To the attention of Marketing Authorisation Holders
Please be advised that applications for assessment of medical technologies in support of proposal for inclusion of new INNs, reimbursable INNs with extension of indication, generics with INNs not reimbursable in the List, biosimilars with INNS not reimbursable in the List and fixed-dose combinations in the List of International Non-proprietary Names of medicinal products as provided to insurants, irrespective of personal contribution, based on medical prescription, in the health insurance system frame, as well as of International Non-proprietary Names of medicinal products granted in national health insurance programs, may be submitted as of 04.08.2014.
Respective documentation shall be submitted in accordance with Order of the Minister of Health no. 861/2014 in both electronic format and on paper, accompanied by application and payment forms, as available under the “Fill-in forms and fees” heading, in two copies.
Schedule for submission: from 10:00 to 12:00, every Monday and Wednesday.