Assessment of hospital-only medicinal products

The focus of Fimea's HTA activity is on the assessment of new hospital-only medicinal products entering the market for the first time. The aim is to produce information on the therapeutic and economic effects of medicinal products to support decision-making. In addition to new medicinal products entering the market for the first time, the subject of assessment may be an extension of a therapeutic indication.

The selection of topics takes place either through an application-based or official-initiated procedure. Procedures related to the selection of topics and other implementation are described in more detail in the process descriptions below. The aim is to produce the assessments so that the assessment report is available as soon as possible after the application submitted by the company, the granting of the marketing authorisation or the extension of a therapeutic indication.

Read more:

• Process description of the assessment of new hospital-only medicinal products (pdf)
• Description of the application-based assessment pilot of hospital-only medicinal products (pdf)