We remind holders of Public Health Authorization issued to address unmet medical needs, in accordance with the provisions of Article 883 of Law No. 95/2006 on healthcare reform, as republished and subsequently amended, of their obligation to comply with the provisions of Article 775, paragraph (6), letter a) of the same law, regarding registration in the National Medicines Verification System (NMVS).
Failure to comply with the provisions of Article 775, paragraph (6), letter a) of Law No. 95/2006, as republished and subsequently amended, constitutes a contravention and is subject to a fine ranging from 50,000 lei to 100,000 lei. The fine will be imposed on the authorization holder for the marketing of medicines needed for public health reasons to address unmet medical needs, as per Article 883 of the law.
