RESOLUTION OF THE MINISTRY OF AGRICULTURE AND FOOD OF THE REPUBLIC OF BELARUS

of March 10, 2025 No. 23

About some measures for implementation of the resolution of Council of Ministers of the Republic of Belarus of April 29, 2017 No. 317

Based on Item 4, the paragraph of the third Item 5, Item parts three 12, Item parts two 14, Item parts three 23, part two of Item 26 of the Regulations on procedure for state registration of veterinary medicines, maintaining the State register of veterinary medicines, procedure and conditions of issue of the registration certificate of veterinary medicine, Item 4, the paragraph of the third Item 5, Item parts three 12, Item parts two 14, Item parts three 23, part two of Item 26 of the Regulations on procedure for state registration of feed additives, maintaining the State register of the feed additives, procedure and conditions of issue of the registration certificate of feed additive approved by the resolution of Council of Ministers of the Republic of Belarus of April 29, 2017 No. 317, of subitem 5.1 of Item 5 of the Regulations on the Ministry of Agriculture and Food of the Republic of Belarus the Council of Ministers of the Republic of Belarus approved by the resolution of June 29, 2011 867, the Ministry of Agriculture and Food of the Republic of Belarus DECIDES: No.

1. Establish:

1.1. form of the expert opinion on opportunity or impossibility of state registration (confirmation of state registration) of veterinary medicine according to appendix 1;

1.2. form of the expert opinion on opportunity or impossibility of modification of the registration file of veterinary medicine according to appendix 2;

1.3. form of the expert opinion on opportunity or impossibility of state registration (confirmation of state registration) of diagnostic means of veterinary appointment according to appendix 3;

1.4. form of the expert opinion on opportunity or impossibility of modification of the registration file of diagnostic means of veterinary appointment according to appendix 4;

1.5. form of the expert opinion on opportunity or impossibility of state registration (confirmation of state registration) of disinfecting, disinsection, disacariasis means of veterinary appointment according to appendix 5;

1.6. form of the expert opinion on opportunity or impossibility of modification of the registration file of disinfecting, disinsection, disacariasis means of veterinary appointment according to appendix 6;

1.7. requirements for forming of the registration file of veterinary medicine, including:

1.7.1. the documents constituting the registration file for state registration, confirmation of state registration of veterinary medicine which treat:

list of documents of the registration file of veterinary medicine;

the copy of the document confirming availability of the current license on production of veterinary medicines, certified in accordance with the established procedure;

the copy of the existing document (certificate) confirming compliance of industrial production of veterinary medicines to the requirements established by the international treaties of the Republic of Belarus, other international legal acts constituting the right of the Eurasian Economic Union in the field of veterinary science;

data on claims concerning quality of the veterinary medicines made on this production site for the last 3 years *;

the copy of the last report of the pharmaceutical inspectorate issued by authorized body not later than 3 years before date of filing of application about registration of veterinary medicine *;

copy of the decision of authorized organization on conducting pharmaceutical inspection *;

data on results of all pharmaceutical inspections of the production site which are carried out prior 3 years prior to date of filing of application about registration of veterinary medicine *;

the report on results of preclinical research (testing) of veterinary medicine corresponding to the general principles of carrying out preclinical researches (testing) and amount of pilot studies (testing) of veterinary medicines for the immunological (immunobiological) veterinary medicines containing live pathogenic microorganisms in the structure together with the copy of permission of authorized body to production of samples of immunological (immunobiological) veterinary medicines certified in accordance with the established procedure **;

the report on results of clinical trial (testing) of veterinary medicine corresponding to the general principles of performing clinical trials (testing) and amount of pilot studies (testing) of veterinary medicines together with permission of Department of veterinary and food supervision of the Ministry of Agriculture and Food to performing clinical trials (testing), in case of performing clinical trial (testing) in the territory of the Republic of Belarus, for the immunological (immunobiological) veterinary medicines containing live pathogenic microorganisms in the structure together with the copy of permission of authorized body to performing clinical trials (testing) of the immunological (immunobiological) veterinary medicines containing live pathogenic microorganisms in the structure, certified in accordance with the established procedure report on results of clinical trial (testing) **;

the draft of the instruction for use of veterinary medicine in the form established by appendix 21 to the Regulations of the address of veterinary medicines on customs area of the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of January 21, 2022 No. 1;

projects of prototypes primary and in the presence of secondary packagings of veterinary medicine with the marking conforming to requirements of Regulations of the address of veterinary medicines on customs area of the Eurasian Economic Union;

the project of technical regulatory legal act or the regulating document on the veterinary medicine (further – the regulating document on veterinary medicine) processed according to requirements according to appendix 7;

the documents containing data on the pharmaceutical substance (pharmaceutical substances) which is part of pharmacological veterinary medicine, including the data about:

name of pharmaceutical substance (international unlicensed or chemical and trade names), its structure, general properties;

the name of the producer, its location (the address of the legal entity), and also the address of the place of implementation of activities (if addresses differ);

impurity;

results of quality control of pharmaceutical substance:

term of its validity;

for immunological (immunobiological) veterinary medicines – the passport copy of production strain certified in accordance with the established procedure or the document containing data on production strains of the microorganisms which are part of immunological (immunobiological) veterinary medicine;

the data on veterinary medicine containing the description of veterinary medicine and its structure, the scheme of engineering procedure of production and its description, the name of production sites and their location (the address of the place of implementation of activities), pharmaceutical compatibility, the description of characteristics and properties of packaging and corking materials, data on validation of the techniques of researches (testing) used for quality control of veterinary medicine;

the data on excipients containing the specification on excipients, information on use of excipients of animal origin;

the quality certificate confirming compliance of veterinary medicine to requirements of the regulating document of veterinary medicine;

the data on stability of veterinary medicine received according to requirements to researches (testing) of stability of active ingredients and veterinary medicines, statutory rules of regulation of the address of veterinary medicines on customs area of the Eurasian Economic Union;

the list of the third countries in which veterinary medicine, with indication of the name of veterinary medicine, and also number and date of issue is registered by competent authority of the document confirming the address of veterinary medicine according to the legislation of this country (in the presence);

the document confirming competence of the applicant (or his representative) on registration of veterinary medicine (including the power of attorney);

the document confirming legal relationship between the owner of veterinary medicine and producer of veterinary medicine if those are different legal entities (the agreement, the licensed contract, the agreement of commercial concession or other);

copies of documents of the registration file of the veterinary medicine made in the third country in English (if necessary);

1.7.2. the documents constituting the registration file for modification of the registration file of veterinary medicine which treat:

the documents confirming the bases of the made change;

the draft(s) of the document(s) of the registration file to which it is planned to make changes;

information on influence of the made change on efficiency, safety and quality of veterinary medicine;

1.7.3. the documents constituting the registration file for state registration, confirmation of state registration of diagnostic means of veterinary appointment which treat:

list of documents of the registration file of diagnostic means of veterinary appointment;

the copy of the document confirming availability of the current license on production of veterinary medicines or on production of diagnostic means of veterinary appointment or the copy of the document issued by authorized body of the country, confirming permission of production of diagnostic means of veterinary appointment, certified in accordance with the established procedure;

the copy of the existing document (certificate) confirming compliance of industrial production of veterinary medicines to the requirements established by the international treaties of the Republic of Belarus, other international legal acts constituting the right of the Eurasian Economic Union in the field of veterinary science;

the copy of the last report of the pharmaceutical inspectorate issued by authorized body not later than 3 years before date of filing of application about registration of diagnostic means of veterinary appointment *;

data on claims concerning quality of diagnostic means of the veterinary appointment made on this production site for the last 3 years *;

copy of the decision of authorized organization on conducting pharmaceutical inspection *;

data on results of all inspections of this production site which are carried out prior 3 years prior to date of filing of application about registration *;

the draft of the instruction for use of diagnostic means of veterinary appointment which is drawn up according to requirements according to appendix 8;

the projects of prototypes of labels which are drawn up according to requirements to marking of diagnostic means of veterinary appointment according to appendix 9;

the draft of the regulating document on diagnostic means of veterinary appointment which is drawn up according to requirements according to appendix 7;

the data on diagnostic means of veterinary appointment containing the trade name of diagnostic means of veterinary appointment, the description of diagnostic means of veterinary appointment, the description of metrological and (or) functional characteristics of means and the components which are part of diagnostic means of veterinary appointment, the description of characteristics and properties of packaging and corking materials, information on storage conditions and transportations of diagnostic means of veterinary appointment, the flowchart and the description of engineering procedure of production of diagnostic means of veterinary appointment, information on development and production of diagnostic means of veterinary appointment, full name of the producer of diagnostic means of veterinary appointment (his representative who is acting on the basis of the power of attorney), its location (the address of the legal entity), the name of production sites their location (the address (addresses) of the place of implementation of activities), the report on risk analysis, connected with use of diagnostic means of veterinary appointment;

data on biological safety (in the presence);

the certificate of deposition of strains of the microorganisms used in case of production of diagnostic means of the veterinary appointment intended for identification of causative agents of infectious diseases of animals and determination of the immune answer, containing including the name, the location (the address of the legal entity) and the address of the place of implementation of activities (if addresses differ), catalog number of strain of microorganisms;

the sterilizations this about the procedure, including information on validation of process, sterility (if necessary) with indication of methods of carrying out researches (testing) and the packagings this about validation (including corking means) (for sterile means);

information on the special software and (or) specialized equipment for work with diagnostic means of veterinary appointment (if necessary);

results of quality control of means according to requirements of the regulating document of diagnostic means of veterinary appointment with appendix of protocols of researches (testing);

data on stability of diagnostic means of veterinary appointment in structure according to appendix 10;

information on recommended methods of destruction of diagnostic means of veterinary appointment;

the document confirming competence of the applicant (or his representative) on registration of diagnostic means of veterinary appointment (including the power of attorney);

the document (the copy of the document certified in accordance with the established procedure) confirming legal relationship between the owner of means and the producer of diagnostic means if those are the different legal entities or physical persons registered as individual entrepreneurs (the agreement, the licensed contract, the agreement of commercial concession or other);

the list of the third countries in which territories means, with indication of the name of means, and also number and date of issue is registered by competent authority of the document confirming the address of means in the territories of the third countries according to the legislation of these countries;

copies of documents of the registration file of diagnostic means of the veterinary appointment made in the third country in English (if necessary);

1.7.4. the documents constituting the registration file for modification of the registration file of diagnostic means of veterinary appointment which treat:

the documents confirming the bases of the made change;

the draft(s) of the document(s) of the registration file to which it is planned to make change;

information on influence of the made change on efficiency, safety and quality of diagnostic means of veterinary appointment;

1.7.5. the documents constituting the registration file for state registration, confirmation of state registration disacariasis, disinsection or disinfectant of veterinary appointment which treat:

list of documents of the registration file;

the copy of the current license on production of veterinary medicines or the document issued by authorized body of the country, confirming permission of production disacariasis, disinsection or disinfectant of veterinary appointment, certified in accordance with the established procedure (in the presence);

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