إجراء مقترح من أوكرانيا: الأدوية واللقاحات

The draft Order has been developed in accordance with the requirements of the Law of Ukraine 'On Medicines' No. 2469-IX of 28 July 2022, taking into account the relevant European Union legislation. The main objective of the draft Order is to align the procedures for medicine registration with the Law of Ukraine 'On Medicines' and to establish a unified and modern framework for the submission and assessment of registration dossier materials. The draft Order establishes new procedures for the assessment of medicine registration dossier materials in relation to: • state registration and re-registration of medicines; • indefinite extension of state registration; • submission and assessment of variations (changes) to the registration dossier during the validity of the registration. The draft Order approves: • the procedure for the assessment of registration dossier materials; • application forms for registration, re-registration and variations; • requirements for the content and scope of the registration dossier; • requirements for the submission of variations to the dossier; • requirements for the Summary of Product Characteristics, package leaflet and labeling; • templates for clinical and non-clinical study reports; • the procedure for providing scientific advice to applicants; • the procedure for determining the significance of the clinical benefit of new therapeutic indications for reference medicines registered in Ukraine; • the list of herbal substances, herbal…