Wizard Navigation
Use the Next and Back buttons at the bottom of the page to navigate within the Wizard. Clicking the Back button in your Web browser does not always return you to the previously viewed page in the XEVMPD Submission Wizard. Instead, a page farther back in the wizard structure may appear, requiring you to use the Next button to return to the appropriate page.
- Select Sender/Receiver Information
- Select XEVPRM Sections:Search Criteria Selection, Search Results
- Create XEVPRM Confirmation
- Create XEVPRM Summary
The following sections are available for selection:
| Section | Description |
|---|---|
| Organisation | Select either Marketing Authorisation Holder (MAH) and/or Sponsor to be included in the XML file. |
| Source | Select the Compendial Designations that will be included in the XML file. |
| Master File Location (MFL) | Choose which Master File Locations you want to include in the XML file. |
| ATC | Anatomical Therapeutic Chemical. Select the ATC codes that will be included in the XML file. |
| Pharmaceutical Form | Select the Dosage/Pharmaceutical forms that will be included in the XML file. |
| Route of Administration | Choose the Route of Administration that will be included in the XML file. |
| Authorised Product | Choose the Authorised Products that will be included in the XML file. |
There are sections that can be sent to EMA independently, and sections that can be sent in a set with other sections:
| Section | Description |
|---|---|
| Organisation (MAH, Sponsor) | Independent from other sections. |
| Source | Independent from other sections |
| Master File Location (MFL) | Independent from other sections. |
| ATC (Development ATC Code, Proposed ATC Code) | Independent from other sections. |
| Pharmaceutical Form (Development Pharmaceutical Form, Proposed Pharmaceutical Form) | Independent from other sections. |
| Route of Administration (Development Route of Administration, Proposed Route of Administration) | Independent from other sections. |
| Authorised Product | Independent from other sections, or in a set with the all other sections. |
| Attachment | Only in a set with an Authorised Product. |
If the operation type is changed from Update to Nullify and you perform the sort, entities with operation type Nullify are omitted and are not included in the sorting.
The Create XEVPRM Confirmation page enables you to choose the location where your XML file will be saved.
The system can save your file to the predefined location. If the Location for XEVMPD Submission field is set correctly during the server setup, then after selecting Next on the Create XEVPRM Confirmation page, the generated Submission XML file will be saved to that location. The predefined location is chosen by default on the Create XEVPRM Confirmation page. The information about the predefined location must be included in insight.var file. If you need to save your file to a folder other than the default, you can change the location manually.
- File System
- Documentum
You can change the location using the Browse button or clear the location with the Clear button.