On 13 April 2020, the Romanian Ministry of Health issued Order No 615/2020 amending Order No 1032/2011 regarding the approval of the “Norms regarding the donations of medicines, medical equipment, medical devices, vaccine, serums and corresponding supplies”, which creates an expedited procedure for approving COVID-19 medicines donated to Romania.
By this Order, the National Agency for Medicines and Medical Devices of Romania (ANMDMR) must issue a permit for the donation of medicines provided in the protocol for the treatment of COVID-19 within a maximum of 48 hours after the request was registered with ANMDMR.
The medicines this order applies to, which include the experimental antiviral compound Remdesivir, the malaria medication hydroxychloroquine, the HIV drugs lopinavir and ritonavir, and the immunosuppressive drug Tocilizumab, were approved by Order No 487/2020 of the Romanian Ministry of Health last month. (See more about this Order here).
During the coronavirus pandemic, however, these medicines can be accepted as donations by medical facilities even if the drugs hold a marketing authorisation application from states outside the European Economic Area. Moreover, the expiry term of these medicines can be less than eight months, but no less than three months as of the request date of the donation permit. Furthermore, these medicines are exempted from the serialisation obligation.
During the pandemic, medical devices approved by the Military Equipment and Technologies Research Agency, the Medico-Military Scientific Research Centre and the CBRN1 Defence and Ecology Scientific Research Centre, can also be accepted as donations.