appdRegulated Product Submission Topic
HL7 Draft Standard for Trial Use
HL7 RPS R2 DSTU R2
HL7 Version 3 Standard: Regulated Product Submission, Release 2, DSTU Release 2
November 2012
HL7 Informative Document
HL7 IG RPS, R1-2008
HL7 Version 3 Implementation Guide: Regulated Product Submission, Release 1
May 2008

Content Last Edited: 2012-10-25T15:37:14


Update to Release 2 DSTU

Further changes and scope adjustments (e.g., addition of International Conference on Harmonisation (ICH) Requirements) have been made to the Regulated Product Submission (RPS) standard during and after the RPS Release 2 DSTU which concluded in December 2010. Development of this latest iteration of the RPS standard began prior to the conclusion of the RPS Release 2 DSTU and, in order to avoid confusion, was referred to as the RPS Release 3 standard. According to HL7 nomenclature rules, the versioning of a standard only occurs following a successful normative ballot. Because the Release 2 DSTU ballot did not culminate in a Normative Ballot, HL7 considers this subsequent iteration of the standard a second DSTU balloting of RPS Release 2.

In addition to the inclusion of the ICH requirements, this release includes enhancements to support:

  • European procedure types and modes and the recent European Variation legislation changes,

  • Japanese health authority (PMDA) requirements for Japanese specific hierarchical concept of a submission in the RPS concepts of Application and Submission, and

  • the ability to define and reuse documents as a single file or as a collection of files (e.g., study and study components).

The definition of product has been reduced to a set of essential components and a product category has been added to further support Japanese review procedures.

New in Release 2

Release 2 added the concept of regulatory approval, data fields for capturing contact information, and the ability to reference other applications. Release 2 also specified the data fields necessary to support basic two-way communication, added further categorization information for submission units and the ability to target documents to a particular regulatory authority.

Introduction

Regulatory Authorities (hereinafter referred to as Regulators) exchange information with the regulated industry (hereinafter referred to as Industry) to address a variety of regulatory issues. The information included in these regulatory exchanges can be provided in paper or electronically in the form of files. Frequently, the new information is directly related to information previously provided. Because information is submitted over time, often in increments, it is difficult to efficiently process and review the new information in light of pre-existing information.

The goal of the Regulated Product Submission message is to facilitate the processing and review of electronic regulatory submissions. Accordingly, the Regulated Product Submission Refined Message Information Model (RPS RMIM) captures all information required for the efficient processing and review of electronic regulatory submissions.

Different regulated product types (e.g., devices, medicinal products) specify different hierarchical constructs (i.e., tables of contents) to organize the information provided in the regulatory exchanges. However, the basic requirements for submitting information electronically over time are the same. Therefore, the objective of the Regulated Product Submission message is to define one message structure that can be used for all regulated products. The message standard is intended to be used worldwide, to support the review of regulated products including, but not limited to, foods, medical devices, human therapeutics, and veterinary medicines. It is important to note that the wide range of products that is contemplated leads to providing a generic structure for the actual specification.

Scope

The scope of the standard is to define the message for exchanging information electronically between Regulators and Industry. The message provides the ability to describe the contents of the regulatory exchange and all information needed to process the exchange between parties. This message is designed to be flexible enough to be used to support regulatory exchanges for any regulated product.

The Regulated Clinical Research Information Management Technical Committee invites anyone with additional requirements to submit content proposals for future releases of the standard.

Note: Harmonization proposals are in process for several classCode and code attributes. When the harmonization process is complete, these codes will be bound appropriately.

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 Storyboards (Sorted by Title)
 Storyboards (Sorted by Display Order)
 
pointer Managing Applications through Submission Units (PORP_ST000001UV01
pointer Managing the contents of submission units (PORP_ST000002UV01
pointer Two Way Communication (PORP_ST000003UV01
pointer Contact information (PORP_ST000004UV01
pointer European Specific (PORP_ST000005UV01
Reference

For details on the interpretation of this section, see the storyboard discussion in the Version 3 Guide.

Purpose

Over time, an application will typically consist of multiple submissions and regulatory assessments. For example, the marketing application for a drug product can generate multiple regulatory decisions. The first decision may support the initial marketing approval of the product for a specific indication. Subsequent regulatory decisions may approve or deny additional indications for the drug product. The application thus contains multiple submissions, each with their own regulatory action. Each of those submissions (e.g., initial marketing application, supplemental marketing application) would generally be comprised of multiple submissions units.

A submission is made up of one or many submission units.

Diagram
Activity Diagram
Interaction List
Submission Unit sent Schema View PORP_IN000001UV01
Narrative Example

Acme Pharmaceuticals has prepared information relating to its new product - Global Fixit. This information provides information about the quality, safety and effectiveness of the product, and consists of many files that Acme has collected over several years. Acme has marshaled these files, which are designed to address a previously defined set of categories, into its first submission unit. That first submission unit will be sent to a regulatory authority for marketing approval in that jurisdiction. In this initial submission unit, the submission unit message identifies all of the submitted files, and indicates the document category or categories that the files belong. This first submission unit commences the application and represents the first regulatory submission for that application.

Since this is the initial submission unit for the application, each file in this submission unit is active. The submission is then transmitted to the regulatory authority.

The regulatory authority receives the submission and validates the message for accuracy. The regulatory authority incorporates the message into their tracking/review system creating a new application, original submission, and the first submission unit to the original submission.

Narrative Example

Device Co. is planning on creating a pre-approval submission for a Class III PMA product. Device Co has already sent the original submission unit message and supporting files. However, new studies are available pertaining to the effectiveness of this device. Device Co will submit a new submission unit and the supporting files. This new submission unit will be linked as an amendment to the original submission. The regulatory authority receives and validates this submission unit and then this submission unit is associated with the original submission

Narrative Example

Device Co. is planning on creating a submission for a Class III product. Device Co. has already sent the original submission unit message (i.e., the original submission) and many amendments to the original submission.

This product is going to be used for a different purpose than stated in the original submission so a new Submission must be initiated. Device Co will submit the new submission and supporting files containing the relevant information that supports the new use of the product. As required by the Regulatory Authority, this new submission and the original submission will be linked together under the same application.

The regulatory authority receives and validates this submission unit for this new submission. This new submission (e.g., referred to as a supplement or variation) and the original submission are both associated to the same application.

Note: In most cases, supplements/variations can only be created after the original has been approved.

Narrative Example

In some regulatory processes, it is acceptable for the Applicant to provide information to the regulatory authority in defined reviewable units. Generally, these units of information support a particular discipline (e.g., clinical) and provide the opportunity to expedite some regulatory review processes.

For example, Acme Pharmaceutics has discovered a potential cure for cancer and received permission to submit a continuous marketing application. Acme now has the ability to send information in predefined reviewable units.

Acme creates a submission unit for transmission to the regulatory authority that addresses the clinical modules. Since it is expected that the regulatory authority review may turn up questions related to particular modules, Acme makes sure that the submission unit indicates which type of module it addresses.

The regulatory authority processes this submission unit and associates the unit to the correct submission.

Narrative Example

In certain regulatory processes, the same documentation may need to be submitted to multiple applications.

Acme Manufacturing produces an annual report that pertains to multiple active applications. The company submits one submission unit and applies that unit to each application that requires the annual report. The regulatory authority processes this submission unit and associates it to all relevant applications.

Narrative Example

In certain regulatory processes, the same documentation may need to be submitted to multiple submissions.

Acme Manufacturing changes some CMC processes that pertains to multiple active submissions for a product. The company submits one CMC submission unit and applies that unit to each submission that it pertains to. The regulatory authority processes this submission unit and associates it to all relevant submissions.

Narrative Example

During the review of a submission, it may be necessary for the Applicant to withdraw the submission from further review or to preempt an unfavorable action by the regulatory authority.

Subsequent to the original submission of the Global Fixit submission, Acme scientists are able to spend time reviewing the outcome of ongoing studies of Global Fixit's efficacy. It turns out, after statistical review, that the product is not particularly effective. As a result, Acme wishes to withdraw the submission from consideration. A submission unit is created to withdraw the submission and all related submission units; it is transmitted to the regulatory authority.

The regulatory authority processes this submission unit message and marks the submission and related submission units as obsolete.

Narrative Example

Acme Pharmaceuticals is sending RAA a submission unit to provide the final labeling for their marketing application and identifies the contact information for the submission (e.g., any points of contact first name and last name, Contact Type, address, phone, email, fax), product information (e.g., product type, product name, proper name, trade name, product code, product code set), Regulatory Authority information (i.e., Agency, Center), submission information (e.g., regulatory authority application, regulatory authority submission number, sequence (serial) number, presubmission identifier), Submission Unit Type (e.g., category and sub category) and Comment field (free text description).

Narrative Example

The RAA is sending an interim action to place the investigational study on hold, the correspondence type would be Interim Action/Clinical Hold, and identifies the contact information for the submission (e.g., any points of contact first name and last name, Contact Type, address, phone, email, fax), product information (e.g., product type, product name, proper name, trade name, product code, product code set), regulatory authority information (i.e., Agency, Center), submission information (e.g., regulatory authority application number, regulatory authority submission number, sequence (serial) number, presubmission identifier), Submission Unit Type (e.g., category and sub category)and Comment field (free text description).

Narrative Example

Device Company ABC submits the first of three modules of a modular Premarket Approval (PMA), a reviewable unit, to the FDA/CDRH for Product Implant 123, including the contact information for the submission (e.g., any points of contact first name and last name, type of contact, address, phone, email, fax), product information (e.g., product type, product name, proper name, trade name, product code, product code set), regulatory authority information (i.e., Agency, Center), submission information (e.g., regulatory authority submission number, regulatory authority reviewable unit number, sequence (serial) number, presubmission identifier), submission unit type (e.g., category and sub category) and Comment field (free text description).

Narrative Example

FDA/CDRH sends questions about three modules submitted for Product Implant 123, including the product information (e.g., product type, product name, proper name, trade name, product code, product code set), regulatory authority information (i.e., Agency, Center), submission information (e.g., regulatory authority submission number, regulatory authority reviewable unit number(s), sequence (serial) number, presubmission identifier), submission unit type (e.g., category and sub category) and Comment field (free text description).

Narrative Example

RAA has received a BLA amendment from BioPharm Co for a product 123 that is under review, the information provided in the submission indicates that a new supplement should have been submitted. The RAA send an update to the submission unit back to the BioPharm to indicate that the submission number has been changed and reassigned a new submission number and sequence number.

Purpose

A submission unit is made up of one submission unit message and many files. Properly defined, the submission unit message concept enables companies to create new submission units from any combination of new and previously submitted files. The submission unit message is processed by the regulatory authority and is integrated into their tracking/review system.

Note: the current specification does not support a message from the regulatory authority to applicant

Diagram
Activity Diagram
Interaction List
Submission Unit sent Schema View PORP_IN000001UV01
Narrative Example

The results of ongoing studies related to Global Fixit are now available; and these results show that the product is even more useful than previously thought. As a result, Acme decides to add this information to the files that were previously submitted in support of the Global Fixit submission. A new submission unit is created that refers to the additional files (i.e., the new study results) and appropriate file references to relate this new information to the existing information. The submission unit is transmitted to the regulatory authority. The regulatory authority processes this submission unit.

Note: A submission unit message contains many file references. When a submission unit message is provided in support of a submission, individual file references can either be added to the submission, supersede existing file references in the submission, append existing file references, or may mark specific files as obsolete from the submission.

Narrative Example

The review process for the Global Fixit submission has extended over a substantial amount of time, and Acme has found that new information relevant to the submission has been received. For example, the original submission contained a summary of clinical pharmacology information derived from a series of studies using human biomaterial, and several new studies contain information that requires changes to this summary. Therefore, researchers working for the company have rewritten this summary and submit a new submission unit with the new file marked as a replacement to the previous file.

The regulatory authority processes this submission unit. If the information referenced as being replaced was not provided in a previous submission unit, the current submission unit may be considered non-filed.

Note: A submission unit message contains many file references. When a submission unit message is provided in support of a submission, individual file references can either be added to the submission, supersede existing file references in the submission, append an existing file reference, or may mark the file as obsolete from the submission.

Narrative Example

Global Fixit has been manufactured at two locations, Big Factory and Little Factory. Acme Manufacturing now wishes to concentrate all its manufacturing at Big Factory. Therefore it is necessary to inform the regulatory authority of this change and to update the submission to ignore all information related to manufacturing taking place at Small Factory. Therefore Acme creates a submission unit to inform the regulatory authority to ignore all files that relate to the manufacture at Small Factory. The regulatory authority processes this submission unit.

Note: This method can also be applied to logical documents consisting of multiple physical files.

Narrative Example

The Calming Myst submission, a medication for heart burn, included the inclusion of a drug-substance file. However, Acme has now decided that it needs to break this file into several smaller files for better file management. In essence, the company wants regulatory authority to review the drug-substance information in the more granular form. A new submission unit is created that contains multiple drug-substance files to meet the documentation requirement for drug substance information. Each file is marked as a replacement for the previously submitted drug-substance file. The original drug-substance file is marked as obsolete (or replaced).

The regulatory authority processes this submission unit.

Note: The life cycle of the new more granular file is linked to the original summary file life cycle.

Narrative Example

Before the clinical study begins, Acme would like to add several new (or not previously submitted) pages to a sample case report form file. The addition will allow reviewers at the regulatory authority to have this new information. The company prepares a submission unit that contains a file with only the new pages. The submission unit message marks this file as an addendum to the previously submitted case report form file. The addendum is considered a separate file that has its own lifecycle

Note: A submission unit message contains many file references. When a submission unit message is provided in support of a submission, individual file references can either be added to the submission, supersede existing file references in the submission, append an existing file reference, or may mark the file as obsolete from the submission.

Narrative Example

Acme employee, Fred Firestone, has carried out further review of the recently submitted addendum to the sample case report form. As a result of his work, the company realizes that it needs to replace the addendum in order to improve the case report form. Therefore, an additional submission unit is created that contains a new addendum file to replace the previously submitted one. The new addendum is linked to the old one, and marked as a replacement.

Note: Addendum files has a life cycle independent of the file they are added to. If a future submission unit replaces the addendum file, the new addendum file would amend the same original file.

Narrative Example

Further review of the - much changed - sample case report form mentioned above, leads Acme's Submission Control Branch to determine that the regulatory authority's review task would be eased if all the contents of the case report form were included in a single file. That is to say, it would be better to support the documentation requirements with a single file, rather than having an original file along with one or more addenda. Acme would like the regulatory authority to only review the new consolidated file, and it would like the regulatory authority to be aware that the new file replaces both previously submitted files. A new submission unit is created that contains the new summary file, and marks it as a replacement for both the previous sample case report form file and the addendum.

Narrative Example

Acme Manufacturing has prepared a submission for a product to be marketed to mountain climbers - known as High Altitude Fixit. One component of the submission will be a protocol file that pertains to three different studies in the submission. It documents the protocol that was followed during those studies. When the High Altitude Fixit submission unit is prepared, it will contain, among other files, the protocol file and other documentation providing the results of the three studies. Each of the three studies references the protocol file. The submission unit transmission contains only one copy of the protocol file. The regulatory authority processes this submission unit.

Narrative Example

Several years ago, Acme submitted a submission to market a medication for heart burn known as Calming Myst, which was to be produced under license from a European manufacturer. However, all the files related to the earlier submission unit have been marked as ignore because Acme was never able to come to a final arrangement with the manufacturer for the production of the product.

However, new management of the European firm is more agreeable, and Acme is confident that it will have the Calming Myst contract in hand by early next year. As a result, Acme would like to reactivate the European manufacturing files for regulatory authority review. A submission unit message is created that refers to the previously submitted files and reactivates them for regulatory review.

Note: The all files associated with this manufacturer have been reactivated. The complete lifecycle of all logical documents associated with this manufacturer are also reactivated.

Narrative Example

Subsequent to the original Global Fixit submission, Acme researchers realize that an analytical procedure file had been mistakenly categorized as the protocol document of one of the studies in that previous submission's units. This was a mistake, since it should have been categorized as an analytical procedure document. The company wants to inform the regulatory authority to change the category assignment of the file. The submission unit that Acme transmits to the regulatory authority is designed to inform the regulatory authority that the previously referenced protocol actually should be referenced as an analytical procedure. The procedure file is not re-transmitted.

Narrative Example

The European manufacturer, who produces the Calming Myst product, has done previous business with Acme manufacturing for a number of years. In a previous application - for Calming Balm - Acme had submitted information for that manufacturer that is relevant to the Calming Myst application. Since the regulatory authority already has the files for the manufacturer, Acme decides to reference those files in the new application. The Calming Myst submission unit contains references to those previously submitted files. The submission unit does not contain copies of the previously submitted files. The regulatory authority processes this submission unit. It is possible for the reviewers to access the referenced files as if they had been submitted in this submission unit.

Note: It is possible for the reviewers to access the referenced files as if they had been submitted in this submission unit.

This method applies to studies, logical files, or any other file or groups of files that the company has previously sent to the regulatory authority.

Narrative Example

Subsequent to the Calming Myst application, the European manufacturer decides to move its manufacturing operations to another facility and to introduce advanced technologies to the processes. This requires changing the manufacturer information in all the applications related to the products they manufacture; in particular, it applies to both the Calming Balm and Calming Myst submissions. Acme will submit a new submission unit as part of the Calming Balm submission that contains the updated files. A new submission unit for the Calming Myst product is submitted as well. In that submission unit, references to the new files are included, but the actual files are not. The regulatory authority processes this submission unit. It is possible for the reviewers to access the referenced file as it was submitted in this submission unit.

Note: This method applies to files, logical documents or any other files or groups of files that the company has previously sent to the regulatory authority.

Narrative Example

In the High Altitude Fixit submission, Acme had previously submitted a protocol file that pertained to three different studies within the application. Since that time, investigators under contract to Acme have updated the protocol file specifically for one of the three studies. However, these changes are not relevant to the other two studies. Acme would like the regulatory authority to review the new protocol file for the one study, while continuing to review the previous protocol file for the other two. A new submission unit is created that has the new protocol file marked as a replacement for the relevant study. The submission unit contains no reference to the other two studies. As a result, regulatory authority continues to review the previous protocol file for them.

Narrative Example

The original Global Fixit submission unit included a safety file. In a later submission unit for the same submission, the same safety file was mistakenly submitted again as an original file. However, new information has been received, which has led to an updated safety report. Acme wants to replace both previously submitted safety files with the new report. A submission unit is created that contains the new safety file, and marks it as replacement for both of the previously submitted files.

Note: This method can be applied when switching from a more granular document structure to a less granular one.

Purpose

The storyboards presented in this section related to the two-way communication between Regulatory Authority and Regulated Industry.

Diagram
Activity Diagram
Narrative Example

Regulatory Authority A (RAA) has reviewed a submission and its components and has a set of questions for the ABC Device Company regarding their product 123 and the information provided about their patient and physician labeling. RAA sends the document, which includes their questions to the ABC Device Company and identifies a correspondence identifier.

Narrative Example

Regulatory Authority A (RAA) has reviewed a submission and needs to communicate an interim or formal action through a decision letter to inform Acme Pharmaceuticals about their action regarding the regulated activity (e.g., investigational or marketing applications) for Product 999. RAA sends the document, a decision letter, which includes the status of the regulated activity (e.g., approved, non-approvable, clinical hold) and identifies a correspondence identifier.

Narrative Example

FDA/CDRH approves 5 PMA supplements after review the changes to the manufacturing site and sends an approval letter to the ABC Device Company indicating the correspondence identifier and the five affected PMA supplement number. In a week, the other 10 PMA supplements are approved after reviewing the manufacturing change submission and send an approval letter indicating the correspondence identifier and remaining affected 10 PMA supplement numbers.

Narrative Example

Regulatory Authority A (RAA) has reviewed a submission and its components and would like to clarify some questions via a meeting with Acme Foods regarding the SweetSugarCane product. RAA sends a document, a meeting request, which includes the details of the meeting request and identifies a correspondence identifier

Narrative Example

Vaccines.com would like to request a meeting with the RAA as they have just come into the marketplace and would like to meet with the regulators prior to submitting an investigational or marketing application. The company would like to discuss their manufacturing facilities and sends a document, the meeting request, which includes the details of the meeting request and identifies a correspondence identifier.

Narrative Example

FDA/CDRH sends Device Company ABC a letter containing questions that relate to modules 1-3 of Product Implant 123's modular premarket application (M089999), and they indicated a correspondence identifier.

Narrative Example

ABC Device Company has addressed the questions presented by RAA about their patient labeling and instructions of use documentation. ABC Device Company sends a response to RAA with the appropriate changes to existing documentation and provides a response to the original correspondence, identifying the originating correspondence identifier.

Two weeks later, ABC Device Company has been able to address the questions that the RAA posed in regards to physician labeling. ABC Device Company sends a second response to the first correspondence from the RAA to add new documentation, update existing documentation and provide a response to the original correspondence, identifying the originating correspondence identifier.

Narrative Example

Acme Pharmaceuticals is sending RAA a submission unit to provide the final labeling for their marketing application and identifies the contact information for the submission (e.g., any points of contact first name and last name, Contact Type, address, phone, email, fax), product information (e.g., product type = 'proprietary', product name = 'Global Fixit"), Regulatory Authority information (i.e., Agency, Center), submission information (e.g., regulatory authority application, regulatory authority submission number, sequence (serial) number, presubmission identifier), Submission Unit Type (e.g., category = 'label' and sub category = 'final') and Comment field (e.g., 'Submission of final labeling'). On receipt of the submission unit, the regulator processes the information and is now ready for review. If there are any questions on the submission unit, the receiver uses the contact information appropriately. On receipt of the submission unit, the sponsor company processes the information and takes appropriate action.

Submission Unit Type: Coding system to describe the submission unit purpose.

Narrative Example

The RAA is sending an interim action to place the investigational study on hold, the correspondence type would be Interim Action/Clinical Hold, and identifies the contact information for the submission (e.g., any points of contact first name and last name, Contact Type, address, phone, email, fax), product information (e.g., product type = 'Proprietary', product name = 'Global Fixit'), regulatory authority information (i.e., Agency, Center), submission information (e.g., regulatory authority application number, regulatory authority submission number, sequence (serial) number, presubmission identifier), Submission Unit Type (e.g., category = 'Clinical Hold' and sub category = N/A) and Comment field (free text description).

On receipt of the submission unit, the regulator processes the information and is now ready for review. If there are any questions on the submission unit, the receiver uses the contact information appropriately.

Narrative Example

Device Company ABC submits the first of three modules of a modular Premarket Approval (PMA), a reviewable unit, to the FDA/CDRH for Product Implant 123, including the contact information for the submission (e.g., any points of contact first name and last name, type of contact, address, phone, email, fax), product information (e.g., product type = 'trade', product name = 'New Jaw', product code = 'LZD'), regulatory authority information (i.e., Agency, Center), submission information (e.g., regulatory authority submission number, regulatory authority reviewable unit number, sequence (serial) number, presubmission identifier), submission unit type (e.g., category = 'New' and sub category = 'Reviewable unit' such as "Amendment" or "Supplement") and Comment field (free text description).

On receipt of the submission unit, the regulator processes the information and is now ready for review. If there are any questions on the submission unit, the receiver uses the contact information appropriately.

Narrative Example

FDA/CDRH sends questions about three modules submitted for Product Implant 123, including the product information (e.g., product type = 'trade', product name = 'New Jaw', product code = 'LZD'), regulatory authority information (i.e., Agency, Center), submission information (e.g., regulatory authority submission number, regulatory authority reviewable unit number(s)(such as "Amendment" or "Supplement"), submission unit type (e.g., category = 'Information request' (such as Major Deficiency or Additional Information) and sub category = 'N/A') and Comment field (free text description).

On receipt of the submission unit in response to the questions, the regulator processes the information and is now ready for review. If there are any questions on the submission unit, the receiver uses the contact information appropriately.

Purpose

For all new applications industry needs to submit a pharmacovigilance system (how to collect, document and report side effects). Checking of this documentation will be done by the pharmacovigilance unit of the agency. Objections and responses from this specific area will be exchanged directly (contact not BfArM but Mrs. Miller) although the process management contact person will remain the same, Mrs. Clark within BfArM. Another example: From agency's point of view we also need contact person details as to who will be the process manager or project team leader I need to contact regularly or in case of emergency. Mrs. Miller and Mrs. Clark are examples of contacts

Diagram
Activity Diagram
Purpose
Due to multiple countries in the European Union, Europe has specific requirements not found in other regions
Diagram
Activity Diagram
Narrative Example

Acme Pharmaceuticals has prepared information relating to its new product - Global Fixit. This information provides information about the quality, safety and effectiveness of the product, and consists of many files that Acme has collected over several years. Acme has collated these files, which are designed to address a previously defined set of categories, into its first submission unit. The first submission unit will be sent to multiple regulatory authorities within Europe for marketing approval through the Decentralised Procedure. One county will be defined and act as Reference Member State (RMS) and the others will be defined and act as Concerned Member States (CMSs). The submission unit contains documents that are common to all countries but also documents that are specific to individual countries and languages.

In this initial submission unit, the submission unit message identifies all the countries (as defined in an external list) and regulatory agencies as defined in an external list) included in the procedure (as defined in an external list), identifies the submitted files, and indicates the document category or categories that the files belong together with identification of applicable country and language (as defined in an external list) for specific documents. The submission unit comprises CTD sections defined by ICH (Modules 2-5) (as defined in an external list) and by EU (as defined in an external list).

This first submission unit commences the application and represents the first regulatory submission (as defined in an external list) for that application.

The submission unit also contains a number of additional items of information, including information about the product, about the MAH, the application ID (but note that this will not be assigned by the receiving agencies at this point in the process) and a submission unit description.

The initial status of the Submission is "submitted". Note: "submitted" is not necessarily a term that would appear in the XML instance.

Since this is the initial submission unit for the application, each file in this submission unit is active. The submission is then transmitted to the regulatory authorities.

Narrative Example

The Reference Member State (RMS) and each Concerned Member State (CMS) receive the first submission unit individually for Global Fixit from Acme Pharmaceuticals. In each regulatory authority the submission unit is loaded into a processing area and a technical validation of the submission unit is undertaken against a defined set of validation criteria.

The results of this validation testing can be:

  • Pass validation with no errors
  • A critical error which will prevent the submission unit from being loaded into the Review System (defined as Pass/Fail)
  • A minor error which will not prevent the submission unit from being loaded into the Review System (defined as a Best Practice check)

If no errors are identified the RMS and CMSs load the submissions into their Review Systems.

If Critical (Pass/Fail) errors are identified the RMS and/or CMSs inform Acme Pharmaceuticals (see Notification critical validation failures). The submission is not loaded into their Review Systems.

If Minor (Best Practice) issues are identified the RMS and/or CMSs may inform Acme Pharmaceuticals (see Notification of technical validation failures) and the submission unit is loaded into their Review Systems

Once loaded into the Review Systems the RMS and CMSs undertake business validation to ensure that the content of the submission unit is appropriate for review (see Bus validate init sub unit Decentralised Proc ).

Narrative Example

The RMS and CMSs have loaded the initial submission unit for Global Fixit into their Review Systems and undertake a business validation to ensure that submission content is appropriate to initiate the formal review of the submission.

The RMS identifies that Module 1 is missing Information about the Clinical Expert and prepares a request to Acme Pharmaceuticals for a replacement file to be provided (see Validation failures - common document).

A CMS (e.g. France) identifies that part of the information in their application form has been completed incorrectly and prepares a request to Acme Pharmaceuticals for a replacement file to be provided (see Validation failures - country specific ).

Alternatively,

The RMS and CMSs have loaded the initial submission unit for Global Fixit into their Review Systems and have undertaken the business validation checks and have found no issues.

The RMS and CMSs conclude that the submission is now appropriate to initiate the procedure. The RMS informs Acme Pharmaceuticals using an RPS Message with an appropriate agency submission type and the procedure timetable. (If created as an RPS message then the message will identify the information on country, regulatory agency, and type of procedure and the information product, application ID, procedure number, submission unit description).

The status for the submission is changed to "pending"

Narrative Example

The Reference Member State (RMS) and each Concerned Member State (CMS) have each identified that the submission unit for Global Fixit from Acme Pharmaceuticals has technical issues that are of a sufficiently critical nature (Pass/Fail) as to preclude loading into the Review System.

The RMS and each CMS sends a communication to Acme Pharmaceuticals that includes the reasons identified for technical invalidation and a request that the submission is corrected and resubmitted.

Note, as the RMS/CMS has been unable to load the submission unit, the communication back to the applicant must be outside of the eCTD/RPS format.

Narrative Example

The Reference Member State (RMS) and each Concerned Member State (CMS) have each identified that the submission unit for Global Fixit from Acme Pharmaceuticals has technical issues that are of a minor nature (Best Practice checks) but do not preclude loading into the Review System.

The RMS and each CMS may send a submission unit to Acme Pharmaceuticals identifying the submission type and a document that includes a list of the minor errors. (If created as an RPS message then the message will identify the information on country, regulatory agency, and type of procedure and the information product, application ID, procedure number, submission unit description for tracking purposes). It also identifies that the submission unit is associated with the new initial marketing application procedure

Narrative Example

The French regulatory authority that has identified the application form for their country has been completed incorrectly and in order for the submission unit for Global Fixit to be accepted for review a replacement application form should be submitted.

The French regulatory authority sends a submission unit to Acme Pharmaceuticals which identifies the submission type and includes a document that identifies the reasons for business validation failure and requests that a replacement application form is submitted in an additional submission unit. It also identifies that this message relates to the initial submission unit for Global Fixit.

Narrative Example

The Reference Member State (RMS) has identified that for the submission unit for Global Fixit from Acme Pharmaceuticals to be accepted for review the missing document detailing information about the clinical expert should be submitted.

The RMS sends a submission unit to Acme Pharmaceuticals, the submission type and includes a document that identifies the reasons for business validation failure and requests that the information about the clinical expert is submitted in an additional submission unit. (If created as an RPS message then the message will identify the information on country, regulatory agency, and type of procedure and the information product, application ID, procedure number, submission unit description). It also identifies that this message relates to the initial submission unit for Global Fixit.

Narrative Example

Acme Pharmaceuticals have received a request from the RMS that identifies that information about the clinical expert needs to be provided and has requested that such a document is provided.

Acme Pharmaceuticals prepares a new submission unit for Global Fixit. It identifies the type of submission unit that the submission unit is associated with the new submission and application. The submission unit contains the new document which is common to all countries. The submission unit message identifies all the countries and regulatory agencies included in the procedure, identifies the submitted files, and indicates the document category or categories that the files belong to. The submission unit comprises dossier sections defined by EU. Additional information about the product, the MAH and submission description may also need to be provided.

Acme Pharmaceuticals sends the submission unit to all regulatory authorities in the procedure which receive it, undertake successful technical validation (Tech validate init sub unit Decentralised Proc), load the submission unit into the Review System. The RMS performs business validation (Bus validate init sub unit Decentralised Proc ) and concludes that the common document set is now appropriate to be able to initiate the procedure.

The RMS informs Acme Pharmaceuticals using an RPS Message with an appropriate agency submission type and the procedure timetable. (If created as an RPS message then the message will identify the information on country, regulatory agency, and type of procedure and the information product, application ID, procedure number, submission unit description).

The submission status is set to "pending".

Narrative Example

Acme Pharmaceuticals have received a request from the French regulatory authority has identified that the application form for their country has been completed incorrectly and has requested a replacement application form.

Acme Pharmaceuticals prepares a new submission unit for Global Fixit. It identifies the type of submission unit that the submission unit is associated with the new initial marketing application procedure (identified by procedure number and variation number). In this submission unit, the submission unit message identifies that France is the only recipient country and regulatory agency (see List 2) included in the procedure, identifies the submitted files, and indicates the document category or categories that the files belong to together with identification of applicable country and language for specific documents. The submission unit comprises categories defined by EU. Additional information about the product, the MAH (Information 2) and submission description may also need to be provided. It identifies that the application form for France in the initial submission unit is to be replaced by the application form in this submission unit.

Acme Pharmaceuticals sends the submission unit to the French regulatory authority which receives it, undertakes successful technical validation, loads the submission unit into the Review System and performs business validation and concludes that the application form is now appropriate to be able to initiate the procedure.

The RMS informs Acme Pharmaceuticals using an RPS Message with an appropriate agency submission type and the procedure timetable. (If created as an RPS message then the message will identify the information on country, regulatory agency, and type of procedure and the information product, application ID, procedure number, submission unit description).

The submission status is set to "pending".

Narrative Example

The Reference Member State (RMS) has assessed the content of the submission unit for Global Fixit from Acme Pharmaceuticals. The RMS creates a summary of the assessment, with points for clarification for the applicant. This summary is called the Preliminary Assessment Report (PrAR).

The RMS sends a submission unit to all CMSs which identifies the submission type. The submission unit consists of the PrAR and the product information (SmPC, PL and labelling). It also identifies that the submission unit is associated with the new initial marketing application procedure (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description.

The RMS also sends a submission unit to Acme Pharmaceuticals, which identifies the submission type. This submission unit consists of a notification of awareness, a copy of the PrAR (but with specific confidential information excluded from the version sent to the CMS) and the product information (SmPC, PL and labelling). It also identifies that the submission unit is associated with the new initial marketing application procedure (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description..

Narrative Example

The Concerned Member State (CMS) have received the submission unit from the RMS, containing the Preliminary Assessment Report (PrAR). The CMSs uploaded the submission unit in the review system and assessed the content of the PrAR.

One CMS agrees with the issues raised in the PrAR by the RMS and informs the RMS and applicant that no further questions are raised.

Another CMS reviewed the PrAR and prepares a request to Acme Pharmaceuticals for clarification. This request is sent to the RMS.

A third CMS reviewed the PrAR and prepares a request to Acme Pharmaceuticals for clarification. This request is sent to the RMS and applicant.

The RMS sends a submission unit to Acme Pharmaceuticals which identifies the submission type. The submission unit consists of the PrAR and a summary of the feedback that the RMS received from the CMSs (i.e. additional points for clarification or a notification that no additional questions were raised) is included. It also identifies that the submission unit is associated with the new initial marketing application procedure ( (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description.

Narrative Example

The Reference Member State (RMS) has consulted with the Applicant, Acme Pharmaceuticals, and a consensus has been reached. The discussion about the draft documents will be carried out outside of the eCTD.

Acme Pharmaceuticals send a submission unit to the RMS and the Concerned Members States (CMS) which contains the final English version of the SmPC, labelling and PL. The submission unit message identifies the submitted files with identification of applicable country and language for these documents. It also identifies that the submission unit is associated with the new initial marketing application procedure

The RMS sends a submission unit to Acme Pharmaceuticals and the CMSs which identifies the submission type. The submission unit contains a letter to inform the Applicant that a consensus is reached and that the procedure is closed and the submission approved. It also identifies that the submission unit is associated with the new initial marketing application procedure (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description.

Narrative Example

The Reference Member State (RMS) has conducted consultations with the Concerned Member State (CMS) and Acme Pharmaceuticals, the Applicant, but it was not possible to reach consensus. These discussions are carried out outside of the eCTD.

The RMS stops the clock to allow the Applicant to supplement the dossier and respond to questions.

The RMS sends a submission unit which identifies the submission type to Acme Pharmaceuticals. It contains a clock stop announcement and the List of Questions. It also identifies that the submission unit is associated with the new initial marketing application procedure (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description.

Within 3 months (could be extended by a further 3 months), the Applicant sends a submission unit to the RMS and CMSs which contains the final response document. The RMS restarts the procedure. It also identifies that the submission unit is associated with the new initial marketing application procedure (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description.

Narrative Example

In the (DC or MR) Procedure the Reference Member State (RMS) is content with the applicant responses on the submission unit for Global Fixit from Acme Pharmaceuticals. The RMS informs the applicant to submit final responses to the CMSs.

The RMS sends a submission unit to Acme Pharmaceuticals which identifies the submission type. The submission unit consists of a letter. It also identifies that the submission unit is associated with the new initial marketing application procedure (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description.

Narrative Example

The RMS informs Acme Pharmaceuticals that the Responses are accepted and asks the Applicant to submit the final Responses to the CMSs (this exchange between RMS and Applicant is not happening in eCTD). This notification to the applicant may be done outside the eCTD.

Acme Pharmaceuticals prepares a new submission unit for Global Fixit. It identifies the type of submission unit that the submission unit is associated with the new initial marketing authorisation procedure (identifies by procedure number and variation number). In this submission unit, the submission unit message identifies that the CMSs are the recipient countries but not the RMS, and the regulatory agencies included in the procedure.

The submission unit contains documents (final set of Responses) which are common to all countries and indicates the documents categories that the files belong to. The submission unit comprises dossier sections defined by EU.

Other information needed for tracking purposes includes Iinformation on the product, the applicant, and submission unit description.

The CMSs regulatory authorities in the procedure receive the submission unit, undertake successful technical validation and load the submission unit into the Review System.

Narrative Example

The Reference Member State (RMS) and applicant agree the timetable. The RMS sends a revised timetable and a clock re-start letter.

The RMS sends a submission unit to all CMSs which identifies the submission type. The submission unit consists of the timetable and clock-restart letter. It also identifies that the submission unit is associated with the new initial marketing application procedure (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description.

[This step is currently done outside the eCTD and may continue to be done outside the eCTD in the future.]

The RMS sends a submission unit to Acme Pharmaceuticals, which identifies the submission type. This submission unit consists of the timetable and clock-restart letter. It also identifies that the submission unit is associated with the initial marketing application procedure (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description.

Narrative Example

The Reference Member State (RMS) has assessed the content of the submission unit for Global Fixit from Acme Pharmaceuticals. Received comments from the Concerned Member States (CMS) and consolidated these into draft summary of the assessment, with points for clarification for the applicant. This summary is called the Draft Assessment Report (DAR).

The RMS sends a submission unit to all CMSs which identifies the submission type (List 8). The submission unit consists of the DAR and the product information (SmPC, PL and labelling). It also identifies that the submission unit is associated with the new initial marketing application procedure (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description.

The RMS also sends a submission unit to Acme Pharmaceuticals, which identifies the submission type (List 8). This submission unit consists of a notification of awareness, a copy of the DAR (but with specific confidential information excluded from the version sent to the CMS) and the product information (SmPC, PL and labelling). It also identifies that the submission unit is associated with the new initial marketing application procedure (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description.

[Currently, these steps are not carried out in the eCTD and may not be in the future.]

Narrative Example

The CMS's final comments have been received by the RMS on day 145. There are no outstanding matters left and the RMS will close the procedure on day 150. The "End of Procedure Letter" including Product Information and commitments will be sent to the involved parties.

The RMS sends a submission unit to Acme Pharmaceuticals and the CMSs which identifies the submission type. The submission unit contains a letter to inform the Applicant that a consensus is reached and that the procedure is closed and the submission approved. The submission unit also includes a copy of the labeling documents and a list of any commitments. It also identifies that the submission unit is associated with the new initial marketing application procedure (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description.

Narrative Example

The CMS's final comments have been received by the RMS on day 145.

The Applicant will respond to those comments. Acme Pharmaceuticals prepares a new submission unit for Global Fixit. It identifies the type of submission unit and that the submission unit is associated with the new submission and application. The submission unit contains the new document which is common to all countries. The submission unit message identifies all the countries and regulatory agencies (see List 2) included in the procedure, identifies the submitted files, and indicates the document category or categories that the files belong to. The submission unit comprises categories defined by EU. Additional information about the product, the MAH and submission description may also need to be provided.

Acme Pharmaceuticals sends the submission unit to all regulatory authorities in the procedure which receive it, undertake successful technical validation, load the submission unit into the Review System.

On day 180 the RMS will give its comments on the response.

Narrative Example

The Reference Member State (RMS) has assessed the content of the submission unit for Global Fixit from Acme Pharmaceuticals. Received comments from the Concerned Member States (CMS) and consolidated these into an assessment report

The RMS sends a submission unit to the Coordination Group which identifies the submission type. The submission unit consists of the assessment report and other relevant information. It also identifies that the submission unit is associated with the new initial marketing application procedure (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description.

The RMS also sends a submission unit to Acme Pharmaceuticals, which identifies the submission type. This submission unit consists of the assessment report and relevant information. It also identifies that the submission unit is associated with the new initial marketing application procedure (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description.

[Currently, these steps are not carried out in the eCTD and may not be in the future.]

Supporting documents (to be provided)

List 8 : Controlled terms for submission types (regulators)

Narrative Example

The breakout session has been held and the Reference Member State (RMS) provides details of the outcome to the CMSs and Applicant. Typically this might be a list of outstanding issues

The RMS sends a submission unit to the CMSs and Applicant which identifies the submission type. The submission unit consists of the outcome of the breakout session and the list of outstanding issues. It also identifies that the submission unit is associated with the new initial marketing application procedure (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description.

Narrative Example

The Concerned Member States (CMSs) have received the submission unit from the RMS, containing the assessment report and the breakout group list of outstanding issues. The CMSs uploaded the submission unit in the review system and made their final review.

The CMS sends a submission unit to the RMS and Acme Pharmaceuticals which identifies the submission type. The submission unit consists of the final positions and key documents. It also identifies that the submission unit is associated with the new initial marketing application procedure (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description.

Narrative Example

The RMS consults with the CMSs and the applicant and is not able to reach consensus. The decision is referred to the Coordination Group

This referral happens outside the eCTD

Narrative Example

In the (DC or MR) Procedure an agreement on acceptance of approval between all CMSs and the RMS has been reached during Coordination Group meeting. The RMS closes the procedure by sending a submission unit to all CMSs and the applicant containing the declaration of the end of the procedure, (including the final assessment report and the specifications in DCP only), the list of commitments (as appropriate) and the declaration of the common renewal date and the clean versions of the endorsed, finalised SmPC/PL/labelling documents.

The submission unit message identifies all the countries and regulatory agencies included in the procedure, identifies the submitted files, and indicates the document category or categories that the files belong to. The submission unit comprises a regulator submission type (see List 8). Information identifying the submission and application the submission unit is associated with is supplied (identifies by procedure number and variation number). Additional information about the product, the MAH and submission description may also need to be provided.

Narrative Example

5 days after the closure of the procedure (see RMS draft assess report to CMSs and Applicant), Acme Pharmaceuticals send national translations for the Product Information to the CMSs and RMS.

Acme Pharmaceutical prepares a new submission unit for Global Fixit. It identifies the type of submission unit and that the submission unit is associated with the new initial marketing application procedure (identifies by procedure number and variation number).

In the submission unit, the submission message identifies the countries recipient for CMSs and RMSand the regulatory agencies included in the procedure. It identifies the submitted files, and indicates the document category(ies) that the files belong to with identification of applicable country and language. The submission unit comprises dossier sections defined by EU. Information identifying the submission and application the submission unit is associated with is suppled (identifies by procedure number and variation number). Additional information about the product, the MAH and submission description may also need to be provided.

Acme Pharmaceutical sends the submission unit to the RMS and CMSs, which receive it, undertake successful technical validation (see Storyboard 2) and loads the submission unit in the Review System.

Narrative Example

In the DC-Procedure the Reference Member State (RMS) and the Concerned Member States (CMSs) [in the MR-Procedure the Concerned Member States (CMS) only] have checked the translations of SmPC, Labeling and PL into national languages against the finally agreed English versions (at end of procedure Product X, YY mg, PharmForm, Acme Pharmaceuticals).

The RMS / CMS send independently a submission unit to Acme Pharmaceuticals which identifies the regulator submission type. The submission unit consists of a letter and product information texts. It also identifies that the submission unit is associated with the new initial marketing application procedure in its national phase (identifies by procedure number and variation number). The submission unit message identifies the one country and regulatory agency commenting on the PI documents resulting from the above mentioned procedure, identifies the submitted files of SmPC, Labeling and PL as appropriate including comments for requested changes, and indicates the document category or categories that the files belong to (SmPC, Labeling and PL, current module 1.3.1). Additional information about the product, the MAH and submission description may also need to be provided.

Narrative Example

The Reference Member State (RMS) and each Concerned Member State (CMS) have reached a consensus on the submission unit for Global Fixit from Acme Pharmaceuticals. This decision could be an approval or a rejection.

The RMS and each of the CMSs send a submission unit to Acme Pharmaceuticals identifies the submission type. The submission unit consists of the relevant documentation for the decision that has been reached. The documentation will include the letter with the decision, but could include other supporting documentation, such as the approved SPC document in the case of an approval It also identifies that the submission unit is associated with the new initial marketing application procedure (identifies by procedure number and variation number). Other information needed for tracking purposes will include name of country, regulatory agency, type of procedure, name of language, type of submission, information on the product, the applicant, and submission unit description.

The status is changed to "approved" or "rejected"

Narrative Example

Acme Pharmaceuticals have decided for business reasons to withdraw their application from the review procedure.

Acme Pharmaceuticals prepares a new submission unit for Global Fixit. It identifies the type of submission unit that the submission unit is associated with the new submission and application. The submission unit contains a letter announcing the decision to withdraw. The submission unit message identifies all the countries and regulatory agencies included in the procedure, identifies the submitted files, and indicates the document category or categories that the files belong to. The submission unit comprises dossier sections defined by EU. Additional information about the product, the MAH and submission description may also need to be provided.

The submission status is set to "withdrawn".

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 Application Roles (Sorted by Artifact Code)
 Application Roles (Sorted by Display Order)
 
pointer Applicant (PORP_AR000001UV01
pointer Regulatory Authority (PORP_AR000002UV01
Reference

For details on the interpretation of this section, see the discussion of application roles and their relationships in the Version 3 Guide.

Description View Interactions

The organization that assumes responsibility for producing documentation for the purposes of regulatory activities such as seeking approval to either start testing or market a specified product, master file submission, etc.

Description View Interactions

The organization that reviews and maintains records on the relevant information.

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 Trigger Events (Sorted by Title)
 Trigger Events (Sorted by Display Order)
 
pointer Unsolicited Submission Unit to Regulators (PORP_TE000001UV01
pointer Regulators Responds To Submissions (PORP_TE000002UV01
pointer Solicited Submission Unit to Regulators (PORP_TE000003UV01
Reference

For details on the interpretation of this section, see the discussion of trigger events in the Version 3 Guide.

Description View Interactions
Type: 

Applicant determines they have enough information that warrants a submission unit to a regulatory authority. The applicant can create a new submission unit, amend an existing submission or withdraw a submission.

Description View Interactions
Type: 

The Regulator responds to documentation provided by the Applicant. This response might contain documents with a list of questions, an approval or hold letter, requests for meetings, or other information, including coded information representing responses documented in regulations. This response will be packaged as a Submission Unit.

There is no necessary or even expected synchrony between Submission Units submitted by an Applicant and Submission Units sent in response by a Regulator.

Description View Interactions
Type: 

Applicant responds to a Regulator's request with a Submission Unit including documents or coded information representing responses documented in regulations.

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 Refined Message Information Models (Sorted by Title)
 Refined Message Information Models (Sorted by Display Order)
 
pointer Regulated Product Submission (PORP_RM000001UV01
Reference

For details on the interpretation of this section, see the description of RMIMs in the Version 3 Guide.

Diagram
T-PORP_RM000001UV.png
Parent:  None
Description

Security, Confidentiality, and Data Integrity

Application systems sending and receiving information are responsible for meeting all legal requirements for document and file authentication, confidentiality, and retention. For communications over public media, cryptographic techniques for source/recipient authentication and secure transport of encapsulated documents and files may be required, and should be addressed with commercially available tools outside the scope of this standard.

Model Overview

RPS Application

The exchange of information between Regulators and Industry is typically performed as part of a defined regulatory process specified in legislation in each country or region (e.g., 21 CFR Part 312 in the US, EudraLex Volume 1 in the EU). The RPS standard represents these regulatory processes as RPS Applications. The RPS Application provides the overall organization for the exchanges of information between the parties prescribed by the defined regulatory processes.

Applications (or Application Acts) are the electronic containers for the information submitted over time and correspond to the paper principle of a dossier for a product. The Application defines the metadata and keywords used to further classify the documents and document components within the table of contents for each Application type.

The RPS Application construct (or Act) has several administrative objects as described below.

  • An optional ReviewProcedure act through the subject ActRelationship. For example, for European drug product marketing applications this takes the value of Centralised, National or Mutual Recognition.
  • An optional TerritorialAuthority role through the informationRecipient participation. For example, for European drug product marketing applications this is used to identify the specific governing authorities or territories to which the application is sent.
  • Zero or more ApplicationReference acts through the reference ActRelationship. This is used to relate the subject Application to other RPS Applications. For example, for drug product applications this could be used to relate a Drug Master File or Active Substance Master File.
  • An optional Applicant role (defined below) related through the Holder participation. This identifies the organization sending the RPS Application to the Regulator on behalf of the Submitter (e.g., Agent for the Submitter, CRO).

RPS Submission

In many instances, the result of the regulatory process is a regulatory approval (e.g., to market a product) in that country or region. In some jurisdictions, it is possible to seek additional approvals for a regulated product through provision of additional information. In some cases additional information may be required to file about changes that do not require approval. The defined Application may have multiple regulatory review and approval processes over time.

For example, following the initial approval to market a drug product in the US or Europe, the regulatory processes allow subsequent requests for approval of the drug product (e.g., new indication) to be considered by the regulatory authorities. These are referred to as Supplements in the US and Variations in the EU.

The RPS standard represents each of these sets of additional approvals as an RPS Submission within the RPS Application construct. In these cases, the RPS standard provides the ability to associate a status to each RPS Submission as defined by the specific regulatory process.

In some regulatory processes, information can be organized for specific reviewers. These subdivisions are referred to as Reviewable Units. Each Reviewable Unit pertains to a single Submission.

An RPS Submission, or Submission Act, may have zero or more Review Acts as specified through the subject2 ActRelationship which is used to indicate the existence and status of a review process, particularly in cases where multiple Regulatory Authorities may be reviewing the same product.

The Review Act will have zero or more Territorial Authorities (through the Author participation), each of which may have an optional Authority (name) and Place (country). It will also have zero or more ProductCategory acts (through the subject2 ActRelationship). The Review may optionally identify the Applicant (through the holder1 participation), which may belong to an Organization. Through the subject1 participation, zero or more DedicatedServiceDeliveryLocation or ManufacturedProduct roles may be identified. Each ManufacturedProduct will have a Product entity that has zero or more Ingredient roles containing a Substance entity, and each DedicatedServiceDeliveryLocation may have a Place and an Organization (as defined above), and may have zero or more A_DeviceActDefinition acts. The A_DeviceActDefinition is a Common Message Element Type (CMET) of the Common Product Model.

Each Submission must be associated to an Application in order to manage the overall product life cycle in that region. An Application may contain multiple Submissions, as described above, and they are connected through a pertainsTo ActRelationship.

A Submission act may also belong to a SubmissionGroup through a pertainsTo ActRelationship. The SubmissionGroup is a label used to identify several submissions as belonging to the same group. A Submission act may optionally have a Mode through a subject1 ActRelationship. The mode would be used in variation or line extension regulatory activities and must be included in every sequence of that activity; the mode codes are defined by regulatory authorities. This is not used by all regulatory authorities, but may be applicable to: a single regulatory activity (e.g. an EU Type II variation), a grouped activity (e.g. several variations grouped into a single submission or a periodic report of EU type IA variations applicable to one or more marketing authorisations), and an activity subject to a worksharing agreement (e.g. an EU Type II variation applicable to more than one marketing authorisation).

Certain types of submissions may be approved by one or more Regulators over time for one Submitter when the regulator only has jurisdiction over a certain territory. The approval could be for a product or a facility. Many products can be the subject of each review. It is possible that not all products in the initial review will be approved.

The collection of documents in a submission unit could also be applicable to more than one application. For example, a change in manufacturing can be applicable to many applications and thus need to be submitted to many applications. Accordingly, a submission unit can pertain to many submissions and each submission can pertain to more than one application. When this occurs, the grouped submission can have one tracking number (i.e. submission group.id). It is also possible that not all of the documentation in a submission unit applies to all of the applications. The submission reference relationship can be negated for each context of use. In other words, unless otherwise stated, all context of use applies to all applications referenced by that Submission Unit.

A single document may be targeted to one or more regulators or one or more submissions in the set of regulators (using the TerritorialAuthority role), or Submissions (using the SubmissionReference Act) associated with the SubmissionUnit in which the ContextOfUse Act is a component. If not specified, the document is assumed to be targeted to all regulators that receive it.

In addition, a Context of Use may be limited to particular regulators by specifying one or more TerritorialAuthority roles through the primaryInformationRecipient Participation. It can also be restricted to being relevant to only particular Submissions through the use of the SubmissionReference act, through the pertainsTo ActRelationship.

RPS Submission Unit

Each exchange of information between Regulators and Industry is a regulatory transaction. Transactions are represented in the RPS model as RPS Submission Units. The entry point for the RPS message is the Submission Unit Act. Applicants transmit information to Regulators in the form of submission units. These submission units support the overall application.

For example, when Industry determines it has enough information to support the approval of a product in that country or region, the regulated party initiates the regulatory process by providing a Submission Unit to the appropriate Regulator. In this case, the regulated party is the sender. Upon receipt and review of the provided information a Regulator might determine that it has information in response and provides a Submission Unit back to the regulated party. In this case, the Regulator is the sender. The regulated party can subsequently create a new Submission Unit which may create new Submissions, amend existing Submissions or withdraw Submissions. Submission units sent by Regulatory Authorities are considered part of the Submission Act in that they can provide information relevant to the existing Submission or change the status of the Submission.

fig1.gif

Figure 1: Exchange of Submission Units between a Regulator and Industry

Each Submission Unit is a single transmission of information about one or more Reviewable Units or Submissions. This relationship is defined in the message through the PertainsTo ActRelationship. A Submission Unit may have Contact Party roles related through its callBackContact participation.

Each Submission Unit contains a CategoryEvent object used to further describe the type or kind of Submission Unit, referenced through the Subject ActRelationship. CategoryEvent objects may be further described using additional CategoryEvents referenced through Subject ActRelationships.

ContextOfUse Codes and Keywords

ContextOfUse (CoU) codes are controlled vocabularies used to define the role of each document in the Submission Unit, and ultimately, in the overall table of contents for the regulated product type in the subject country or region. A Context Of Use is a reference to a document in a particular submission unit with a particular code value that assigns the document to a specific section of the table of contents. A single document may be assigned to more than one section of the table of contents, i.e., be associated with more than one ContextofUse (see Document Reuse).

ContextofUse codes are typically provided as controlled lists by the regulatory authorities in each region for each regulated product class. In some regulated industries (e.g., drug products) the controlled vocabulary (i.e., the CoU codes) can be harmonized across regions.

A single Submission Unit may include codes from multiple lists or even multiple authorities, as permitted by the particular submission type. For example, a US FDA New Drug Application (NDA) may include CoU codes provided by the International Conference on Harmonisation (ICH) eCTD code list, and by the US FDA Center for Drug Review and Evaluation list, and particular items specific to NDA applications but not other application types.

To enable further distinction between multiple documents using the same CoU code, the Keyword act may be provided on individual ContextOfUse acts to provide further differentiation. The Keyword act contains either an ID of a KeywordDefinition Act (connected to the Application act through the ReferencedBy ActRelationship), or a coded value from a predefined code set.

Keywords have a name, which identifies the kind of keyword, e.g. route of administration, and a value, e.g. oral. Some keywords will be in predefined code lists, which contain their values as both text and code, but the keyword name will be determined or inferred from the code system id or name. User-defined keywords can be defined in an application by a keyword definition and have their value given in the value attribute of the definition object, and their name assigned in the code attribute of the definition object.

The combination of ContextOfUse Codes and Keywords enables submission assembly and review tools to create a logical organization and grouping of the submitted content to be presented to the end user independent of the sequence the information is provided within the submission unit. For example, user-defined Keywords would be used in CTD section 3.2.S to provide further specificity regarding the drug substance and manufacturer. A coded value would be used to further distinguish studies in the same section according to the species of animal used in each study. The KeywordDefinition would be used to provide specific, user-defined text to further distinguish a set of documents (for example, by the study number).

Please note that the RPS message does not include the ordering information that keywords and context of use codes imply -- this is determined by the Regulatory Authority as a separate process.

Documents

The content of an electronic regulatory submission is provided in named digital files of various formats (e.g., .pdf, .xml, .jpg) as may be required by the regulator. These files are not part of the RPS XML message but are usually transmitted in conjunction with the RPS message and represented as simple documents.

In the RPS message, a document can be either simple or compound. A simple document comprises (i.e., references) exactly one file and the reference to the file is the path/name of the file carried in the document.text attribute.

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Figure 2: Examples of Simple Documents

A compound document comprises (i.e., references) more than one simple document. Therefore, a compound document does not directly reference files but rather references other documents through the unique id of each document carried as the target of each document component. The component.priority sets the sort order of the components in the compound document.

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Figure 3: Example of a Compound Document

Stated more formally, the unit of content managed and referenced in RPS is the document, represented in the model by the class document (of type document, a subtype of class act). The attributes of document are:

  • id, a required unique identifier
  • document code, an optional type code drawn from a regulator-defined controlled vocabulary
  • title, an optional text string
  • text, an optional attribute used to reference a file in a simple document
  • status code, a code drawn from an HL7-defined controlled vocabulary
  • set id, a unique identifier assigned to the set of versions of the same document
  • version number, an integer greater than any earlier version number

In addition, the document class is the source of zero or more act relationship classes named component. This relationship is defined recursively on the class itself indicating that a document may contain other documents as components. These components are not really nested within the parent document, but are referenced by their id values. Note that a document object (an instance of the document class) cannot have both a text attribute and any component relationships; i.e. it must specify either a simple or a compound document.

Composition of Documents

An original document is the first version of a document. It gets a new unique value for Document.id, a new unique value for Document.setId, and has the value of Document.versionNumber. Rules and values for Document.versionNumber are defined by each specific implementation of the message (code = CD). For some documents (e.g., ICH study report documents), further specificity can be assigned to the components of the document through the use of appropriate document codes.

For example, a protocol for a study might be provided as a single file (protocol.pdf). This file is presented as a simple document in the RPS message and is assigned the appropriate document code for "protocol-or-amendment" from the controlled vocabulary for documents to further describe the contents of the document relative to the other documents being submitted related to Study XXX.

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Figure 4: Example of Simple Document with Document Code Assigned

A more complex document might be submitted as a collection of files. For example, a study report document might be provided as three files: a synopsis, the body of the study report and the previously submitted protocol document. Each of the new files (i.e., the synopsis and the body of the report) are first provided as unique documents in the message.

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Figure 5: Additional Simple Documents with Document Codes Assigned

A single study report document can now be created from all of these components; the sequencing of the components controlled by the component priority value.

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Figure 6: A Compound Document with Document Codes Assigned to Components

Document Revisions

There are two ways to modify a document: by the addition of information (e.g., amendment, errata, addenda) or by the replacement of the document with an updated version of the document (e.g., replacement with a revised document).

When modifying a document by the addition of information, the addendum is an appendage to the existing document that contains the supplemental information. As such, the addendum itself must first be presented as an original document, as described in the previous paragraph (thus it has its own Context of Use and Document unique id and setId, and versionNumber="1").

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Figure 7: An Amendment to be Associated with an Existing Document

Depending on the complexity of the information associated with Study XXX, the protocol and protocol amendment documents can be left as discrete entities. However, in more complicated situations, it might be desirable to formally join these documents into a single new protocol document. In this example, the intent is to add the amendment to the existing protocol document to create a revised protocol document containing the protocol and the protocol amendment. The new document (i.e., the protocol amendment) is essentially being appended to the existing document (i.e., the protocol) but does not use an 'append' construct.

When a document is modified in a subsequent SubmissionUnit, a new version of the Document is created within the Application act, keeping the same setID but with a new ID and version number, and the sequelTo ActRelationship that points to the previous Document. This indicates that new content is available. In order to associate the protocol amendment (Figure 7) with the original protocol (Figure 4), the new protocol document (now containing two components) would be described as shown in Figure 8. It is important to note the setId of the original protocol (from Figure 4) is retained in this new version of the protocol (Figure 8) composed of two components.

Therefore, when a document replaces an existing document, the replacement document gets a new globally unique ID value (e.g., id = nkc96d) but uses the same value for document.setId as the document being replaced (e.g., setId = 23456), and increments the value of document.versionNumber by 1. (Note that version number must be incremented by one when a document is replaced, but can also be incremented more often to meet local requirements). The related document is considered superseded, but is still retained in the system for historical reference. The related document being replaced is referenced via an ActRelationship, where the ActRelationship.typeCode is set to equal "RPLC" (for "replace").

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Figure 8: Appending a Protocol with a Protocol Amendment through Creation of a New Version of the Protocol Document

Placement of Documents in Applications

The use of a document within a Submission Unit requires assignment of new unique numbers for ContextOfUse.id and ContextOfUse.setID, and a ContextOfUse.versionNumber (see Context of Use Codes and Keywords section above). The context of use of the study report document (defined above in Figure 6) in a Submission Unit would be described as shown in Figure 9.

fig9.gif

Figure 9: Associating a Document with a Specific Section of the Table of Contents

The priority value assigned to the CoU as a component of the submission unit is not part of the CoU object itself, but specifies the relative display position of the particular CoU with respect to other CoUs that carry the same code value. Since this priority value is a real number it is always possible to insert a CoU between any two previously submitted CoUs (e.g., priority 1.5 can be submitted to specify the display between priorities 1 and 2.)

Document Reuse

Since the same information might need to be submitted to different sections of the same application or to support multiple applications, it is imperative that the standard allow for the re-use of documents. Reuse is accomplished by using the ID scheme (through the ID property of the II datatype) in the DocumentReference Act of ContextOfUse. The ID scheme allows a context of use in one application to provide a reference to a document that was submitted in another submission or even another application.

The ContextOfUse Act provides the relationship of a document to a section of the Submission Unit (or Application). Since a submission unit can contain multiple ContextOfUse acts, this class can be used to indicate each assignment of a document to a section. Looking across multiple submission units, it is possible to identify a single document's context in multiple applications as needed.

For example, a simple document is submitted to support each of the two manufacturers for the drug substance in an application. The submission unit would specify the document.

Note that one Context Of Use instance associates exactly one Document with exactly one heading in the Table Of Contents, as specified by the code. Where multiple Documents file under the same heading, that is, where several Context Of Use instances (each representing a single document) specify the same code value, then the CoU priority, the associated Keywords and the Context of Use code together determine the position of those Documents in the submission, but each Document still appears only once in the sequence. Adding additional keywords will not cause a Document as represented by one Context Of Use instance to file in more than one position; at best such additional Keywords will have no effect and at worse they will cause a misfiling or a validation error.

fig10.gif

Figure 10: A New Simple Document Applicable to Multiple Drug Substance Manufacturers

Two contexts of use for the document would then be created, both referencing the same document id (i.e., dd1234).

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Figure 11: One Document Represented in Two Sections of a Table of Contents for an Application

A reference to this same document could similarly be established from another application entirely as long as the document id is accessible on the receiving end of the message. Regional implementation guides will specify the extent of document reuse allowed by the local regulatory authorities.

Document Statuses and Transitions

Documents only assume a subset of the states that other Acts can take on. When a document is provided to the regulatory authorities in a specific CoU, its status becomes "active." Documents that are "active" are rendered "obsolete" when they are replaced with a revision, and this should be done explicitly using the replacement relationship between the new version and its predecessor. A document can be rendered "nullified" by a status change. RPS will NOT provide a mechanism for a submitter to physically delete submitted content. If a document is rendered "obsolete" or "nullified," that document can be reactivated. Obsolete and nullified documents cannot be revised (i.e., replaced).

A document can be nullified by the submitter sending a copy of the same document object (i.e., with the same id) and a status code of "nullified. Any documents or contexts of use associated with a nullified document must themselves be separately nullified or otherwise updated.

Status Code Description
Active This document is active, and is available. All documents start with an active state. Active also means current
Obsolete This document was superseded by a replacement document and is now obsolete. It is no longer available.
Nullified This document was created in error or is no longer relevant. It is no longer available.

Once made OBSOLETE a document object cannot be referenced by a compound document or CoU object submitted later; that would be an error.

When a document object is made OBSOLETE other documents and CoUs with which it is associated would usually need to be updated also. However, since one document object can be associated with multiple CoU objects (i.e., filed in multiple locations), a replacement document must explicitly replace ALL contexts of use for that document. Replacing a document in one CoU does not automatically replace it in all CoUs.

As described above, a context of use is a reference to a specific document in a particular submission unit with a particular code value. Because a document may have several contexts of use, it is possible that each context of use of the same document will have different statuses.

For example, a document D0 relating to manufacturing processes might be filed under two different manufacturers Q and R (i.e., D0 would be associated with two different CoU objects, CQ and CR, each version 1 in a different set). If the manufacturing process changed at R but not at Q, the document D0 would NOT be replaced, rather a new document, DR, would be created (as version 1 in a new set, not in the same set as D0). DR would be submitted along with an updated CoU CR (version 2 in the same set, replacing version 1). Document D0 would remain active, as would CoU CQ. It is expected that RPS management tools will provide their users with a 'used in' list showing the associated contexts of use for any document object (i.e., specific version).

Modification of Documents in Applications

When an existing document is modified by a subsequent SubmissionUnit, there are two operations that should happen:

1) A new version of the Document must be created within the Application Act; this indicates that new content is available. Usually, the replacement document will retain the same setID as the replaced document but will have its own unique new ID and version number, and the sequelTo ActRelationship will point to the previous Document (through the setId).

2) A new version of each ContextOfUse that was derived from the previous version is created within the SubmissionUnit act, each keeping the same setId as its predecessor, but with a new ID and version number, and the sequelTo ActRelationship that points to the previous ContextOfUse. This indicates that the new content is being used in the particular Contexts of Use for the replaced document.

For example, in a previous example (see Document Reuse, Figures 10-11) a simple document (id=dd1234) was presented as being used to support two manufacturers in the drug substance section of an application. In order to revise that document the two steps above must be performed.

First, the new document must be created within the Application Act. The new document can be a simple or compound document. One can create this replacement document as a new version of the document being replaced (Option A) or, as a unique, new document with no relation to the document being replaced (Option B).

Document to be Replaced

fig12-1.gif

Replacement Options

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Figure 12: Options for Replacing a Document

If all instances of the CoUs derived from the original document are being updated, Option A would be the preferred approach as it provides a cleaner life cycle and history of changes to the original document. However, if only one instance of the document was being updated, consideration of potential future revisions suggests Option B would be the preferred approach as it allows the original setId of the document to be retained for the unchanged context of use (i.e., Little Factory) and creates a new setId for the context of use being updated (i.e., Big Factory). From there, subsequent changes to either manufacturer are more readily effected with a unique setId for each document.

In the case of option A all of the CoUs would be updated, retaining their individual setIds with incremented version numbers and a derived from reference to the new version of the document.

In the case of Option B where only one CoU (i.e., pertaining to the Big Factory manufacturing site) is being updated, it would retain its predecessor's setId with an incremented version number and a derived from reference to the new document as shown in Figure 13. The receiving system is responsible for changing the status code on its copy of the replaced document object and for rejecting subsequent references to it (e.g., replacements) as errors.

CoU to be Replaced

fig13-1.gif

CoU Replacement

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Figure 13: Replacing One Instance of a Document in a Section of the Table of Contents

Document Deletions

There is occasionally the need to delete (or withdraw) documents which have previously been submitted (e.g., erroneously submitted or no longer relevant to the review of the application). To do this, a subsequent submission message will specify the document id to be deleted and indicate the status as being inactive. For example, in order to delete (or withdraw) the document described in Figure 10 from one of its locations in the application (as shown in Figure 11) a subsequent submission unit would contain the following document reference.

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Figure 14: Deleting (or Withdrawing) a Document from a Section of the Table of Contents for an Application

Keyword Definition States and Transitions

It should be noted that Keywords do NOT have a life cycle because when any change is made to a keyword associated with a document or a CoU, a new version of that document or CoU must be submitted with all associated keywords. Keyword definitions, however, can also have a lifecycle to support changes to a keyword over time (e.g., change in Company name, to correct an error). The lifecycle concept for keywords is similar to documents.

keywordstate.gif

Status Code Description
Active This keyword definition is active, and is available. All keywords start with an active state.
Obsolete This keyword definition was superseded by a replacement document and is now obsolete. It is no longer available.
Nullified This keyword definition was created in error or is no longer relevant. It is no longer available.

If a keyword definition is replaced a new keyword definition is sent that references its predecessor by means of a replacement of relationship, which causes the status code of the predecessor to be set to "OBSOLETE".

A keyword definition can be withdrawn in the same way a document is withdrawn (nullified).

Submission Statuses and Transitions

The submission act has a status code attribute that would be set to active on the initial submission. The formal state machine for submission objects is as follows:

substate.gif

However, the exact use of the submission status code will be determined by the implementation rules established by each regulatory authority.

The actual regulatory status of a submission is represented by the code value in the regulatory status act associated with the submission through a pertinent information relationship. This code will be drawn from a controlled vocabulary to be defined by the regulator. It will usually be set by the regulator and communicated to the submitter as part of a reply submission unit; however, each regulatory authority may establish its own specific implementation rules for the use of regulatory status.

The following table lists some possible examples of regulatory status codes.

Regulatory Status Code Display Name Description
Active This submission is currently being reviewed.(FDA: Marketing/IND: Pending, CDRH is called Under Review; EU: Marketing Active, CTA: Under Assessment; HC TBD, Japan, TBD). Many regulators have milestones within an active submission.
Filed The submission has been transmitted, but a technical check is outstanding or the confirmation of receipt has not yet been issued by the regulator (or receiver) respectively
Completed This submission is complete and the intended purpose (e.g., marketing) can proceed. (FDA: Marketing Approved, IND in effect, Approved (PMA, HD) or Clear (510k), EU; Approved, Authorised or accepted - depending on procedure (Devices has closed
Held This submission is not currently being reviewed. FDA; Marketing Complete Response, Investigation Clinical hold, Devices on hold; EU suspended
Nullified This submission has been withdrawn.; Devices on closed

Other states (Submission Unit, Contacts, etc.)

Many concepts in RPS have a simple lifecycle. The concepts are either "in use" or no longer relevant. These concept do not have more complicated lifecycle since the extra complication is not needed compared to the effort.

Regulatory Status Code Display Name Description
Active Current
Nullified No longer relevant.

Contact information is needed so the Regulator and Submitter know who to communicate with if a problem arises. The contact could be of many types (e.g. technical, clinical, cmc).

Contained Hierarchical Message Descriptions
Submission Message PORP_HD000001UV01

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 Hierarchical Message Descriptions (Sorted by Title)
 Hierarchical Message Descriptions (Sorted by Display Order)
 
pointer Regulated Product Submission (PORP_HD000001UV01
Reference

For details on the interpretation of this section, see the description of HMDs in the Version 3 Guide.

Description

This is the HMD for the Regulated Product Submission, submission units message.

Common Message Element Types Used
A_DeviceActDefinitionUniversal POCP_MT070000UV01
Base Hierarchical Message Description Goto RMIM Table View Excel View
Message Type List
Regulated Product Submission MT PORP_MT000001UV01

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 Interactions (Sorted by Title)
 Interactions (Sorted by Display Order)
 
pointer Submission Unit sent (PORP_IN000001UV01
Reference

For details on the interpretation of this section, see the definition of Interactions in the Version 3 Guide.

Description Schema View

The submission unit is sent from the application to the regulatory authority

Trigger Event Unsolicited Submission Unit to Regulators PORP_TE000001UV01
Transmission Wrapper Send Message Payload MCCI_MT000100UV01
Control Act Wrapper Trigger Event Control Act MCAI_MT700201UV01
Message Type Regulated Product Submission MT PORP_MT000001UV01
Sending and Receiving Roles
Sender Regulatory Authority PORP_AR000002UV01
Sender Applicant PORP_AR000001UV01
Receiver Regulatory Authority PORP_AR000002UV01
Receiver Applicant PORP_AR000001UV01

This Annex holds an Implementation Guide that has been developed to support the Implementation of Regulated Product Submission (RPS), Release 1 an HL7 approved standard.

This document is currently in a "stand-alone" format. HL7 currently has no approved format for implementation guides. When such a format becomes available, this document will be converted so that it can be represented here directly as domain content. Click here to download a copy of the approved document.

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