In accordance with section 83 of the Medicines Act (395/1987), Fimea has compiled a recommendation for a list of medicinal products. Under section 1 of the decision on the medicinal products list the substances listed in the Annex 1 to the decision are medicinal products. In addition, the herbal medicinal products listed in Annex 2 and substances in Annex 1 A are medicinal substance analogs and prohormones which are considered to be medicines.
Purpose of the list
This decision includes a list of the substances and herbals that are in medicinal use in Finland.
The list of medicinal products is compiled taking into consideration the provisions of Sections 3 and 5 of the Finnish Medicines Act.
A medicinal product means a product or substance intended for internal or external use to cure, alleviate, or prevent a disease or its symptoms in humans or animals. Medicinal products are also considered to include substances or combinations of substances used internally or externally that can be used to restore, correct or modify the vital functions of humans or animals through pharmacological, immunological or metabolic influence or to determine the state of health or the reason for a disease.
The list is not exhaustive. Any substances and herbals that are not mentioned in the list but that meet the definition of a medicinal product under the Finnish Medicines Act are therefore also considered medicinal products.
In addition to approving the list of medicinal products, the Finnish Medicines Agency decides, by virtue of Section 6 of the Finnish Medicines Act, whether a substance or a product should be classified as a medicinal product.
The substances in Annex 1 A are analogues and prohormones.
All substances in Annex 1 A are, based on effect, comparable to medicinal products supplied by prescription only
Decision of the Finnish Medicines Agency on the medicinal products (415/2019).
Unofficial translation of the decision in English (pdf)
Annex 1 ,Substances on the list of medicines, contains 2646 substances
Annex 1 A, 46 medicinal substance analogs and prohormones
Annex 2 , Herbals on the list of medicines, contains 399 herbs or herbals
The names of the substances and herbals are in Finnish, Latin, Swedish and English.
Final Decision 415/2019 is published in: www.finlex.fi(in Finnish and in Swedish)
Decision of the Finnish Medicines Agency on medicinal products list (415/2019) (pdf)