Regulatory Dossier Submission
A regulatory submission is the last step in a successful product development. What is actually submitted to the regulatory authority is a dossier assembled during product development. The submission can be applicable for a unique product in a single country, or to several products in several countries. The content of the dossier is adapted for each country, or for each group of countries.
Information Tracked by a Submission
A Regulatory Lead monitors and tracks every exchange made with regulatory authorities in the
context of a submission.
- Regulatory information
Details about the countries (and their regulatory
authorities) where market authorization is being sought, dates of dossier submission,
registration numbers and expiration dates, and so on.
- Prerequisites
Documents and tasks required as prerequisites for the phases in a
submission procedure (managed by milestones and checklists)
- Calendar
The schedule for all regulatory and business activities so the submission
project meets deadlines set by the regulatory authorities.
- Documents
Documents received from regulatory authorities.
- Correspondence
All correspondence sent and received from
regulatory authorities.
- Question and Answer
For the initial submission and any
interactive review phases, all questions received from the regulatory authority and
the answers provided.
- Request for work
Manage the tasks assigned to business experts (Regulatory Request Responders), such as preparing and
delivering documents required for the dossier.
Submission Milestones
The actions a Regulatory Lead can perform depends on the current phase of the submission project.
The schedule for a submission starts with milestones related to preparing the dossier, and the final milestone for receiving market authorization from the regulatory lead: - Dossier Ready
- Dossier Published
- Dossier Submitted
- Dossier Received
- Market Authorization
The schedule should be defined to include tasks for all of the documentation required for the dossier, and the tasks should be configured for the appropriate reviews and approvals. Once the regulatory authority receives the dossier, they have a calendar they must adhere to. The calendar, which consists of turn-around times for the various activities, is defined in the published regulatory guidelines for the regulatory context. The schedule uses a regulatory calendar phase to track this part of the progress. This phase can include interactive review phases (question-and-answer cycles), and additional regulatory milestones. See Regulatory Milestones for more information.
Derived Submissions
If a regulatory submission type depends on the submission type of another submission project, you can create a derived submission. Derived submissions are different from related submissions.
Submission Master Record and Regulatory Activity Categories
After a submission has been successful and market authorization is obtained, the product may require additional submissions. For example, regulatory activities such as variations, supplements, renewals, repeal, commitments, or sunset clause exemptions may be pursued. Each of these activities is managed by a separate submission project. The submission master record binds the latest information together to present complete information about the product authorizations. When creating a submission from within the context of a submission master record, Market Registration: - Copies all market authorizations (except obsolete ones) and the products and countries they are connected to, with the following exceptions:
- For a Renewal, only copies market authorizations that have required expiration dates.
- For a Sunset Clause Exemption, only copies market authorizations that have required sunset clause dates.
- Copies the following country-specific information for each country copied:
- Market authorization holder
- Regional company representative
- Distributor
- Prescription specification
- Registered product name
- Primary / secondary information
- Copies regulatory contexts using the following logic:
- For an Initial Submission, if you select a regulatory context that is not already
included with the submission master record, does not copy any other regulatory
contexts to the new submission.
- For any other type, copies all regulatory contexts.
- Copies all active indications.
- Connects all active ATC classifications.
- For a Commitment, adds the new submission to the list of Related Submissions for the one selected when you started the create procedure.
Note:
When all market authorizations associated with a submission master record have been promoted to Obsolete, Market Registration automatically promotes the submission master record to Archive.
Market Registration defines activities such as variations, supplements, renewals, repeal, commitments, and sunset clause exemptions as regulatory activity categories, and some of them are configured with subcategories.
Variation
You use the Variation regulatory activity category when any change to the product occurs. The regulatory authority provides detailed descriptions of what information needs to be provided based on the type of change. When the regulatory authority grants market authorization, it notifies the applicant if the authorization requires a renewal, and if so, what the renewal date is. When that time comes (Market Registration provides a reminder sufficiently ahead of that date so all renewal activities have time to be completed), you can choose to submit for a renewal. That submission can include the original product and any subsequently approved variations. You use the Renewal regulatory activity category for this type of submission. By default, Market Registration lets you choose from these regulatory activity subcategories when defining a submission project for variation as defined by the European Medicines Agency: - IA
- IAIN
- IB
- II-Extended
- II-Reduced
- II-Standard
Commitment
You use the Commitment regulatory activity category if the regulatory authority requests additional information about the dossier.
Repeal
You use the Repeal regulatory activity category if the product should be pulled permanently from being marketed. Although the company could simply stop marketing the product, regulatory activities (with their associated costs) would continue. To repeal the market authorization, you submit a repeal submission to notify the regulatory authority that the product will not be marketed anymore. Repeal is usually issued in the context of a change process that requests the market retrieval of a product. The change process describes all necessary activities to perform this retrieval, such as batch recall or sales till stock-out. Once the repeal is accepted by the authorities, the Regulatory Lead may have to inform other countries in which the product is marketed that the product has been repealed in a country: this is a mandatory post requirement.
Sunset Clause Exemption
You use the Sunset Clause Exemption regulatory activity category to end the validity of the market authorization if the product is not placed on the market with three years of the marketing authorization being granted, or where a product previously placed on the market is no longer actually present on the market for three consecutive years.
Restricted Authorization
In certain circumstances, a regulatory authority can grant a market authorization after a limited assessment of the regulatory dossier. this situation could occur for some treatments of life-threatening diseases, or for diseases that do not normally exist in that country. Because the assessment is limited, the market authorization is restricted. The restrictions can be the number of doses, number os subject, or duration. Your company must still track or regulatory details of this product. If you have a restricted authorization in a country, you could also submit an initial submission for the product. When granted, that market authorization would replace the restricted authorization. In addition, you can also have multiple restricted authorizations for a product in the same country. Each restricted authorization is connected to a separate market authorization. By default, Market Registration lets you choose from these regulatory activity subcategories when defining a submission project for restricted authorization as defined by the European Medicines Agency: - Tender Offer
- Authorization of Temporary Use - Nominative
- Authorization of Temporary Use - Cohort
Grouped Submissions
While maintaining market authorizations for a product, the Regulatory Lead could have several concurrent submission projects for different regulatory activities. You can group these submission projects under a lead submission, and then define the regulatory dossier, submission schedule and regulatory calendar, and any questions and common documents. You use the Related Submissions page for the lead submission to add other submission projects to group them with this one. You can add a submission project that already has a regulatory calendar, questions, and documents defined to the lead submission, however, the items for the lead submission overwrite the items for the grouped submission. To build the list of submission projects you can group to combine regulatory activities, Market Registration follows these rules: - The submission project cannot be a lead submission. You cannot create a hierarchy of submissions. That is, for the lead submission, you cannot add another submission project if it is also a lead submission.
- If the lead submission has not reached the Dossier Submitted milestone, you cannot add a submission project that has reached that milestone.
- If a submission project belongs to the same submission master record, it must use the same regulatory category and regulatory submission type as the lead submission.
- Submission projects cannot be in the Cancelled or Complete states.
When you add a submission project, Market Registration promotes the selected submission project to cancelled, and then creates a copy of that
submission project without any schedule or calendar details and adds it to the lead
submission schedule as a sub project. If you remove a submission project from a group, the configuration for the lead submission is removed, and the now stand-alone submission project needs to be configured. You can use the items on the History page as a guide for configuring that submission project.
Leading and Following Countries
For economic or historical reasons, some countries acknowledge the market authorization of another country as valid in their own country. If market authorization is granted in a leading country, then it is granted in the following country. You still need to create and complete two submission projects (one for the leading country and one for the following country), but Market Registration maintains a connection between the submissions, and once received, the market authorizations for both countries. To define a leading/following relationship, you view the Leading Countries page tab on the Related Countries category for the following country, and add the required leading country. When working with a submission project, you need to specify how that submission fits with the leading and following country definitions. you do this on the Regulatory Information page. That page includes these fields: - Follows Leading Country
- Leading Country
This table describes the possible values for "Follows Leading Country." Follows Leading Country Value | Description |
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As Defined | The defined leading/following countries relationship is used. | Not Required | The defined leading/following countries relationship is not used. | With Deviation | The normal leading/following countries relationship is not used, but the country for the context submission will follow another country. The Regulatory Lead must select a leading country. |
To use this feature, follow this general process: - Use Geography Configuration to define the leading country.
- Define two regulatory contexts, one for each country.
- Create a submission project for the product for the leading country.
- Work on the submission project as normal.
- Create a submission project for the same product for the following country.
- On the Regulatory Information page for this submission, add the leading country.
- Promote the following submission project to Assigned.
The Related Marketing Authorizations category for both submission projects is updated. For the leading country, the Following Market Authorizations shows the following country. For the following country, the Leading Market Authorizations tag shows the leading country. - Complete the market authorization process for both submission projects. Market Registration maintains a connection between the market authorizations for both countries.
Promote Submissions
When you promote a submission from the Draft to the To Do state, the alert message is
appeared about the country, which is not connected with the submission. The message is
appeared when the Device Identification is present for the products that are connected with the context submission and all the
countries are added to the product also present for the context submission.
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