EMA submissions

The role of mpü in EMA submissions

The European Medicines Agency (EMA) plays a key role in all registration procedures for medicinal products in the European Union (EU).

The registration procedure involves the entire life cycle of a medicinal product and includes

  • Research and development
  • Phase I-III clinical studies
  • Marketing authorisation and market launch
  • Post-marketing surveillance

As a DIN EN ISO 17100 and DIN EN ISO 9001 certified language service provider, mpü has a reputation for reliability throughout the translation workflow in accordance with EMA requirements in compliance with all quality assurance requirements.

Translating for EMA approvals

To demonstrate the efficacy, safety and quality of a medicinal product, the authority’s strict requirements call for
qualified and specialised technical translations for a smooth registration procedure.

We are very familiar with the process and know what needs to be done

  • when translating specific regulatory documents
    • Summaries of product characteristics (SmPCs) using technical language
    • Patient information (PLs) in non-technical language
    • Labels
    • (e)CTD
  • in all registration procedures
    • CP (centralised procedure)
    • DCP (decentralised procedure)
    • MRP (mutual recognition procedure)
    • NP (national procedure)
    • Variations
    • etc.

With our experience, we know how to help.

Preparation and reliability with the mpü translation process

To prepare your documents for the translation process as well as possible and avoid unnecessary delays, our experienced “Regulatory Affairs” and “Labelling Translations” expert teams will support you with the following options

  • Consultation to establish an efficient and reliable translation process with corresponding labelling quality assurance reviews, including software-supported processes and national reviews where necessary.

  • Tailored service packages available depending on the procedure or process.

  • Translations, revisions and technical reviews of all the required languages by our regulatory affairs specialists, medical translators and language experts, all exclusively native speakers.

  • Quality assurance (QA) in all languages with special QA processes and tools.

  • Well-qualified and highly trained project managers.

  • Consistent quality and terminology, as well as compliance with the regulatory requirements for current and future projects through our broad range of options using translation memory tools, term bases and QRD and quality assurance tools.

  • Adaptations to reflect the current QRD template versions and 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.

Timelines

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 amended sections into the documents in national language as early as possible. This process should ideally be started as early as the day of submission of the application for marketing authorisation or variation/variation notification.

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

Regulatory requirements are standard at mpü

All regulatory requirements are taken into account

  • EMA QRD templates including 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 dosage forms
  • Formatting based on EMA QRD conventions, national requirements or customer specifications
  • Creation of Member State versions

Linguistic review

The importance of having a technically accurate translation when marketing medicinal products in the EU is highlighted by the requirement to have a linguistic review.

Your mpü service

  • Handling communications with regulatory authorities
  • Incorporating content and linguistic feedback from regulatory authorities for central EU marketing authorisation procedures
  • Rapid problem solving based on medical and regulatory expertise in all queries and finalisation of the labelling (QRD Form 2)

Other services

CREATION – In compliance with all regulatory requirements

  • Originator adaptation
  • PL writing
  • PL-SmPC: consistency check
  • PL-SmPC: QRD adaptation
  • PL: patient friendliness revision
  • Layout adaptation to customer specifications
  • Harmonisation of labelling texts

Readability compliance

Proof of readability and legibility

  • PL adaptation and updating
    • PL readability user tests (RUT)
    • Bridging reports
    • Focus tests

The mpü processes ensure your success.