Methodological norms on statement and payment of the contribution stipulated under art. 3631 para (1) and (2) under Law no. 95/2006 on healthcare reform.
According to the present law, holders of authorizations for trading on the market for medicinal products, for medicinal products included in national health programs, for drugs from which benefit the insured in ambulatory treatment, with or without personal contribution, based on medical prescription, in the health insurance system, and for drugs from which benefit the insured in hospital treatment, who obtain incomes from trading of the respective drugs in Romania, are required to contribute, after deduction of VAT, with a quarterly contribution of the value of these revenues, determined based on the volume of sales, according to grid related to the quarterly contribution established by law.
If the holders of authorizations for trading the respective drugs do not carry out trading activities in Romania, their contribution is due by legal entities who derive revenues from the sales of drugs in Romania, as a consequence of obtaining the marketing right directly from the holder of the marketing authorization, respectively from the person who directly or indirectly received from the holder of marketing authorization , the right to transfer to third parties the right of trading of drugs in Romania.
© 2024 Contexpert Consulting SRL. All rights reserved.
For comments and / or suggestions please visit our Contactpage.