General principles

The Agency will not accept any editorial changes as part of VNRA. This is due to the fact that VNRA notifications are administrative in nature and do not have a validation or an assessment phase.

Editorial changes should be submitted within procedures that have an administrative validation phase (e.g. VRA). This allows the appropriate review of proposed editorial changes during validation and the consequential amendment of the submission prior to assessment, if needed. The editorial changes proposed should affect the same part of the dossier concerned by the variation procedure. For example, if a variation affects Part 2.C of the dossier, editorial changes to Part 2.C can be submitted.

MAHs are reminded to follow this guidance and to ensure the high quality of variation applications in support of a timely processing of these submissions.

Editorial changes in Part 2 (quality)

If editorial changes are required and there is no upcoming procedure with a validation phase, the MAH may consider submitting these changes as a separate VNRA (B.43).

The following may be considered as examples of editorial changes to Part 2: adding headers for ease of use, reordering of existing information without changing the meaning, alignment of information among/within the sections provided the correct reference that had been previously agreed can be demonstrated (e.g. alignment of information in flow charts to process description), punctuation changes and grammar/orthographic corrections that do not alter the meaning of the text.

Examples of changes that cannot be considered editorial: removal of specification parameters or manufacturing description, update of information to bring the dossier content in line with the current manufacturing process, etc.

Proposed changes that require confirmation by the rapporteur may only be accepted when submitted within the scope of an upcoming VRA which impacts upon the corresponding section of Part 2.

Editorial changes in Parts 3 (safety & residues) and 4 (pre‑clinical & clinical)

Editorial changes in Parts 3 and 4 are not foreseen. Please contact vet.applications@ema.europa.eu in advance of an upcoming submission.

Editorial changes to the product information in Part 1.B (SPC, labelling and package leaflet)

Should there be no upcoming regulatory procedure with a validation phase in which to include the editorial changes, these could also be submitted as a stand-alone VNRA (C.9).

Formatting changes, correction of typographical errors and/or mistakes to the English product information or other linguistic versions of the product information are considered editorial changes provided that the meaning of the text is not altered. These changes can be included within the scope of any upcoming procedure impacting on the product information and including an administrative validation phase (e.g. VRA).

Changes in the scientific content or meaning cannot be accepted as an editorial change. These changes should be classified under the scope of the relevant category as per the EMA/CMDv Guidance on the details of the classification of variations requiring assessment (e.g. VRA, G.I.4).

Proposed changes that may require confirmation by the rapporteur or linguistic review will only be accepted when submitted within the scope of an upcoming VRA under chapter G (of the EMA/CMDv Guidance on the details of the classification of variations requiring assessment) which impacts upon the product information and where linguistic review is foreseen, if applicable.

The MAH should liaise with the Agency without delay if the mistake concerns an incorrect or missing important information (e.g. contra-indication or adverse event), in the English or any of the other language versions, that could affect the safe and effective use of the veterinary medicinal product and/or lead to a potential medication errors (e.g. wrong strength, wrong posology, wrong route of administration).

In cases where MAH is submitting editorial changes as VNRA, under B.43 or C.9 scopes, the changes should be clearly identified in the UPD “submission comments” field as editorial changes, as well as any minor linguistic amendments introduced for each language. Alternatively, such listing may be provided as a separate annex to the be included VNeeS file. A declaration that the content of the concerned part of the dossier has not been changed by the editorial changes beyond the scope of the variation submitted should be also provided. Any changes not listed will not be considered as part of the variation application.

Changes that can be classified as a variation according to the Annex to the Implementing Regulation (EU) 2021/17 Variations Guidelines or to the EMA/CMDv Guidance on the details of the classification of variations requiring assessment are not considered editorial changes and should be submitted under the appropriate variation category.

In cases where any other ongoing procedures may affect the product information Annexes, the MAH is advised to contact the Agency in advance of submission or finalisation of the procedure(s) concerned.

In case of doubt, MAHs can contact vet.applications@ema.europa.eu in advance of the planned submission.

References