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The document ceased to be valid since  January 26, 2020 according to Item 2 of this Order

It is registered

Ministry of Justice

Russian Federation

On November 19, 2019 No. 56555

ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of August 5, 2019 No. 602n

About approval of the Procedure for issue by the Ministry of Health of the Russian Federation to participants of foreign economic activity of the import permit to the Russian Federation specific batch of the unregistered biomedical cellular product and form of the specified import permit to the Russian Federation specific batch of the unregistered biomedical cellular product

According to item 4 of Rules of import to the Russian Federation of the biomedical cellular products approved by the order of the Government of the Russian Federation of July 13, 2019 No. 893 (The official Internet portal of legal information http://www.pravo.gov.ru, on July 18, 2019, to No. 0001201907180009), I order:

1. Approve:

Procedure for issue by the Ministry of Health of the Russian Federation to participants of foreign economic activity of the import permit to the Russian Federation specific batch of the unregistered biomedical cellular product according to appendix No. 1;

form of the permission issued by the Ministry of Health of the Russian Federation to participants of foreign economic activity to import to the Russian Federation specific batch of the unregistered biomedical cellular product according to appendix No. 2.

2. This order is effective till January 25, 2020.

Vr.i.o. Minister

T. V. Yakovleva

Appendix №1

to the Order of the Ministry of Health of the Russian Federation of August 5, 2019 No. 602n

Procedure for issue by the Ministry of Health of the Russian Federation to participants of foreign economic activity of the import permit to the Russian Federation specific batch of the unregistered biomedical cellular product

1. This Procedure establishes rules of issue by the Ministry of Health of the Russian Federation (further - the Ministry) to participants of foreign economic activity of the import permit to the Russian Federation of specific batch of the unregistered biomedical cellular product intended for its state registration (including for conducting biomedical examination, preclinical researches and clinical trials) or for delivery of health care to the specific patient according to vital indications <1> (further - permission).

--------------------------------

<1> Item 2 of Rules of import to the Russian Federation of the biomedical cellular products approved by the order of the Government of the Russian Federation of July 13, 2019 No. 893 (The official Internet portal of legal information http://www.pravo.gov.ru, on July 18, 2019, No. 0001201907180009) (further - Rules of import).

2. Permission is issued by the Ministry to the following legal entities <2>:

--------------------------------

<2> Item 3 of Rules of import.

a) to the producer of biomedical cellular product - for self-produced biomedical cellular product;

b) the organization having rights to results of preclinical researches of biomedical cellular product, clinical trials of biomedical cellular product and (or) to the production technology of biomedical cellular product or the legal entity authorized by it - for implementation of state registration of biomedical cellular product;

c) to the educational organizations of the higher education and (or) the organizations of additional professional education participating in the organization of carrying out preclinical researches and (or) clinical trials of biomedical cellular products or conducting such researches and also other organizations which participate in the organization of carrying out preclinical researches and (or) clinical trials of biomedical cellular products or in which such researches are conducted, - for the organization and carrying out the corresponding researches;

d) to the medical organizations and specified in subitems "an" - "in" this Item to the organizations - for delivery of health care to the specific patient according to vital indications.

3. For receipt of permission the legal entities specified in Item 2 presents of the Procedure (further - applicants), or persons authorized by them direct (represent) to the Ministry on paper or in the form of electronic documents through the official site of the Ministry on the Internet the following documents or data:

a) statement for issue of permission;

b) the copy of the agreement (contract), appendix and (or) amendment to it, and in case of lack of the agreement (contract) - the copy of other document confirming intentions of the parties;

c) the manufacturer's certificate of origin of biomedical cellular product certifying compliance of the imported biomedical cellular product to requirements of the regulating documentation of biomedical cellular product;

d) the specification on biomedical cellular product;

e) data on the primary state registration number and identification taxpayer number of the applicant;

e) in case of import of specific batch of the unregistered biomedical cellular product intended for conducting biomedical examination and (or) preclinical researches - reasons for quantity of the imported biomedical cellular product;

g) in case of import of specific batch of the unregistered biomedical cellular product intended for performing clinical trials of biomedical cellular product:

reasons for quantity of the imported biomedical cellular product;

data on permission of the Ministry to performing clinical trial of biomedical cellular product;

copies of the documents (prototypes and (or) photos of packagings) confirming the proper marking of biomedical cellular product causing its target use it is exclusive in clinical trials;

h) in case of import of specific batch of the unregistered biomedical cellular product intended for delivery of health care to the specific patient according to vital indications:

data on full name and the address of federal institution in which medical care is provided to the patient;

the conclusion of consultation of doctors of federal institution in which medical care is provided to the specific patient, signed by the chief physician (head) or person fulfilling its duties about appointment to this patient of the biomedical cellular product unregistered in the Russian Federation, for rendering medical care to it according to vital indications with indication of quantity of the biomedical cellular product which is subject to import to the Russian Federation;

the passport copy or certificates of birth of the patient to whom the biomedical cellular product according to vital indications for delivery of health care is appointed.

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