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This document summarizes the decisions requested by submitters regarding Variation 6 of the Proposed Canterbury Natural Resources Regional Plan, specifically focusing on water quality provisions for
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How to fill out summary of decisions requested
How to fill out Summary of Decisions Requested - Variation 6
01
Obtain the Summary of Decisions Requested - Variation 6 form from the relevant authority.
02
Read the instructions carefully to understand the required information.
03
Fill in your personal details in the designated sections, such as name, address, and contact information.
04
Clearly specify the decisions you are requesting to vary, providing detailed descriptions.
05
Include any supporting documents or evidence that justify your requests.
06
Review the completed form for accuracy and completeness.
07
Submit the form by the specified deadline either electronically or in person, following the submission guidelines.
Who needs Summary of Decisions Requested - Variation 6?
01
Individuals or organizations seeking to request changes or variances in previous decisions made by a governing body.
02
Professionals involved in legal or regulatory compliance who need to formally document their requests.
03
Stakeholders affected by previous decisions that require adjustments to meet their needs.
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People Also Ask about
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.
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 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 a type 1 variation?
A minor change to a marketing authorisation that has a minimal or no impact on the quality, safety or efficacy of the medicine and does not require prior approval before implementation by the marketing authorisation holder.
What is the timetable for Type 2 variation DCP?
In terms of duration, type II variation assessments typically follow a 60-day timetable. These include all standard type II variations to implement quality changes, changes to the Product Information or to the conditions of the marketing authorisation, or submission of final (non-)clinical study results.
What is a Type 2 variation 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 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.
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What is Summary of Decisions Requested - Variation 6?
Summary of Decisions Requested - Variation 6 is a document used to outline and summarize amendments or changes being proposed in a specific decision-making process, typically related to regulatory or compliance matters.
Who is required to file Summary of Decisions Requested - Variation 6?
Individuals or organizations that are seeking to amend a previously made decision or are involved in a regulatory process that requires the submission of amendments must file Summary of Decisions Requested - Variation 6.
How to fill out Summary of Decisions Requested - Variation 6?
To fill out Summary of Decisions Requested - Variation 6, users should carefully review the instructions provided, ensure all required fields are completed, provide clear and concise information regarding the decisions being amended, and attach any necessary supporting documentation.
What is the purpose of Summary of Decisions Requested - Variation 6?
The purpose of Summary of Decisions Requested - Variation 6 is to transparently communicate intended changes in decision-making, allowing stakeholders and regulatory bodies to review and assess the implications of the proposed variations.
What information must be reported on Summary of Decisions Requested - Variation 6?
The information that must be reported includes details about the original decision, the specific amendments being requested, the rationale for the changes, and any relevant supporting information that justifies the requested variations.
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