Sunset clause - concepts
Placing on the market and marketing
A medicinal product subject to marketing authorisation is considered to have been placed on the market if any preparation in the “product family” is available wholesale for release into consumption in any package size and any strength. The medicinal product in the product family must be actually available in Finland for distribution and supply to consumers. A change in the marketing authorisation holder does not affect the obligations relating to the marketing of the product family. In the event that the marketing authorisation is transferred to another holder, the three-year period, within which the product must be placed on the market and marketed, shall be calculated from the date of the original granting of the marketing authorisation.
Global marketing authorisation (so-called product family)
Any additional strengths, pharmaceutical forms, administration routes, target species and packaging types subsequently included in the initial marketing authorisation (marketing authorisation X and marketing authorisation holder Y) shall be considered as belonging to the product family.