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RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of November 28, 2014 No. 1120

About questions of state registration of biomedical cellular products

(as amended of the Resolution of Council of Ministers of the Republic of Belarus of 25.03.2022 No. 175)

Based on part two of article 39-1 of the Law of the Republic of Belarus of June 18, 1993 "About health care" the Council of Ministers of the Republic of Belarus DECIDES: No. 2435-XII

1. Approve Regulations on procedure for state registration of biomedical cellular products it (is applied).

2. Determine the list of the biomedical cellular products which are not subject to state registration according to appendix.

3. Authorize the Ministry of Health on acceptance of regulatory legal act about approval of procedure and amount of carrying out clinical testing of biomedical cellular products.

4. No. 175 is excluded according to the Resolution of Council of Ministers of the Republic of Belarus of 25.03.2022

5. This resolution becomes effective since December 27, 2014, except for Item 3, of the official publication of this resolution which is becoming effective later.

Prime Minister of the Republic of Belarus

M. Myasnikovich

Approved by the Resolution of Council of Ministers of the Republic of Belarus of November 28, 2014 No. 1120

Regulations on procedure for state registration of biomedical cellular products

Chapter 1. General provisions

1. This Provision determines procedure for state registration of biomedical cellular products in the Republic of Belarus.

2. Requirements of this provision are obligatory for the legal entities and individual entrepreneurs including performing import, realization, medical application of biomedical cellular products and their state registration.

3. In this Provision the main terms and their determinations in the values established by the Law of the Republic of Belarus "About health care" and also the following terms and their determinations are used:

biomedical cellular products – the transfer material received on the basis of cells of the person, except for embryonic, fetalny stem and gametes of the person;

safety of biomedical cellular products – the positive characteristic of biomedical cellular products based on risk assessment of possible damnification of life and to health of the person;

state registration of biomedical cellular products – the procedure of recognition of compliance of biomedical cellular products to requirements for safety and quality imposed to them performed for the purpose of the admission to production, realization and medical application of the biomedical cellular products made in the Republic of Belarus and also to realization and medical application of the biomedical cellular products arriving because of limits of the Republic of Belarus;

The state register of biomedical cellular products of the Republic of Belarus (further – the State register) – the document containing data on the biomedical cellular products registered in the Republic of Belarus;

the applicant – the legal entity or the individual entrepreneur making (placing the order for production) biomedical cellular products;

complex of preliminary technical works – conducting examinations, inspections, testing, including the clinical, and other researches preceding submission of documents for state registration of biomedical cellular products (confirmation of state registration), modification of the registration file on the biomedical cellular products which are earlier registered in the Republic of Belarus;

medical application – use of the biomedical cellular products which underwent state registration (except as specified when passing of state registration is not required), according to the method of delivery of health care or the clinical protocol approved by the Ministry of Health;

the registration file – the documents submitted for state registration (confirmation of state registration) and containing the data confirming safety and quality of biomedical cellular products;

the registration certificate – the document issued in accordance with the established procedure by results of state registration;

registration number – the specification symbol appropriated to biomedical cellular product in case of state registration;

serious collateral reaction – any adverse clinical manifestations leading regardless of frequency or duration of application of biomedical cellular products to the death of the patient, or posing threat for his life, or requiring its hospitalization or its prolongation, or bringing to resistant or the expressed disability (disability), and also the developments which are shown congenital anomaly (defect) or essentially worsening the patient's condition which in case of lack of medical intervention can lead to development of the specified conditions.

4. Complex of preliminary technical works, and also works on technical supply of maintaining the State register and its annual edition are performed by the republican unitary enterprise "The Center of Examinations and Testing in Health Care" (further - RUP "The Center of Examinations and Testing in Health Care") according to the procedure, determined by the Ministry of Health.

RUP "The Center of Examinations and Testing in Health Care" provides according to the procedure, established by the legislation, record keeping and the document storage connected with state registration of biomedical cellular products.

Chapter 2. State registration of biomedical cellular products

5. Biomedical cellular products are subject to state registration:

for the first time created in the Republic of Belarus and offered for realization and medical application in the Republic of Belarus;

made in other countries and for the first time offered for realization and medical application in the Republic of Belarus;

similar to the biomedical cellular products included in the State register, but made by other producer.

6. The biomedical cellular products specified in article 39-3 of the Law of the Republic of Belarus "About health care" and also the biomedical cellular products called in appendix to the resolution which approved this Provision are not subject to state registration.

7. State registration of biomedical cellular products is performed by the Ministry of Health.

8. The applicant after passing of complex of preliminary technical works according to item 4 of this provision represents the registration file including to the Ministry of Health:

8.1. for state registration and confirmation of state registration of biomedical cellular product:

the statement in the form established by the Ministry of Health;

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