The amended Regulation of the Minister of Health of Poland on Good Manufacturing Practice is in force as of 18 December 2024. This is good news for Polish manufacturers of sterile medicinal products, as the amended regulation implements the requirements of Annex 1 of the EU GMP Manufacture of Sterile Medicinal Products into Polish law, thus bringing them into line with European requirements. SciencePharma actively participated in public consultations covering the draft annex to the regulation of the Minister of Health on the requirements of Good Manufacturing Practice concerning the manufacture of sterile medicinal products.
- reference to the Regulation of the Minister of Health of Poland on GMP (available only in Polish): https://dziennikustaw.gov.pl/D2024000181601.pdf
- reference to information on changes (available only in Polish): https://www.gov.pl/web/gif/nowelizacja-rozporzadzenia-ministra-zdrowia-ws-wymagan-dobrej-praktyki-wytwarzania