The need to translate these drugs into prescription leave has been identified. This requirement is based on up-to-date information on the safety and efficacy of domperidone.
In connection with the retention of medicinal preparations of domperidone in the territory of the Russian Federation as non-prescription drugs, we consider it necessary to oblige holders or holders of drug registration certificates or other legal entities authorized by them to amend the documents contained in registration dossiers for registered medicinal products for medical use in accordance with established procedure in accordance with Article 30 of the Federal Law of 12.04.2010 61-FZ "On Circulation of Medicines" in order to exclude the possibility of non-prescription, including,combined medicinal products containing as one of the components domperidone.