For informed consent applications only one Technical Labeling Review will be performed by the Agency
by Day 60.
The same general principles as for the post-opinion linguistic review for any new marketing
authorisation application apply. If another procedure for the reference product has been concluded at
the same time, both procedures will follow a parallel linguistic review. In such a case, the Agency will
send the highlighted English version of the final product information of the reference product to the
applicant of the generic/hybrid application. As soon as the linguistic review for the reference product
has been completed, EMA will also send those translations (including Icelandic and Norwegian) to the
applicant of the generic/hybrid product and request updated translations within 2 days.
In case another procedure for the reference product has been concluded at least one month or two
months before and no information has been published on the Agency’s website, EMA will proactively
send the translations validated by the Member States to the applicant of generic/hybrid product.
Where the existence of usage patent(s) leads to differences in SmPC/PL compared to the reference
medicinal product, this should be indicated accordingly in the QRD Form 1 (Annex 5).
Apart from the specific sections of the product information (e.g. Quality part) that differ from the
reference medicinal product, the product information annexes (in all other EU languages, including
Icelandic and Norwegian) of the generic, hybrid and biosimilar applications should follow the respective
approved product information annexes of the reference product. Format changes to the generic, hybrid
or biosimilar's SmPC in comparison to the reference medicinal product’s SmPC are acceptable as long
as the content remains consistent. The current QRD template and the SmPC guideline should be
applied to the generic, hybrid or biosimilar SmPC as far as possible, if the relevant information is
available (for details on the general principles regarding the SmPC information for a
generic/hybrid/biosimilar product refer to relevant QRD guidance). Only the English product
information should indicate with tracked changes those sections which differ from the reference
For informed consent applications, no post-opinion linguistic review of the product information Annexes
in all other EU languages (including Icelandic and Norwegian) will be performed and the MAH will be
responsible for ensuring compliance of the translations with the respective linguistic version(s) of the
reference medicinal product.
5. The linguistic review process for small and medium-sized
enterprises (SMEs) new applications
The same general principles as for the pre-opinion linguistic review of New Applications apply, as
illustrated by the attached timeline (Annex 1):
However, in the post-opinion phase, as part of the incentives offered to SMEs according to Article 11 of
Regulation (EC) No 2049/2005 at Day 215, the Centre de Traduction (CdT) will provide translations of
the adopted product information, Annex IV and Annex 127a (if applicable) and Annex A (list of
products) in all other EU languages (excluding Icelandic and Norwegian) electronically to the Agency,
on behalf of the SME in question.
The SME applicant will provide electronically (in one Eudralink package) the English adopted product
information annexes and Annex A (list of products), Annex IV and Annex related to the Art. 127a (if
applicable), together with the Norwegian and Icelandic translations as well as “QRD Form 1” (Annex 5)
The linguistic review process of product information in the centralised procedure –