If the variations subject to worksharing affects the summary of product characteristics (SmPC), labelling or package leaflet, the revised product information annexes must be submitted as follows:

a. Worksharing procedure for type-II variations

At submission (day 0):

After CHMP opinion (day +5):

• All European Union (EU) languages (including Norwegian and Icelandic): Complete set of annexes of one CAP electronically only in Word format (highlighted).

After linguistic check (day +25):

• All EU languages (including Norwegian and Icelandic): Complete set of annexes of all CAPs electronically only in Word format (highlighted) and in PDF (clean).

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.

b. Worksharing procedures for type-IB variations

At submission (day 0):

• English language: Complete set of Annexes for all CAPs electronically only in Word format (highlighted);
• All EU languages (including Norwegian and Icelandic): Complete set of annexes of one CAP electronically only in Word format (highlighted).

Day +25 after start of procedure:

• All EU languages (including Norwegian and Icelandic): Complete set of annexes of all CAPs electronically only in Word format (highlighted) and in PDF (clean).

For such procedures, a linguistic review will take place in parallel to the scientific assessment. It is therefore expected that the texts provided at day +25 after start of procedure will be the final texts.

Overview

*Complete set of annexes i.e. annexes I, II, IIIA and IIIB submitted as one document per language.

The 'complete set of annexes' includes annexes I, II, IIIA and IIIB, i.e. all SmPC, 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). The QRD convention should be followed. When submitting the full set of annexes in PDF format, this should be accompanied by the completed formatting checklist and following the user guide on how to generate PDF versions of the product information - human .

The electronic copy of all languages should be provided as part of the variation application in the eCTD for the product concerned, on Gateway / Web Client . 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.

The annexes provided should only reflect the changes introduced by the variation concerned. However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments in the texts (e.g. further to a specimen check) this should be clearly mentioned in the cover letter and in the 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 a listing may be provided as a separate document attached 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 procedure concerned.

For variations that affect annex A (e.g. introduction of a new presentation), the following principles apply:

Upon adoption of the opinion, the Agency will prepare and send the revised English annex A to the MAH for each CAP reflecting the new or amended presentation.

After CHMP opinion (day +5), the MAH will provide the Agency with the electronic versions of the complete set of annexes in all languages as well as the translations of the revised annex A for each CAP as a separate Word document.

Please be reminded that in accordance with Union data protection requirements, no personal data should be included in the annotated PIs. This applies to the English version submitted at the time of opinion, the draft translation versions of the PI in all languages submitted at D+5 as well as the final translations submitted at D+25. Please submit annotated PIs in an anonymised format (i.e. names of the reviewers removed from the track-changes). If you do not wish to do so, please ensure that the individuals whose data is included consented to its sharing with EMA and its further sharing by EMA with third parties such as other marketing authorisation applicants, marketing authorisation holders and National Competent Authorities, as relevant. EMA expressly disclaims any liability or accountability for the presence of unnecessary personal data in the annotated PI submitted by the marketing authorisation holder.

References