Product Information (labelling, artwork)

Compiling and maintaining medical and scientific product information,
also in collaboration with your product managers, EU subsidiaries and
other appointed individuals:

Nationally (for Germany and Austria):

  • Writing (also translation from English), optimising and updating of
    product summaries, package leaflets and labelling in accordance
    with German and Austrian pharmaceutical legislation
  • Completing marketing authorisation forms for obtaining authorisation
    in Germany
  • Review of packaging materials and compulsory texts for promotional
    materials with a view to compliance with the marketing authorisation
    (regulatory conformity) and legal provisions (AMG, HWG), also in
    collaboration with the company’s information officer
  • Entries in the German ROTE LISTE®, GELBE LISTE, self-medication
    list; managing entries in the product information service
    [Fachinformationsservice] of ROTE LISTE® GmbH
  • Registration of medicinal products with the IFA and maintenance
    of data

Other European member states:

  • Colleagues in all other EU member states support us with the compilation
    and maintenance of product information, ensuring compliance with the
    respective European and national requirements
  • Coordination of translations and the production of artwork