Regulatory Affairs

 
 

The DWL team - consisting of experienced specialist medical translators and project managers - offers the following translation service for Marketing Authorisation Applications and Variations for both human and veterinary medicinal products.   

  • Centralised Procedure
    • Translation of Product Information (Annexes I to III) –
      Summary of Product Characteristics, Labelling and Package Leaflet from English into all EU and EEA languages.
    • Quality Control and Project Management
      • Liaising with the client, translators and reviewers to ensure that all translations are complete, comply with EMEA QRD requirements and meet agreed timelines.
      • Managing client changes prior to, and after, submission.
      • Managing the outcome of the linguistic review including discussion with, if requested by the client, a representative of the individual National Competent Authority (NCA).
  • Type Ia/Ib and Type II Variations to existing Marketing Authorisations

    Smaller in size than the full scale Centralised Procedure, we offer the same careful and high quality translation and project management service.

  • Mutual Recognition, Decentralised and Referral Procedures

    Consisting of fewer languages compared with the Centralised Procedure, the same high quality translation and project management approach is applied. 

  • Common Technical Document (CTD)

    The full capability of DWL’s  translators and project managers, in terms of subject matter and size, is demonstrated in the translation of the whole CTD or the following parts:

    •     Clinical overviews and summaries
    •     Non-clinical overviews and summaries
    •     Quality, Safety and Efficacy Expert Reports
  • Product Information Management (PIM)   
    • PIM, based on XML, is the European Medicines Agency's (EMEA) proposed voluntary method of electronic submission for Marketing Authorisation for the Centralised Procedure, and possibly later, for Mutual Recognition and Decentralised Procedures.
    • At the time of going to press, PIM is still under development by the EMEA.
    • DWL is working in parallel to be ready for the launch of PIM at the given time. We intend to be able to handle new applications for Marketing Authorisation as well as variations using clients' legacy data of both the English and the existing translations.
    • Please refer regularly to this website for our progress with PIM.