Frequently asked questions


On this page you will find frequently asked questions related to Fimea's operations. Subjects of questions include biological drugs and biosimilars, special permits for veterinary compassionate use , other special permits, EudraVigilance -system, narcotics control, clinical drug trials, coronavirus, invoicing, Meds75+, marketing authorisations, generic medicines and reporting shortages.


  • Biological drugs and biosimilars
    • Here you will find frequently asked questions about biological drugs and biosimilars.
  • Special permits for veterinary
    • Here you will find frequently asked questions about how to fill in the form, permit application, decision and the processing of the application and other questions and answers.
  • Special permits
    • Here you will find frequently asked questions regarding special permits for medicines.
  • EudraVigilance -system
    • Here you will find operating instructions and answers to daunting questions about reporting adverse reactions.
  • Narcotics control
    • Here you can find the most common answers to questions about import and export licences for narcotics, processing permits, and more information on matters related to applying and applications.
  • Clinical drug trials
    • What is an investigational medicinal product? And do all those have to be manufactured in a pharmaceutical manufacturer? How are adverse reactions reported and how should the EudraCT form be handled?
  • Coronavirus (COVID-19)
    • Here you will find frequently asked questions regarding corona vaccines, adverse effects of vaccines and other matters related to the corona virus.
  • Invoicing
    • How do I report billing information? When will the invoices arrive?
  • Meds75+
    • The purpose of the Meds75+ database of medication for older persons is to support the clinical decision-making on the pharmacotherapy of persons over 75 years of age and to improve medication safety in primary health care. The database contains classification and recommendation for almost 500 drug substances or their combination when used in older persons.
  • Marketing authorisations
    • This page contains answers for questions on marketing authorisation, fees, composition, product information, package sizes, therapeutic indication and variation applications related to marketing authorisations. In addition, you will find frequently asked questions about the local representative, and the summary of the product characteristics in Swedish.
  • Generic medicines
    • What is a generic product? What are the benefits of generics for patients and society? Why can the package leaflets of different generic products differ from each other?
  • Reporting shortages
    • Here you will find frequently asked questions about reporting shortages. In addition, you will find daunting questions about the new E-service for shortage notifications.