Russian Ministry of Health published a draft Decree “On Approval of the Procedure for Importation of Biomedical Cell Products to the Russian Federation.”
According to the document, the biomedical cell products imported to the Russian Federation must be included in the state register of biomedical cell products, except for specific lot of unregistered biomedical cell product intended for its state registration (including for biomedical expertise, preclinical and clinical studies) or for provision of vital medical care to a particular patient.
At the importation to the Russian Federation of biomedical cell product included in the state register of biomedical cell products, the applicants shall submit the following documents to customs authorities of the Russian Federation (on paper or in electronic format):
- Certificate of biomedical product manufacturer confirming the compliance of imported biomedical cell product with regulatory requirements for biomedical cell product
- Specification for biomedical cell product.