EMA provides free-of-charge translations of the product information into all EU languages for initial EU marketing authorisations (this excludes Icelandic and Norwegian).

EMA provides translation assistance at the time of CHMP or CVMP opinion through the EU Translation Centre (CdT). The national competent authorities verify the quality of translations.

The translation process can begin as soon as the CHMP/CVMP has issued a positive opinion on the medicine's authorisation, provided that the applicant has a valid SME status at this time. 

During the evaluation of a marketing authorisation application, EMA sends procedural details on the translation assistance to the applicant, who can also contact the SME office for any practical questions.

For access to incentives following mergers, acquisitions or product out-licensing, see sections 2.4.1 and 2.5.3 of the SME user guide. EMA strongly advises companies to contact the SME office to discuss these specific cases.