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This document summarizes the decisions requested by submitters regarding the variation to the Proposed Natural Resources Regional Plan focusing on water quality and the discharge of sewage effluent
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How to fill out summary of decisions requested
How to fill out Summary of Decisions Requested – Variation 14
01
Begin by obtaining the Summary of Decisions Requested – Variation 14 form.
02
Read the instructions carefully to understand the sections required.
03
Fill out the application number and title of the variation at the top of the form.
04
Describe the decisions that are being requested in detail.
05
Include any relevant supporting documents that may be required.
06
Make sure to provide your contact information for follow-up.
07
Review the filled form for completeness and accuracy.
08
Submit the form through the specified submission method (e.g., electronically or by mail).
09
Keep a copy of the submitted form for your records.
Who needs Summary of Decisions Requested – Variation 14?
01
Individuals or entities involved in a decision-making process that require changes or variations.
02
Applicants seeking modifications to previously approved decisions.
03
Organizations needing to update regulatory authorities or committees about their requests.
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People Also Ask about
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 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 II 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 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.
How long does it take for EMA approval?
Typically, the EMA review process takes about 210 days, but this does not include the time the company may need to respond to questions or provide additional information. Therefore, it's not uncommon for the entire process to extend beyond a year.
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)
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 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.
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What is Summary of Decisions Requested – Variation 14?
Summary of Decisions Requested – Variation 14 is a document used to outline the specific changes or decisions being requested, which could include amendments, variations, or modifications to existing regulations or agreements.
Who is required to file Summary of Decisions Requested – Variation 14?
Individuals or organizations that are seeking modifications to existing policies, regulations, or agreements are typically required to file Summary of Decisions Requested – Variation 14.
How to fill out Summary of Decisions Requested – Variation 14?
To fill out Summary of Decisions Requested – Variation 14, one must accurately provide all required information, including the specific variations being requested, relevant details about the changes, and any supporting documentation.
What is the purpose of Summary of Decisions Requested – Variation 14?
The purpose of Summary of Decisions Requested – Variation 14 is to formally communicate to relevant authorities the specific changes or adaptations being sought, enabling them to review and make informed decisions.
What information must be reported on Summary of Decisions Requested – Variation 14?
The information that must be reported includes the nature of the requested decisions, justification for the requests, any impact assessment, and necessary supporting data or documentation.
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