Product information for the marketing authorisation

As part of the marketing authorisation process, the medicinal product information is also generated in the form of the summary of product characteristics (SmPC, SPC) and the package leaflet (PL, patient information) based on Directive 2001/83/EEC and these must meet statutory requirements and are used to better identify the medicinal product.
The preparation and updating of these documents require ever greater efforts because of the continuously changing regulatory requirements within the EU and other countries. The orangeglobal group offers you a solution that enables you to greatly reduce your internal workload!
Comprehensive support for labelling As well as support with the preparation of SmPC and PL, our service includes the preparation and harmonisation, notification of various information services (fachinfo.de, IfA, Rote Liste, Gelbe Liste), the preparation of the necessary mandatory texts and translations of these – the orangeglobal group offers you optimal document and data management.
We extract, digitalise, encode and format the relevant data and information for XEVMPD and IDMP from your product information. In this way we reduce the number of correction runs, saving you time and money in light of the ever growing pharmacovigilance requirements.
On request we carry out all preliminary processing steps and communication with the FachInfo service of the German drug indices Rote Liste and Gelbe Liste. The preparation and continuous modification of the texts in the drug indices and master files as well as full administration and communication with the administrative office of the Rote Liste and Gelbe Liste as well as that of Ifa (Informationsdienst für Arzneimittel, an information service provider for the pharmaceutical sector) are in safe hands with us. We can act as a contact for pharmaceutical companies that is known by name. We also collaborate with your company’s service providers and graphics design agencies. We carry out the preparation and maintenance of labels and PL mock-ups for our customers.
The orangeglobal group is a general business for internationalisation of pharmaceutical products with more than 30 years’ experience and works with a team made up of medical writers, regulatory affairs experts, project managers with labelling experience, pharmacovigilance / graduated plan and information officers and pharmaceutical desktop publishers, offering an all-round, no worries package for compliance with all labelling and publishing obligations. 

In concrete terms, this means for your company:

  • Continuous availability on all business days
  • Flexibility regarding job volume
  • Option to complete urgent jobs, even at peak times with high job volumes
  • Completion and release always by different people


Benefits for customers of the orangeglobal group:

  • Satisfaction of all statutory and customer requirements
  • Timely delivery of requested production quantities (or the artwork) for the labelling 
  • Standardised and custom workflows
  • Monitoring and measures for ongoing quality assurance throughout the entire process


Possible job packages for support in the labelling process by the orangeglobal group:

A. Summary of product characteristics (SmPC, SPC)

  • Communication management with your company’s information officer and with the 
  • FachInfo service of the Rote Liste
  • Preparation of the text for the summary of product characteristics from your raw and master texts
  • Proofreading and comparison between raw text and the final proofs (non-parallel text comparison, digital quality control, linguistic and layout check)
  • Correction run and confirmation of the correctness of the final proof using precertification


B. Mandatory texts in accordance with the Health Services and Products Advertising Act (HeilmittelWerbeGesetz, HWG)

  • Independent creation/modification/typesetting and release of the mandatory text
  • Correction run between the pharmaceutical company and orangeglobal group
  • After release by the information officer the typesetting
  • Correction run and confirmation of the correctness of the final proof using precertification


C. Publication in the Rote Liste

  • Completion of all of the processing steps 
  • Preparation of new text / text modification for the master data list in accordance with specific requirements of the Rote Liste administrative office
  • Review of the congruence between the summary of product characteristics and the master data list by a second person
  • (use of digital tools)
  • Correction run between Rote Liste service and orangeglobal in terms of master data list and
  • summary of product characteristics and confirmation of the correctness of the master data list using precertification
  • Track & trace management of the documents and deregistration and registration of the customer’s preparations
  • in the Rote Liste
  • Independent monitoring of the structural and signature changes

D. Publication in the Gelbe Liste

  • Completion of all of the processing steps 
  • Preparation of new text / text modification for the master data list in accordance with specific requirements of the Gelbe Liste administrative office
  • Review of the congruence between the summary of product characteristics and the master data list by a second person
  • Correction run between Gelbe Liste service and orangeglobal in terms of master data list and 
  • summary of product characteristics and confirmation of the correctness of the master data list using precertification
  • Track & trace management of the documents and deregistration and registration of the customer’s preparations 
  • in the Gelbe Liste
  • Independent monitoring of the structural and signature changes


E. Package leaflet (patient information)

  • Preparation of the text of the package leaflet from the summary of product characteristics
  • Consolidation, splitting and review of existing texts
  • Text check for regulatory compliance (in accordance with QRD templates of the EMA and NCA and 
  • your QRD conventions)
  • Proofreading for linguistic compliance (spelling, grammar, punctuation) and comparison
  • between raw text and the final proofs (non-parallel text comparison, digital quality control, linguistic check)


F. Other services from our established portfolio

  • Artwork: Layout/mock-up preparation by our pharmaceutical graphic artist
  • Readability compliance of the package leaflet (readability user test)
  • Generation of the artwork and printing of the labelling
  • Translation into all languages and central management and checking of all language versions of the regulatory documents with translations from every language into every language

 

YOUR CONTACT PERSON:

Frau Dipl. Biol. Jana Wolkow
Project Manager Regulatory Affairs
Tel. +49 (0) 731 954 95 - 511
jana.wolkow@orangeglobal.(.)de