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Fimea monitors the positive opinions of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on a monthly basis. For all new medicinal products entering the market for the first time, Fimea contacts the company to assess the timeliness of the evaluation and requests application materials. The company can also contact Fimea earlier. If necessary, the evaluation can also be official-initiated by Fimea.

When a therapeutic indication of a hospital-only medicinal product is extended, the network of chief assessment physicians can propose transferring the assessment to the Fimea-COHERE process, if the topic is financially significant or if there is otherwise a need for more extensive assessment. The assessment model related to the extension of the indication is currently being piloted (palveluvalikoima.fi, in Finnish).

Below is a monthly updated Excel file (in Finnish) that provides a brief summary of CHMP's positive opinions on hospital medicines and information on the stage of the evaluation process (starting from the beginning of 2025). Additionally, the Excel file has a separate tab with information on evaluation statements for the expansion of indications (starting from June 2024). Information on ongoing evaluations and completed evaluations can be found on the Arviointiraportit webpage (only in Finnish). Information on CHMP's positive opinions and initiated evaluations from 2020–2024 can be found in a separate Excel file (in Finnish).

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Further information:

Vesa Kiviniemi, Head of Assessment, tel. +358 29 522 3516

E-mail addresses take the form [email protected].