On 7 April 2020, Romania enacted Government Emergency Ordinance No. 43 (GEO 43) for the approval of support measures following the spread of COVID-19 during the state of emergency, which the government is expected to extend until 16 May. Among… Read moreAcquisitions of COVID-19-related medical supplies to be reimbursed from EU funds
On 31 March 2020, the Romanian Senate adopted a draft law that caps the prices of over-the-counter (OTC) medicines included in the protocol for the treatment of the infection associated with the SARS-Cov-2 virus (coronavirus), which was approved by Order No 487/2020 of… Read moreRomania proposes temporary capping of prices for coronavirus medicines
On 23 March 2020, the Romanian Ministry of Health issued Order No 487/2020 for the approval of a protocol for the treatment of the infection associated with the SARS-Cov-2 virus, also known as the coronavirus. This Order came into force… Read moreRomanian Ministry of Health approves protocol for coronavirus treatment
On 23 March 2020, the Romanian Department for Emergency Situations (DSU) issued Order No. 74527/2020, which implements measures to limit the spread of the coronavirus at healthcare units. This Order was passed after more and more hospitals in Romania reported… Read moreRomania adopts new restrictions for limiting the spread of coronavirus at healthcare units
In response to the COVID-19 pandemic, the Romanian National Agency for Medicines and Medical Devices (ANMDM) announced that it will prioritise approval of clinical trials of those medicines earmarked for treatment of coronavirus infections. Depending on the number of applications… Read moreRomanian health authorities to prioritise approval of COVID-19 clinical trials
According to media reports, on 26 March 2020 the Budget Commission from the Chamber of Deputies of the Romanian Parliament adopted an amendment to the claw-back tax legislation. MPs are discussing a reduction of the level of the claw-back tax… Read moreProposed changes of claw-back tax in Romania
On 13 November 2019, the European Data Protection Board (“EDPB”) adopted its draft Guidelines 4/2019 on Article 25 – Data Protection by Design and by Default (“DPbDD”) (the “Guidelines”). The Guidelines are currently open for pubic consultation (20 November 2019… Read moreNew European Data Protection Board Guidelines on DPbDD
