Fimea to launch application procedure pilot for the assessment of hospital medicines

One of the goals of the reform of pharmaceutical matters launched by the Ministry of Social Affairs and Health is to standardize the principles for evaluating the introduction of medicines used in outpatient care and in hospitals. Currently, the methods for launching assessments vary: there’s an application procedure for outpatient medicines and an official-initiated model for hospital medicines. 

In order to harmonise the principles, Fimea will pilot the application procedure for the assessment of hospital medicines from 1 March 2023. Any enquiries and assessment requests must be sent to [email protected], after which Fimea will contact the company.

Piloting the application procedure can be used with products intended for hospital use that are entering the market for the first time, and for which there are no plans to seek reimbursement status in outpatient care. However, a hospital medicine that has not been previously assessed and is not in use may also be considered for the inclusion in the application procedure pilot. 
If necessary, Fimea will also carry out evaluations of hospital medicines during the piloting phase according to the evaluation model for hospital medicines.

For the purpose of the pilot, Fimea has prepared a description of the new practice and the guidelines applied to applications. Practices and guidelines will be developed together with stakeholders through the experiences gained from the pilots. 

Read more:

Pilot for the application procedure for new hospital medicines, 21 February 2023 (pdf)