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DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of November 3, 2016 No. 87

About approval of Rules of proper practice of pharmakonadzor of the Eurasian Economic Union

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 12 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 81 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, and the Decision of the Supreme Eurasian economic council of December 23, 2014 "About implementation of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union" Council of the Eurasian economic commission solved No. 108:

1. Approve the enclosed Rules of proper practice of pharmakonadzor of the Eurasian Economic Union (further - Rules).

2. This Decision becomes effective after 10 calendar days from the effective date of the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, but not earlier than after 10 calendar days from the date of official publication of this Decision.

Section 4 of Rules becomes effective since January 1, 2017.

The paragraph the fifth subitem 7.2.1 of Item 7.2 and Item 7.4 of Section 7 of Rules become effective since June 1, 2016.

Members of council of the Eurasian economic commission:

From the Republic of Armenia

 

V. Gabriyelyan

From the Republic of Belarus

V. Matyushevsky

From the Republic of Kazakhstan

A. Mamin

From the Kyrgyz Republic

O. Pankratov

From the Russian Federation

I. Shuvalov

Approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 87

Rules of proper practice of pharmakonadzor of the Eurasian Economic Union

1. Determinations

For the purposes of these rules concepts which mean the following are used:

"the important absent information" (important missing information) - significant gaps in the available knowledge of certain aspects of safety of medicine or groups of patients which appoints medicine;

"the important identified risk", "important potential risk" (important identified risk and important potential risk) - the identified risk or potential risk which the advantage - risk" medicine can exert impact on ratio "or to implicate for public health;

"validirovanny signal" (validated signal) - signal for which in the course of accomplishment of validation and assessment of confirmatory data it is determined that the available documentation is sufficient for the assumption of availability of new potential cause and effect relationship or new aspect of the known interrelation between acceptance of the suspected medicine and development of adverse effect and, therefore, need of implementation of complex of further actions according to signal is determined;

"the impact connected with occupation" (occupational exposure) - impact of medicine to which the person as a result of accomplishment of activities both professional, and not connected with professional activity underwent;

"end date of data collection" (data lock point) - date of completion of data collection for inclusion in the periodic updated report on safety;

"activities for risk minimization (measure for risk minimization)" (risk minimization activity (risk minimization measure)) - complex of the actions directed to prevention or reduction of probability of emergence of the undesirable reaction connected with medicine impact or to reduction of severity of undesirable reaction in case of its development;

"complete clinical trial" (completed clinical trial) - research on which the final report about clinical trial is prepared;

"the closed signal" (closed signal) - signal which assessment was complete during the accounting period of creation of the periodic updated report on safety;

"abuse of medicine" (abuse of a medicinal products) - the permanent or one-time excessive use of medicine which is followed by harmful physiological or psychological effects;

"the identified risk" (identified risk) - undesirable effect of pharmacotherapy concerning which the adequate evidence of availability of interrelation with the suspected medicine is obtained;

"the individual message on undesirable reaction (the report on undesirable reaction (on medicine))" (individual case safety report (ICSR) (adverse (drug) reaction report)) - information transferred according to established by form and content, about one or several suspected undesirable reactions to medicine arising at the certain patient at a given time;

"sources of receipt of individual messages on undesirable reactions of medicine on demand" (solicited sources of individual case safety reports) - organized systems on data collection which include clinical testing (researches), registers, post-registration programs the personalized medicine uses, other programs for support of patients and monitoring of diseases, poll of patients or attending physicians or information collection about efficiency of therapy and commitment of patients to treatment;

"quality of system of pharmakonadzor" (quality of a pharmacovigilance system) - all characteristics of system of pharmakonadzor which according to assessment of probability result in the results answering the purpose of system of pharmakonadzor;

"clinical trial" (clinical trial (study)) - the clinical studying satisfying at least to one of the following conditions:

appointment to the subject of clinical studying of specific therapeutic strategy (intervention) happens in advance and is not routine clinical practice (that is sample (same) medical diagnostic and medical procedures, technologies or actions which are performed for this group of patients or this standard of delivery of health care) in state member of the Eurasian Economic Union which research centers take part in this clinical studying;

the decision on purpose of the researched medicine is made together with the decision on inclusion of the subject in clinical studying;

to subjects of clinical studying, in addition to procedures of routine clinical practice, supplementary procedures of diagnosis or monitoring are performed;

"control and quality assurance of system of pharmakonadzor" (quality control and assurance) - monitoring, assessment, ensuring efficiency and compliance of structural elements and processes of system of pharmakonadzor to the established requirements;

"medicine" (medicinal product)" - the means representing or containing the substance or combination of substances intended for treatment, prevention of diseases of the person or recovery, correction or change of physiological functions by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and condition of the person;

"medicine" (drug, remedy) - the medicine in the form of dosage form coming into contact with human body;

"the master file of system of pharmakonadzor, MFSF" (pharmacovigilance system master file (PSMF)) - the detailed description of the system of pharmakonadzor applied by the holder of the registration certificate concerning data on one or several registered medicines;

"the international date of approval of the developed medicine, MDORLS" (development international birth date (DIBD)) - date of the first approval (or authorizations) performing intervention clinical trial in any of the countries of the world;

"the international registration date, MDR" (international birth date (IBD)) - date of the first registration (approval to use) in any country of the world of the medicine containing certain active ingredient;

"proper practice of pharmakonadzor, NPF" (Good Pharmacovigilance practices (GVP)) - management on implementation of pharmakonadzor in state members of the Eurasian Economic Union;

"undesirable reaction" (adverse reaction) - the inadvertent adverse reaction of organism connected using the medicinal (researched) drug and assuming availability, at least, of possible interrelation using (researched) drug suspected medicinal. Undesirable reactions can arise in case of use of medicine according to the approved general characteristic of medicine or the instruction on medical application either with their violation or as a result of the impact connected with occupation. Use cases with violation of general characteristic of medicine or the instruction on medical application include the use which is not corresponding to general characteristic or the instruction, overdose, abuse, misuse and medical mistakes;

"the undesirable phenomenon" (adverse event) - any adverse change in the state of health of the patient or the subject of clinical trial to which the medicinal (researched) drug, irrespective of cause and effect relationship with its use was appointed. The undesirable phenomenon can represent any adverse and inadvertent change (including variation of laboratory indicator from regulation), symptom or disease which time of origin does not exclude cause and effect relationship using medicine, regardless of availability or lack of interrelation using medicine;

"not intervention research" (non-interventional studies) - research which corresponds to the following conditions:

medicine is appointed according to general characteristic of medicine;

the decision on appointment to the patient of certain treatment is not made according to the protocol of research in advance, but routine clinical practice, and purpose of medicine is accurately separated the decision on inclusion of the patient in research;

any supplementary diagnostic or control procedures are not applied to patients, and for the analysis of the obtained data epidemiological methods are used.

Not intervention researches are determined by the applied methodological approach, but not the scientific purposes. Not intervention researches include researches of the database or review of medical records in which all considered phenomena are already described (in particular the researches "case-control", cross and cohort researches). Not intervention researches also include the researches implying collection of primary data (in particular prospective not intervention researches and registers in which the obtained data of routine medical process are fixed), in case of accomplishment of the above conditions.

In this context interviews, surveys can be conducted and to be selected blood samples within customary clinical practice;

"the wrong use" (misuse) - intended and inadequate use of medicine which does not correspond to the operating general characteristic of medicine or the instruction on medical application;

"unexpected undesirable reaction" (unexpected adverse reaction) - undesirable reaction, nature, severity or outcome of which does not correspond to information containing in the operating general characteristic of medicine or in the brochure of the researcher for the unregistered medicine;

"the new identified signal" (newly identified signal) - the signal for the first time identified during the accounting period of the periodic updated report on safety with instructions of further actions for its assessment;

"the main information on safety of the holder of the registration certificate, OIBK" of company core safety information (CCSI)) - the information concerning safety of medicine, containing in the list of specification on medicine of the holder of the registration certificate of medicine, developed by it and represented according to its statement to authorized bodies of state members of the Eurasian Economic Union in which markets this medicine is implemented, except as specified, when changes upon the demand of these authorized bodies are made to information. OIBK represents information of help nature which determines the status of the listed and not listed undesirable reactions for the purpose of creation of the periodic updated report on safety of medicine, but does not determine the expected and unexpected undesirable reactions for fulfillment of requirements by immediate submission of messages on undesirable reactions;

"the absent information" (missing information) - lack of data on safety or about features of use of medicine for certain groups of patients which can be clinically significant;

"the report on safety of the developed medicine, ROOB" (development safety update report (DSUR)) - the periodic updated report on safety of the medicine which is in development;

"medicine use error" (medication error)" - any inadvertent mistake of the health care provider, patient or consumer in appointment, leave, dosage, introduction or acceptance of medicine;

"overdose" (overdose) - use of medicine for 1 acceptance or during the day in quantity which exceeds recommended maximum daily dose according to the operating general characteristic of medicine. Also cumulative effect connected with overdose is considered;

"the list of specification on medicine of the holder of the registration certificate, PODLS" of company core data sheet (CCDS)) - the document developed by the holder of the registration certificate of medicine, containing along with information on safety the material concerning instructions for use, dosage, pharmacological properties and the other information concerning medicine;

"the periodic updated report on safety, POOB" (periodic safety update report (PSUR)) - the report for representation of assessment of ratio "advantage - risk" medicine the holder of the registration certificate of medicine during certain period of time during post-registration stage;

"risk management plan" (risk management plan) - the detailed description of risk management system;

"post-registration research of safety, PRIB" (post-authorization safety study (PASS)) - the research concerning the registered medicine, conducted for the purpose of determination, the characteristic or quantitative assessment of safety hazard, confirmation of profile of safety of medicine or efficiency evaluation of measures for risk management. The post-registration research of safety can be intervention clinical trial or can be conducted as research of the observation not intervention design;

"potential risk" (potential risk) - undesirable effect of pharmacotherapy concerning which there are bases for suspicions on availability of interrelation with medicine however this interrelation properly was not confirmed;

"consumer" (consumer) - person who is not the health care provider, for example, the patient, the lawyer, the friend or the relative (parent), the patient's child;

"use" out of the instruction" (off-label) - intended use of medicine with the medical purpose not according to general characteristic of medicine or the instruction on medical application;

"problem on safety" (safety concern) - important identifiable risk, important potential risk or the important absent information;

"the continuing clinical trial" (ongoing clinical trail) - research in which inclusion of patients or which is carried out at the moment time or on which the analysis is complete began, but the final report on clinical trial is not available;

"the risks connected using medicine" (risks related to use of a medicinal product) - the risks connected with quality, safety or efficiency of medicine in relation to health of patients or the populations or leading to undesirable impact on the environment;

"serious undesirable reaction" (serious adverse reaction) - undesirable reaction which leads to death poses threat for life, requires hospitalization of the patient or its prolongation, results in the resistant or expressed disability or disability, to congenital anomalies or malformations, requires medical intervention for prevention of development of the listed conditions. Any inadvertent suspected transfer of the infectious agent through medicine is also considered serious undesirable reaction;

"signal" (signal) - information arriving from one or several sources which assumes availability of new potential cause and effect relationship or new aspect of the known interrelation between impact of medicine and the undesirable phenomenon or set of the interconnected undesirable phenomena, estimated as sufficient for further actions for verification of signal. As a rule, generation of signal requires more than 1 single messages depending on gravity of the undesirable phenomenon and quality of information;

"the signal on which work" (ongoing signal) - signal which was revealed till the accounting period of the periodic updated report on safety is performed and on end date of data collection was in process of assessment;

"the quality system of system of pharmakonadzor" (quality system of a pharmacovigilance system) - organizational structure, obligations, procedures, processes and resources of system of pharmakonadzor, including proper resource management, documentation and compliance to regulation regulations;

"risk management system" (risk management system) - complex of the actions and actions for pharmakonadzor directed to identification, the characteristic, prevention or risk minimization, connected with medicines including efficiency evaluation of these actions and activities;

"system of pharmakonadzor" (pharmacovigilance system) - the system organized by holders of registration certificates of medicines and authorized bodies of state members of the Eurasian Economic Union for accomplishment of tasks and obligations on pharmakonadzor, intended for control of safety of medicines, early detection of all changes in ratio assessment "advantage - risk" medicines, development and deployment of measures for ensuring use of medicines in case of excess of advantage over risk;

"ratio" advantage - risk" (risk-benefit balance) - assessment of positive therapeutic effects of medicine in relation to the risks connected with its use (the concept of risk includes any risk connected with quality, safety or efficiency of medicine in relation to health of the patient or the population);

"the spontaneous message (the spontaneous notice)" (spontaneous report (spontaneous notification)) - voluntary transfer by the worker of health care field or the consumer to authorized body of state member of the Eurasian Economic Union, the holder of the registration certificate of medicine or other authorized organization (including the World Health Organization, the regional centers of pharmakonadzor, the toxicological centers) data which contain the description of one or several undesirable reactions at the patient accepting one or several medicines and which were not obtained during conduct of clinical trial or use of other method of organized data collection;

"reference information on safety of medicine" (reference safety information) - information included in the main information on safety of the holder of the registration certificate of medicine;

"essential changes of indications to medical application" (significant change in indication) - change of indications to use which include change of the allowed indications for use of medicine in case of which new target population significantly differs from that for which medicine use, inclusion of the new nosological indication to use, new age group (for example, pediatric indications), change of severity of the indication from more serious condition to less heavy, transition from the second line of therapy to the first line and other changes significantly influencing ratio "advantage - risk" medicine was originally authorized;

"requirements to the quality level" (quality requirements) - the characteristic of the quality system which with certain probability lead to achievement of required results or the purposes;

"pharmakonadzor" (pharmacovigilance) - the type of activity directed to identification, assessment, understanding and prevention of undesirable effects of use of medicines;

"target population" (target population (treatment) (treatment population target)) - patients to whom medicine according to indications to use and the contraindications provided by the operating general characteristic of medicine can be appointed.

2. Requirements to the quality system

2.1. Quality system

2.1.1. The quality system is the integral component of system of pharmakonadzor. The quality system shall cover organizational structure, areas of responsibility, the procedure, processes and resources of system of pharmakonadzor. The quality system shall include proper resource management, control of compliance to requirements of the legislation of state members of the Eurasian Economic Union (further respectively - state members, the Union) the international treaties and acts constituting the right of the Union, and management of documentation.

2.1.2. The quality system provides:

creation of structure of system and planning of the integrated and approved processes (quality planning);

accomplishment of tasks and obligations of the quality system (quality control);

control and efficiency evaluation of work of structures and processes of the quality system (quality assurance);

adjustment and improvement of structure and processes of the quality system (quality improvement).

2.1.3. General purposes of the quality system in system of pharmakonadzor are:

fulfillment of requirements of the legislation of state member, the international treaties and acts constituting the right of the Union, and obligations on pharmakonadzor;

prevention of undesirable effects of use of the registered medicines;

ensuring use of medicines in case of excess of advantage over risk;

assistance to protection of health of patients and public health.

2.2. Principles of proper practice of pharmakonadzor

2.2.1. For accomplishment of the common goals of quality specified in Item 2.1.3 of these rules it is necessary to adhere to the following principles by development of systems and processes, and also in case of accomplishment of all tasks and obligations:

providing satisfaction of requirements of patients, health workers and society in general concerning safety of medicines;

ensuring effective management on implementation of the quality system and motivation of personnel;

involvement of all staff of the organization (company) in process of support of system of pharmakonadzor at the level of the obligations assigned to them;

involvement of all staff of the organization (company) in permanent process of improvement of quality of system of pharmakonadzor;

the organization of resource base and the tasks set for system of pharmakonadzor in the form of structures and processes so that to provide the active, corresponding to risk level, continuous work on pharmakonadzor;

the accounting and assessment of all which are available evidential data on ratio "advantage - risk". For adoption of further decisions all data which can exert impact on this ratio and use of medicine shall be considered and be estimated;

assistance to development of effective cooperation between developers, holders of registration certificates of medicines, authorized bodies of state members, healthcare institutions, patients, health workers, the scientific organizations and other concerned parties according to the legislation of state members.

2.3. Responsible for the quality system

2.3.1. All specialists performing work on the organization of the quality system bear responsibility for ensuring system operation of pharmakonadzor according to requirements to the quality system. It is necessary to provide system approach to implementation and maintenance of the quality system at the proper level. The organization shall provide enough the competent and trained specialists having the corresponding professional training for accomplishment of required amount of works on pharmakonadzor at the proper level.

2.3.2. System approach to quality assurance shall be provided with heads of the organization. Heads of the organizations within accomplishment of functions for ensuring system approach bear responsibility for:

ensuring documentation of the quality system according to requirements of these rules;

ensuring proper control and documentation of all changes in system of pharmakonadzor and quality system of pharmakonadzor;

training possibility;

providing with required resources (including necessary rooms, equipment, etc.);

accomplishment of regular job evaluation of system of pharmakonadzor, including the integrated quality system, with confirmation of its efficiency. If necessary corrective and precautionary actions shall be implemented;

ensuring availability of the effective mechanism of realization of adequate measures in case of identification of changes of profile of safety of the developed and produced drugs;

ensuring early detection and acceptance in need of adjustment and preventive measures in case of non-compliance with quality requirements of system of pharmakonadzor;

ensuring carrying out regular audits of system.

2.4. Personnel training

2.4.1. The possibility of ensuring required quality of accomplishment of the processes connected with pharmakonadzor, and the received results is directly connected with availability of enough the competent, skilled and trained staff.

2.4.2. In the organization shall be the training plan of specialists in pharmakonadzor is developed and shall be implemented. Training shall include introduction training and the subsequent training at extent of the entire period of work according to the carried-out functions and objectives. Training shall be directed to increase in the corresponding professional skills, implementation of scientific achievements in practice and the performed procedures, ensuring compliance of all specialists to requirements to qualification, professional skills, knowledge and understanding of the performed procedures connected with pharmakonadzor. All specialists shall be trained in performing procedures, the changes of profile of safety of medicines provided in case of identification.

2.4.3. The processes operating in the organization for carrying out training shall provide elements of control of results of training in achievement of required understanding and accomplishment of functions on pharmakonadzor.

2.4.4. In the organization carrying out the corresponding training in certain aspects of pharmakonadzor of specialists of other divisions which activities can affect indicators of system of pharmakonadzor and accomplishment of functions on pharmakonadzor is required. The specified activities include including conduct of clinical trials, work with claims, preparation of medical information, sale and marketing, preparation of registration documents, legal issues and audit.

2.5. Means and equipment for pharmakonadzor

2.5.1. Achievement of the required quality level of implementation of processes of pharmakonadzor and the received results is connected also with providing system with the necessary means and the equipment used in these processes.

2.5.2. Means and the equipment shall be located, be designed, adapted and serviced so that to answer effective objective according to the quality purposes in pharmakonadzor. The means, the equipment and their functional properties important for implementation of pharmakonadzor are subject to the corresponding check, qualification and (or) validation for confirmation of conformity of the intended purpose. For determination of scale of check, qualification or validation it is necessary to use documentary risk assessment. This risk management method needs to be applied during all useful life of means and the equipment taking into account such factors as influence on patient safety and quality of data, and also complexity of appropriate means and the equipment.

2.6. Providing medicines of compliance with holders of registration certificates to requirements of the legislation of the state members, international treaties and acts constituting the right of the Union

2.6.1. For the purpose of ensuring compliance to requirements of the legislation of the state members, international treaties and acts constituting the right of the Union, holders of registration certificates of medicines processes on quality assurance of system which purposes are shall be carried out:

accomplishment of permanent monitoring of data on pharmakonadzor, development and deployment died risk minimizations in case of determination of their need, proper assessment of data on safety regardless of source of their obtaining (from patients, health and pharmaceutical workers published in medical literature, revealed during the post-registration researches);

accomplishment of scientific assessment of all information on profile of safety of medicine, including information on the undesirable reactions which developed including in case of use not according to the approved general characteristic of medicine (further - OHLP) or the instruction on medical application (leaf insert) (further - IMP (LV));

fulfillment of requirements of the legislation of state member on submission to authorized body of state member of information on undesirable reactions and other information on safety of medicines. For the purpose of proper accomplishment of this function and quality assurance, integrity and completeness of the provided information ought to validation of signals, and also exceptions of duplication of messages shall be developed and implemented the corresponding standard operational procedures;

ensuring effective interrelation with authorized bodies of state members, including informing on changes of profile of safety of medicines and new risks, the master file of system of pharmakonadzor, risk management system, died risk minimizations, the periodic updated report on safety, adjustment and preventive measures, post-registration researches on safety;

ensuring compliance of information on medicines (OHLP, IMP (LV)) to the modern level of scientific knowledge;

providing health workers and patients with information on safety.

2.7. Providing state members of compliance with authorized bodies to requirements of the legislation of the state members, international treaties and acts constituting the right of the Union

2.7.1. Authorized bodies of state members shall have the corresponding system of quality assurance of processes for the purpose of:

quality evaluations of the represented data on pharmakonadzor;

estimates and data processing on pharmakonadzor according to requirements of the legislation of the state members, international treaties and acts constituting the right of the Union;

ensuring the guaranteed independence in accomplishment of activities for pharmakonadzor;

effective informing patients, health workers, holders of registration certificates and society in general;

conducting inspections, including doregistratsionny inspection.

2.7.2. Independence in accomplishment of activities for pharmakonadzor is determined by adoption of all regulatory decisions only for the benefit of health of the patient and public health.

2.8. Management of documentation

2.8.1. The management system documentation is part of the quality system, extends to all documents of system of pharmakonadzor and provides possibility of search of the data and traceability of the performed procedures, including assessment procedures of new data on safety concerning time of accomplishment of assessment and the made decisions.

2.8.2. The management system shall provide with documentation:

quality of data on pharmakonadzor, including their completeness, accuracy and integrity;

effective internal and external data transmission;

document storage, concerning systems of pharmakonadzor and implementation of pharmakonadzor on each of medicines, according to applicable storage durations.

2.8.3. The holder of the registration certificate of medicine (further - the holder of the registration certificate) shall provide proper documentation, the address and storage of all information on pharmakonadzor for the purpose of performing procedures of exact reportirovaniye, interpretation and verification of data. The system of traceability and subsequent assessment of messages on undesirable reactions shall be provided with the holder of the registration certificate.

Within these rules "reportirovaniye" means process of transfer in the established form of information on undesirable reactions authorized bodies of state member or the expert organizations subordinated to them in the sphere of competence of which include pharmakonadzor.

2.8.4. The management system documentation shall include package of measures for safety and confidentiality of data for the purpose of fulfillment of requirements on personal data protection of patients according to requirements of the legislation of state member. The specified measures shall include strict restriction according to which access to documentation and databases is available only for authorized persons.

2.8.5. The management system documentation shall include processes of ensuring information security on pharmakonadzor from loss and destruction.

2.9. Documentation of the quality system

2.9.1. All elements, requirements and provisions of the quality system shall be documented and systematized as appropriate in the form of such managements and procedures in writing as the plan for quality, the quality manual and reports on quality.

2.9.2. The plan for quality determines main objectives of the quality system and processes which shall be implemented for achievement of effective objectives. Procedures for quality represent the description of established procedure of accomplishment of processes and can have the form of standard operational procedures and work instructions or managements. The quality manual determines the field of distribution of the quality system, processes of the quality system and their interrelation. Reports on quality include the received results of system operation or confirmation of the carried-out activities.

2.9.3. The quality system shall be reflected in the following documents:

documentation on organizational structure and obligations of personnel;

the training plan and reports on the provided training;

instructions on compliance of management processes;

instructions for critical processes of pharmakonadzor, including providing continuity of process;

indicators of accomplishment of processes which are used for permanent monitoring of proper accomplishment of functions on pharmakonadzor;

reports on audit and the subsequent audit of the quality system, including obtained yielded and results.

2.9.4. Documentation on the quality system shall include also:

methods of monitoring of efficiency of functioning of the quality system and, in particular, its capability of accomplishment of tasks of the quality system;

the reports by results of the performed procedures for pharmakonadzor confirming accomplishment of the provided stages and actions;

documents and reports on means and the equipment, including check of functional properties, activities for qualification and validation which confirm accomplishment of all stages provided by relevant requirements, protocols and procedures;

the reports confirming control of variations from the installed quality system, acceptance of the precautionary and adjusting actions, efficiency evaluation of the taken measures.

2.10. Additional documentation on the quality system of the holder of the registration certificate

In addition to required documentation on the quality system the holder of the registration certificate shall approve in document type in writing the organizational structure determining hierarchical interrelation of supervision and supervisory personnel, and also obligation and function of personnel, resource management system.

2.11. Additional documentation on the quality system of authorized bodies of state members

In addition to required documentation on the quality system the authorized body of state member shall document organizational structure, task allocation and responsibility of all personnel, and also to determine contact persons for ensuring interaction between authorized bodies of state members, the holders of registration certificates and persons providing information on the risks connected with medicines.

2.12. Critical processes in pharmakonadzor

2.12.1. Critical processes in pharmakonadzor include:

continuous monitoring of profile of safety and ratio "advantage - risk" the registered medicines;

implementation, realization and assessment of risk management system with efficiency evaluation of measures of risk minimization;

procedures of work with individual messages on undesirable reactions: collection, processing, management, quality control, receipt of missing data, assignment of number, classification, detection of repeated messages, assessment and timely representation;

identification, studying and assessment of signals;

development, preparation (including assessment of data and quality control), representation and assessment of the periodic updated reports on safety;

accomplishment of obligations by challenge authorized bodies of state members and representation of replies to the requests of authorized bodies of state members, including submission to authorized bodies of state members of the correct and complete information;

ensuring interaction between pharmakonadzor and quality control system of medicines;

informing authorized bodies of state members on all changes in ratio assessment "advantage - risk" the registered medicines;

informing health and pharmaceutical workers, patients on all changes in ratio assessment "advantage - risk" for the purpose of safety and effective use of medicines;

ensuring compliance of information on medicine, including general characteristic of medicine for medical application, to the modern level of scientific medical knowledge, including the made conclusions about assessment and the recommendation of authorized bodies of state members;

accomplishment of all required actions in case of change of the registration status because of review of profile of safety.

2.12.2. The plan of providing continuity of process shall include:

determination of events which can influence significantly personnel of the organization in general or structures and processes of pharmakonadzor in particular;

reserve systems on case of need of the emergency exchange of information in the organization, with other organizations performing functions on pharmakonadzor with other developers, holders of registration certificates and authorized bodies of state members.

2.13. Control of functioning and system effectiveness of pharmakonadzor and its quality system

2.13.1. Control methods of activities and system effectiveness of pharmakonadzor shall include:

overview and analysis of system persons responsible for management of system;

audits;

control of compliance to requirements;

inspections;

efficiency evaluation of the taken measures for risk minimization and ensuring safe and effective use of medicines.

2.13.2. For the purpose of accomplishment of monitoring in the organization indicators on which the efficiency evaluation of functioning of system of pharmakonadzor from the point of view of quality requirements is carried out shall be in advance determined.

2.13.3. The audit of the quality system based on risk assessment shall be carried out regularly through certain intervals of time for the purpose of confirmation of conformity to the established quality requirements and efficiency determinations. Audit of the quality system shall include audit of the system of pharmakonadzor having the integrated quality system. It shall be audited by the specialists who are not involved in accomplishment of the functions and procedures which are subject to audit. By results of each audit of the quality system and the subsequent audit the report which is subject to assessment by persons responsible for the organization of the corresponding audited processes shall be constituted. In case of need by results of audit the adjusting and preventive measures shall be taken.

2.13.4. Authorized bodies of state members shall provide monitoring of accomplishment by holders of registration certificates of functions and obligations on pharmakonadzor. Accomplishment of inspection of holders of registration certificates from authorized bodies of state members is among measures for ensuring monitoring.

2.14. The authorized person on pharmakonadzor

2.14.1. The holder of the registration certificate shall appoint and have at the permanent order the authorized person on pharmakonadzor (further - ULF) in state members having required qualification. The holder of registration certificates gives surname and contact information on ULF in authorized bodies of state members. In case of change of this information the holder of registration certificates shall inform authorized bodies of state members in time, established by the legislation of state members.

2.14.2. In each system of pharmakonadzor there can be only one ULF. More than one holder of registration certificates in general or separate systems of pharmakonadzor can use services ULF, or person can perform the ULF functions more than for one system of pharmakonadzor of one holder of registration certificates provided that ULF is able to carry out all the obligations. In addition to appointment of ULF authorized bodies of state members have the right to require appointment of the contact person on pharmakonadzor at the national level, subordinate ULF. The contact person at the national level can perform the ULF functions.

2.14.3. Obligations of ULF shall be determined by the job description.

2.14.4. The holder of the registration certificate confers to ULF sufficient powers on management of activities for pharmakonadzor and the quality system. The holder of the registration certificate provides to ULF access to the master file of system of pharmakonadzor, and also appropriate authority and provides information on any changes in the master file. The powers concerning system of pharmakonadzor and the master file of system of pharmakonadzor shall allow ULF to enter changes into the system, risk management plans, and also into preparation of the regulating actions in response to emergency situations for change of profile of safety.

2.14.5. The holder of the registration certificate provides availability of all systems and processes allowing ULF to carry out the obligations assigned to it. For this purpose the holder of the registration certificate develops mechanisms by means of which ULF obtains all necessary information and has access to all data which can be required by him, for example:

information on emergency situations on changes of profile of safety and other information concerning ratio assessment "advantage - risk" medicines to which the system of pharmakonadzor extends;

information on the continuing and ended clinical trials and other researches about which the holder of the registration certificate knows and which can be related to safety of medicines;

information from other sources, except sources of the holder of the registration certificate, for example, sources with which the holder of the registration certificate has contractual arrangements;

procedures of pharmakonadzor which are developed by the holder of the registration certificate at each level for the purpose of ensuring coordination and observance of requirements within the organization.

2.14.6. ULF obtains information from managing personnel on results of permanent reviews of the quality system and the taken measures, this about compliance to requirements, the planned audits of system of pharmakonadzor. ULF has powers to initiate audit in case of need. The managing personnel provides to ULF the copy of the plan of the adjusting and precautionary actions after each audit that ULF could be convinced of acceptance of the relevant adjusting activities.

2.14.7. The holder of the registration certificate provides possibility of receipt of information of ULF from the database of undesirable reactions which is available at its order.

2.15. Qualification of person, representative for pharmakonadzor in the Union

2.15.1. ULF shall have the corresponding theoretical and practical knowledge of implementation of activities for pharmakonadzor. ULF shall have skills of management of systems of pharmakonadzor, and also conducting examination or to have access to conducting examination in such areas as medicine, pharmaceutical sciences, and also epidemiology and biostatistics.

2.15.2. The holder of the registration certificate provides training of ULF in the field of the system of pharmakonadzor before ULF holds position of the authorized person. Training and its results shall be documented properly.

2.16. Functions of person, the representative for pharmakonadzor in the Union

2.16.1. The qualified person authorized on pharmakonadzor in the Union is physical person.

2.16.2. ULF appointed by the holder of registration certificates shall have qualification according to Item 2.15 of these rules and to be at the permanent order of the holder of registration certificates. ULF shall live and work in one of state members. ULF is responsible for creation and functioning of system of pharmakonadzor of the holder of registration certificates and, therefore, has enough powers for rendering influence on implementation of activities for pharmakonadzor and the quality system of system of pharmakonadzor, assistance, observance and increase in level of observance of requirements of the legislation of the state members, international treaties and acts constituting the right of the Union. Therefore, ULF shall have powers and responsibility concerning the master file of system of pharmakonadzor to provide and increase the level of observance of requirements of the legislation of the state members, international treaties and acts constituting the right of the Union.

2.16.3. Concerning medicines to which the system of pharmakonadzor of the holder of registration certificates extends ULF has the following obligations:

carry out the overview of profiles of safety of medicines and emergency situations on change of profiles of safety;

possess the complete information about the conditions and obligations established in case of issue of registration certificates, and other obligations concerning safety or safe use of medicines;

possess the complete information about risk minimization measures;

take part in studying and approval of protocols of post-registration researches of safety;

possess the complete information about post-registration researches on safety which carrying out is appointed by authorized body of state members, including results of such researches;

supplement risk management plans;

provide accomplishment of functions on pharmakonadzor and submit all documents concerning pharmakonadzor according to requirements of the legislation of the state members, international treaties and acts constituting the right of the Union;

provide necessary quality, including the accuracy and completeness, the state members this on pharmakonadzor, represented to authorized bodies;

represent complete and timely replies to the requests of authorized bodies of state members about submission of the additional information necessary for assessment of advantage and risk of medicines;

provide any information concerning ratio assessment "advantage - risk", in authorized bodies of state members;

give help in preparation of regulatory measures in response to emergency situations of safety (for example, changes in recommendations about medical application, urgent restrictions and bringing information to patients and health workers);

function as the single contact person on pharmakonadzor for authorized bodies of state members, and also as the contact person for inspectorates for pharmakonadzor with ensuring 24-hour access.

2.16.4. ULF exercises control of functioning of all aspects of system of pharmakonadzor, including its quality system (for example, standard operational procedures, contractual arrangements, transactions for the database, fulfillment of requirements of the quality system, observance of requirements to data presentation regarding completeness and timeliness, to submission of the periodic updated reports on safety, reports on audits and to personnel training on pharmakonadzor). ULF shall have information on the validation status of the database of undesirable reactions to medicines, including all defects revealed during validation and taken corrective actions. ULF also shall have information on all essential changes made to the database (for example, changes which can exert impact on activities for pharmakonadzor).

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