Danish translations of product information

Linguistic proof-reading of product information for medicinal products authorised via the national, mutual recognition and decentralised procedure.

In the process of authorisation of a new medicinal product, the applicant will have to translate the text of the SPC into Danish. Such work is obviously needed in relation to products authorised via the mutual recognition procedure (MRP) or via the decentralised procedure (DCP). However, also in national applications the original product information will most often be in English, i.e. a translation is needed.

We have informed the industry at various occasions that we are not at all satisfied with the quality of the translations presented to us. Furthermore, we have announced that we would prepare to publish examples of bad translations on our website.

We strongly encourage applicants to ensure that all translations are subject to quality assurance from a person qualified in Danish medical terminology. If the actual translation is not performed by such person, a thorough quality check should be carried out before the translation is submitted to the us.

From now on we intend to return proposed SPC translations to the applicant in case the quality is deemed substandard, i.e. if too many errors and mistranslations are found. Further processing to prepare for granting the marketing authorisation will be put on hold until an acceptable translation has been received.

Moreover, the Danish Medicines Agency wishes to refer to the CMDh's guideline, "Best Practice Guide on the submission of high quality national translations", current applicable version.