Medicines Act (No. 395 of 1987).

The objective of this Act is to maintain and promote the safety of medicinal products and their safe and proper use, as well as to ensure the appropriate manufacture and availability of medicinal products in Finland. It applies to medicinal products, their manufacture, import, distribution, sale and other release for consumption; to medicinal product manufacturers, medicinal product wholesalers and pharmacies practicing these activities; to laboratories performing preclinical safety testing of medicinal products; etc.
The Act contains 111 Sections divided into the following Chapters: 1. Scope of Application; 2. Manufacture of medicinal products; 3. Import of medicinal products; 4. Marketing authorisation and registration; 5. Sale of medicinal products by medicinal product manufacturers and medicinal product wholesalers; 6. Pharmacies; 7. Pharmaceutical services in hospitals, health centres and social welfare institutions; 8. [repealed]; 9. Control and general supervision; 10. Miscellaneous provisions; 11. Sanctions, appeals and authorisation to issue decrees; 12. Entry into force and transitional provisions.
Marketing of medicinal products other than those listed in Regulation (EC) No 726/2004 are subject to authorization by the Finnish Medicine Agency under the requirement that the conditions laid down in Section 21 are met. Veterinary medicinal products cannot be considered to be hazardous to the consumer, the environment or the target animal to receive a marketing authorization. Detailed rules for the submission of the findings of preclinical and clinical trials or safety and residue testing on veterinary medicinal products and exemptions thereof are included. Notwithstanding these marketing authorization requirements, the Finnish Food Safety Authority can grant import authorization for an immunological veterinary medicinal product in cases of serious animal disease epidemics if required.
The Act also lays down rules on the monitoring of adverse effects to to ensure medicinal product safety. When the adverse effect appears in an animal, the data necessary to specify the owner of the animal as well as the species of animal must be entered in the register specified in Section 30. Further, Section 77a stipulates that holders of marketing authorizations for veterinary medicinal products must, when so requested by the Finnish Medicines Agency, provide advice and instructions so that laboratories can adopt an analytical method for detection of veterinary medicinal product residuals.
Finally, the Act establishes veterinary surgeons' right to supply medicinal products for veterinary medication subject to the rules contained in Section 95 and 95a. Further provisions will be issued by Government decree on the requirements for importing veterinary medicinal products, the maximum amounts of medicinal products to be imported, the supply of medicinal products to animal owners or keepers, bookkeeping concerning the use of medicinal products and document storage.