Special permits

Special permission for compassionate use

According to the Medicines Act, the Finnish Medicines Agency (Fimea) may give permission for a medicinal product without a marketing authorisation in Finland to be released for consumption in individual cases for special therapeutic reasons.

The Medicines Decree (693/1987, 1184/2002 and 868/2005) (www.finlex.fi) only allows compassionate use in exceptional cases where no other treatments are appropriate or yield the desired effect.

Medicinal products subject to a special permit for compassionate use without a marketing authorisation in Finland may be prescribed by physicians and dentists.  The use of electronic prescriptions is currently not possible.

In outpatient care, permission should be obtained for each individual patient. Health care institutions may apply for an institutional permission that applies to several users within the institution. The permission is valid for one year, starting from the date of issue.

Account of special therapeutic reasons

The physician/dentist prescribing products subject to a special permit for compassionate use is required to supplement the compassionate use application with an account of the special therapeutic reasons for choosing the product concerned. This should show that the case is exceptional and that no other treatments are appropriate or yield the desired effect.

It is also recommended to list the pharmacotherapies previously used by the patient without the desired effect.

Physician's responsibility

The physician in charge of the patient's treatment is ultimately responsible for any treatments she/he prescribes.

When applying for special permission for compassionate use, it should be remembered that the product in question does not yet have a marketing authorisation or that its marketing authorisation has been withdrawn. This may be due to inadequate efficacy, safety or product quality or to a changed view of the medical value of the product, its necessity or its safety and efficacy. The person prescribing the product may be unaware of changes to the product.

When prescribing a medicinal product subject to a special permit without a marketing authorisation in Finland, the physician must take into account the fact that there is no national translation available of the summary of product characteristics or the package leaflet. For this reason, the physician prescribing the medicine may be unaware of the potential precautions for use.

When considering an individual treatment plan involving a medicinal product subject to a special permit for compassionate use, the physician concerned should update their knowledge of the product concerned as applicable.

Responsibility of the party releasing the product for consumption

The releasing party is responsible for ensuring the appropriateness of the application when submitting the application to Fimea. When a medicinal product is released for consumption under a special permit for compassionate use, the releasing party is required, for its part, to ensure that the user of the product is provided with sufficient information on the safe and correct use of the medicinal product concerned, along with storage and other relevant instructions.

See also

Special licence procedure in Finland (pdf)

Forms

Compassionate Use application forms

Ex tempore preparations(in Finnish)

Information on products available for compassionate use

Further information

erityisluvat@fimea.fi