PSUSA/00010269/202407

PSUSA/00000761/202408

PSUSA/00010464/202407

List of medicines currently in PRIME scheme

Standard operating procedure for renewal of micro-, small- or medium-sized-enterprise status

Standard operating procedure for assignment of micro-, small- or medium-sized-enterprise status

Human medicines European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Sun, sitagliptin,metformin hydrochloride, Date of authorisation: 31/03/2023, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Elebrato Ellipta, fluticasone furoate,umeclidinium,vilanterol, Date of authorisation: 15/11/2017, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Posaconazole Accord, posaconazole, Date of authorisation: 25/07/2019, Revision: 12, Status: Authorised

UPD registration guide for UI and API users