Principles of classification

 

If necessary, Fimea, will decide whether a substance or a product is considered a medicinal product in accordance with section 6 of the Medicines Act (395/1987). Products are classified into medicinal products or non-medicinal products. The classification is based on the composition and intended use of the product.

Classification into medicinal products or non-medicinal products

Subject to section 83 of the Medicines Act (395/1987) , Fimea has compiled a medicinal substance list, which is a list of substances classed as medicinal. As referred to in section 1 of the of the decision of list of medicines (207/2015)the substances listed inAnnex 1 are medicinal substances. Also, the herbals listed in Annex 2and substances in Annex 1Aare considered medicinal. The names in the lists are in Finnish, In Swedish, in Latin and in English.

Other products or substances which, although they deviate from normal medicinal products in form, composition, method of manufacture, or mechanism of action but are used as referred to under sections 3 and 5 of the Medicines Act, can also be classified as medicinal products. These include for example radioactive medicinal products, allergen products, vaccines and medicinal gases.

As referred to in section 3 of the 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.

Products or substances referred to above which are to be taken internally or externally for the purposes of establishing state of health or the cause of a disease, or for restoring, correcting, or modifying physiological functions in humans or animals are also considered to be medicinal products. A product’s intended use is medicinal when it is used in accordance with section 3 of the Medicines Act.