إجراء مقترح من أوكرانيا: الأدوية واللقاحات

The draft Resolution is developed to establish requirements for the state registration of veterinary medicinal products manufactured industrially or by a method involving an industrial process and intended to be placed on the market. The draft Resolution provides for: - procedures for state registration of veterinary medicinal products, including submission of applications and the required documents in electronic form; examination of applications by the State Service of Ukraine on Food Safety and Consumer Protection; timelines for decision-making; grounds for suspending the processing of applications; procedures, timelines and fees for assessment of registration dossier materials by the authorized (designated) authority; grounds for taking a decision on the state registration or refusal of such registration; - specific provisions for the state registration of certain types of veterinary medicinal products, including antimicrobial veterinary medicinal products; veterinary medicinal products containing or consisting of genetically modified organisms; veterinary medicinal products intended exclusively for export; immunological veterinary medicinal products for notifiable or rare (exotic) animal diseases and generic, hybrid, combined and homeopathic veterinary medicinal products; - requirements for applications, registration dossiers and other documents attached to the application; - conditions for the suspension, restoration and termination of the state registration; - time…