XEVMPD Acknowledgement Report Codes

Numbered codes that appear in the Acknowledgement Report can be Success Codes or Failure Codes. Those success and failure codes are described in the following tables.

Only the first error encountered is reported in the Acknowledgement Report.

For all elements and operations except product operations, any failure code results in the entire message being rejected with the 03 transmission acknowledgement code. Failures generated by product operations generate the 02 transmission acknowledgement code. In this case, all operation results will be reported in the acknowledgement.

9. Table 1. Success Codes

Operation Result Code Text in Acknowledgement
2 The entity was inserted successfully.
3 The entity was nullified successfully.
4 The entity was updated successfully.
29 The entity was withdrawn, or the MA was invalidated successfully.

Table 10. Table 2. Failure Codes

Operation

Re­

sult

Code

Text in Acknowledgement
1 The entity is already presented in the EVMPD. You need to use the EV Code specified in the acknowledgement.
5 Impossible to find the specified EV Code.
6 Impossible to find a referred entity. You need to check the specified foreign keys.
7 Impossible to find a referred entity. You need to check the specified foreign keys.
8 The requested operation does not exist.
9 The requested operation is not implemented.
10 Security Error. Insufficient Rights. You need to check the Ownership of the specified entity.
12 Missing Mandatory Information.
13 Unsuccessful Insert. You need to contact the EMA Help Desk.
14 Unsuccessful Update. You need to contact the EMA Help Desk.
15 Unsuccessful Nullify. You need to contact the EMA Help Desk.
16 Security Error. Impossible to update a private entry owned by another Organisation.
17 Impossible to add the substance, a specified name is already present in the EVMPD.
18 Referred entity(EV_CODE) could not be found.
19 You need to contact the EMA Help Desk.

Operation

Re­

sult

Code

Text in Acknowledgement
20 General Error. You need to contact the EMA Help Desk.
21 Security Error. The sender Organisation is not registered with EV system.
23 Impossible to find a referred entity. You need to check the specified foreign keys.
24 The entity is referred to by others entities: Nullification not allowed.
25 Ambiguous EV Code. You need to contact the EMA Help Desk.
26 Version Date specified is not valid.
27 Standard Term Type Error. There is a more recent term (Proposed or Standard) in the EVMPD.
28 Only Authorised Products can be withdrawn.
30 Unsuccessful Withdrawn Generic Error. You need to contact the EMA Help Desk.
70 Error in the Product indication referred by the Product.
71 Sponsor data supplied matches <EV CODE> within the xEVMPD. Please use <EV CODE> or correct the submitted data.
73 Update of preferred name of substance <EVCODE> is forbidden. If the name is a synonym of <current preferred name>, you need to add the new name as an alias for <EVCODE>. If <new name> is a different substance to <original name>, you need to enter a new substance with your preferred name. If the original name contains an error, you need to contact the EMA.
76 Only the EMA may update products where the authorisation status is within the not valid authorisation status sub-list. If your product is in this status in error, you need to contact the EMA to request a correction.
77 If the value of authorisation status is Valid – Transferred Marketing Authorisation or Valid – Renewed Marketing Authorisation of MA then the Previous EV Codes section must be present.
78 If the value of authorisation status is Valid – Transferred Marketing Authorisation or Valid – Renewed Marketing Authorisation then at least one Previous EV Code section must reference the EV Code of a current authorised product.
79 If the operation type is withdrawal or Invalidate MA, the authorisation status must be one of the values in the published Not Valid Authorisation Status.

Operation

Re­

sult

Code

Text in Acknowledgement
80 If the operation type is Insert, Update or Variation then the authorisation status must be one of the values from the published valid authorisation status.
81 If the value of authorisation status does not signify a current valid MA then WithdrawnDate must be present.
82 If the value of authorisation status signifies a current valid MA then WithdrawnDate must be empty.
83 The EMA is not currently accepting updates to proposed Pharmaceutical Forms and Routes of Administration standard terms. You need to check that the term you have used does not exist and if necessary add a new proposed term.
85 The EMA is not currently accepting nullifications of proposed Pharmaceutical Forms and Routes of Administration standard terms.
99 The code idicates the Parsing error(s).
500 SME status field must be absent for Sponsor organisation.
501 SME status field must be present for current MAH organisation.
502 SME number field value prohibited with SME status field value provided.
503 MAH data supplied matches <EV CODE> within the XEVMPD. You need to use <EV CODE> or correct the submitted data.
504 At least 1 authorised pharmaceutical form is mandatory for this operation type.
505 Where multiple authorised pharmaceutical forms are specified each must be unique, code <duplicated code> is duplicated.
506 Referenced local pharmaceutical form (local ref:<localref>) not found or is a development term.
507 Referenced global pharmaceutical form (<EVCode>) not found or is a development term.
508 The legal basis is mandatory for this operation type.
509 The value of the legal basis field is not in the list of permitted values.
510 Authorisation country must be in EEA if an EU authorisation procedure is specified.
511 At least 1 medicinal product type is mandatory for this operation type.

Operation

Re­

sult

Code

Text in Acknowledgement
512 Where multiple medicinal product types are specified each must be unique, code <duplicated code> is duplicated.
513 The value <unmatched value> in the medicinal product type field is not in the list of permitted values.
Error Message Description
Validity Declaration on Registration FPP Attachment entity is required to be with value for submission. This error occurs when there is no value in the Validity Declaration field for the selected Registration FPP Attachment entity.
At least one Registered ATC must be selected on Registration entity. This error occurs when there is no ATC assigned to the Registration entity.
Qualified Person for Pharmacovigilance (QPPV) is required for this operation type. This error occurs when there is no value in the QPPV field on Registration entity.
QPPV name should be valid (positive integer). This error occurs when there is no value in the QPPV field on Registration entity.
Short Name must be specified. This error occurs when there is no value in the Short Name field for the selected FPP entity.
Short Name must not exceed 250 characters. This error occurs when there are more than 250 characters in the Short Name field for the selected FPP entity.
Withdrawn/Invalidated Date must be specified to Invalidate MA the authorised product. This error occurs when there is no date specified in the Withdrawn/Invalidated Date field for the selected FPP entity.
XEVMPD Comments must be specified on FPP entity for Invalidate MA operation of Authorised Product. This error occurs when there is no value in the XEVMPD Comment field for the selected FPP entity.