The State Institute for Drug Control (SWD) will accelerate registration medicines used in COVID-19 (coronavirus) disease. At the same time speed up the approval of a clinical trial for patients with the disease.
Applications for approval of such a medicinal product will be assessed by the SWD preferably within the shortest possible time, up to a maximum of seven days if the product is registered in the European Union. An application for registration of such medicinal product by means of a so-called MRP or RUP procedure. (Standard The European phase was to last a maximum of 90 days and continues after this phase National phase of 30 days). Not authorised in the EU the State Institute will deal with the application for registration within 30 days at the latest. Except registration in the SWD can also be used to apply for temporary registration for Ministry of Health of the Slovak Republic. The national procedure usually lasts a maximum of 210 days. ed
Applications for authorisation of a clinical trial for patients with COVID-19 will treat SWD as a matter of priority, as soon as possible. It also invites sponsors wishing to submit an application for authorisation a clinical trial related to the treatment of this disease, in order to the submission of an application for a SWD has also provided the necessary documentation for the appropriate ethical the committee. This will speed up the approval process for the relevant clinical trial.