04.03.2021
To the attention of interested persons
The NAMMDR took note of the existence in the public space of some statements announcing the intention to conduct a clinical study in Romania in order to investigate the efficacy of ivermectin in preventing and treating the Sars-CoV-2 infection.
The NAMMDR states that, so far, no application has been submitted for authorisation of a clinical trial for investigation of ivermectin.
Please note that, in Romania, according to the provisions of Article 7011 of Law no. 95/2006 on healthcare reform, republished, as amended, the NAMMDR authorises and controls clinical trials with medicinal products for human use by assessing compliance with good practices in clinical trials with or without therapeutic benefit, as well as the clinical trial site.
Thus, clinical trials are conducted in compliance with the principles and detailed guidelines on good clinical practice, the Rules on the implementation of good clinical practice rules conducted with medicinal products for human use approved by Order of the Minister of Health no. 904/2006 for approval of Norms relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use and Scientific Council Decision no.2 / 22.04.2014 on approval of Regulations for authorisation of sites for conduct of clinical trials on medicinal products for human use – as amended through Scientific Council Decision no. 24/03.07.2015.