Is there a requirement for all investigational medicinal products to be manufactured in a pharmaceutical facility?

No, in addition to pharmaceutical facilities and units manufacturing medicinal substances for the purpose of clinical drug trials, investigational medicinal products can be produced in hospital pharmacies, medicines dispensaries, pharmacies or branch pharmacies. They must notify the Finnish Medicines Agency (Fimea) of their intention to manufacture prior to commencing production. The notification must include details of the relevant medicinal products, form, research project identifier, an estimate of the production volume and a statement on the quality control and release mechanisms.