MRP/DCP - national translations
According to Notice to Applicants Volume 2A Chapter 2 the applicant should submit high quality national translations of the following documents to the CMS and RMS within 5 days after approval of DC- or MR-procedures:
- Summary of product characteristics (SmPC)
- Product information leaflet (PIL)
- Accessible user information (PIL) (PDF ua) including confirmation in the comment field that the PDF/UA version is identical in content to the approved Word version
- Labelling (Lab): outer packaging and immediate packaging summarized in one document
- Mock ups for primary and secondary packaging summarized in one document
For updated information on the electronic submission of the product information also refer to the FAQ eService "Marketing Authorisation & Lifecycle Management of Medicines".
Please regard the following for the submission of high quality national translations:
- All german translations of the texts (SmPC, PIL, Lab, Mock ups), which are approved by the RMS have to be sent as single texts (including all text-relevant variations, which are approved at this time).
- It is also possible to submit a Lab which is translated in more languages than German. Text passages, which are identical for all strengths and pharmaceutical forms in the RMS texts, must also be translated identically in the national versions (exemption: informations on the Marketing Authorisation Holder and country-specific requirements).
- The texts must not contain any information in header or footer except page numbers. Please submit the texts in “clean versions”.
- If the submission is carried out by a consultant it is needed to send a Letter of Authorisation which is signed by the marketing authorisation holder.
- Requirements regarding accessibility have to be considered.
Important note: National translations should only be submitted by appropriately trained staff in accordance with the following:
- Excellent knowledge and active implementation of the above mentioned criteria and literature
- Excellent knowledge of German
- Excellent knowledge of Englisch
- Knowledge of regulatory/medicinal affairs
Links and literature for high quality national translations:
Relevant points have to be considered and implemented by the applicant.
- EMA: Excipients-Guideline
- PV-Wordings, wordings following Paediatric Worksharings - wordings for the active substance(s)
- EMA: Medicines under Additional Monitoring
- EMA: QRD-Template
- BASG German QRD-Template accessible
- EMA: Names of the EU / EEA countries - german diction of EU/EEA member states
- CMDh: Best Practice Guide on the submission of high quality national translations
- EDQM: standard terms– german translations
- Eudralex: Blue Box Requirements
- Austrian law (i.a. Regulation prescription requirement , Regulation Lab, Regulation PIL, Regulation SmPC, Regulation narcotics)
- FAQ Anti-doping warning, NADA Request medicinal products
- FAQ SmPC and PIL (including "Stylistic recommendations")
- FAQ Braille writing System
- FAQ Naming of a medicinal product
- European Pharmacopoeia (german translation), Austrian Pharmacopoeia: Notation of active pharmaceutical ingredients and excipients
- AT Guidance document – Mock-ups
If no marketing of the medicinal product is planned in Austria in the foreseeable future, there is an opportunity to apply for a conditional authorisation.
The submitted texts are checked for the implementation of above mentioned criteria and literature.
After the assessment of the texts and the mock ups the applicant receives the corrected ones electronically in order to discuss the corrections (via email, via eService or by telephone).
As soon as everything is clarified and no more corrections are necessary the applicant will be asked to provide the final texts and the mock ups for primary and secondary packaging in “clean versions” electronically.
After the text discussion has been completed, the final texts and mock-ups are forwarded for notification. The notification is created, checked, released and delivered.
The final texts, mock-ups and the notification can be found in the PHAROS e-service portal.
The final product information and the final product information (together with the accessible patient information leaflet ) are published in the Austrian Medicinal Product Index.