GLOBAL PRODUCT REGISTRATION

[Pages:17]GLOBAL PRODUCT REGISTRATION

Distributor Training Leo Catt, Sr Regulatory Specialist

AGENDA

? Roles and Responsibilities ? Request Process Flowchart ? System Requirements ? Form elements and submitting a request ? Form questions ? Pending Registration Flowchart ? Tips and Tricks

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ROLES AND RESPONSIBILITIES

Group

Distributor

Responsibility

? Requesting documents for the purposes of product registration. ? Presenting documentation to the government body for the purposes of

product registration.

Regulatory Affairs

Regional Sales Managers (RSM)

? Fielding registration requests. ? Tracking registration status and workflows. ? Collecting and preparing proper documentation to present to government

bodies. ? Tracking received registration certificates and initiate renewal processes.

? Field business from international customers to justify registrations for that country.

? Approve registration requests that come from distributors. ? Estimate revenue resulting from registrations.

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SYSTEM REQUIREMENTS

? Any Modern Web Browser ? Email Client ? Access to

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GPR ? Approval Process

Start Process

Request GPR

Notification ? Sales Manager &

Distributor

Approve Request

YES

Email Notification of Approval

NO

Email Notification Of Rejection

Email Notification of Rejection

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Process Moves to RA

End Process

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THE PRODUCT REGISTRATION REQUEST FORM ELEMENTS

Web Address:

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DISTRIBUTOR ID / REGISTRATION TYPEDISTRIBUTOR ID / REGISTRATION TYPE

Field

Definition

Distributor ID

Security field ? for now, Populate with "N/A"

Registration Type Request Types

New Registration ? Products Registered for the first time.

Renewal Registration ? Registered products needing a renewal of the registration Certificate.

Tender ? Bid for business within a country.

Custom Clearance ? Documentation for Customs to let product in a country.

Factory Inspection ? Documentation for QMS 13485 regulation.

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DISTRIBUTOR INFORMATION

Field

Distributor Name

Definition

Name of Distributor Company or Person.

Distributor Email

Distributor Phone

Country to be registered

Method of delivery

Contact Email for the Distributor.

Contact Phone Number for the Distributor. Country the product will be registered. The Method in which documents will be delivered to the distributor.

By Checking the "Ship to" box, the "Ship to Address" text box will appear.

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