If the variations subject to worksharing affect the SPC, labelling or package leaflet, the revised product information annexes must be submitted as follows:

-    English language: a complete set of Annexes for all CAPs electronically only in Word format (highlighted)

• After CVMP opinion (day +5)

-    All EU languages (incl. Norwegian and Icelandic, and from 1 January 2022 onwards Irish for MAHs established in Ireland that have not submitted an Irish language derogation):
- if a linguistic review will be performed: complete set of annexes of one CAP electronically only in Word format (highlighted)
- if a linguistic review will not be performed: complete set of annexes for all CAPs
electronically only in Word format (highlighted) and in PDF (clean)

• After linguistic check (day +25)

-  All EU languages (incl. Norwegian and Icelandic): complete set of annexes for all CAPs electronically only in Word format (highlighted) and in PDF (clean bookmarked)

Only one centrally authorised medicinal product will undergo a linguistic check. In the cases where the changes to the product information may vary between products, the product with the most complex changes will generally be the one subject to linguistic check.

Overview in case of linguistic review:

* = complete set of Annexes i.e. Annex I, II, IIIA and IIIB submitted as one document per language

The ‘complete set of Annexes’ includes Annex I, II, IIIA and IIIB i.e. all SPC, labelling and package leaflet texts for all strengths and pharmaceutical forms of the product concerned, as well as Annex II. The complete set of Annexes must be presented sequentially (i.e. Annex I, II, IIIA, IIIB) as one document for each official EU language. Page numbering should start with "1" (bottom, centre) on the title page of Annex I. All Annexes should be in compliance with the ‘Quality Review of Documents (QRD) convention to be followed for the European Medicines Agency QRD templates’ published on the Agency website. When submitting the full set of Annexes in PDF format, the formatting checklist and the User guide on how to generate PDF versions of the product information - veterinary should be followed.

Highlighted changes should be indicated via ‘Tools – Track changes’. Clean versions should have all changes ‘accepted’.

Icelandic and Norwegian language versions must always be included. From 1 January 2022 onwards an Irish language version must be included for MAHs established in Ireland that have not submitted an Irish language derogation.

The Annexes provided should only reflect the changes introduced by the variations concerned. However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments in the texts or to align the product information with the latest QRD template, this should be clearly mentioned in the cover letter and in the precise scope section of the application form. In addition, the section “present/proposed” in the application form should clearly list the minor linguistic amendments introduced for each language. Alternatively, such listing may be provided as a separate annex to the application form. Any changes not listed will not be considered as part of the variation application. In such cases, and 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 procedures concerned.

References