Market Authorization and Market Authorization Change Properties | ||
| ||
Fields
| Section | Field Name | Description |
|---|---|---|
| Name | The automatically-generated name for the market authorization. | |
| Type | The item type: Market Authorization | |
| Title | The descriptive name for the market authorization. | |
| Description | Description for the market authorization. | |
| State | The current lifecycle state. | |
| Dossier Submitted | When the market authorization supports a submission project that uses the Initial Submission regulatory activity: Shows as blank until the milestone that has the Dossier Submitted purpose has been marked complete, then shows Yes. | |
| Submission | The submission project associated with this market authorization or market authorization change. Click to open the submission project. | |
| Submission Master Record | The submission master record associated with the above submission project. Click to open the submission master record. | |
| Market Authorization Only shows for market authorization changes. | The market authorization associated with this market authorization change. | |
| Products | The name of the products the change supports. Click to open the product. | |
| Country | Country | 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 indicates whether an expiration date is required for this market authorization. By default, No is selected. | |
| Expiration Date | The expiration date of the market authorization. | |
| Sunset Clause Date Required | Yes or No indicating if a sunset clause date is required for this market authorization. By default, No is selected. | |
| 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 (in days) | The number of days between notifications that the date for the sunset clause is approaching. | |
| Renewal Notification Interval (in days) | The number of days between notifications that the market authorization needs to be renewed. | |
| Restricted Authorization | Scope of Authorization | The scope of the market authorization. Shows "Restricted" if the regulatory activity category is Restricted Authorization. For all other regulatory activity categories, shows as "Full". |
| Regulatory Activity Sub Category Only shows for restricted authorizations. | The subcategory of the restricted authorization regulatory activity. | |
| Quantity of Units Only shows for restricted authorizations. | The number of units that can be used in this country granted by this restricted authorization. | |
| Clinical Product Only shows for restricted authorizations. | The name of the clinical product authorized by this restricted authorization. | |
| Obsolescence This section only shows for a market authorization in the Obsolete state. | Date | The obsolescence date for the market authorization. |
| Reason | The explanation of why the market authorization became obsolete. | |
| Status | The reason why the market authorization was made obsolete:
| |
| File list | - | Lists the files, usually license documents, checked into the market authorization or market authorization change. |
Actions/Toolbar Commands for a Market Authorization
Required access role: Regulatory User
| Action Name | Description | For More Information |
|---|---|---|
Upload/Check In  | Copies an existing or new file from your local machine and checks it into this Document object. If you check in an existing file, a new version of that file is created. | Collaboration and Approvals User's Guide: Uploading Files |
Delete All Versions  | Deletes all versions of the selected file. Click OK to confirm. | - |
| Delete This Version | Deletes the most recent version of the selected file. Click OK to confirm. The version listed is deleted, and the previous version shows on the page. | - |
Subscribe  | Subscribes to events related the submission master record or the items it manages. | Collaboration and Approvals User's Guide: Subscription Management |
Edit  | Edits the properties. You can edit the description, and change the owner and start renewal date. Required access role: Regulatory User | Editing Properties for Market Authorizations and Market Authorization Changes |
Actions/Toolbar Commands for a Market Authorization Change
Required access role: Regulatory User
| Action Name | Description | For More Information |
|---|---|---|
| Approve For Update | Promotes the market authorization change to Authorized and enters Update as the result of the associated 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 Authorized. 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 Authorized. 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 Obsolescence | Promotes the market authorization change to Authorized and enters Obsolete as the result of the associated market authorization. | Making Market Authorizations Obsolete |
| Close | Promotes the market authorization change to Closed. You can only close market authorization changes for submissions that use Variation or Repeal as the regulatory activity category. The market authorization change must be in the In Work state. You can close the market authorization change prior to the submission's Dossier Submitted milestone, or all regulatory milestones that use the Market Authorization purpose, are complete. | Closing Market Authorization Changes |
Upload/Check In  | Copies an existing or new file from your local machine and checks it into this Document object. If you check in an existing file, a new version of that file is created. | Collaboration and Approvals User's Guide: Uploading Files. |
| Delete All Versions | Deletes all versions of the selected file. Click OK to confirm. | - |
| Delete This Version | Deletes the most recent version of the selected file. Click OK to confirm. The version listed is deleted, and the previous version shows on the page. | - |
Subscribe  | Subscribes to events related the submission master record or the items it manages. | Collaboration and Approvals User's Guide: Subscription Management |
| Edit | Edits the properties. You can edit the description, and change the owner and start renewal date. | Editing Properties for Market Authorizations and Market Authorization Changes |