Calyx RIM XEVMPD

XEVMPD Submission Wizard Data Collection Features

The XEVMPD Submission Wizard enables you to collect data and files from the database to include in XEVMPD submissions, and to generate .zip files that include the collected data and attachment files to submit to the European Medicines Agency (EMA).

The following sets of features are applicable for the XEVMPD Submission Wizard data collection.

Full Product Presentation

Important: If any Package Set is associated to the Registration, but is not associated to the Full Product Presentation under the Registration, then the Active Ingredient, Substance, Indication/Intended Use (non-Veterinary), or Species Indication (Veterinary) Details of the parent Product Details Set are not included to the XEVMPD submission.
The following is applicable for the Full Product Presentation entity:
  • If you set the Use Reference Ingredient for XEVMPD field in the Full Product Presentation entity to Yes, you will see the reference active ingredient or reference strain data (for a Flu Vaccine) in an appropriate section in the XML file. If you need to include active ingredient information or strain (for a Flu Vaccine), the field should be set to No. Reference Active Ingredient or Reference Strain must have an appropriate EV_CODE in Data Administration.
  • If the XEVMPD Marketing Authorisation Number and XEVMPD MAH/Organisation in the Full Product Presentation entity are populated with values, then these values are included to the appropriate section in the XML file instead of the Package Set Registration values. This feature is applicable for the Invalidate MA operation type for Not Valid Authorisation Status only.
  • For the Authorised Product XEVMPD section, when an Application has one of the EU CP (Centralised Procedure) types (e.g. EU CP Bio) selected, you can send the XEVMPD submission specific for EEA Countries, such as Norway, Iceland, or Liechtenstein. To be included to the .xml file, Norway, Iceland, or Liechtenstein should be selected in the EEA Country field on the Full Product Presentation. Otherwise, the Country from the PSet (Package Set) Registration is added to the XML file.

Product Detail Set

Important: The Active Ingredient, Substance, Indication/Intended Use (non-Veterinary), or Species Indication (Veterinary) PDS Details are included in an XEVMPD submission only if Package Sets from the parent PDS are associated to the Full Product Presentation.
The following is applicable for the Product Detail Set entity:
  • If you set the Use as Active Ingredient for XEVMPD field in the PDS Substance Detail to Yes, then the data from Substance Detail is added as an Active Ingredient (regardless of the selected Substance Type) to an appropriate section in the XML file. If you set this field to No, then Substance Detail is used as an Excipient or Adjuvant, depending on the selected Substance Type.
  • If the Strength-related fields in the PDS Active Ingredient are populated with values, then these values are included in the appropriate section in XML file instead of Component Active Ingredient values.
  • For the Authorised Product XEVMPD section: if the PDS Indication/Intended Use Detail (non-Veterinary) or PDS Species Indication Detail (Veterinary) has the same Country assigned as the Country selected for the Authorised Product, then this data is added to the appropriate section in the XML file.
Note: For Insert and Update operation types, at least one indication should exist within an Authorised Product for all supported Product Family types. The indication data is added to the appropriate section in the XML file if: it is associated on the Product Family level, it is created in the Product Detail Set with an Approved status, and the indication country is a value from either Registration entity (Country field) or Full Product Presentation entity (EEA Country filed).
The prior approved PDS Detail from the previous Event is taken into the XEVMPD Submission if the current PDS Detail has one of the following statuses:
  • Pending Modify
  • Pending Withdrawal
This rule is applicable to the following PDS Details:
  • Active Ingredient (including the Reference Active Ingredient logic)
  • Indication/Indented Use
  • Indication (under Veterinary Product Family)
  • Strain
  • Reference Strain
  • Substance (Excipient, Adjuvant, and Substance entities used as Active Ingredient)

The PDS Details with status set to Withdrawn are not included into XEVMPD Submission.

For Package Set Detail with the Withdrawn status, the following rules apply:

  • If there is a FPP with EMA Authorisation Status Code for ‘Not Valid’ value, the PSet is included into XEVMPD logic.
  • If there is a FPP with EMA Authorisation Status Code for ‘Valid’ value, then PSet is not included into XEVMPD logic.

For the Indication/Intended Use (non-Veterinary Product Detail Sets), Indication (Veterinary Product Detail Sets), Active Ingredient, and Substance PDS Details when there are several identical values under different Product Detail Sets, but under the same Full Product Presentation, they are represented with a common tag in the XEVMPD XML file as one value, instead of multiple values.

Applications

The following is applicable for applications of CP (Centralised Procedure) Type:
  • For the Authorised Product XEVMPD section, when the Application is of CP Type, the CP number is taken from Application Code field when the Procedure Identifier field contains no data. When the Procedure Identifier field is populated with data, the CP number is taken from Procedure Identifier.
The following is applicable for applications of Mutual Recognition Procedure (MRP) or Decentralised Procedure (DCP) Types:
  • For the Authorised Product XEVMPD section, when the Application is of MRP or DCP Type, the MRP or DCP number is taken from Application Code field when the Procedure Identifier field contains no data, with the addition of the Speciality Number field information from the Product Detail Set Attributes page. For example: [Application Code][Speciality Number1]. When the Procedure Identifier field is populated with data, the MRP or DCP number is taken from Procedure Identifier field, with the addition of the Speciality Number field information from the Product Detail Set Attributes page. For example: [Procedure Identifier][Speciality Number1] .
If there is more than one PDS with the Speciality Number field populated with data, the formula for concatenation is: [Procedure Identifier/Application Code][Speciality Number1]'-'DISTINCT [Speciality Number2]. Where DISTINCT means the value different from the [Speciality Number1]. If both Speciality Number1 and Speciality Number2 are the same values, than only Speciality Number1 is taken.
Note: The Speciality Number field is also available in PDS for the EU Herbal and EU Homeopathic types. However, this field is not connected with the XEVMPD XML file for those Application Types.

Registrations

The Package Set Registration > Legal Basis value is included in the XEVMPD Submission XML file instead of the Application > Legal Basis value, when:
  • The field is populated with a value for both entities.
  • The Application > Legal Basis field is not populated with a value.
Important: If the Legal Basis field in not populated for an Application or for a Registration, a warning message is displayed.

Product Detail Sets

If configured, a field named Local Route of Administration for tracking country Route of Administration on PDS level is presented on the PDS Attributes page. This field is hidden by default and can be enabled via the overrides. The Route of Administration value can be taken into an XEVMPD submission from the PDS level according to the following set of rules:
  • If the Local Route of Administration value is populated on the PDS Attributes page and the Component associated to this PDS is also associated to the Pharmaceutical Product, then this value is taken to the XEVMPD Submission XML file.
  • If the Local Route of Administration value is not populated on the PDS Attributes page, then the Route of Administration value is taken from the Product or Component (if more than one component exists) to the XEVMPD Submission XML file.
  • If the Route of Administration value is not populated on the PDS, Product, or Component Attribute page, then a warning message stating that Route of Administration is required is displayed in the XEVMPD Submission wizard.
  • If the Route of Administration value selected in the Local Route of Administration field does not have an EV Code assigned in the Data Administration > Product Maintenance > Route of Administration Values > Route of Administration XEVMPD Information, then a warning message stating that Route of Administration must be submitted in the XEVPRM message is displayed in the XEVMPD Submission wizard.