Webcast Series: Legal Issues in Regulatory Affairs
Legal basis for marketing authorisations

15:00 CET

Marketing Authorisation Application & Lifecycle

Legal basis for marketing authorisations

  • Full dossier
  • Abridged procedures for generics, hybrid application and literature-based applications

Legal questions in marketing autho-risation and lifecycle management

  • Marketing authorisation with conditions
  • Deadlines in the various procedures - what to be done if missed?
  • Lifecycle management: variation not approved


FORUM Institut für Management GmbH

Sträter Lawyers
Kronprinzenstraße 20
D-53173 Bonn

Fon +49 (0) 228 93454-0
Fax +49 (0) 228 93454-54



Dr. Christian Moers

Dr. Moers has been with the law firm since 2013. He advises pharmaceutical companies in the field of marketing authorisation and the distribution of medicinal products, pharmacovigilance, wholesale trade with medicinal products, distribution and manufacture of medicinal products.