To the attention of all interested parties
The National Agency for Medicines and Medical Devices of Romania (NAMMDR) hereby advises on amendment of Article 893 of Law no. 95/2006, in accordance with ORDER no. 9 of August 8, 2019 for amendment of Law no. 95/2006 on healthcare reform and amendment of certain healthcare regulatory acts, of regulations for national government programs and regarding fiscal-budgetary measures (published in: the Official Gazette No. 668 of 9 August 2019),
as follows:
15. Article 893 is amended and shall read as follows:
“Article 893 – On submission of documentation for grant of marketing authorisation, applicants shall pay to the NAMMDR a marketing authorisation fee amounting to 5,000 EURO or its equivalent in LEI at the rate of the National Bank of Romania, which constitutes NAMMDR own revenue.”