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News | 11.10.2021

Swedish SPC approved for less than 50% of human medicinal products

Fimea reminds marketing authorisation and registration holders of the requirement to submit a Swedish Summary of Product characteristics by 9 February 2022.

To date, the Swedish SPC has been submitted and approved for 47,8% of all medicinal products for human use and 31.6% of veterinary medicinal products.

https://www.fimea.fi/-/myyntiluvallisella-laakkeella-ja-rekisteroidylla-perinteisella-kasvirohdosvalmisteella-on-oltava-myos-ruotsinkielinen-valmisteyhteenveto-9.2.2022-mennessa

Blogs | 24.01.2023

Biological medicines: how does their manufacturing process differ from traditional medicines?

The differences in the manufacturing process and the nature of the active substance itself mean that biologicals differ from traditional medicines in many ways.

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News | 13.12.2022

EU Council to postpone the MDR deadlines

The commission’s plan would not automatically apply an extended transitional period for all the medical devices, but the extension would be allowed on the condition that it is critical for the safety of the patients.

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News | 12.12.2022

Our team of great colleagues has grown again

We are proud to introduce our new team of experts

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More News & Blogs

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