_ref/rpm_new2 • FDA publishes all classified recalls in the weekly Enforcement Report, which is posted on FDA’s website at ▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/opacom/enforce.html.
None of Seller or any of its Affiliates nor, to Knowledge of Seller, any third party engaged by Seller or any of its Affiliates in connection with the manufacture of the Products has received in the three (3) years prior to the date hereof, or as of the date hereof is subject to, a Warning Letter (as described in the FDA’s Regulatory Procedures Manual) or has received a Form FDA 483 for which the inspection file remains open with respect to the manufacture of any Product.