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Ministry of Justice of Ukraine

December 19, 2016

No. 1649/29779

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of September 26, 2016 No. 996

About introduction of amendments to some orders of the Ministry of Health of Ukraine

According to Bases of the legislation of Ukraine on health care, the Laws of Ukraine "About medicines", "About protection of the population against infectious diseases", "About ensuring sanitary and epidemic wellbeing of the population", "About the Nation-wide program of adaptation of the legislation of Ukraine to the European Union law", I order to the Procedure for state registration (re-registration) for medicines and the amount of collection for state registration (re-registration) of medicines approved by the resolution of the Cabinet of Ministers of Ukraine of May 26, 2005 No. 376, to Item 8 of the Regulations on the Ministry of Health of Ukraine approved by the resolution of the Cabinet of Ministers of Ukraine of March 25, 2015 No. 267,:

1. In heading and the text of the order of the Ministry of Health of Ukraine of December 27, 2006 No. 898 "About approval of the Procedure of supervision of collateral reactions of the medicines allowed for medical application" No. 73/13340, of the word "Procedure of Supervision of Collateral Reactions of the Medicines Allowed for Medical Application" registered in the Ministry of Justice of Ukraine on January 29, 2007 in all cases shall be replaced with words "Pharmakonadzor procedure" in the corresponding cases.

2. Make changes to the Procedure of supervision of collateral reactions of the medicines allowed for medical application, No. approved by the order of the Ministry of Health of Ukraine of December 27, 2006 898, registered on January 29, 2007 for No. 73/13340, having been reworded as follows it which is applied the Ministry of Justice of Ukraine.

3. Subitems 1.4 - 1.6 Items 1 of the order of the Ministry of Health of Ukraine of September 16, 2011 No. 595 "About procedure for carrying out preventive inoculations in Ukraine and quality control and addresses of medical immunobiological supplies", registered in the Ministry of Justice of Ukraine on October 10, 2011 on No. 1159/19897, to exclude.

With respect thereto subitems 1. 1.8 to consider 7, respectively subitems 1. 4, 1.5.

4. In the paragraph the second Item 5 of the Calendar of preventive inoculations in Ukraine approved by the order of the Ministry of Health of Ukraine of September 16, 2011 No. 595, registered in the Ministry of Justice of Ukraine on October 10, 2011 on word No. 1159/19897,"," to exclude anatoksin.

5. In paragraph six of Item 5.2 of Section 5 of Storage precautions and monitoring procedures of quality of medicines in the treatment and prevention facilities approved by the order of the Ministry of Health of Ukraine of December 16, 2003 No. 584, registered in the Ministry of Justice of Ukraine on March 3, 2004 at No. 275/8874, of the word "and collateral reactions or death of people in case of application of series of medicines" to exclude.

6. Registered in the Ministry of Justice of Ukraine on January 30, 2012 for No. 126/20439, to state subitem 3.2.5 of Item 3.2 of the Section III of the Procedure for establishment of prohibition (temporary ban) and renewal of the drug circulation in the territory of Ukraine approved by the order of the Ministry of Health of Ukraine of November 22, 2011 No. 809, in the following edition:

"3.2.5 negative conclusions about quality of samples of series or series of the suspect of causing death, unpredictable collateral reaction and/or lack of efficiency of medicine in the presence of cause and effect relationship based on receipt of messages from the Ministry of Health of Ukraine and/or territorial authorities of Public service of Ukraine from medicines and control of drugs;".

7. Approve the Provision about central and regional groups of rapid response to unfavorable events after immunization / tuberkulinodiagnostiki which is applied.

8. Recognize invalid:

1) the order of the Ministry of Health of Ukraine of June 15, 2007 No. 325 "About approval of Indicators of quality of immunobiological medicines (vaccines and anatoksin)", registered in the Ministry of Justice of Ukraine on July 6, 2007 at No. 773/14040;

2) the order of the Ministry of Health of Ukraine of July 24, 2009 No. 531 "About approval of the Procedure for carrying out monitoring of safety and efficiency of medicines in hospitals of healthcare institutions", No. 774/16790 registered in the Ministry of Justice of Ukraine on August 17, 2009.

9. To provide to management of pharmaceutical activities and quality of pharmaceutical products submission of this order on state registration in the Ministry of Justice of Ukraine in accordance with the established procedure.

10. I reserve control of execution of this order.

11. This order becomes effective from the date of its official publication.

Acting minister

V. Suprun

Approved by the Order of the Ministry of Health of Ukraine of December 27, 2006, No. 898

(in edition of the Order of the Ministry of Health of Ukraine of September 26, 2016 No. 996)

Pharmakonadzor procedure

I. General provisions

1. This Procedure is developed according to Bases of the legislation of Ukraine on health protection, the Laws of Ukraine "About medicines", "About protection of the population against infectious diseases", "About ensuring sanitary and epidemic wellbeing of the population", "About the Nation-wide program of adaptation of the legislation of Ukraine to the European Union law", the Procedure for state registration (re-registration) for medicines and the amount of collection for state registration (re-registration) of medicines approved by the resolution of the Cabinet of Ministers of Ukraine of May 26, 2005 No. 376, provisions of the Directive of the European Parliament and EU Council No. 2001/83, of Regulations of the European parliament and EU Council No. 726/2004, establishing the basic rules and requirements for implementation of pharmakonadzor.

2. In this Procedure terms are used in the following values:

vaccination (inoculations, active/passive immunization) - creation of artificial immunity at the person to certain infectious diseases by introduction of vaccine or immunoglobulin;

lack of efficiency of medicine - lack of favorable diagnostic, medical or preventive effect of medicine for establishment of nature of disease, its current, duration or correction of condition or physiological functions of human body according to the indications to application specified in the instruction for medical application;

group unfavorable events after immunization - two or more cases of the unfavorable events after immunization having the similar clinical manifestations connected on time, the venue of immunization / tuberkulinodiagnostiki and type of the entered vaccine, tuberkulina;

group collateral reactions - two or more cases of the collateral reactions connected using medicine, vaccine and tuberkulin, having the similar clinical manifestations connected on time, the location of healthcare institution and/or series of medicine, vaccine, tuberkulin;

efficiency of vaccines - decrease in percent of the managed infectious diseases in group of the imparted faces in comparison with group of not imparted faces;

efficiency of medicine - favorable diagnostic, medical or preventive effect of medicine concerning nature of disease, its current, duration or correction of condition or physiological functions of human body according to the indications to application specified in the instruction for medical application;

the general report according to cards of epidrassledovaniye about the registered cases of infectious diseases, managed by means of specific immunoprevention at imparted, - the report about all the registered cases of the infectious diseases managed by means of specific immunoprevention at imparted, constituted based on these cards of epidrassledovaniye about cases of the infectious diseases managed by means of specific immunoprevention at imparted;

the fixed collateral reaction of medicine, vaccine, tuberkulin collateral reaction, nature or weight of manifestations of which corresponds to the available information containing in the main information on safety of the applicant of medicine, vaccine, tuberkulin;

aggregated data about cases of collateral reactions after application of vaccine, tuberkulin - the report which generalizes information on collateral reactions after application of vaccine, tuberkulin according to the list of clinical manifestations of collateral reactions after application of vaccine, tuberkulin and/or their description containing in instructions for medical application of vaccine, tuberkulin for the accounting period;

the report on cases of collateral reactions of medicines, vaccines, tuberkulina, and/or lack of efficiency of medicines and/or unfavorable events after immunization / tuberkulinodiagnostiki in healthcare institutions the annual report on all cases of collateral reactions of medicines, vaccines, tuberkulina, and/or lack of efficiency of medicines and/or unfavorable events after immunization / tuberkulinodiagnostiki which is constituted and give all healthcare institutions, irrespective of patterns of ownership, structural divisions concerning health care of the Autonomous Republic of Crimea, the regional, Kiev and Sevastopol city public administrations;

the report of rather postregistration research on safety and efficiency of medicine, vaccine, tuberkulin - the results of postregistration research on safety and efficiency of medicine, vaccine, tuberkulin reported in writing and their analysis;

vaccine immunogenicity - capability of vaccine to form humoral (certain levels of antibodies as a percentage) and/or the cellular mediated immunity. This indicator according to clinical trials there shall be more than 90% (except vaccines for prevention of flu); for the combined vaccines each of components shall correspond to this indicator;

information which identifies case of collateral reaction of medicine, vaccine, tuberkulin, and/or lack of efficiency of medicine, and/or unfavorable event after immunization / tuberkulinodiagnostiki, - data on source of receipt of information, the suspected medicine, vaccine, the tuberkulena, the patient, the description of collateral reaction / specifying of information on absence the efficiency/description of unfavorable event after immunization / tuberkulinodiagnostiki;

other important medical assessment - case of collateral reaction and/or lack of efficiency which does not pose direct threat for life of the patient or does not lead to death or hospitalization, but endangers the patient or requires intervention for prevention of manifestation of collateral reaction, and/or lack of efficiency which develops;

the card of epidrassledovaniye - form according to which the responsible person of district or regional structural division concerning health care provides information on case of the infectious diseases managed by means of specific immunoprevention at imparted;

the map message about collateral reaction of medicine, vaccine, tuberkulin, and/or lack of efficiency of medicine, and/or unfavorable event after immunization / tuberkulinodiagnostiki - form in which doctors, pharmacists, paramedics, obstetricians, druggists, nurses of all healthcare institutions, irrespective of patterns of ownership, report about any cases of collateral reactions of medicines, vaccines, tuberkulina, lack of efficiency of medicines and unfavorable events after immunization / tuberkulinodiagnostiki;

the combined vaccines - the vaccines intended for protection against several infectious diseases which can be caused by various strains, various microorganisms or serotypes of microorganisms;

advantage - set of extents of positive influence of medicine, vaccine and tuberkulin on reduction of weight or decrease in intensity of manifestations of symptoms of disease, intensity of positive pharmacological reaction to introduction of medicine, vaccine, tuberkulin and its duration;

the master file of system of pharmakonadzor - the document containing the description of system of pharmakonadzor which is used by the applicant concerning one or several medicines, vaccines and tuberkulin;

meta-analysis - method of receipt of information, including on collateral reactions of medicines, vaccines, tuberkulin in which statistic analysis for integration of these several independent researches for monitoring of medicines, vaccines, tuberkulin and collateral reactions is used including those that arise through long period of time. At the same time all information on the patient from various sources (healthcare institution, where it was treated, maternity hospital, the written-out recipes, etc.) which is saved up during all his life which is basis for creation of the file of the patient and the subsequent analysis is considered;

the international birth date of medicine, vaccine, tuberkulin - date of issue to the applicant of the first permission to sale of medicine, vaccine, tuberkulin in any country of the world;

monitoring of recipes - the method of receipt of information on collateral reactions of medicines, vaccines based on accounting of prescriptions of medicine, vaccines when for the established period of time certain number of the registered collateral reactions and the number of patients which applied medicine, vaccine allows to reveal interrelation between collateral reaction and use of medicine, vaccine;

monitoring of hospital(s) - method of receipt of information on collateral reactions of medicine, vaccine which allows to determine the frequency of collateral reactions and to reveal features of interaction of medicines, vaccines, at patients is one or several hospitals when during the certain period of time under control there are all patients of hospital(s), all medicines, vaccines are considered, also all collateral reactions which arise are appointed;

inefficiency of vaccination - is determined on the basis of clinical displays of infectious disease, laboratory confirmed with lack of protective markers from this disease. Primary inefficiency of vaccination can be consequence of not achievement of the planned effect of inoculation (lack of serokonversiya or seroprotektion), secondary - the congenital and/or acquired defects of immune system or inadequate introduction of the appointed vaccine;

unrecorded collateral reaction of medicine, vaccine, tuberkulin - collateral reaction, nature or weight of manifestations of which does not correspond to the available information containing in the main information on safety of medicine, vaccine, the applicant's tuberkulin. Those which on nature, weight of manifestations, specificity or consequences do not correspond to information containing in the main information on safety of medicine, vaccine, the applicant's tuberkulin including the reactions inherent in certain pharmacological group of medicines, vaccines, tuberkulin which did not arise in case of use of medicine, vaccine, tuberkulin belong to collateral reactions;

unforeseen collateral reaction - collateral reaction, nature or weight of manifestations of which will not be approved with the available information on medicine, vaccine, the tuberkulena in the instruction for medical application / to the short characteristic of medicine, vaccine, tuberkulin;

frivolous collateral reaction - any collateral reaction which does not lead to death does not pose threat for life, does not require hospitalization or increase in term of hospitalization, does not cause steady or considerable disability or disability and congenital anomalies or malformations and has no other important medical assessment;

the unfavorable event after immunization / tuberkulinodiagnostiki - any event, adverse from the medical point of view, which is observed after immunization / tuberkulinodiagnostiki and optionally has cause and effect relationship with use of vaccine and/or tuberkulin. Any adverse or inadvertent sign of variation in results of laboratory researches, symptoms of disease or disease can be unfavorable event;

the main information on safety of the applicant - the document constituted by the applicant, containing all necessary information on safety which is compound the list of specification of the applicant. The additional information on safety of the applicant is used in case of creation of the reporting for determination, is fixed or not collateral reaction in the list of specification of the applicant. Data of the main information on safety of the applicant are not used for determination whether collateral reaction is provided or unpredictable, for the notification on case of collateral reaction (Company Core Safety Information (CCSI));

source documents - outgoing documents, data and records (for example, clinical records, out-patient maps, laboratory records, service records, the diaries researched or questionnaires, magazines of issue of medicines, the listings of devices verified and verified copies or disaggregations of soundtracks, microfiches, photographic negatives, microfilms or magnetic carriers, x-ray pictures, administrative documents, records which are stored in drugstore, laboratory and in department of tool diagnostics of healthcare institutions) and other;

the provided collateral reaction - collateral reaction, nature or weight of manifestations of which will be approved with the available information on medicine, vaccine, the tuberkulena in the instruction for medical application of the registered medicinal means / to the short characteristic of medicine, vaccine, tuberkulin;

the list of specification of the applicant - the document constituted by the applicant contains information on medicine, vaccine, the tuberkulena concerning safety, the offered indications to application, forces of action, features of application, pharmacological properties, etc. (Company Core Data Sheet (CCDS));

the period after application of vaccine, tuberkulin - period after the carried-out immunization / tuberkulinodiagnostiki which fluctuates ranging from one days up to 24 months and depends on type of vaccine, tuberkulin and for the vast majority of them constitutes 30 days;

the suspected medicine, vaccine, tuberkulin - medicine, vaccine, tuberkulin, in case of whose purpose (which) there is cause and effect relationship between clinical manifestations of any collateral reaction and/or lack of efficiency and/or unfavorable event after immunization / tuberkulinodiagnostika and his (her) application;

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