CMDh Best Practice Guide for the translation of the SmPC, PIL and Labelling

Professional translation providers specializing in medical translation and pharmaceutical translation are largely reliant on the best practice standards set out by the CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures – Human). In what follows, we will briefly summarise the criteria defined for the SmPC, PIL and Labelling translation review and the process that must be followed in order to ensure high quality, consistency, readability, coherence, and eventually successful and timely national submissions.

1. Review criteria for the Product Information


When reviewing any pharmaceutical translation of the SmPC, PIL and Labelling, the following main criteria are taken into account:


a)    The translation must comply with the final agreed English product information


This entails that the final pharmaceutical translation of the SmPC, PIL and Labelling must be a faithful copy of the product information approved at the end of the European phase. This final version should also include a list of all national manufacturers responsible for batch release.


b)    The relevant country- and language-specific QRD template must be used


All titles, subtitles and sentences used in the final pharmaceutical translation should be exact copies of those used in the latest update of the QRD template or its appendices.


c)    The national requirements of the specific style sheet must be adhered to


All requirements set out in the specific national style sheets should be met. This includes the way the final pharmaceutical translation is organised in paragraphs and tabs, the type and font size and style of headers and footers. Unless otherwise stated, adherence to the Readability Guideline is also required.


d)    Appropriate scientific terminology must be used


The provider of the document translation services should take care to use the correct scientific terminology and that each standard phrase of the original is echoed by a standard equivalent in the target text. The main reference guides used to ensure this are the QRD template, European and National Pharmacopoeias (e.g. EDQM, medDRA standard terminology) and the country-specific version of the Guideline.


e)    Terminology must be consistent with other NCA-approved products


If pharmaceutical translations of similar products (same active substance or from the same therapeutic class) have already been approved by the NCA, the document translation services provider must ensure that corresponding terminology is used. The same goes for generic medications of an already centrally approved product.


f)     PILs must contain user-friendly wording


Familiar, user-friendly terminology should be used for PILs and any other information that is directly intended for the patient. The relevant target patient group should be kept in mind at all times.


g)    National Blue Box requirements must be met



2. Review process for pharmaceutical translations


The final review process of all SmPC, PIL and Labelling translations should take into account the following:


a)    All national pharmaceutical translations must be of the highest quality, fully based on the final approved English versions and in accordance with the CMDh guidelines.

b)    Translators preparing multilingual pharmaceutical translations should ensure complete harmonisation between the different national translations of the package.

c)    Providing all requirements have been met, the NCA should review and approve all national translations within 30 days of receipt.

d)    If an unacceptable translation has been submitted, the NCA will request a revised version from the Applicant.

e)    Any other translation will be reviewed by the NCA and re-submitted as a tracked-change version, to be returned as a clean, final version by the Applicant.

f)     The deadline for the finalisation of the national translation will be extended in case of a request for resubmission.


As we have seen before, there is no room for errors when it comes to translating SmPCs, PILs, labelling and other pharmaceutical document translation services, not in the least because of the critical nature of their content. The Best Practice Guide is therefore a powerful and indispensable tool for any pharmaceutical translation supplier and its use is yet another criterion clients should look out for when selecting their preferred translation partner.