| Title | The descriptive name for your template. The name shows in selection lists when Regulatory Leads create a submission from the template. |
| Owner | Click  to change the person responsible for the template. |
| Regulatory Activity Sub Category | Select a subcategory for the regulatory activity category from the list. You cannot change the activity category, only the subcategory. |
| Group Products Under One MA Only shows when the Regulatory Activity Category is Initial Submission. | Specifies whether a market authorization covers multiple products per country when it is created:| Value | Description |
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| Yes | A single market authorization is created to cover multiple products per country. | | No | A market authorization is created for each product per country. |
Note:
If this value is set to No, a separate market authorization is created for each product per country. Additional products can be added to any of these market authorizations after they are released. Therefore, this value does not necessarily mean that the market authorizations can only ever cover one product per country, just that they did at the time they were created.
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| Description | Details about the template. |
| Registration Fee | Enter the fee using the shown currency. You can select a different currency from the drop-down list. |
| Publishing File Format | Select the file format required for submission to the regulatory authority:- eCopy: The electronic submission is an exact duplicate of the paper-based submission. (You must select this format to see the Publishing category on the Submission page.)
- eCTD: The electronic submission content is based on the Common Technical Document (CTD) format.
- NeeS: The electronic submission is in a non-eCTD format.
- Paper-based: The submission is paper-based.
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