Article 48. Legal Entities Authorized to Import Medicines into the Russian Federation

Medicines may be imported to the Russian Federation by:

1) manufacturers of medicines for the purpose of in-house manufacture of medicines;
2) foreign developers of medicines and foreign manufacturers of medicines or other legal entities on the instructions of the developer of a medicines for the purpose of carrying out clinical trials of the medicinal product, state registration of the medicinal product, inclusion of the pharmaceutical substance in to the state register of medicines, quality control of medicines, subject to a permit from an authorized federal executive body to import a specific consignment of medicines;
3) wholesalers of medicines;
4) research centres, higher professional educational institutes, manufacturers of medicines for the development, study and control of the safety, quality and efficacy of medicines subject to a permit from an authorized federal executive body;
5) medical institutions and other institutions mentioned in Clauses 1 to 4 of this Article for delivery of health care in accordance with individual vital indications for a patient subject to a permit from an authorized federal executive body to import a specific consignment of medicinal products issued in the established order in the form of the electronic document signed with the electronic digital signature.