Since 30.10.2017, the obligatory provision for applicants in drug registration and re-registration is to provide a Risk management plan (read more details in sеction Pharmacovigilance) and clinical data addenda (DCRA, see more details in section Drug clinical review addendum (DCRA). Nowadays, a 2-year transitional period is provided to applicants for preparation of the documents.
Up to 30.10.2017, all and any drug distributors and manufacturers in Ukraine should have a developed Pharmacovigilance system (master file), qualified person in Pharmacovigilance, Risk management plan on each of drug submitted for registration or re-registration. Periodic Safety Update Reports (PSUR). Our company provides all the service, see more details in section Pharmacovigilance.