Pharmaceutical wholesale – Ordering products subject to special authorisation

Products with Special Authorisation

Medicinal products used in Finland, such as vaccines, must have a marketing authorisation. If a product does not have a marketing authorisation, the Finnish Medicines Agency Fimea may, for particularly compelling reasons, grant the medicinal product a temporary special authorisation.

If no temporary special authorisation is in place, a patient‑specific authorisation must be applied for when the product is used. When using antitoxin products supplied by THL, it must first be verified whether the product has a temporary special authorisation. Fimea maintains a list of valid temporary special authorisations on its website.
Fixed-term special permits (Fimea)

Temporary special authorisations (Fimea)
On the basis of a temporary special authorisation granted by Fimea, the pharmaceutical wholesaler imports the following products into Finland:

Antitoxins (i.e. antidotes)

  • Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) (Equine) used against the neurotoxin produced by Clostridium botulinum
  • Diphtheria Antitoxin I.P.

Ordering instructions for antitoxins

Botulinum antitoxin (BAT) and diphtheria antitoxin (DAT) are stocked at several university hospital pharmacies, from which other hospital pharmacies and medicines centres can order them when needed for patient treatment. It is recommended to agree in advance on ordering practices with the university hospital pharmacies that stock antitoxins.

Products with Exemption

The reason for an exemption is most often the use of a foreign vaccine package in Finland.

Vaccines are subject to occasional availability disruptions. In such cases, the vaccine supplier may need to deliver foreign packages in order to ensure the implementation of the National Vaccination Programme or to control a vaccine‑preventable epidemic.

Fimea may grant an exemption for a product that has a marketing authorisation if the product is critical to Finland’s medicine supply and there would otherwise be a disruption in availability. Vaccines included in the National Vaccination Programme are considered critical products for Finland’s medicine supply.
The package labelling of products granted an exemption is often in a foreign language, and the instructions in the package leaflet may differ from the vaccination instructions of the National Vaccination Programme. When administering the vaccine, the instructions on the vaccine‑specific webpage must be followed.


List of vaccine products currently in use for the National Vaccination Programme that have been granted an exemption by Fimea: