Changes at the Romanian Drug Agency
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14 Aug Changes at the Romanian Drug Agency

Posted at 19:01h in Legislation, Regulatory Affairs by

In July 2019, the National Agency for Medicines and Medical Devices (NAMMD) was reorganised and changed its name to National Agency for Medicines and Medical Devices of Romania (NAMMDR). This change needs to be considered in relation to the communication with the Agency and, more importantly, this change will lead to changes of the bank accounts which will be reflected in the next invoices issued by the Agency.

NAMMDR also announced a change in the tariff, effective from 12 August 2019: “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”. The state fee under Article 893 of Law no. 95/2006 was thus increased from 1000 to 5000 EURO.