Article 26. Accelerated Procedure for Expert Examination of Medicines

1. Accelerated procedure for expert examination of medicines for the purpose of state registration of medicinal products shall be applied to generic medicinal products. For the purpose of such expert examination information obtained in clinical trials of the medicinal products and published in specialized editions, as well as documents containing the results of bioequivalence and (or) therapeutic equivalence studies of the medicinal product for medical use or the results of bioequivalence studies of the medicinal product for veterinary use are submitted.

2. Accelerated procedure for expert examination of medicines shall not be applied to immunobiological medicinal products, insulin products and medicinal products to be registered in the Russian Federation for the first time.

3. Accelerated procedure for expert examination of medicines shall be performed under decision of the relevant authorized federal executive body within the period not exceeding sixty business days. In this case expert examination of the documents contained in the registration dossier for the purpose of obtaining a permit to conduct a clinical trial of a medicinal product for medical use and ethical expert examination shall be performed within the period not exceeding fifteen business days, and expert examination of the quality of a medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of a medicinal product shall be performed within the period not exceeding five business days.

4. Accelerated procedure for expert examination of medicines shall be performed in the manner prescribed in Articles 17 -20, 23 and 24 hereof, and it does not mean downgrading of requirements for safety, quality and efficacy of medicinal products.