Registration Documents Database

| 6 minutes

Documents refer to a database of documents for registration of products in a country.

Getting started with Documents Database

Under the “Registration Module”, a dropdown will be shown when you hover over the top button “Documents”.

The drop down includes the following, and intended for as a Master List of:

1) Documents

All documents that exist in our system, it lists the documents that a Vendor can provide and/or documents that have been provided to a Customer in a registration. The table under Documents will have the following fields:

• Document Name
• Document Type - there are 3 types of documents as follows:
- Site Document: A document related to a manufacturing site of a Vendor, relating to a product range under that site but not related to a specific product. (eg. GMP for Pharmaceutical Injections)
- Product Document: A document that is product specific. (eg. COA, COPP)
- Registration Certificate: A registration certificate that has been obtained from the customer upon registration completion.
• Registration Agreement - the RA number in which a document was provided.
• Responsible Entity - referring to which party has provided the document.
• Vendor - the factory related to a document, can be either provided by the Vendor, prepared under the name of the Vendor, or registration completed with this Vendor.
• Product - filled if a document is related to a product under one of our registrations.
• Product Packaging - packaging information of the product.
• Expiration Date - the validity of a document. If a new updated document has been provided to replace the expired ones, Purchasing/RA Dept. is to revise the document expiration date.
• Registration Country - the country related to a document, can be either a document/registration certificate obtained from a Country MOH, or provided for registration in that Country.
• Sales Order - the SO number that the document was provided under.
• Customer Reference - the Customer related to the document, can be either document has been provided or registration certificates are obtained from.
• Status - there are 3 types of status as follows:
- Draft: documents under draft are NOT valid/have NOT been verified.
- In Progress: documents that have been verified but not present in the AC Drive.
- Complete: documents that are present in the AC Drive. All completed documents can be found in one of the following folders:
China Registrations:

Z:\Shared drives\AdvaCare Cloud Server\Manufacturers\Manufacturers\(Vendor Name)\Certificates

Z:\Shared drives\AdvaCare Distributors Cloud Server\(Customer Code) - (Customer Name) - (Country) - (Salespersons)\REGISTRATION DOCUMENTS\SOXXX\Final

India Registrations:

Z:\Shared drives\AdvaCare Purchase India Control\AdvaCare Purchasing\Manufacturers\Manufacturers\(Vendor Name)\Certificates

Z:\Shared drives\AdvaCare Purchase India Control\AdvaCare Purchasing\Registration\(SOXXX) - (Customer Code) - (Country) - (Salesperson)\REGISTRATION DOCUMENTS\Final

2) Required Documents

All documents any Country MOH may require. The documents under this list are to be added to Customer contact cards and their Registration RA based on each Customer requirements. The table under Required Documents will have the following fields:

• Document Name - consistent with the Document Name under Documents.
• Document Type
• Category - referring to the category a document is applicable to.
• Responsible Entity

3) Registration Certificates

All completed registrations under AdvaCare with any Country MOH. In the system, a registration certificate is called CPR (Certificate of Product Registration). The table under Registration Certificates will have the following fields (* meaning there is only one option):

• Document Name*
• Document Type*
• Registration Agreement - the RA number that the registration was handled in.
• Responsible Entity*
• Vendor - the Vendor which registration was done under.
• Product - product registered.
• Product Packaging - packaging registered.
• Expiration Date - validity of the Certificate of Product Registration.
• Registration Country - the country that each product is registered in.
• Sale Order - SO# of the registration product.
• Customer Reference - the Customer which registration was done with.
• Status - there are 3 types of status as follows:
- Draft: CPR has expired and is due for renewal.
- In Progress: CPR is either being renewed or we have yet to receive a newly completed registration certificate.
- Complete: CPR is valid and currently in the AC Drive. All completed CPRs can be found in these folders:

Z:\Shared drives\AdvaCare Distributors Cloud Server\(Customer Code) - (Customer Name) - (Country) - (Salespersons)\REGISTRATION DOCUMENTS\Registration Certificate\SOXXX

Z:\Shared drives\AdvaCare Cloud Server\Manufacturers\Manufacturers\(Vendor Name)\Registration Certificates

Z:\Shared drives\AdvaCare Registration Control\Countries\(Country)\Registration Certificates

4) Authentication

All document authentications (legalization/notarization) any particular Country MOH may require. The documents under this list are to be added to Customer contact cards and their Registration RA based on each Customer requirements.. The table under Authentication will have the following fields:

• Internal Reference
• Document name
• Document Type
• Authentication - shows either “Legalization”, meaning required to be legalized under a country embassy, or or “Notarization” at the local Notary Office/CCPIT.
• Product Range

Using the Documents Database

The following provides standard instruction to use the Documents database and its main objectives.

a. Open the “Registration Module”, hover to the top button “Documents” and select “Documents”
b. A search functionality and table will appear on the screen. Type the document Name that is required. It is also possible to Quick Search by “Product Name”, “Vendor”, “Registration Country” or “Customer Reference”.

c. Click “Enter”.
d. A table will layout searched documents.

Note: It is also possible to search multiple different fields at the same time.

Some useful functionalities of the Documents database includes:

• Checking possible Vendors for registration in a Country

Some countries have strict requirements in which physical site inspections by the MOH are required before registration can be completed, or a reference country (stricter country) MOH registration must be completed. BD Salesperson/Purchasing Dept. can check the database to find compatible Vendors for better efficiency when working on an RFQ.

• Checking if Required Product Document has been obtained from previous registration

Some technical documents such as SmPC (Summary of Product Characteristics) contain basic information of a product from a vendor that can be reused with minimal revisions. Rather than asking for the same documents multiple times from the same vendor, RA Dept. can first check the database if it has been received previously.

• Checking if a Product Document required from an agent has been previously purchased

Some documents such as CTD Dossier, BE Studies can be reused for different registrations even with different Vendors. Before purchasing a new required product document from the Agent, BD Salesperson/RA Dept. can check whether these documents have existed before.

Note: only the documents with Responsible Entity “Agent” can be reused for a different Vendor.

Using the Registration Certificate Database

The following provides standard instruction to use the Registration Certificate database and its main objectives.

a. Open the “Registration Module”, hover to the top button “Documents” and select “Registration Certificates”
b. A search functionality and table will appear on the screen, with a preset filter “Registration Certificate”.
c. The document name will be the same for all Registration Certificates, type and select one of the Quick Search options by “Product”, “Vendor”, “ , “Registration Country” or “Customer Reference”.

d. Select the relevant Registration Certificate.
e. More information will be displayed under each CPR. The following are some important information that was not shown on the table:

- Marketing Authorization Holder: the owner of product registration recognized by the Country MOH.
- Brand Name: brand name of the product registered.
- Issue Date: date of issuance of the CPR.
- Info: additional information relevant to the product packaging. (eg. Some country registration does NOT include Vendor name in the CPR and requires no vendor information on the product packaging).

Some useful functionalities of the Registration Certificate database includes:

• Examining registration possibility in a certain country
• Using CPR in one country for submission in another country as a requirement
• Checking all completed registrations in a country
• Confirming registered Vendors for an Order RFQ of a completed registration

After product registration completion, Customer will start an order of the product. When working on an RFQ, Purchasing/BD Salesperson/AM Salesperson can check all information relevant to the registration including Vendor, Packaging, Brand Name, and additional Info for the packaging.

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