Countries List

Columns


Section	Column Name	Description
	Name	The country name. Click to view its Properties page. See Properties for a Country. On the countries list for a submission master record, you can expand the country name to see the list of submissions associated with that country.
	Type	Country.
	State	The current lifecycle state of the country: Active Inactive You might see an inactive country if it had been active when added to the list, but was made inactive after that point.
	Region Does not show in the list of countries for a submission master record.	A list of regions that include this country. Click to open the region.
Regulatory Information Section only shows for a submission and submission master record.	Status Only shows on the countries list for a submission.	When a submission relates to multiple countries, the status indicates if this country is a Primary or Secondary country for the submission. Only one country can be defined as the Primary country for a submission. See Context Menu for Countries.
	Market Authorization Holder	The organization that holds the market authorization for this product in this country. Click the name to view the Properties page for the organization.
	Regional Company Representative	The organization acting as the regional company representative for this product in this country.
	Distributors	The organizations that distribute the related product in this country.
	Prescription Specification	The prescription details for this product in this country.
	Registered Product Name	The registered name of the product for this country.
Submission Section only shows for a submission master record.	Regulatory Activity Category	The regulatory activity category defined for the submission.
	Regulatory Activity Sub Category	The subcategory for the activity category.
	Result	The results for this submission, either Approved, Rejected, or Withdrawn.
	Result Date	The date the results were entered.
	Continent Code Does not show in the list of countries for a submission master record.	The two-letter code for the continent where the country is located.
	Description	The full name of the country.

Actions/Toolbar Commands

For the list of countries for a regulatory request, only Regulatory Requestors can use these actions, and the regulatory request must be in the Create state.

For the list of countries for a submission template, only Regulatory Administrators can use these actions, and the regulatory authority or submission template must be in the Inactive state.

For the list of countries for a submission or document in a submission project folder, any person with at least the Regulatory User role can use these actions. You can use these commands until the Market Authorization milestone for the submission is completed. If the submission is in the Ready or In Work state, you must also provide a justification for adding or removing a country.

For the list of countries for a submission master record, no actions are available.

Action Name

Description

For More Information

Add Existing

Searches for and adds countries to the regulatory request or submission template.

Tip: When adding a country to a submission project, check the Regulatory Information page first. If the Follows Leading Country field on the Regulatory Information page uses the "As Defined" or "With Deviation" options, make sure a Leading Country is also defined.

You can only add active countries that are connected with the languages to the list.

For a submission template, you can only add countries from any associated regulatory authorities.

For a library, you can add a country to the document only if the language is added to the context country. For more information, see Adding Languages to Regions and Countries.

Rules for adding a country to a submission project:

You cannot add a country if already appears in the list for the submission master record, unless all market authorizations for that country are obsolete.
You can add countries until the submission project reaches the Submitted state.
You can add countries until the first market authorization milestone is completed. If the submission is beyond the Preliminary state, you also need to provide a justification, and Market Registration creates the associated market authorization and market authorization change for that country (one for each product covered by the submission master record).

About Searches and Justifying Changes to Submissions

Remove Selected

Removes the selected countries from the list. Click OK to confirm. You can only remove countries if the regulatory request is in the Create state or the submission template is in the Inactive state.

Market Registration also removes the languages associated with that country, unless the language is also used by another country associated with the context item.

Rules for removing a country from a submission project:

The related market authorization change cannot be beyond the In Work state.
Market Registration checks if the Dossier Submitted milestone is complete.
If it is, Market Registration also marks all related market authorizations as closed and market authorization changes as obsolete. The country is connected to the submission master record and is available to be added to regulatory activities. If done, new market authorizations and market authorization changes are created.

If the Dossier Submitted milestone is not complete, the related market authorizations and market authorization changes are deleted.

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Enable Edit

/ Disable Edit

Toggles between edit and view model. In edit mode, you can change the organization for the Market Authorization Holder and Regional Company Representative.

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Context Menu for Countries

The custom context menu (right mouse button) is only available on the category page for a submission. On other pages, the standard context menu opens. You can use these commands until the Market Authorization milestone for the submission is completed. If the submission is in the Ready or In Work state, you must also provide a justification for the change.

When using the Mutual Recognition Procedure (MRP) for submissions to the European Union regulatory authority, you designate the Reference Member State (RMS) by setting it as the Primary country. You then designate other countries as Concerned Member States (CMS) by setting them as Secondary countries.

When using the Centralized Procedure (CP) for submissions, you designate the Rapporteur country by setting it as the Primary country. You then designate other countries as Co-Rapporteur countries by setting them as Secondary countries.

You must be the submission lead to execute these actions, and the submission must be in the Preliminary state. You can use these commands until the Market Authorization milestone for the submission is completed. If the submission is in the Ready or In Work state, you must also provide a justification for adding or removing a country.


Action Name	Description
Set as Primary	Marks this country as the primary country for this submission. If any other country is marked as primary, this action removes the primary status from the other country.
Set as Secondary	Changes a primary country to a secondary country for this submission. The list of countries must include one set as the primary country before you can set any other countries as secondary.
Reset	Erases the value of the Status column for this country. If you reset the status for a primary country, the apps automatically resets the status for all secondary countries (to avoid having secondary countries without a primary country).