Marketing authorisation holders must provide Swedish summaries of product characteristics for medicines within a transition period ending in 2022
As of 9 February 2019, submission of Swedish summaries of product characteristics has been a mandatory requirement for all new marketing authorisations of human and veterinary medicinal products in Finland. A Swedish summary of product characteristics is required for all marketing authorisation applications submitted after 9 February 2019. For marketing authorisations already issued as well […]
Rotary tablet press CPR-18 is now up and running
Our newest technological addition to Medfiles’ laboratories, a rotary benchtop tablet press, is now up and running. The equipment qualification is completed, and we have passed Fimea’s manufacturing authorisation extension inspection with flying colours. The tablet press reinforces our R&D and production services even further by extending our manufacturing authorisation. This eight-station tablet press, best […]
Clinical and regulatory expertise for your medical devices – all from one contact point
The Medfiles Clinical Team is your perfect partner in planning, coordinating, monitoring and reporting clinical investigations related to medical devices (MD) or post-marketing clinical follow-up studies (PMCFs). As we all know, the European Commission decided to postpone the date of application of the Medical Devices Regulation (MDR) by one year. We now encourage you to […]
Nitrosamine impurity risk evaluations will be required for all human medicinal products – are you prepared?
Nitrosamines are chemical compounds classified as probable human carcinogens. Since September 2019, marketing authorisation holders of human medicinal products have been required to evaluate their manufacturing processes for all products containing chemically synthesised active substances to identify and, if necessary, mitigate the risk of presence of nitrosamine impurities. The call for review was extended also to biological […]
Get to know our leading experts!
I work as a Senior Pharmaceutical Chemical Expert at the Medfiles regulatory affairs unit. I have worked at Medfiles for seven years now, and during that time, I have been involved in many kinds of projects related to pharmaceutical quality. My educational background is in organic chemistry, in which I hold a master’s degree. Before […]