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RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of November 28, 2014 No. 1120

About some questions of state registration of biomedical cellular products

According to article 39-3 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:

1. Approve the enclosed Regulations on procedure for state registration of biomedical cellular products.

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. Add the single list of the ministerial procedures performed by state bodies and other organizations concerning legal entities and individual entrepreneurs, No. 156 approved by the resolution of Council of Ministers of the Republic of Belarus of February 17, 2012 "About approval of the single list of the ministerial procedures performed by state bodies and other organizations concerning legal entities and individual entrepreneurs, entering of amendment into the resolution of Council of Ministers of the Republic of Belarus of February 14, 2009 No. 193 and recognition voided some resolutions of Council of Ministers of the Republic of Belarus" (The national register of legal acts of the Republic of Belarus, 2012, No. 35, 5/35330), Items 10.12-1-10.12-3 of the following content:

"10.12-1. State registration and issue of the registration certificate on biomedical cellular products of national production, confirmation of this state registration

Ministry of Health

statement

technical regulatory legal acts on biomedical cellular products (the project or the copy certified by the producer)

the analytical passport (the project or the copy certified by the producer)

the document containing the description of technological production phases, issued by the producer

the instruction for application (the project or the copy certified by the producer)

prototype of graphic design of the label (the project or the copy certified by the producer)

the protocols and (or) acts of sanitary and hygienic testing on indicators of sterility, lack of the skin irritating, irritativny and all-toxic actions issued by accredited laboratories (centers)

the protocols and (or) acts of conformity testings to requirements of technical regulatory legal acts issued by accredited laboratories (centers)

the protocols and (or) acts of clinical testing (determination of viability, authenticity, microbiological safety) issued by the state organizations of health care

15 days, and in case of sending an inquiry in other state bodies, other organizations – 1 month

5 years, in case of confirmation of state registration – are termless

5 basic sizes

10.12-2. State registration and issue of the registration certificate on biomedical cellular products of foreign production, confirmation of this state registration

Ministry of Health

statement

the documents certifying quality of biomedical cellular products, including the documents confirming availability at the producer of quality management system of products (the original or copies certified of the procedure established by the legislation)

regulating documents on biomedical cellular products (the copy certified by the producer)

the analytical passport (the copy certified by the producer)

the document containing the description of technological production phases, issued by the producer

the instruction for application (the copy certified by the producer)

prototype of graphic design of the label (the copy certified by the producer)

the protocols and (or) acts of sanitary and hygienic testing on indicators of sterility, lack of the skin irritating, irritativny and all-toxic actions issued by accredited laboratories (centers)

the protocols and (or) acts of conformity testings to regulating documents issued by accredited laboratories (centers)

the protocols and (or) acts of clinical testing (determination of viability, authenticity, microbiological safety) issued by the state organizations of health care

15 days, and in case of sending an inquiry in other state bodies, other organizations – 1 month

5 years, in case of confirmation of state registration – are termless

5 basic sizes

10.12-3. Modification of the registration file on the biomedical cellular products which are earlier registered in the Republic of Belarus

Ministry of Health

statement

the reference reasons of the made changes issued by the producer

15 days, and in case of sending an inquiry in other state bodies, other organizations – 1 month

within effective period of the registration certificate on biomedical cellular products

free of charge".

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 of June 18, 1993 "About health care" are used (Vyarkho¸naga Savet's Vedamastsi of Respubliki Belarus, 1993, No. 24, Art. 290; National register of legal acts of the Republic of Belarus, 2008, No. 159, 2/1460), and also following terms and their determinations:

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