About Market Authorizations

A company applies for market authorization by submitting a dossier containing all required information about the product, according to the regulation guidelines, to the regulatory authority. The regulatory authority evaluates the dossier, and if the evaluation is successful, gives a market authorization number for the product. The applicant becomes the market authorization holder and can commercialize the product.

Market authorization is specific to the combination of product, country, and plants that the regulatory authorized via the submission process. In Market Registration, the market authorization is associated with the submission project. A Regulatory User must upload the license document to the market authorization.

The applicant must abide by any regulatory activities requested by the regulatory authorities. For example, the regulatory authority can require the applicant to renew its authorization after a defined period of time or provide complementary information at specific dates.

The market authorization holder must update the regulatory authority if any changes are made to the product. In this case, the holder should submit a variation.

To waive follow-up regulatory actions, the market authorization holder can ask the competent authorities to repeal the market authorization. Once this occurs, the market authorization holder cannot commercialize the product.

The market authorization includes an expiration date and Renewal Notification Interval. When the current date reaches the interval number of days prior to the expiration date, the app sends a notification to the person who owns the market authorization so that the renewal process can be initiated.

When you revise a part, the market authorizations that are not in the Withdrawn and Obsolete states and connected with the current revision of the part are also connected to the next revision of the part if the context part is selected to enable auto propagation.

The market authorization that is in the Withdrawn and Obsolete states and connected with the current revision of the part are not connected to the next revision of the part even the context part is selected to enable auto propagation. By default, the status of the market authorization changes to disable auto propagation.

When the status of market authorizations is disabled for auto propagation, these market authorizations are not connected with the next revision of a part.

When you revise a product, the market authorizations that are not in the Withdrawn and Obsolete states and connected with the current revision of the product are also connected to the next revision of the product if the context product is selected to enable auto propagation.

The market authorization that is in the Withdrawn and Obsolete states and connected with the current revision of the product are not connected to the next revision of the product even the context product is selected to enable auto propagation. By default, the status of the market authorization changes to disable auto propagation.

When the status of market authorizations is disabled for auto propagation, the market authorization is not connected with the next revision of a product.

By default, the market authorizations are listed using the Authorization Info filter.

The Pagination capability is supported with the default page size=100 objects per page for the All Info, Authorization Info, and Country Info filters.

Earlier, you can expand a market authorization to view the market authorization changes that are associated with it. Now, you can view the associated market authorization changes to the market authorization listed under the separate column as MAC.

If you are using the Product & Country, Country & Product, and Product filters to view the list of market authorizations and the system has more than 10000 objects, there is a delay to load the Market Authorizations page. By default these views are not expanded. To expand these views, select the required view and its connected objects.

The refinement filter capability has been removed for following columns (MAC, Products, Parts, Type, Scope).

Market Registration creates a market authorization in the In Work state, and creates an associated market authorization change, also in the In Work state. The change is then worked on and processed until the regulatory authority authorizes the submission. When you enter that information, including the effective date of the authorization, you promote the market authorization change to the Approved state. Market Registration automatically copies the relevant details from the change to the market authorization, and promotes the market authorization to the Authorized state.

On the effective date, Market Registration automatically promotes the market authorization change to Closed and the market authorization to Released.

If you withdraw the market authorization change, or the regulatory authority cancels or rejects it, Market Registration promotes the market authorization change to Closed and promotes the related market authorization to Obsolete.

For a released market authorization, a submission with a different regulatory activity (such as Variation) could be processed. In this case, Market Registration creates a new market authorization change (in the In Work state) for this market authorization (which remains in the Released state). When the market authorization change is promoted to Closed (on the effective date after receiving approval from the regulatory authority), Market Registration merges the information from this market authorization change to the market authorization.

However, your Business Administrator can configure Market Registration what happens to the original market authorization depending on the regulatory activity category of the follow-on submission.

When an Approved market authorization change reaches the effective date, Market Registration promotes it to Closed, and then either updates the market authorization or promotes it to Obsolete. Update means that the details from the market authorization change are merged with the market authorization. None means that no actions are taken for the market authorization. This table lists the as-installed values.

The Market Authorizations page for a submission lets you add additional market authorizations to that submission. Market authorizations can be connected to multiple submissions, however, various issues determine in a specific market authorization can be connected to a specific submission. Market Registration takes all of these rules into consideration when building the list of market authorizations available to be added to the submission.

Market Registration only lets you add market authorizations that meet ALL of these requirements:

• Are in the In-Work, Authorized, or Released lifecycle state
• Associated with the same submission master record as the context submission
• Connected to a product and country associated with the context submission
• Do not already have an associated market authorization change associated with the submission

The value for the regulatory activity category for the submission project determines which market authorizations can be added. If the value is:

• Initial Submission or Commitment: you cannot add a market authorization.
• Sunset Clause Exemption: only market authorizations that have the Sunset Clause Date Required = Yes setting can be added.
• Renewal: only market authorizations that have the Expiration Date Requrired=Yes setting can be added.
• Other values: market authorizations that meet all other criteria can be added.

To add a market authorization, the submission must meet ALL of these requirements:

• The regulatory milestone with the Dossier Submitted purpose is not complete.
• The submission is not in the Preliminary state.

Market Registration lets you remove a market authorization from a submission under certain conditions. Depending on the states of other items connected to it and values for certain attributes, the app might not allow you to remove the market authorization.

You cannot remove a market authorization from a submission that uses Initial Submission or Commitment for the regulatory activity category.

If any product connected to the selected market authorization is also connected to a submission master record, Market Registration checks the status of the regulatory milestone with the Dossier Submitted purpose.

• If that milestone is complete, the app promotes the market authorization change for that combination of submission-product-country to Closed and updates the status to Withdrawn.
• If the regulatory milestone is not complete, the app deletes the market authorization change. If any of the changes are beyond the In Work state, you cannot remove the market authorization.

If the connected product is NOT connected to a submission master record, Market Registration also checks the status of the regulatory milestone with the Dossier Submitted purpose.

• If that milestone is complete, the app promotes the market authorization change to Closed and defines the status to Withdrawn. The app promotes the market authorization to Obsolete and defines the status to Withdrawn.
• If that milestone is not complete, the app deletes the selected market authorizations and market authorization changes. If any of the changes are beyond the In Work state, you cannot remove the market authorization.

If, based on these rules, Market Registration deletes the market authorization, the app also determines whether any of the countries and products related to the market authorization are connected to the submission via a different market authorization. If not, the app removes the country or product from the submission.

If removing a market authorization results in a product or country still connected to the submission, but without any associated market authorization change, the app removes the product or country from the submission.

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 completing the submission's Dossier Submitted milestone, or prior to completing all Regulatory Milestones that use the Market Authorization purpose.

If the market authorization is in the in Work state, the app:

• Promotes the market authorization changes objects to Closed
• Promotes the market authorization to Obsolete

Closing a market authorization change at this point in the process is the same as withdrawing, canceling, or rejecting it: the result is no open market authorization.

If the market authorization is in the Released state, the app promotes the market authorization change to Closed. Closing the change object does not affect the released market authorization.