Getting Started with the Registration Agreement (RA)

Registration Agreement (RA) refers to an agreement between Vendor and AdvaCare (on behalf of a Customer) to start a registration process of a list of products in a country. In the system, RA is the platform used to keep track of a registration status under this agreement in the ERP system.

Getting started with the RA

Once the RA Specialist is clear on the list of documents and where the documents will come from, they can start to work on the system RA. When opened, the Registration Agreement (RA) page shows an overview the following information for a RA Specialist to check:

GENERAL INFORMATION

The general information of an RA can be found on the main top part of the page. It includes some basic information such as the assigned RA Specialist, SO#, BD Salesperson, Vendor, etc. Some important details to be aware of are:

• Priority

An RA will be assigned a priority level between 1-3, with 3 being the most important. The level of priority is important for RA Specialist to assess which registration to prioritize when there is a backlog of workload.

• Vendor: manufacturer that we are registering with for this registration. It is important that documents reflect the manufacturer information correctly. The manufacturer will be producing the products for distribution in the registering country after registration completion.

• Customer Reference: name of the Customer.

• Export Country: intended country for registration. Information regarding the regulatory requirements of that country in general (not related to this particular Customer), can be accessed from here.

• Range: type of products under this registration. Registration requirements within a country can vary depending on its range.

• Site Registration

This checkbox is normally left blank for product registrations.

If this checkbox is ticked, it means that the registration is only for SITE REGISTRATION at the moment. The product list is to be ignored for now. In most cases, registration can go straight to PRODUCT REGISTRATION which is approval of a specific product by submission of the product technical dossiers with some information of the manufacturing site. However, some countries require the approval of the Site first before even starting with product registration.

Note: Site Registration refers to the process of getting approval of a manufacturing site under a country’s GMP standards.

• Authentication

Shows whether there are any documents that may require Notarization, Legalization, or Apostille for this registration.

IMPORTANT INFORMATION (in the tabs)

• Products

The list of products and its packaging that is to be registered with this Vendor.

• Document Types

The Document Types tab is the most important part of the RA. It is the list of documents that will be required in this registration, this list is created by BD Salesperson as per the Customer’s list of requirements. The list summarizes:

1. Document Name: referring to the documents required

2. Document Type: there are two types of documents.

2.1 Site Documents will be listed on the top, meaning that these documents are related to the actual manufacturing site and NOT specific to a product (eg. GMP).

2.2 Product Documents will be listed at the bottom. Meaning that each product will require these documents.

3. Responsible Entity: there are four possible responsible entities.

3.1 Vendor: the document is to be obtained from the Vendor.

3.2 Agent: the document is to be/already purchased from the Agent and to be edited.

3.3 AdvaCare: the document is prepared by AdvaCare, usually Salesperson.

3.4 Customer: the document is to be prepared by the Customer.

Note: RA Dept. is responsible to ensure that all documents from Vendor and Agent are completed and revised according to standards for MOH submission.

• Site Documents

This table tracks the Site Documents, or the quality/technical documents, that the Vendor has confirmed they have for their production site, in relation to the list of documents required from Document Types. It shows the list of site documents that the Vendor has provided, or can provide. There are three ways it will show on the table based on the “Received” checkbox:

1. Ticked - the document has been provided and can be found in the Manufacturer folder.

2. Not ticked - Purchasing/RA Dept. has confirmed with the Vendor before that Vendor has this certificate, but the certificate copy has not been received/saved in the Server.

3. Site Document does not show at all - if a site document is in the list of required documents but does not show on this table, it does not mean that the Vendor cannot provide it. Purchasing Dept. must have confirmed that the document can be provided. RA Specialist can communicate with Vendor directly to get these documents.

• Authentication

If the “Authentication” checkbox is ticked, it means that some documents will require legalization/notarization. Under the table, a list of documents (Site and Product) that require authentication will be shown. In the column “Authentication” will be the process needed for each document, whether to legalize at the local embassy or to notarize.

Note: “Legalization” also covers the requirements for document Apostille. The two in general are interchangeable as they require an official body recognized by the requesting country: Embassy - Legalization, Hague Convention - Apostille.

After checking all information of the RA, RA Specialists will start working with the Vendor/India Purchasing Person based on the requirements of the RA. If anything is not clear, send a task to BD Salesperson to clarify. If everything is clear, proceed to create Product Registrations (PR).

Checking the RA

Start by checking the following information on the RA:

1. Product List

2. Required Documents (Document Types tab)

3. Document Authentication

Cross-check whether the product list and required documents are corresponding. Check as well if the list of documents required under the Handover Task and Task Description are consistent with the document list under the RA.

Note: Some documents may have slightly different terminology used to describe them. As long as the essence of the document remains the same, the small differences can be ignored.

Note: In general, each document has the pre-assigned “Responsible Entity”, for example: CTD Dossier - Vendor. In the actual process, there are times when the document needs to be sourced from other entities. BD Salesperson will inform this in the handover task.

If there are inconsistencies between requirements mentioned in the task description in comparison to the RA, send a task to BD Salesperson to make the changes. If everything is consistent and RA is ready to be started, proceed to the next part of this SOP.

Moving to the Next RA

If the Registration SO has more than 1 RA (more than 1 Vendor that we are registering with), RA Specialist needs to check the other created RA(s) as well.

Use the breadcrumbs to return to the Task page and locate the other RA(s) from “Opportunity Info” - “Registrations” section again.