General principles

If amendments to the dossier only concern editorial changes, such changes should generally not be submitted as a separate variation. They may be included in any variation that concerns the part of the dossier in which the editorial changes are to be made. In such cases the changes should be clearly identified in the application form as editorial changes, and 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 provided. Changes that can be classified as a variation according to the Guidance are not considered editorial changes and should be submitted under the appropriate variation category. The Agency strongly recommends the submission of editorial changes within procedures that have an administrative validation phase (i.e. VRA). This allows for the appropriate review of proposed editorial changes during validation and any consequential amendment of the submission prior to assessment, if needed. The editorial changes proposed should affect the same part of the dossier as concerned by the variation procedure. For example, if a variation affects Part 2.C, editorial changes to Part 2.C can be submitted.

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

Since editorial changes should generally not be submitted as a separate variation, no reference to a variation category is required when they are encompassed within another variation procedure.

Within the ‘Precise scope and background…’ section of the variation application form, the MAH should provide:

• a brief description of the proposed editorial changes and a justification as to why they are considered ‘editorial’ (i.e. why they should not trigger a specific variation);
• a declaration confirming that the changes proposed as editorial do not change the content of the concerned part(s) of the dossier beyond the scope of the variation within which the editorial changes are being submitted;
• confirmation that all relevant parts of the dossier have been updated accordingly and are included within the variation package.

Additionally, all the editorial changes should be listed in the present/proposed table (or provided as a separate annex that is cross-referred to from this table), identifying each related change in the dossier down the lowest section heading and page numbers where possible.

Any changes proposed by the applicants as editorial will be carefully considered by the Agency at time of submission and may be subject to further assessment at the same time as the overarching variation. Proposed editorial changes that cannot be accepted as such will be rejected. In case of doubt, applicants can contact vet.applications@ema.europa.eu in advance of the planned submission.

Editorial changes in Part 2 (quality)

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.

If editorial changes are required and there is no upcoming procedure, the MAH may consider submitting these changes separately as a variation not requiring assessment (VNRA, B.43).

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)

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.

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 in accordance with the Guidance (e.g. 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 the Guidance which impacts upon the product information and where linguistic review is foreseen, if applicable.

Should there be no upcoming regulatory procedure in which to include the editorial changes, these could also be submitted as a stand-alone variation not requiring assessment e.g. under C.9 if they affect the English product information. If other languages are affected and in case no procedure affecting the product information is upcoming, MAHs are advised to contact vet.applications@ema.europa.eu to discuss how to handle these necessary changes.

The MAH should liaise with the Agency without delay if a mistake is noted that concerns 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 medicinal product and/or lead to potential medication errors (e.g. wrong strength, wrong posology, wrong route of administration).

References