LEGISLATION AND AGENCIES
1. What are the main regulations on medicinal products?
In line with European regulations and practice, the regime of medicinal products in Romania is highly regulated.
Law No. 95/2006 on the healthcare system reform - Title XVIII (Health Law) is the main regulation in this field while detailed substantive provisions are included in secondary legislation issued by the Government or competent public authorities. The
main secondary enactments on medicinal products include Minister of Health Order No. 368/2017 on pricing, Government Decision No. 140/2018 approving the services packages and Framework contract regulating the conditions for granting medical assistance within the social health insurance system for 2018-2019 (extended for 2020 – March 2021), and Government Decision No. 720/2008 on the list of INNs corresponding to reimbursed medicinal products.
Essentially, the Romanian legislation in the pharmaceutical area observes the European one, with which it has been properly harmonised during the past 14 years. There are, however, specific requirements set forth by the Romanian regulatory authorities in certain domains, such as reimbursement and pricing of prescription-based medicinal products, clawback tax applied to the marketing authorisation holders or the health technology assessment (HTA). Notably, these special regulations may be subject to unpredictable changes, depending on variations in economic policies and budgetary constraints.