Licensing Unit

Head of Licensing Unit

Jóhann M. Lenharðsson

Assessment Division

Ulrike Muus

  • Quality Assessment
  • Active Substances
  • Finished Products
  • Bioequivalence Assessment
  • Assessment of Risk Management Plans 
  • Scientific advice

 

Marketing Authorisation Division

Jóhann M. Lenharðsson (temporarily)

  • Granting of marketing authorisations and other authorisations
  • Variations, withdrawals and suspensions of marketing authorisations and other authorisations
  • Review of Icelandic translation of product information
  • Product information assessment
  • Named-patient basis use applications
  • Conditions or restrictions regarding supply and use
  • Direct Healthcare Professional Communication, DHPC
  • QRD, ATC and Standard terms

 

Project Management

Örn Guðmundsson

  • Project Management within the Licensing Unit
  • Validation of application
  • Legal and regulatory aspects of marketing authorisations
  • CMDh member and cross agency distribution of CMDh information