XEVMPD Error Message for Authorised Product
The following table lists the Authorised Product error messages and their description.
| Error Message | Description |
| Procedure Type is required. | This error occurs when there is no procedure type for the selected Application entity. This error also occurs if an incorrect value is entered for the Procedure Type Code in DA. |
| At least one Indication is required for this operation type. | This error occurs when there is a no Indications/Intended Use PDS Detail created. |
| MedDRA Code is required to submit indication data. | This error occurs when there is no value in the MedDRA Code field in DA for the created Indications/Intended Use PDS Detail. |
| MedDRA Level in Data Administration is required to submit indication data. | This error occurs when there is no value in the MedDRA Level field in DA for the created Indications/Intended Use PDS Detail. |
| MedDRA Term version is required to submit indication data. | This error occurs when there is no value in the MedDRA Term Version field in DA for the created Indications/Intended Use PDS Detail. |
| Authorisation Status on FPP entity is required to be with value for this Operation Type. | This error occurs when there is no value in the Authorisation Status field for the selected FPP entity and Operation Type in the Wizard. |
| Authorisation Number cannot exceed 100 characters. | This error occurs when there are more than 100 characters in the License Code field for the Registration entity. |
| Authorisation/Renewal Date on FPP entity is required to be with value for this Operation Type. | This error occurs when there is no Authorisation/Renewal Date field for the selected FPP entity. |
| MRP Number is required for this procedure type. | This error occurs when there is no value for the condition Application Code or the Application Identifier and PDS->Speciality Number (CP only). |
| Orphan Drug on Application entity is required to be with value for selected Operation Type. | This error occurs when there is no value in the Orphan Drug field for the Application entity. |
| Withdrawn/Invalidated Date is required for this operation type. | This error occurs when there is no value in the Withdrawn/Invalidated Date field for the selected FPP entity. |
| Withdrawn/Invalidated Date must be empty if Authorisation Status is valid MA. | This error occurs when there is no value in the Withdrawn/Invalidated Date field for the selected FPP entity. |
| Withdrawn/Invalidated Date is required to be with value for this status type. | This error occurs when there is no value in the Withdrawn/Invalidated Date field for the selected FPP entity. |
| The operation type must be Invalidate MA for this status type. | This error occurs when an invalid value is selected for the Authorisation Status field for the selected FPP. |
| Error Message | Description |
| The operation type cannot be Invalidate MA for this status type. | This error occurs when an invalid value is selected for the Authorisation Status field for the selected FPP. |
| If the Operation Type is Insert, Update or Invalidate MA then Legal Basis on Registration or Application entity must be specified. | This error occurs when the Operation Type is Insert, Update or Invalidate MA and there is no value for the Legal Basis field on Registration or Application entity. |
| If the Operation Type is not Nullify then at least one Medicinal Product Type must be specified. | This error occurs when the Operation Type is not Nullify and there is no value for the Medicinal Product Type on Registration entity. |
| If the Operation Type is not Nullify then at least one Authorised Pharmaceutical Form must be specified. | This error occurs when the Operation Type is not Nullify and there is no value for the Authorised Pharmaceutical Form on FPP entity. |
| This Authorised Pharmaceutical Form must be submitted in this message. | This error occurs when there is no value in the Authorised Pharmaceutical Form field on FPP entity. |
| This Authorised Pharmaceutical Form must not represent a Development Pharmaceutical Form. | This error occurs when the Authorised Pharmaceutical Form selected on FPP entity has a Development Term in Dosage/Pharmaceutical Form Values in DA. |
|
If the Operation Type is Insert or Update and Authorised Pharmaceutical Form has XEVMPD Code then Authorised Pharmaceutical Form must represent a Standard or Proposed Pharmaceutical Form. |
This error occurs when the Authorised Pharmaceutical Form selected on FPP entity does not have a EV Code or Standard Term, or Proposed Term in Dosage/Pharmaceutical Form Values in DA. |
| Product INN/Common Name on FPP entity is required to be with value. | This error occurs when there is no value in the Product INN/ Common Name field for the selected FPP entity. |
| Product INN/Common Name cannot exceed 250 characters. | This error occurs when there are more than 250 characters in the Product INN/Common Name field for the selected FPP entity. |
| Company Name on FPP entity is required to be with value. | This error occurs when there is no value in the Company Name field for the selected FPP entity. |
| Company Name cannot exceed 250 characters. | This error occurs when there are more than 250 characters in the Company Name field for the selected FPP entity. |
| Product Strength cannot exceed 250 characters. | This error occurs when there are more than 250 characters in the Product Strength field for the selected FPP entity. |
| Product Form cannot exceed 250 characters. | This error occurs when there are more than 250 characters in the Product Form field for the selected FPP entity. |
| Error Message | Description |
| Package Description cannot exceed 2000 characters. | This error occurs when there are more than 2000 characters in the Package Description field for the selected FPP entity. |
| MFL on Registration entity is required to be with value for selected Operation Type. | This error occurs when there is no value for the MFL field on Registration entity. |
| The Master File Location must be submitted in this message. | This error occurs when there is no value in the MFL field on Registration entity. |
| Registration Attachment EV Code is required for submission. | This error occurs when there is no value in the EV Code field on Registration Attachment entity. |
| This substance can be used only once within Pharmaceutical Product. | This error occurs when a same substance is selected as AI and Excipient/Adjuvant. |
| The Marketing Authorisation Holder must be submitted in this message. | This error occurs when MAH/Organisation selected on Registration entity does not have a EV Code or MAH Code in MAH/Development Sponsor/Organisation Values in DA. |
| No Marketing Authorisation Holder was specified. | This error occurs when there is no value for the MAH/Organisation field on Registration entity. |
| Pharmacovigilance Enquiry Email is required for this operation type. | This error occurs when there is no value in the Enquiry Email field on Registration entity. |
| Pharmacovigilance Enquiry Phone Number is required for this operation type. | This error occurs when there is no value in the Enquiry Phone Number field on Registration entity. |
|
No valid Pharmaceutical Products were found. At least one Pharmaceutical Product with Active Ingredient measure information must be specified. |
This error occurs when there is no Pharmaceutical Product created. |
| No Active Ingredients were specified. |
This error occurs when Substance selected as Active Ingredient (Reference AI/Reference Strain/PDS AI) entity does not have a EV Code or Approved in Substance Values in DA. |
| High Amount Numerator Value must be empty for non-Range Concentration Type. |
This error occurs when there is no value in the High Amount Numerator field on Component Product AI/Reference AI or on PDS AI (Reference Strain/Excipient/Adjuvant ) entity for selected Non-Range Concentration Type. |
| High Amount Numerator Unit must be empty for non-Range Concentration Type. | This error occurs when there is no value in the High Amount Numerator Unit field on Component Product AI/Reference AI or on PDS AI (Reference Strain/Excipient/Adjuvant ) entity for the selected Non-Range Concentration Type. |
| Error Message | Description |
| High Amount Numerator Prefix must be empty for non-Range Concentration Type. | This error occurs when there is no value in the High Amount Numerator Prefix field on Component Product AI/Reference AI or on PDS AI (Reference Strain/Excipient/Adjuvant ) entity for the selected Non-Range Concentration Type. |
| High Amount Denominator Value must be empty for non-Range Concentration Type. | This error occurs when there is no value in the High Amount Denominator field on Component Product AI/Reference AI or on PDS AI (Reference Strain/Excipient/Adjuvant ) entity for selected Non-Range Concentration Type. |
| High Amount Denominator Unit must be empty for non-Range Concentration Type. | This error occurs when there is no value in the High Amount Denominator Unit field on Component Product AI/Reference AI or on PDS AI (Reference Strain/Excipient/Adjuvant ) entity for selected Non-Range Concentration Type. |
| High Amount Denominator Prefix must be empty for non-Range Concentration Type. | This error occurs when there is no value in the High Amount Denominator Prefix field on Component Product AI/Reference AI or on PDS AI (Reference Strain/Excipient/Adjuvant ) entity for selected Non-Range Concentration Type. |
| High Amount Numerator Unit must match Low Amount Numerator Unit. |
This error occurs when the value in the High Amount Numerator Unit field on Component Product AI/Reference AI or on PDS AI (Reference Strain/Excipient/Adjuvant ) entity is different to the value of the Low Amount Numerator Unit field for the same entity. |
| High Amount Denominator Unit must match Low Amount Denominator Unit. | This error occurs when the value in the High Amount Denominator Unit field on Component Product AI/Reference AI or on PDS AI (Reference Strain/Excipient/Adjuvant ) entity is different to the value of the Low Amount Denominator Unit field for the same entity. |
| High Amount Denominator Prefix must match Low Amount Denominator Prefix. | This error occurs when the value in the High Amount Denominator Prefix field on Component Product AI/Reference AI or on PDS AI (Reference Strain/Excipient/Adjuvant ) entity is different to the value of the Low Amount Denominator Prefix field for the same entity. |
| High Amount Denominator Value must match Low Amount Denominator Value. | This error occurs when the value in the High Amount Denominator field on Component Product AI/Reference AI or on PDS AI (Reference Strain/Excipient/Adjuvant ) entity is different to the value of the Low Amount Denominator field for the same entity. |
| Error Message | Description |
| Concentration Measure Type Code is required. | This error occurs when there is no value for the Concentration Measure Type Code field on PDS AI (Reference Strain/Excipient/Adjuvant ) entity. |
| Low Amount Numerator Value is required. | This error occurs when there is no value for the Low Amount Numerator field on PDS AI (Reference Strain/Excipient/Adjuvant ) entity. |
| Low Amount Numerator Prefix is required. | This error occurs when there is no value for the Low Amount Numerator Prefix field on PDS AI (Reference Strain/Excipient/Adjuvant ) entity. |
| Low Amount Numerator Unit is required. | This error occurs when there is no value for the Low Amount Numerator Unit field on PDS AI (Reference Strain/Excipient/Adjuvant ) entity. |
| Low Amount Denominator Value is required. | This error occurs when there is no value for the Low Amount Denominator field on PDS AI (Reference Strain/Excipient/Adjuvant ) entity. |
| Low Amount Denominator Prefix is required. | This error occurs when there is no value for the Low Amount Denominator Prefix field on PDS AI (Reference Strain/Excipient/Adjuvant ) entity. |
| Low Amount Denominator Unit is required. | This error occurs when there is no value for the Low Amount Denominator Unit field on PDS AI (Reference Strain/Excipient/Adjuvant ) entity. |