2021/0839/FIN
EC/EFTA
FI Finnland
  • C00P - PHARMAZEUTIKA, KOSMETIKA
2022-03-09
2021-12-15

Medicinal products and substances

The Finnish Medicines Agency Fimea has drafted a new Decision on the list of medicinal products and its annexes. Fimea ratifies the list of medicinal products at least once every three years pursuant to Section 83 of the Finnish Medicines Act (395/1987).

Finland's new draft decision:
The Finnish Medicines Agency Fimea’s Decision (2022/xx) on the list of medicinal products.

The Decision is intended for the supervisory authorities, particularly to facilitate the monitoring of imports and to provide clarification for the public as to what substances are deemed to be medicinal products. Fimea has updated the substances in the annexes and added substances relevant for control purposes to the previous list.

The list of medicinal products is drawn up taking into consideration the provisions of Sections 3 and 5 of the Finnish Medicines Act.
The most important changes to the annexes of the previous list of medicinal products are:
Annex 1. 2,778 medicinal substances, of which a total of 140 are new medicinal substances
Annex 1A. 92 medicinal substance analogues and prohormones, 46 of which are new
Annex 2. 399 herbal products with medicinal properties, no changes