Medicines and medicinal substances

The Finnish Medicines Agency Fimea has drafted a new decision concerning the List of Medicines and its Annexes. Fimea ratifies the List of Medicines at least once every three years pursuant to § 83 of the Medicines Act (395/1987).

New draft decision by Finland:

The Finnish Medicines Agency Decision (2019/xx) on the List of Medicines.

The Decision is intended for the monitoring authorities, particularly to facilitate the monitoring of imports and to provide clarification for the public as to what substances are deemed medicines. Fimea has updated the substances in the Annexes and has added to the previous list some substances that are critical from the perspective of monitoring.

The List of Medicines is drawn up taking into account the provisions of §§ 3 and 5 of the Medicines Act.

The most important changes to the Annexes of the previous List of Medicines Decision are:

Annex 1. 2647 medicinal substances, of which a total of 141 medicinal substances are new

Annex 1 A. 46 medicinal substance analogues and prohormones, 6 of which are new

Annex 2. 399 medicinal herbals, with Sanguinaria canadiensis added

and Mimosa Hostilis removed.