Handling Agent Product Documents

| 2 minutes

A few documents are required from the Agent, when the Vendor that we are working with is unable to provide the said documents. Normally Agent documents include, but are not limited to:

• CTD Dossier and its parts
• BE Studies
• DMF
• Dissolution Studies

When a document is required to be obtained from our Agent, some information needs to be provided to the Agent so that the documents will be prepared according to the specifications of the products that we are actually registering, and also with the information of the Vendor that we are registering the product with.

Check Existing Agent Document Server

Over the years, many documents have been received from the Agent for various registrations. When a requirement for a document from an Agent is informed by BD Salesperson, RA Specialist must first check the Server to see whether this document has been provided prior. The process to check the documents are listed here:

1. Open the Server folder for product dossiers.

AdvaCare Cloud Server → Products → Dossiers
Location: Z:\Shared drives\AdvaCare Cloud Server\Products\Dossiers

2. Search the document by Product Type, Form, or Document Name.
3. Find the document that matches the product that requires this document.
Note: Document for a product with the same active molecules and form, even if the dosage strength is not the same, can be used.
4. Copy and paste the document to the Registration SO Folder - Documents from Agent to be revised in the next SOP.
5. If the required document is not in the folder, send a task to BD Salesperson to inform that the document needs to be sourced from the Agent and prepare the information required to provide to the agent from Vendor.

Preparing Information from Vendor

1. Open the Server folder to find templates to fill in for the Agent.

Registration Control Server → Registration Document Templates → Information for Agent
Location: Z:\Shared drives\AdvaCare Registration Control\Registration Document Templates\Information for Agent

2. Select the correct template for the intended document. Copy and paste the template to the Registration SO Folder - Information for Agent.
3. Fill in as much as possible the information of the manufacturer and product as much as possible. For information that is not clear yet, leave blank and ask the manufacturer to fill in.
4. If there is more than one product per Vendor, copy and paste the table under the first table and rename it table as “Product 2”, “Product 3”, etc.
5. If there is more than 1 Vendor, create a separate word file.
6. Send the document to the Vendor to fill in and provide the requested attachments.
7. After the filled in form has been received, check the information to make sure that they are correct and save them in the same folder.
8. Send a task to BD Salesperson to check the information from Vendors. BD Salesperson will then forward the files to BD Manager to be shared with the Agent.

Agent Product Document Received

1. When the product document from Agent has been received, BD Manager will send a task to RA Specialist with the location of the file. It is normally saved in the Registration SO Folder - Documents from Agent.
2. Unzip the file and do a quick check that the files are correct as per the requirements.
3. Save the same file in the Server folder for Dossiers.

AdvaCare Cloud Server → Products → Dossiers
Location: Z:\Shared drives\AdvaCare Cloud Server\Products\Dossiers

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