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RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of April 23, 2015 No. 55

About complex of the preliminary technical works preceding state registration of medical products

(as amended on 07-03-2023)

Based on part two of Item 3 of the Regulations on state registration (re-registration) of products of the medical prescription and medical equipment approved by the resolution of Council of Ministers of the Republic of Belarus of September 2, 2008 No. 1269, of subitem 8.25-1 of Item 8 and subitem 9.1 of Item 9 of the Regulations on the Ministry of Health of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446, the Ministry of Health of the Republic of Belarus DECIDES:

1. Approve:

The instruction about procedure for carrying out complex of the preliminary technical works preceding state registration (re-registration) of products of medical prescription and medical equipment, to modification of the registration file on the products of medical prescription and medical equipment which are earlier registered in the Republic of Belarus (is attached).

2. This resolution becomes effective after its official publication.

First Deputy Minister

D.L.Pinevich

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of April 23, 2015 No. 55

The instruction about procedure for the organization and carrying out complex of the preliminary technical works connected with conducting examinations, the inspections of industrial production of medicines and pharmaceutical substances, testing and other researches, the previous state registration (confirmation of state registration) of medicines and pharmaceutical substances, to modification of the registration file on medicine, pharmaceutical substance which are earlier registered in the Republic of Belarus

No. 93 voided according to the Resolution of the Ministry of Health of the Republic of Belarus of 02.11.2020

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of April 23, 2015 No. 55

The instruction about procedure for carrying out complex of the preliminary technical works preceding state registration (re-registration) of products of medical prescription and medical equipment, modification of the registration file on the products of medical prescription and medical equipment which are earlier registered in the Republic of Belarus

1. This Instruction determines procedure for carrying out by the republican unitary enterprise "The Center of Examinations and Testing in Health Care" (further, unless otherwise specified, – the Company) complex of the preliminary technical works connected with conducting primary and specialized examinations of documents, inspections of production of products of medical prescription and medical equipment (further, unless otherwise specified, – inspection), the sanitary and hygienic, technical and clinical testing, clinical assessment and other researches preceding state registration (re-registration) of products of medical prescription and medical equipment, modification of the registration file on the products of medical prescription and medical equipment which are earlier registered in the Republic of Belarus.

Action of this Instruction does not extend much carrying out:

complex of the technical works connected with conducting examinations, inspections of production of medical products, testing and other researches for implementation of registration, modification of the registration file and connected with registration of other medical products of procedures within the Eurasian Economic Union;

complex of the preliminary technical works preceding the state re-registration of the medical products made (imported) by residents of the Chinese-Belarusian industrial park "Great Stone" to modification of the registration file on the medical products made (imported) by residents of the Chinese-Belarusian industrial park "Great Stone", which are earlier registered in the Republic of Belarus, the Regulations on special legal regime of the Chinese-Belarusian industrial park "Great Stone" approved by the Presidential decree of the Republic of Belarus of May 12, 2017 No. 166 provided by Items 99 and 100.

2. For the purpose of this Instruction as the applicant it is understood:

the legal entity (individual entrepreneur) who is making products of medical prescription and medical equipment, including placed the order for production of products of medical prescription and medical equipment or the legal entity (individual entrepreneur) who is part of one merging with producer of products of medical prescription and medical equipment;

the legal entity (individual entrepreneur) of the Republic of Belarus who is making medicines, placed the order for production and (or) acquisition of products of medical prescription of foreign production, held for use in industrial production of medicines if these products of medical prescription are not registered in the Republic of Belarus by the foreign producer;

the legal entity (individual entrepreneur) participating in the product circulation of medical prescription and medical equipment delivered in limited quantity for the state organizations of health care for the purpose of accomplishment of the international programs by them in the field of health care for medical application in the conditions of emergence of emergency situation or diagnosis of new, natural and focal or especially dangerous infectious diseases as foreign free aid (further if other is not determined – products of medical prescription and the medical equipment delivered in limited quantity).

3. In this Instruction terms and their determinations in the values established by the Law of the Republic of Belarus of June 18, 1993 No. 2435-XII "About health care" and Regulations on state registration (re-registration) of products of medical prescription and medical equipment are used.

4. Carrying out complex of preliminary technical works begins with primary examination of the documents of the registration file submitted by the applicant according to the list according to appendix 1 (further – documents) which provides:

check of completeness and correctness of their registration;

check of completeness and relevance of information specified in them;

refining of the list and name of products of medical prescription and medical equipment according to nomenclature classification of products of medical prescription and medical equipment by types and by classes depending on potential risk of their use.

Conducting primary examination of documents is performed based on the agreement signed between the Company and the applicant. The term of conducting primary examination of documents shall not exceed 15 calendar days.

If by results of primary examination of documents there are notes, the Company in writing notifies the applicant on need of their elimination in time, not exceeding 45 calendar days from the date of the notification. After elimination by the applicant of notes primary expertize of documents is carried out repeatedly. The term of conducting repeated primary examination shall not exceed 10 calendar days. In case of not elimination of notes in time, specified in the notification, the result of primary examination of documents is recognized negative.

In case of positive result of primary examination of the documents, except as specified, specified in part three of Item 5 of this Instruction, the Company determines preliminary technical works which carrying out is necessary for confirmation of safety, efficiency and product quality of medical prescription and medical equipment (further – preliminary technical works) what the Company in writing informs the applicant on.

The negative result of primary examination of documents is reflected the Company in the conclusion about compliance of products of medical prescription and medical equipment to safety requirements, efficiency and quality in form according to appendix 2 (further – the conclusion).

5. Preliminary technical works are performed based on the agreement signed between the Company and the applicant, and the term of their carrying out shall not exceed 150 calendar days from the date of its conclusion, except as specified, specified in parts two and third this Item.

By agreement of the parties agreements the term of carrying out preliminary technical works can be prolonged up to 300 calendar days.

Based on the agreement signed between the Company and the applicant whose effective period shall not exceed 70 calendar days the preliminary technical works (including primary examination of documents) preceding entering of the following changes into the registration file on the products of medical prescription and medical equipment which are earlier registered in the Republic of Belarus in case of are carried out:

change of the name of product of medical prescription and medical equipment without change of the properties and characteristics influencing quality, efficiency and safety of product of medical prescription and medical equipment, or enhancement of their properties and characteristics in case of invariance of functional purpose and (or) principle of action – for product of medical prescription and medical equipment of foreign production;

reorganization and (or) change of the name of the legal entity – the producer of product of medical prescription and medical equipment (further – the producer);

modification of marking and (or) packaging of product of medical prescription and medical equipment.

Preliminary technical works are performed in the relation:

products of medical prescription and medical equipment of national production;

products of medical prescription and medical equipment of foreign production;

products of medical prescription of foreign production, held for use in industrial production of the medicine represented on state registration by the legal entity or individual entrepreneur of the Republic of Belarus making medicines;

the products of medical prescription and medical equipment of foreign production which are in circulation in the territory of the United States of America or state members of the European Union;

the products of medical prescription and medical equipment delivered in limited quantity.

6. State registration of products of medical prescription and medical equipment is preceded by the following preliminary technical works:

6.1. inspection which is carried out in cases:

representations by the applicant of products of medical prescription and the medical equipment made on for the first time the declared production site, except for products of medical prescription and medical equipment of foreign production of the I class of potential risk (except sterile products of medical prescription and medical equipment);

representations by the applicant of products of medical prescription and the medical equipment made on the production site which is earlier declared only in case of the state registration of products of medical prescription and medical equipment of foreign production which are in circulation in the territory of the United States of America and the state members of the European Union, and also the products of medical prescription and medical equipment made and allowed to use in state members of the Eurasian Economic Union and which are in circulation in the territory of the United States of America or state members of the European Union, products of medical prescription and medical equipment, delivered in limited quantity, except for products of medical prescription and medical equipment of foreign production of the I class of potential risk (except sterile products of medical prescription and medical equipment);

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