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Annex 2: Notification of Amendment Form REQUEST FOR Authorization OF A SUBSTANTIAL AMENDMENT TO A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR THE OPINION
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How to fill out a request for authorization:

01
Start by filling out the header section of the request form. This typically includes your name, contact information, and the name of the organization or department you are representing.
02
Provide a detailed explanation of the reason for the request. Clearly state the purpose of the authorization and why it is necessary. Include any relevant background information or supporting documentation to strengthen your case.
03
Specify the duration or timeline for the authorization. Indicate the start and end dates, or provide an estimated period for which the authorization is needed.
04
Outline any specific requirements or conditions for the authorization. This could include location restrictions, equipment or resource needs, or any other relevant information that may impact the approval process.
05
Include any necessary supporting documentation. This may include permits, licenses, certifications, or any other paperwork that is required for the authorization.
06
Sign and date the request form. By doing so, you acknowledge that the information provided is accurate and complete.

Who needs a request for authorization:

01
Individuals or organizations seeking permission to access restricted areas or facilities. This could include contractors, visitors, or employees who need temporary access to specific locations.
02
Individuals or organizations requesting permission to use certain equipment or resources. This could include requesting authorization to use a company vehicle, office space, or specialized tools.
03
Anyone seeking official approval to conduct certain activities or actions that require authorization. This could include requesting permission to perform research, hold an event, or implement a new policy or procedure.
In summary, filling out a request for authorization involves providing detailed information about the reason for the request, specifying the duration and requirements, and including any necessary supporting documentation. Individuals or organizations who need authorization vary depending on the specific circumstances, but could include those seeking access to restricted areas, requesting the use of specific equipment or resources, or seeking approval for various activities or actions.
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The request for authorisation of is a formal application for permission to carry out a specific action or obtain a specific right.
Any individual or entity that needs to seek authorization for a particular activity or right is required to file a request for authorisation.
The request for authorisation of can be filled out by providing all the necessary information and documentation related to the specific request being made.
The purpose of the request for authorisation of is to obtain permission to proceed with a certain action or gain a specific right in a legal and formal manner.
The request for authorisation of must include detailed information about the activity being requested, the reasons for the request, and any supporting documentation that may be required.
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