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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of October 3, 2018 No. 1184

About approval of the Regulations on licensing of activities for production of biomedical cellular products

(as amended on 01-11-2021)

According to the Federal Law "About Licensing of Separate Types of Activity" Government of the Russian Federation decides:

Approve the enclosed Regulations on licensing of activities for production of biomedical cellular products.

Russian Prime Minister

D. Medvedev

Approved by the Order of the Government of the Russian Federation of October 3, 2018 No. 1184

Regulations on licensing of activities for production of biomedical cellular products

1. This Provision determines procedure for licensing of activities for production of biomedical cellular products.

2. Licensing of activities for production of biomedical cellular products is performed by the Federal Service on supervision in the field of health care (further - the licensing body).

3. Activities for production of biomedical cellular products include works on the list according to appendix.

4. The licensed requirements imposed to the license applicant on implementation of activities for production of biomedical cellular products (further - the license), are:

a) availability belonging to the license applicant on the property right or on other legal cause of the rooms, buildings, constructions and other objects, technical means, the equipment and technical documentation corresponding the stipulated in Article 35 Federal Laws "About Biomedical Cellular Products" to regulations of production of biomedical cellular products and rules of proper practice on work with biomedical cellular products;

b) compliance of production of biomedical cellular products the stipulated in Article 35 Federal Laws "About Biomedical Cellular Products" to rules of proper practice on work with biomedical cellular products;

c) availability according to article 35 of the Federal law "About Biomedical Cellular Products" of regulations of production of the biomedical cellular products necessary for accomplishment of the declared works;

d) availability according to article 35 of the Federal law "About Biomedical Cellular Products" of the authorized person of the producer of biomedical cellular products certified according to the procedure, established by the Ministry of Health of the Russian Federation which performs confirmation of conformity of the made biomedical cellular product to the requirements established in case of its state registration and compliance of process of its production to requirements of rules of proper practice for work with biomedical cellular products;

e) availability of the workers who signed employment contracts, having the higher or secondary professional pharmaceutical, medical, chemical, chemical and technology, chemical and pharmaceutical, biological or biotechnology education and the certificate of the specialist or the certificate on accreditation of the specialist (for specialists with medical and pharmaceutical education), biomedical cellular products, responsible for production.

5. The licensed requirements imposed to the licensee when implementing activities for production of biomedical cellular products are:

a) availability belonging to the licensee on the property right or on other legal cause of the rooms, buildings, constructions and other objects, technical means, the equipment and technical documentation corresponding the stipulated in Article 35 Federal Laws "About Biomedical Cellular Products" to regulations of production of biomedical cellular products and rules of proper practice on work with biomedical cellular products;

b) observance of the stipulated in Article 35 Federal Laws "About Biomedical Cellular Products" of rules of proper practice on work with biomedical cellular products;

c) observance according to article 35 of the Federal law "About Biomedical Cellular Products" of requirements of regulations of production of biomedical cellular products;

d) availability according to article 35 of the Federal law "About Biomedical Cellular Products" of the authorized person of the producer of biomedical cellular products certified according to the procedure, established by the Ministry of Health of the Russian Federation which performs confirmation of conformity of the made biomedical cellular product to the requirements established in case of its state registration and compliance of process of their production to requirements of proper practice for work with biomedical cellular products;

e) availability of the workers who signed employment contracts, having the corresponding higher or secondary professional pharmaceutical, medical, chemical, chemical and technology, chemical and pharmaceutical, biological or biotechnology education and the certificate of the specialist or the certificate on accreditation of the specialist (for specialists with medical and pharmaceutical education), biomedical cellular products, responsible for production;

e) agreement availability on receipt of biological material for production of biomedical cellular products with the organization having the license for medical activities;

g) observance by the licensee of requirements of article 35 of the Federal law "About Biomedical Cellular Products" on prohibition of production of counterfeited biomedical cellular products;

h) observance according to article 37 of the Federal law "About Biomedical Cellular Products" of storage precautions of biological material, cages for preparation of cellular lines, the cellular lines intended for production of biomedical cellular products, biomedical cellular products;

i) observance according to article 38 of the Federal law "About Biomedical Cellular Products" of procedure for destruction of counterfeited biomedical cellular products, poor-quality biomedical cellular products and counterfeit biomedical cellular products.

6. Implementation of activities for production of biomedical cellular products with gross violation of licensed requirements involves the responsibility established by the legislation of the Russian Federation.

At the same time gross violation is understood as failure to carry out by the licensee of the requirements provided by subitems "a", "b", "g" - "and" Item 5 of this provision, entailed the effects provided by part 11 of article 19 of the Federal law "About Licensing of Separate Types of Activity".

7. For receipt of the license the license applicant directs (represents) to the licensing body on paper or in the form of electronic documents:

a) the statement and data specified respectively in part 1 and item 4 of part 3 of article 13 of the Federal law "About Licensing of Separate Types of Activity";

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