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This document provides a summary of decisions requested by submitters regarding the deletion of provisions for the Waipara Catchment in the Proposed Natural Resources Regional Plan under the Resource
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How to fill out variation 17 summary of
How to fill out Variation 17 Summary of Decisions Requested
01
Gather all relevant information regarding the decisions requested.
02
Clearly state the title and purpose of Variation 17 at the top of the form.
03
Fill out each section of the form carefully, ensuring all required fields are completed.
04
Provide a concise summary of each decision that is being requested in the designated areas.
05
Review all information for accuracy and completeness before submission.
06
Submit the completed form to the appropriate authority as per the guidelines.
Who needs Variation 17 Summary of Decisions Requested?
01
Individuals or organizations applying for approvals or modifications related to Variation 17.
02
Stakeholders who require clarification on decisions made under Variation 17.
03
Regulatory bodies and agencies responsible for overseeing compliance with Variation 17.
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People Also Ask about
What is the difference between Type IB and Type IA variation?
A Type IA variation will only be validated and the content will not be assessed by the MEB. Type IB variation: any change that cannot be defined as Type IA variation, Type II variation or as a line extension and that will not have a significant effect on quality, safety or efficacy of the medicinal product.
What is an example of a type of variation?
Answer: Examples of types of variation include direct, inverse, joint, and combined variation. What Is Direct Variation? In direct variation, as one variable is multiplied by a constant and increases, another variable (the quotient) also increases.
What is a Type 1 variation in EMA?
Type IA variations are intended to provide for a simple, rapid and efficient procedure for minor changes. The MAH should be aware that the submission of redundant information or a confusing dossier presentation will not facilitate such procedures.
What is a type 2 variation in EMA?
A major change to a marketing authorisation that may have a significant impact on the quality, safety or efficacy of a medicine, but does not involve a change to the active substance, its strength or the route of administration. Type II variations require a formal approval.
What is a type ib variation?
A minor change to a marketing authorisation that the marketing-authorisation holder must notify to the regulatory authority before implementation, but which does not require formal approval.
What is an example of a type IB variation?
Some examples of Type IB variations where, in principle, a linguistic review will not be performed are: Quality variations: change in the shelf life of the finished product. change to the storage conditions of the finished product.
What is an example of a type 1a variation?
As an example, if an applicant has three Type IA variations to the same marketing authorisation implemented on 1 February 2025, 7 March 2025 and 21 April 2025 respectively, an annual update of Type IA variation grouping the three variations would be expected between 1st November 2025 (9 months after 1st February 2025)
How long does EMA type 2 variation approval take?
The majority of type II variation procedures following a 30-day timetable (e.g. urgent safety issues) will most commonly follow the monthly start timetable. This is because they are likely to require Commission Decision within two months from CHMP Opinion and discussion during the CHMP plenary meeting.
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What is Variation 17 Summary of Decisions Requested?
Variation 17 Summary of Decisions Requested is a document that outlines the specific changes or adjustments being proposed in a planning application or regulatory process.
Who is required to file Variation 17 Summary of Decisions Requested?
Individuals or organizations submitting a planning application or seeking regulatory changes are required to file the Variation 17 Summary of Decisions Requested.
How to fill out Variation 17 Summary of Decisions Requested?
To fill out the Variation 17 Summary of Decisions Requested, applicants need to provide detailed information about the proposed variations, including relevant descriptions, justifications, and supporting documents.
What is the purpose of Variation 17 Summary of Decisions Requested?
The purpose of the Variation 17 Summary of Decisions Requested is to ensure transparency and provide a clear outline of proposed changes, enabling stakeholders to review and respond appropriately.
What information must be reported on Variation 17 Summary of Decisions Requested?
The information that must be reported includes the nature of the variation, the reasons for the changes, impacts on existing permissions, and any relevant consultation responses.
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