Practically 100 per cent of Orion’s pharmaceutical products fall under the scope of PR1, and also the proportion of the full product range is very close to that.

Orion is responsible for monitoring the safety of every pharmaceutical product throughout the entire time the product is available on the market. No drug comes without adverse effects, but continuous monitoring and reporting to authorities help ensure that adverse effects do not surpass the drug’s medicinal treatment benefits. Orion collects all the quality feedback received for its products from all the markets where the products are used and assesses the feedback systematically.

As the marketing authorisation holder, Orion is responsible for the quality and safety of its products to the Finnish Medicines Agency (Fimea), which according to the Pharmaceutical Products Act is the authority also inspecting pharmaceutical plants and their contract manufacturers. This also covers pharmacovigilance and premises of the marketing authorisation holder. 

The product safety requirements of diagnostic tests are not as strict as those for pharmaceuticals, but the US Food and Drug Administration (FDA), for example, requires that queries are responded within certain time limits, i.e., the manufacturer has a monitoring obligation. The Finnish regulatory authority responsible for diagnostic tests is Valvira.