The preparation, manufacturing and marketing of pharmaceutical products are highly regulated in the EU and Finland. According to the experts at the seminar, it is worth getting well acquainted with the laws, directives and statutes at an early stage in order to avoid unpleasant surprises later.

Finland has good regulations know-how and experts that can help a pharmaceutical or diagnostics company coming to Finland or provide advice related to the statutes affecting equipment in the health sector, for example on how to obtain the Europe-wide CE mark.

“Methodical planning and managing change help in taking a project through the process. Bringing production into the EU requires a manufacturing permit issued by the authorities. The national authority must be informed about any changes this is essential in all the processes,” said Sirkku Holttinen from Haabio Consulting, when discussing the challenges posed by the regulations.

The experts at the seminar provided a very realistic picture of what the processes involve, for example that documentation in the sector takes time and is something that should be prepared for.

Text and pictures: Maria Arruda