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Focus on labelling translations


OPTIMAL PREPARATION AND IMPLEMENTATION OF TRANSLATIONS FOR MARKETING AUTHORISATION AND LIFE CYCLE MANAGEMENT FOR MEDICINAL PRODUCTS INTO ALL EU LANGUAGES

In order to ensure that your documents for this process can be prepared in the best way possible and that annoying delays can be avoided, our experienced orangeglobal group Regulatory Affairs and mpü Labelling Translations team will support you throughout the process with the following options:

  • Consultation to establish an efficient and reliable translation process with various labelling quality assurance
    reviews, including software-supported processes and national reviews where necessary
  • Various service packages depending on your requirements or processes
  • Translations, revisions and reviews of all the required languages by regulatory affairs specialists, medical language experts and native speakers


PREPARATION AND RELIABILITY WITH THE MPÜ TRANSLATION PROCESS

    • Consistent quality and terminology as well as compliance with the regulatory
      requirements for current and future projects thanks to the various options for using
      translation memory tools, term bases and QRD and quality assurance tools.
    • Adaptations to the current QRD template versions and reviews/proofreading of
      existing translations can be completed prior to the completion of the
      application assessment or the Positive Opinion in preparation for the next step.

 


To make sure you do not miss the deadline for submitting all documents in the national languages after receiving a Positive Opinion (CP) or after the MRP/DCP approval, we recommend starting the translation process of the source texts or incorporating changed text components into the national language documents as early as possible, preferably from the day of submission of the application for marketing authorisation or the variation application or the variation notification.

The 5-day deadline post-opinion (CP) or after DCP/MRP approval should be reserved for making last-minute changes only.

 

Labelling translation process


The comprehensive, interdisciplinary range of services offered by mpü together with its parent company, orangeglobal, means that it is able to provide a process specifically for labelling and variation translations that complies with all the requirements for time management, security, quality and efficiency and ensures acceptance by authorities.


BEFORE THE TRANSLATION PROCESS

  • Analysis, process definition, project planning
  • Product and project training for translators, revisors/reviewers, QA checkers
  • IT team during the preparation phase
  • Determine QA software, software workflow and processes




DURING THE TRANSLATION PROCESS

All regulatory requirements are taken into account

  • EMA QRD templates plus Annexes I–IV and Appendices I–V
  • National templates such as BfArM, Swissmedic and others
  • EDQM standard terms
  • Lay terms in PL (MHRA, AGES)
  • Excipients guidelines
  • Non-standard abbreviations
  • MedDRA terminology (mpü database)
  • MedDRA side effects and system organ classes
  • Blue box requirements – adaptation



Synchronisation/creation of documents for different product strengths, routes of administration and pharmaceutical forms


AFTER THE TRANSLATION PROCESS

  • Quality assurance (QA) in all languages with special QA processes and tools
  • Formatting based on EMA QRD conventions, national requirements or customer specifications
  • Preparation of Member State versions
  • QA report prepared by our QA checkers for continuous monitoring and improvement of the translation
    quality in all languages



LINGUISTIC REVIEW PROCESS

  • Handling communications with regulatory authorities
  • Incorporating content and linguistic feedback from regulatory authorities for centralised
    EU marketing authorisation procedures




CONSISTENT QUALITY AND TERMINOLOGY


in current and future projects by using 

  • Translation Memory tools
  • Customer-specific labelling terminology databases

 

Additional labelling services


CONSULTING

Consultancy services for an efficient and secure software-guided labelling translation process, including national reviews if necessary


CREATION
Compliance with all regulatory requirements

  • Originator adaptations
  • PL writing
  • PL-SmPC: Consistency check
  • PL-SmPC: QRD adaptation
  • PL: Patient friendliness revision
  • Layout adaptation to customer specifications
  • Harmonisation of labelling texts
  • Safety labelling




READABILITY COMPLIANCE

  • Analysis of a customer’s product portfolio in terms of readability compliance
  • PL adaptation and updating
  • PL readability user tests
  • Focus tests




ARTWORK AND PRODUCTION
All types of pharmaceutical packaging and labelling

  • Concepts for new packaging designs
  • Latest style guides
  • Preparation of mock-ups and printing the PL
  • Blister packaging