roszdr**nadzor Russian expert opinion or conclusion.
On the import and export of samples of human organs and tissues, blood and its components, and human biological materials.
When importing (or exporting) human organs and tissues, blood and its components, samples of human biological material into the customs territory of the Eurasian Economic Union (EAEU), it is necessary to obtain a roszdr**nadzor conclusion.
In accordance with the Decree of the Russian Federation No. 1567-R of September 23, 2010, the Federal Service for Health Supervision (ROSZDR**NADZOR) is the authorized body responsible for issuing conclusions on the import and export of human organs, tissues, blood and blood components, samples of human biological materials.
Which cargoes need the opinion of Roszdr**Nadzor?
The import and export of the following items must be subject to the opinion of Roszdr**Nadzor.
Human organs and tissues, blood and its components.
In this case, the conclusions of Roszdr**Nadzor, submitted to the Ministry of Industry and ** of Russia as a document of approval, are the basis for obtaining a license;
Samples of human biomaterial, hematopoietic stem cells, bone marrow, donor lymphocytes, germ cells, and embryos for non-relative transplantation.
In this case, the conclusion of the roszdr**nadzor is a separate approval document.
The conclusion on the import (export) of human biomaterials obtained in clinical studies of medicines for medical use, as well as human biomaterials obtained in clinical studies of biomedical cell products, was issued by the Ministry of Health of Russia for the purpose of clinical research.
How to get roszdr**nadzor
Conclusion?In order to obtain an opinion, the applicant should submit a set of documents and information to roszdr**nadzor:
An application in accordance with the prescribed form;
Contract;If there is no contract, another document confirming the intention of both parties;
Other documents requested by Roszdr**Nadzor.
It is very easy to get the opinion of roszdr**nadzor through us :
Send us an existing product description.
We will analyze the characteristics of the cargo and make sure that:
This product falls under section 2Scope of Section 21;
The documents you provide allow us to make a statement.
We will prepare a set of documents to get a conclusion.
Based on the information we receive, our specialists will prepare a complete set of documents to submit to Roszdr**Nadzor.
We will send you an application and instructions prepared by us for your signature.
Our experts will submit the documents to Roszdr**Nadzor.
We will control the process, contact the executor, ask all questions and give us answers about the documents submitted or the imported (exported) goods.
Roszdr**Nadzor issues a conclusion on the import (export) of human organs and tissues, blood and their components within 5 working days.
We obtain the original copy of the Conclusion and deliver it to you (by courier or courier service).
The issuance period of the ROSZDR**NADZOR conclusion report does not exceed 1 year.