Market Authorization Changes List | ||||
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Columns
| Section | Column Name | Description | |||||
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| Name | The automatically-generated name for the market authorization change. Click to open the market authorization change. On the list page for a submission, the first row shows the name of the submission project, and the child rows show the names of the market authorization changes. | ||||||
| Type | The item type: Market Authorization Change. | ||||||
| Title | The descriptive name for the market authorization change. When created, the app generates the name but not the title. You can edit the properties for the market authorization change to give it a title. | ||||||
| State | The current lifecycle state. | ||||||
| Dossier Submitted | This column only shows a value while the market authorization change is in the In Work state.
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| Products | The number of products covered by this market authorization change. Click the number to open the list of products covered by the market authorization change. | ||||||
| Parts | The number of parts covered by this market authorization change. Click the number to open the list of parts covered by the market authorization change. | ||||||
| Country | Country | The country where this market authorization is valid. Click to open the Properties page for the country. | |||||
| Market Authorization Holder | The organization that is 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 for this country. | ||||||
| Registered Product Name | The registered name of the product for this country. | ||||||
| Authorization | Number | The authorization number for the product. | |||||
| Approval Date | The date of the approval of the market authorization. | ||||||
| Start Effectivity Date | The effective state date of the market authorization. | ||||||
| Expiration Date Required | Yes or No indicating if an expiration date is required for this market authorization. By default, the value for the expiration date required is selected as No. | ||||||
| Expiry Date | The expiry date of the market authorization. | ||||||
| Renewal Notification Interval | The number of days between notifications that the market authorization needs to be renewed. | ||||||
| Sunset Clause Date Required | Yes or No indicating if a sunset clause date is required for this market authorization. By default, the value for the sunset clause date required is selected as No. | ||||||
| Sunset Clause Date | The date by which if the company does not commercialize the product, the market authorization might be lost. | ||||||
| Sunset Clause Notification Interval | The number of days between notifications that the date for the sunset clause is approaching. | ||||||
| Submission | Context | Shows the name of the related submission project. Click to open the default page for the submission project. | |||||
| Result | Indicates if the change was approved or rejected. | ||||||
| Result Date | The actual finish date of the first regulatory milestone with a regulatory purpose set to market authorization. | ||||||
| Scope of Authorization | Shows Restricted if the regulatory activity category is Restricted Authorization. For all other regulatory activity categories, shows as Full. | ||||||
| Description | Additional descriptive information about the market authorization change. |
Actions/Toolbar Commands
These commands show on the Market Authorization Change page for a submission project. The list of market authorization changes for a market authorization has no actions.
Required access role: Regulatory User
| Action Name | Description | For More Information |
|---|---|---|
Approve  | Approves the selected market authorization change. Enters None as the result action on the market authorization. The market authorization change must be in the In Work state. If the selected market authorization is Released, Market Registration promotes the market authorization change to Approved. When those changes reach their start effectivity dates, the app automatically promotes the changes to Closed. | - |
Approve For Update  | Approves the selected market authorization change. Enters Update as the result action on the market authorization. The market authorization change must be in the In Work state. If the market authorization is in the In Work state, the app promotes the market authorization and the market authorization change to Approved. When these items reach the start effectivity date, the app automatically:
If the market authorization is in the Released state, the app promotes the market authorization changes to Approved. When those changes reach their start effectivity dates, the app automatically promotes the changes to Closed and copies the regulatory information from the change to the market authorization. | - |
Approve For Obsolesence  | Approves the selected market authorization change. Enters Obsolete as the result action on the market authorization. | Making Market Authorizations Obsolete |
| Close | Closes the selected market authorization changes. You can only close market authorizations for submissions that use Variation or Repeal as the regulatory activity category. The associated market authorization change must be in the In Work state. You can close the market authorization prior to the submission's Dossier Submitted milestone, or all Regulatory Milestones that use the Market Authorization purpose, are complete. | Closing Market Authorization Changes |
Enable Edit | Toggles into edit mode. | - |
Disable Edit  | Toggles into view mode. | - |