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Regulatory House

Which products cannot be registered?

SÚKL has published several types of products on its website for which it is no longer possible to apply for registration as a medicinal...

Regulatory House

New general MDCG guideline Medical Device Software (MDSW)

The MDCG 2023-4 provides several examples to help determine whether or not the hardware and the software used with it can be considered...

Regulatory House

Safe cosmetics for young children - second edition available

The European Committee for Cosmetics and Consumer Health (CD-P-COS, co-ordinated by the European Directorate for the Quality of Medicines...