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Version: ATPBAN001000
March 2021ANNEX 1 FORM TO LIST CLASS 1 CELL, TISSUE OR GENE THERAPY PRODUCTS
Product Notification No. CTGT0006N
S/Product Overproduce NameProduct Code-name & Address of
Manufacturing
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How to fill out annex-1-form-to-list-of-class-1-cell-tissue-or-gene-formrapy-products
How to fill out annex-1-form-to-list-of-class-1-cell-tissue-or-gene-formrapy-products
01
Obtain the Annex-1 form from the relevant regulatory authority.
02
Fill out the form with accurate information about the class 1 cell, tissue, or gene therapy product.
03
Provide details such as the name of the product, manufacturer information, intended use, and any adverse effects.
04
Include relevant supporting documents and data as required by the regulatory authority.
05
Submit the completed form to the regulatory authority for review and approval.
Who needs annex-1-form-to-list-of-class-1-cell-tissue-or-gene-formrapy-products?
01
Companies or individuals who are developing or manufacturing class 1 cell, tissue, or gene therapy products need the Annex-1 form to list their products for regulatory approval.
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What is annex-1-form-to-list-of-class-1-cell-tissue-or-gene-formrapy-products?
Annex-1-form-to-list-of-class-1-cell-tissue-or-gene-formrapy-products is a form used to list Class 1 cell tissue or gene therapy products.
Who is required to file annex-1-form-to-list-of-class-1-cell-tissue-or-gene-formrapy-products?
Manufacturers or distributors of Class 1 cell tissue or gene therapy products are required to file annex-1-form.
How to fill out annex-1-form-to-list-of-class-1-cell-tissue-or-gene-formrapy-products?
Annex-1 form is typically filled out by providing detailed information about the Class 1 cell tissue or gene therapy products being listed.
What is the purpose of annex-1-form-to-list-of-class-1-cell-tissue-or-gene-formrapy-products?
The purpose of annex-1-form is to ensure regulatory compliance and provide transparency regarding Class 1 cell tissue or gene therapy products.
What information must be reported on annex-1-form-to-list-of-class-1-cell-tissue-or-gene-formrapy-products?
Information such as product name, manufacturer details, intended use, and product classification must be reported on annex-1-form.
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