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Annex 1. Detailed examples of filenames for different application types The use of Product Number H/C/xxx is applicable after the Initial MAY is submitted to the EMA. Prior to the Initial MAY submission,
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Annex 1 detailed examples refer to specific instances and scenarios that provide further explanation and clarification of the content outlined in Annex 1.
Who is required to file annex 1 detailed examples?
Entities and individuals who are directly involved in the activities outlined in Annex 1 are required to file annex 1 detailed examples.
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To fill out annex 1 detailed examples, you need to provide detailed information and specific examples that align with the content outlined in Annex 1. This may involve providing descriptions, data, and references to support the given examples.
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The purpose of annex 1 detailed examples is to provide further clarity and explanation to the content outlined in Annex 1. They help in better understanding and implementation of the guidelines and requirements specified in Annex 1.
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Annex 1 detailed examples should include relevant information, such as specific activities, circumstances, or situations that illustrate the concepts and requirements mentioned in Annex 1. It may also require supporting data, references, and explanations for a comprehensive understanding.
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