Uutiset-näyttösivun murupolku en
Information on exemptions granted for Nordic flex EN/EN packages will from now on be published on Fimea’s website
From now on, Fimea will publish information on the exemptions granted for Nordic flex EN/EN packages on its website. The common Nordic pilot project on exemptions for small-scale hospital products concerns the period between 1 January 2025 and 1 January 2030.
The list of exemptions provides information on the products for which an exemption has been granted. The following details are included: package sizes, name of the marketing authorisation holder in Finland, period for which the exemption has been granted, date on which the exemption was granted and ATC code. It is also separately mentioned in the list if another European language in addition to English has been approved for the packages in the pilot project. For another European language to be approved for the packages, the marketing authorisation for the small-scale hospital product in question must have been granted through the centralised procedure.
The list of the granted exemptions can be found through the website and link below:
Granted Exemptions (Nordic flex EN/EN packages)
More information:
Ask more
- About applying to the pilot project, the process and the table of exemptions: Sirpa Lohi, Pharmacist (M.Sc.), Research Coordinator, tel. +358 29 522 3382, [email protected]