After the initial registration requirements have been completed and provided to the Customer, oftentimes the Customer/Country MOH will come back with queries for additional information or revisions. In this case, BD Salesperson will send a task to RA Specialist to work on these additional/revision requirements. Status of the relevant PR and RA will also be changed to “REVISION”. Following are the steps on how to handle these queries while keeping all information organized:
1. After receiving the task, read the task carefully as soon as possible before even considering starting with the revisions. If any points are not clear, send a task back to BD Salesperson immediately to clarify these points. Once the task is clear and understood, schedule the new requirements based on the work priority.
2. Any revisions/additional documents needed from the Vendor should be communicated with them as soon as possible. Confirm if requested revisions can be made. After confirmation, send a task to BD Salesperson to inform the estimated date revised documents can be completed.
3. For revisions that can be done in-house, schedule the time to work on said revisions and send a task to BD Salesperson to provide the estimated completion date.
4. Open the RA/PR, depending on the type of amendments, follow these steps:
• Revision to existing document: change the status of the document back to “In Progress”.
• Additional documents: BD Salesperson must have added them in the RA. For product documents, open the PR and click “GENERATE DOCUMENTS” on the top left part. The newly added document will be created under this PR without making any changes to the existing ones. Change the status of the document to “In Progress”.
5. Under the Registration Folder - Final, move the older version of the document in a new “Old” folder under the current file location.
6. Once each revised document is completed, save in the revisions folder and send a task to inform BD Salesperson.
7. After all revisions have been completed and confirmed by the BD Salesperson, change the document status back to “Complete”.
8. Update the registration milestone REG: 14. Document Revisions Completed.
After all revisions have been sent to the Customer, BD Salesperson will change the RA/PR status back to “PROVIDED ”.