Market Authorizations Renewals List

Market Registration automatically creates a market authorization and associated market authorization change for a submission project when that submission reaches the Ready state. Any product or country added to the submission project after that point also generates a new market authorization. The Market Authorizations renewals list only shows released market authorizations that are eligible for renewal.

Required access role: Regulatory User

You cannot manually delete market authorizations. If you remove a country or product from a submission project, Market Registration automatically deletes all market authorizations and market authorization changes associated with that country or product. You cannot remove a country or product from the submission after the dossier submitted milestone. However, you can move a market authorization to the Obsolete state by changing its status to Withdrawn.

To view market authorizations renewal information, click Home .

To view market authorizations for a product, open the required product. See Opening the Regulatory and Additional Details Categories for a Product. The Market Authorizations tab is displayed by default.

To view market authorizations for a country, open the required country. See Opening a Country. The Market Authorizations tab is displayed by default.

This topic describes:

This page discusses:

Columns

Section Name Column Name Description
Name The automatically-generated name for the market authorization. Click to open the Properties page.
MAC

This column do not display when the page is filtered by Product & Country, Country & Product, and Product.

 The number of market authorization changes that are associated with the market authorization. Click to open the list of market authorization changes.
Products

This column does not appear when viewing the list of market authorizations for a product.

The number of products covered by this market authorization. Click the number to open the list of products covered by the market authorization.
Country

This column does not appear when viewing the list of market authorizations for a country.

The country associated with the market authorization. Click to open the Properties page for the country.
Type The item type: Market Authorization
Title The descriptive name for the market authorization.
State The current lifecycle state of the market authorization.
Country

Columns do not display when the page is filtered by Authorization Info. or when it is accessed from the Market Authorizations category for a country.

Market Authorization Holder The organization responsible for holding the market authorization for any product in this country. Click to open the Properties page for the organization.
Regional Country Representative The organization that acts as the company's regional representative in this country. Click to open the Properties page for the organization.
Distributors The organizations that distribute the product in this country. Click to open the Properties page for the organization.
Prescription Specification The prescription details of the product in this country.
Registered Product Name The registered name of the product for this country.
Mfg. Site The manufacturing site for the product in this country.
Authorization

Columns do not display when the page is filtered by Country Info.

Number The market authorization number for the product.
Start Effective Date The effective state date of the market authorization.
Expiry Date The expiration date of the market authorization.
(Renewal Status) Indicates the status of the market authorization relative to its key dates:

Icon Meaning
Current date is before the market authorization's renewal date or if there is no expiry date available.
Current date is between the market authorization's renewal date and its expiry date.
Current date is after the market authorization's expiry date.

Renewal Due The date by which the market authorization must be renewed.
Scope Shows Restricted if the regulatory activity category is Restricted Authorization. For all other regulatory activity categories, shows as Full.
Context The name of the related submission master record. Click to open the Properties page for the submission master record.
Renewal Application Displays either a link to the submission associated with the market authorization or icons that allow the Regulatory Lead to create a renewal or add to an existing renewal.

Icon Meaning
Create Renewal

Action not available when the page is accessed from the Market Authorizations category for a country or product.

Creates a renewal submission project for selected market authorization that has an expiry date (irrespective of the due date). The submission project is created in the Ready state.
Add to Renewal

Action not available when the page is accessed from the Market Authorizations category for a country or product.

Adds to an existing renewal submission project for the market authorization. You cannot add renewal submission projects in the Preliminary state.
Renewals are shown with a comma-separated list of dates on which they were submitted.

Submitted On The date on which the dossier for market authorization renewal was submitted.

Filters

The market authorizations renewals list can be filtered in two ways: by market authorization status and by information type.

Filters are not available when the page is accessed from the Market Authorizations category for a country or submission master record; or from the Market Authorizations tab in the Regulatory category of a product.

Status Filter Description
Current Lists only the released market authorizations that are currently effective. This is the default page view.
Applied For Lists only the released market authorizations where a renewal has been applied for and a dossier has been submitted.
Active Lists only the released market authorizations that are currently active.

Information Type Filter Description
Authorization Info. By default, the list of market authorizations is displayed using this filter. Shows the generic columns and the columns that contain market authorization information, grouped by country by default. You can use the Group By, Then By and Finally By filters to further group the market registrations by the other columns.
Product & Country Shows all of the columns, grouped first by product and then by country. This is the default page view.
Country & Product Shows all of the columns, grouped first by country and then by product.
Product Shows all of the columns, grouped only by product.
Country Info. Shows the generic columns and the columns that contain country information, grouped by country by default. You can use the Group By, Then By and Finally By filters to further group the market registrations by the other columns.
All Info. Shows all of the columns, grouped by country by default. You can use the Group By, Then By and Finally By filters to further group the market registrations by the other columns.

On the market authorizations renewals list for a submission master record, you can select what shows when you expand an item in the list.

View Name Description
Market Authorization Changes Shows the related market authorization changes when you expand a market authorization. You can expand the market authorization change to view the related submission project.
Leading Market Authorization Shows the market authorizations that this one follows. You can expand that one to view its associated market authorization change.
Following Market Authorizations Shows the market authorizations that follow this one. You can expand that one to view its associated market authorization change.

Actions/Toolbar Commands

These actions on the Market Authorization renewals list page are available only for market authorizations that have an expiry but do not already have a renewal submission project created for them.

These actions are not available when the Market Authorization renewals list page is accessed from the Market Authorizations category for a country or submission master record; or from the Market Authorizations tab in the Regulatory category of a product.

Required access role: Regulatory Lead

Action Name Description For More Information
Create Renewal Creates a renewal submission project for selected market authorizations that have expiry dates (irrespective of the due date). The submission project is created in the Ready state.

When creating a renewal for multiple market authorizations at once, a single renewal submission project will be created for all selected market authorizations.

Creating Submissions
Add to Renewal Allows you to search for and select an existing renewal submission to add the market authorization to. You cannot add renewal submission projects in the Preliminary state.

You can only add market authorizations to an existing renewal submission project that has the same submission master record.

When adding multiple market authorizations to an existing renewal submission project at once, all selected market authorizations must have the same submission master record.

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You can perform these actions on the Market Authorization renewals list page for a specific submission master record. You can use these commands with selected market authorizations, but not with selected market authorization changes.

Required access role: Regulatory Administrator

Market Registration notifies the owners of the market authorization and submission master record, plus all regulatory administrators whenever any of these actions are performed.

Action Name Description For More Information
Suspend Selected Promotes the selected market authorization to the Suspended state.

You can only suspend Authorized or Released market authorizations, and you must provide an explanation (justification) for this action.

For an Authorized or Released market authorization, the associated market authorization change is either Approved or Closed.

The app promotes the Approved market authorization change to Closed when it reaches the effectivity date, but only if the related market authorization is in the Authorized or Released state. For a Suspended market authorization, the app checks daily to determine if the it has been resumed. If so, the market authorization change is promoted to Closed.

Justifying Changes to Submissions
Resume Selected Returns the market authorization to the state it was in when it was Suspended (Authorized or Released). You must provide an explanation for resuming the market authorization.

If the start effective date for an Authorized market authorization has passed, the app automatically promotes it to Released.

Revoke Selected Makes the selected market authorizations Obsolete and enters Revoked as the status. You can only revoke a Suspended market authorization, and you must provide an explanation.