At the beginning of the registration process, BD Salesperson has created RA and informed RA Dept./India Purchasing Dept. to proceed with getting registration documents from the Vendors. At the same time, some documents are to be provided from AdvaCare’s side which is prepared in-house, and documents that are needed from the Agent. This SOP explains the steps to handle these documents.
Firstly, make sure that all Registration related documents are saved in the correct folders:
• China Registration:
Z:\Shared drives\AdvaCare Distributors Control\”Distributor Name”\REGISTRATION DOCUMENTS\”SOXXXX”
• India Registration:
Z:\Shared drives\AdvaCare Purchase India Control\AdvaCare Purchasing\Registration\”Registration Number”\REGISTRATION DOCUMENTS
AdvaCare Registration Documents
On the Registration Agreement (RA), it is quite obvious which documents are to be prepared in-house almost exclusively. These documents have the “Responsible Entity” of “AdvaCare”. These are the standard AdvaCare Registration Documents and the steps how to prepare the documents:
JV Declaration Agreement
1. Check to see if the JV Agreement required is already in the server. BD Salesperson can check this from the Registration Agreement (RA) page with this Vendor, and clicking on the Site Documents tab. If the JV Declaration Agreement is already saved in the Manufacturer folder, the checkbox will be ticked on the RA.
2. If not, click the “Print” button on the RA page, and click “Joint Venture Declaration Agreement” option on the dropdown.
3. Save the draft in the Manufacturer Folder - AdvaCare Declaration of Joint Venture Partnership subfolder.
4. Send a task to RA Dept. to send the draft to the Vendor to add their logo and sign/stamp the letter.
5. After the signed/stamped copy has been received, print it out and ask Sales Dept. Manager to sign/stamp.
6. Scan the final document and save the file in the same Manufacturer Folder - AdvaCare Declaration of Joint Venture Partnership subfolder and the registration folder under the name:
“Vendor Name” - AdvaCare DECLARATION OF JOINT VENTURE PARTNERSHIP (signed by all)
3-Party Manufacturing Agreement
Note: Prior to signing any 3-Party Manufacturing Agreement, BD Salesperson must first ask Purchasing Dept. to sign a CPA with the Vendor as it contains Customer information.
1. Open the Registration Agreement (RA) of the specific Vendor which 3-Party MA is required.
2. Click “Print” and click on the “Manufacturing Agreement (3 party)” option from the dropdown.
3. The 3-Party MA draft will be downloaded, save this template in the Distributor Folder - 3 Party Manufacturing Agreement subfolder.
4. Edit the information on the 3-party Manufacturing Agreement draft as required and save the file in PDF format.
5. Send the PDF MA draft to the Customer to confirm if all contents are acceptable. Make revisions as required. Note that some major revisions will require approval from BD Dept. Manager and VP of Sales.
6. After Customer has confirmed the draft, BD Salesperson can ask Purchasing Dept. to send the same draft to the Vendor to sign/stamp.
7. After signed/stamped by the Vendor, print out the copies and ask Sales Dept. Manager to also sign/stamp.
8. Scan the signed/stamped copies and save it in the same Distributor Folder - 3 Party Manufacturing Agreement subfolder.
9. Send the scanned copies to the Customer and ask them to sign/stamp the document. Once received, save the final document in Distributor Folder - 3 Party Manufacturing Agreement subfolder, Distributor Folder - Documents from Factory subfolder, and the registration folder.
Letter of Authorization (LoA)
1. Open any RA related to the Customer.
2. Click “Print” and click on the “Letter of Authorization” (LoA) option from the dropdown.
3. The LoA draft will be downloaded, save this template in the registration folder.
4. Edit the information on the LoA draft as required and save the file in PDF format.
5. Send the PDF format to the Customer and confirm if all contents are acceptable.
6. After Customer has confirmed the draft, BD Salesperson can print the LoA and ask Sales Dept. Manager to sign/stamp the document.
7. Scan the signed/stamped copies and save it in the same registration folder - FINAL subfolder.
Others
Other AdvaCare documents that may be required in a registration have the templates accessible in this location:
Z:\Shared drives\AdvaCare Cloud Server\Templates\Business Templates
Make sure to copy & paste the template to the registration folder before making any edits.
Agent Registration Documents
Some documents have to be obtained from the Agent. In order to do so, follow these steps:
1. BD Salesperson must have informed RA Dept. at the beginning of the registration process which documents will be required from the Agent.
2. BD Salesperson must confirm with RA Dept. whether the documents required for specific products have previously already been acquired from the Agent and are in the system. If the document is not in the system, RA Dept. will notify BD Salesperson to get the documents from the Agent.
3. BD Salesperson will send a task to BD Dept. Manager and Sales Dept. Manager on the list of product documents needed from the Agent.
4. BD Dept. Manager will send a task with the cost of each document and the final cost of all documents.
5. BD Salesperson must confirm via task if the final cost is acceptable to BD Dept. Manager and Sales Dept. Manager. At the same time, send a task to Accounting Dept. to record this cost under the registration SO.
6. Send a task to RA Dept. to prepare the Information for Agent template for each product. RA Dept. may take some time to prepare this information as they have to be first obtained from the Vendors.
7. Once the filled in Information for Agent templates are ready and saved in the registration folder, BD Salesperson must check and confirm if the following informations are correct as per the registration:
• Type of document required from Agent.
• Manufacturer Name & Address.
• Product Generic and Brand Name (should be the same as packaging).
• Product Dosage/Strength, Form and Packaging.
8. After the information is confirmed correct, send a task to BD Dept. Manager to send the templates to the Agent to start preparing the required documents
9. BD Dept. Manager will send a task when the documents have been received from the Agent.
10. Send a task to RA Dept. to start revising the Agent documents as per this registration requirement.
11. Once completed, RA Dept. will save the final document in the registration folder - FINAL subfolder.