Market Authorizations 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.

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 However, you can move a market authorization to the Obsolete state by changing its status to Withdrawn.

You can view market authorizations for a submission master record or a list of related market authorizations for a specific market authorization.

Required access role: Regulatory User

To view market authorizations for a submission master record:

  1. Open the required submission master record. See Opening a Submission Master Record.
  2. In the navigation pane, click Authorizations.
  3. Click the Market Authorizations page tab.

    This page lists market authorizations and expands to show related market authorization changes.

To view market authorizations related to a market authorization:

  1. Open the required market authorization. See Opening a Market Authorization.
  2. In the navigation pane, click Related Market Authorizations.
  3. View either the Leading Market Authorizations or Following Market Authorizations page tab.

A submission project lists related market authorization changes. See Market Authorization Changes List.

This topic describes:

This page discusses:

See Also
Market Authorization and Market Authorization Change Properties

Columns

SectionColumn NameDescription
NameThe automatically-generated name for the market authorization or market authorization change. Click to open the Properties page.

The list of all market authorizations does not expand. Click on the name or use the Related Changes page to view the market authorization changes.

The Market Authorization page for a submission master record expands to list market authorization changes, plants, manufacturing sites, and storage conditions.

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

In the list for a submission master record and Leading Market Authorization or Following Market Authorization tabs, the products are shown at the end of this section.

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

In the list for a submission master record and Leading Market Authorization or Following Market Authorization tabs, the country is shown in the Country section.

The country associated with the item. Click to open the Properties page for the country.
TypeThe item type: Market Authorization or Market Authorization Change, or other related item.
TitleThe descriptive name for the market authorization or market authorization change. When created, the app generates the name but not the title. You can edit the properties for the item to give it a title.
StateThe current lifecycle state.
Context

In the list for a product, submission master record, and Leading Market Authorization or Following Market Authorization tabs, the context is shown in the Submission section.

On rows for market authorizations, shows the name of the related submission master record.

On rows for market authorization changes, shows the name of the related submission project. Click to open the item.

CountryMarket Authorization HolderThe organization responsible for holding the market authorization for any product in this country. Click to open the Properties page for the organization.
Regional Country RepresentativeThe organization that acts as the company's regional representative in this country. Click to open the Properties page for the organization.
DistributorsThe organizations that distribute the product in this country. Click to open the Properties page for the organization.
Prescription SpecificationThe prescription details of the product for this country.
Registered Product NameThe registered name of the product for this country.
Mfg. SiteThe site authorized to manufacture the product in this country.
Authorization

These columns are blank until the market authorization change is released.

NumberThe authorization number for the product.
Approval DateThe date of the approval of the market authorization.
Start Effective DateThe effective state date of the market authorization.
Expiration Date Required

Only shows on the list for a product, submission master record, and Leading Market Authorization or Following Market Authorization tabs.

Yes or No to indicate whether the expiration date must be specified prior to completing the submission project.
Expiry DateThe expiration date of the market authorization.
Renewal Notification Interval (in days)

Only shows on the list for a product, submission master record, and Leading Market Authorization or Following Market Authorization tabs.

The number of days prior to the renewal date that Market Registration sends an email notification to the Regulatory Lead for the related submission project.
Sunset Clause Date Required

Only shows on the list for a product, submission master record, and Leading Market Authorization or Following Market Authorization tabs.

Yes or No to indicate whether the sunset clause date must be specified prior to completing the submission project.
Sunset Clause DateIf the company does not commercialize the product by this date, the market authorization might be lost.
Sunset Clause Notification Interval (in days)

Only shows on the list for a product, submission master record, and Leading Market Authorization or Following Market Authorization tabs.

The number of days prior to the sunset clause date that Market Registration sends an email notification to the Regulatory Lead for the related submission project.
Renewal Due

Does not show for Leading Market Authorization or Following Market Authorization tabs.

The date by which the market authorization must be renewed.
Scope

Shows in the Submission section for Leading Market Authorization or Following Market Authorization tabs.

Shows Restricted if the regulatory activity category is Restricted Authorization. For all other regulatory activity categories, shows as Full.
Context

On rows for market authorizations, shows the name of the related submission master record.

On rows for market authorization changes, shows the name of the related submission project. Click to open the item.

Submission

or

Renewal

Application

Does not show for Leading Market Authorization or Following Market Authorization tabs.

Displays either a link to the submission associated with the market authorization or icon that allows the Regulatory Lead to add to an existing renewal.

IconMeaning
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 OnThe date on which the dossier for market authorization renewal was submitted.
Result

Only shows a value for a market authorization change, and for Leading Market Authorization or Following Market Authorization tabs.

Indicates whether the change represented by the market authorization change was approved or rejected.
Result Date

Only shows a value for a market authorization change, and for Leading Market Authorization or Following Market Authorization tabs.

The actual finish date of the first regulatory milestone with a regulatory purpose set to market authorization.
Description

Only shows a value for a market authorization change, and for Leading Market Authorization or Following Market Authorization tabs.

Descriptive information about the market authorization.

Actions/Toolbar Commands for Related Market Authorizations

The Leading Market Authorizations tab lets you define a leading/following relationship between market authorizations for two countries. The Following Market Authorizations tab does not have any actions available.

Note: To define the leading/following relationship, view the Related Market Authorizations page for the following country.

Required access role: Regulatory Administrator

Action NameDescription
Add Existing Searches for and adds an existing market authorizations to the list. You also need to provide a justification. You can only add a market authorization to an empty list.

When the submission project defines a leading country, Market Registration takes care of adding the required leading market authorization. However, if that relationship was not defined, you can define it now.

Remove Selected Removes the selected market authorization from the list. Click OK to confirm. You also need to provide a justification.

If a following country no longer follows the leading country (for example, its regulatory authority now evaluates submissions without relying on the results from another country), you can remove the leading market authorization form the list.