Regulatory House23. 8. 20221 minMDCG 2022-11: Ensure timely compliance with MDR requirements!Medical Device Coordination Group has published a MDCG Possition Paper- MDCG 2022-11 recommending manufacturers to submit their...
Regulatory House2. 8. 20221 minBoric acid and borates used as excipients – does your PIL need a revision? Boric acid is used as an antimicrobial preservative and is used as a buffering agent to control the pH. It can be found in products like...
Regulatory House19. 7. 20221 minReporting drug shortages - new version of the electronic form availableState Institute for Drug Control (SÚKL) informs all MAHS about the transition to the new version of the electronig form of the mandatory...