Forms

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Fimea forms can be found here and are organised by topic. Some of the forms can be completed electronically and printed, others are available for printing only.

 

Forms: Marketing authorisation application and notification forms

Application forms for marketing authorisation, marketing authorisation variation and marketing authorisation renewal are available from the European Commission website: Application for marketing authorisation for medicinal products. Part IA / Common technical document (CTD) module 1.2

Form: Contact detail forms

Forms: Marketing status

Forms: Sunset clause

Forms: Medicinal products for human use

Forms: Veterinary medicines

Form: Narcotics

Self-certification templates – authorisation for the import, export, manufacturing and handling of narcotic substances:

Forms: Licensing

Forms: Other licenses and notifications