› ‹
  • 1
  • 2
  • 3
  • 4

Services

CoreX Regulatory Labelling Service:
A “one-stop-shopping”

The CoreX team offers a comprehensive labelling package that goes beyond the provision of the required translations.

The service is both:

  • advisory / strategic – providing regulatory guidance and labelling expertise
  • operational – providing experienced resources and process know-how.

The service covers all EU Procedures (New MAA, variations, renewals, line extensions etc.), including:

  • Support to set up / optimise the English text
  • Optimisation of the language versions
    • Guiding the translators e.g. by commenting on critical text elements and providing reference materials
    • Including a proofreading step by a second native speaker
    • Applying appropriate in-house QC steps, reducing / eliminating possible QC steps for the client
  • Management of the whole process between Day 0-235 (+25)
    • Complete coordination of all activities related to the set-up of the language versions
    • Management of a review by client affiliates (on request)
    • All authority interactions related to the linguistic review process, including submissions

 

Goal:
Minimise involvement of client resources, maximise quality

Interface function of CoreX

 

Read more about our “one-stop-shopping” service in our flyer
CoreX Produkt Information Support [PDF 1,8 MB]

Challenges

The Authorities require "high quality” and "faithful" translations

  • Currently the English Product Information has to be translated into up to 24 EU / EEA languages, taking into account numerous QRD-requirements (general and language specific) as well as other mandatory sources (e.g. EDQM Standard terms, WHO ATC-codes)
  • During the Linguistic Review Process, the local language texts are scrutinised by the national competent authorities (CA) against the English source document

Timeliness is critical in all translation process steps

  • The linguistic review process is based on strict, pre-established (by authorities) timetables
  • Especially within Centralised Procedures, at D215 (+5) and D235 (+25), only 5-6 working days over weekends are available to finalise all language versions

Solution

The reliability of the CoreX Labelling Service with regard to quality and timelines is ensured by

  • a strict and well-defined project management and translation / review process
  • the longstanding working relationship with the translation vendor
  • our well-established contacts with Member State reviewers, involved in the linguistic review process

Other Services

Product Maintenance Submissions / Lifecycle Management

  • Submissions in the context of lifecycle management, with focus on labelling variations and module 1.
  • For other types of applications and submissions involving eCTD, support via an external partner will be included.

Readability Testing of Package Leaflets

  • Support with optimisation of Package Leaflets.
  • Execution of Readability Testing (User Testing) in several languages including English, German, French and Dutch in collaboration with a specialised provider.

Mock-ups / Artwork

  • Support with mock-ups / artwork: consulting regarding contents / blue box requirements.
  • Support with updates of artwork based on editable existing artwork files.
  • Further support with updates of artwork is possible via an external partner.

Background-Information

Labelling / Labeling

The term “Labelling / Labeling” in the context of EU Application Procedures for medicinal products is used for the Product Information documents, essentially consisting of

  • Summary of Product Characteristics (SmPC)
  • Package Leaflet (PL) / Patient Information leaflet (PIL)
  • Labels (text on outer and inner packaging / container).

 

These are the core documents

  • summarising the main information relevant for the users of the medicinal product (patients, health care professionals) to use the product safely and effectively,
  • which must be agreed between Authority and Applicant in the final phase of the application review process.

Languages / Translations

Within EU Application Procedures, the Product Information documents are approved by the Authority as English versions but must then be provided in all relevant EU languages (currently up to 25 EU / EEA languages).

Regulations require “high quality” and "faithful" translations to be set up and the final approval process involves a linguistic review of the language versions by the respective Member States.

 

Risk consideration

Poor quality translations of Product Information can be rejected by National Authority reviewers during the linguistic review, with the possible consequence of a delay in approval of the Product Information and consequently a delay in marketing of the product.

After placing the product on the market, the identification of critical translation errors in a Product Information text can have even more significant consequences:

  • Corrigendum to National Authority notifying and correcting the error.
  • Exchange of affected labelling element (PIL, packaging material) from produced batches, potentially including a recall of affected product batches from the market.
  • Worst case: physical injury of a user caused by wrong use of the medicinal product.