The new rules introduce a simplified procedure for the state registration of drugs for pets, if these drugs have already been registered for the treatment of people. Such drugs are subject to an accelerated procedure for state expertise - for their state registration as a veterinary drug, the results of a preclinical study conducted for the use of the drug in the treatment of humans can be submitted. Instead of a report on the results of a clinical study, an overview of scientific papers on the results of clinical studies of these drugs in the treatment of animals for which they are intended may be presented.
Необходимость принятия закона продиктована тем, что применение лекарственных препаратов в РФ сегодня возможно только в том случае, если они зарегистрированы в соответствующем реестре, сообщали разработчики закона. Закон вступает в силу с 1 сентября 2023 года.