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Ministry of Justice of Ukraine

October 29, 2009

No. 1010/17026

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of September 23, 2009 No. 690

About approval of the Procedure for carrying out clinical testing of medicines and examinations of materials of clinical testing and Standard regulations on the commissions on questions of ethics

(as amended on 01-10-2015)

According to Articles 7, 8 Laws of Ukraine "About medicines", the Directive of the European Parliament and Council 2001/20/EU "About approach of the laws, bylaws and administrative provisions of state members concerning introduction of proper clinical practice when carrying out clinical testing of medicines for application by the person" of April 4, 2001 (with changes), and also for the purpose of achievement of harmonization with the international rules of carrying out clinical testing of medicines of PRIKAZYVAYU:

1. Approve the Procedure for carrying out clinical testing of medicines and examination of materials of clinical testing which is applied.

2. Approve Standard regulations on the commissions on questions of ethics.

3. Recognize invalid the order of the Ministry of Health of Ukraine of February 13, 2006 as No. 66 "About approval of the Procedure for carrying out clinical testing of medicines and examinations of materials of clinical testing and Standard regulations on the commission on questions of ethics", the order of the Ministry of Health of Ukraine registered in the Ministry of Justice of Ukraine on March 10, 2006 for No. 252/12126, of May 17, 2007 No. 245 "About approval of the Procedure for determination of specialized treatment and prevention facilities in which clinical testing of medicines can be carried out", registered in the Ministry of Justice of Ukraine on August 17, 2007 for No. 950/14217, and the order of the Ministry of Health of Ukraine of August 11, 2006 No. 560 "About approval of the List of treatment and prevention facilities in which clinical testing of medicines can be carried out".

4. To provide to the director of the department of regulatory policy in the sphere of drug circulation and products in health care system Yu.B.Konstantinov in accordance with the established procedure state registration of this order in the Ministry of Justice of Ukraine.

5. To impose control over the implementation of the order on the deputy minister Z.M.Mytnik.

6. The order becomes effective from the date of its official publication.

Minister of Health of Ukraine

V. M. Knyazevich

 

Approved by the Order of the Ministry of Health of Ukraine of September 23, 2009, No. 690

Procedure for carrying out clinical testing of medicines and examination of materials of clinical testing

І. General provisions

1.1. This Procedure ICH GCP, the international ethical principles of biomedical researches with involvement of the person and the ethical code of the doctor is developed according to Articles 3, of 44 Bases of the legislation of Ukraine on health care, Articles 7, 8 Laws of Ukraine "About medicines", the Law of Ukraine "About personal data protection", taking into account requirements of Directives of the European Parliament and Council 2001/20/EU of April 4, 2001, 2001/83/EU of November 6, 2001, Resolutions of the European Parliament and Council 1901/2006 of December 12, 2006 and 1902/2006 of December 20, 2006.

1.2. This Procedure establishes the main requirements to carrying out clinical testing of medicines which can be carried out with the assistance of patients (volunteers) according to the complete or reduced program, including to bioavailability/bioequivalence testing, and also the international multicenter clinical testing.

1.3. This Procedure extends to all types of clinical testing of medicines, except for not intervention researches and clinical researches which are conducted without participation of the pharmaceutical companies within research works.

This Procedure does not extend to all types of clinical testing of fabric and cellular transplants, including barreled cells of chordate (funic) blood.

1.4. Conducting examination of materials of clinical testing, and also carrying out clinical audit of clinical testing of medicines is assigned to GP "State Expert Centre of the Ministry of Health of Ukraine" (further - the Center).

ІІ. Determination of terms

2.1. In this Procedure terms are used in such value:

multicenter clinical testing (research) - testing of medicine according to the single protocol of clinical testing which is carried out more than in one venue of research;

bioavailability - the speed and degree with which active ingredient or its active component is absorbed (is soaked up) from dosage form and becomes available in the scene of action;

bioequivalence - two medicines are considered bioequivalent if they are pharmaceutical equivalent or pharmaceutical alternative and if their bioavailability after introduction in the same molar dose are similar to such degree that effects of these medicines concerning efficiency and safety will be in essence identical;

close relatives - and legal value in cases, stipulated by the legislation has physical persons between which natural communication is based on origin one from another or from general ancestors. Close relatives are the husband/wife, parents, children, relatives brothers and sisters;

the brochure of the researcher - abstract statement of preclinical and clinical data on the researched medicine which matter for its studying on the person;

producer of medicine - the legal entity who performs at least one of medicine production phases, including packagings;

researched (the subject of research) - the patient (the healthy volunteer) who according to the operating procedure takes part in clinical testing;

the researched medicine - dosage form of active substance or placebo which is studied or used for comparison in clinical testing, including medicines on which the registration certificate is already issued, but they are used or produced (are constituted or packed) in a different way in comparison with the registered dosage form, or are used on the unregistered displays, or used for more information on the registered medicine form;

the researcher / soissledovatel - the doctor who has sufficient professional training and experience of treatment of patients, knows rules of proper clinical practice and the corresponding regulatory legal acts. The researcher bears responsibility for carrying out in the place of research of clinical testing of medicine. If clinical testing is carried out by group of persons in certain venue of research, one of researchers is determined by the responsible head of research group and can be called the responsible researcher;

the file of the researched medicine - information concerning quality of each researched medicine, including medicines of comparison and placebo, and also supplied preclinical researches and the information on the previous clinical testing or clinical use of the researched medicine;

examination of materials of clinical testing - check, the analysis and assessment of materials of clinical testing of medicine for the purpose of preparation of the motivated conclusions concerning carrying out clinical testing / rather essential amendment;

health care institution (treatment-and-prophylactic institution) (further - LPZ) the legal entity of any pattern of ownership and form of business or its separate division which main objectives is ensuring medical attendance of the population on the basis of the corresponding license and professional activity of health (pharmaceutical) workers;

legal representatives are parents, adoptive parents, parents tutors, guardians, custodians, representatives of institutions who fulfill duties of guardians and custodians;

the applicant of clinical testing - physical person or legal entity (for example, the sponsor, the contractual research organization) which submits the application to the Center for receipt of the conclusion concerning carrying out clinical testing / rather essential amendment. The applicant, if he is not sponsor, can submit the application only in the presence of the order issued by the sponsor with accurately certain delegated powers;

the report on clinical testing - the results of clinical testing reported in writing and their analysis;

identification code researched / number - the unique identifier which is appropriated by the researcher to each subject of testing for ensuring its anonymity and is used instead of surname in materials of clinical testing;

individual registration form (further - IRF) - the printing, electronic or optical document intended for entering into it of all information provided by the protocol of clinical testing which is subject to transfer to the sponsor, concerning each researched;

the informed consent - the decision to take part in clinical testing which shall be constituted in writing, dated and is signed is accepted voluntarily after proper notification about nature of clinical testing, its value, influence and risk, is appropriately documentary drawn up by person who is capable to agree, or his legal representative (close relative); in exceptional cases, if it is insolvent to write the corresponding person, it can give oral assent in the presence of at least one witness who certifies the consent of the subject of research in the written informed consent;

clinical testing (research) of medicine - research work which purpose is any research with the assistance of the person as the subject of research, intended for identification or confirmation clinical, pharmacokinetic, phracodynamic and/or other effects, including for studying of absorption, distribution, metabolism and removal of one or several medicines and/or identification of collateral reactions to one or several researched medicines for the purpose of assessment of its safety and/or efficiency;

clinical audit of clinical testing - the procedure of official check of materials (documents) of clinical testing by the Center, rooms, the equipment and equipping, records, systems of security guarantee, quality and other resources which are related to clinical testing and which can contain in treatment-and-prophylactic institution, laboratories, rooms of the sponsor or the contractual and research organization, etc.;

the commission on questions of ethics in case of treatment-and-prophylactic institution (further - the commission on questions of ethics) - independent body which is effective in case of health care institution (treatment-and-prophylactic institution) where clinical testing which includes medical/scientific specialists, persons of other specialties, the public representatives who exercise supervision of observance of the rights, safety, wellbeing of the researched patients (healthy volunteers), ethical and moral legal principles of performing clinical trial are carried out.

The commission on questions of ethics in case of health care institution (treatment-and-prophylactic institution) based on assessment ethical and moral legal principles approves carrying out clinical testing directly in the place of its carrying out which is located based on LPZ under which it is created and this commission is effective;

the contractual research organization - physical person or legal entity which within the agreement with the sponsor carries out one or more its functions (powers) in clinical testing and acts on the basis of the order issued by the sponsor with accurately certain delegated powers;

medicines - substances or their mixes of natural, synthetic or biotechnological origin which are applied to the prevention of pregnancy, prevention, diagnostics and treatment of diseases of people or change of condition and functions of organism;

the venue of testing (further - MPI) - the place where the main activities connected with clinical testing (inclusion of patients, treatment, observation, etc.) in treatment-and-prophylactic institution are directly carried out;

the monitor - person designated by the sponsor or the contractual research organization who controls carrying out clinical testing according to the protocol of clinical testing;

not intervention research - research in which medicines are appointed regular method according to the approved instruction on medical application. Involvement of the patient with certain method of treatment in the protocol of clinical trial is not provided previously in group, and prescription of medicine is dictated by modern practice and does not depend on the decision to include the patient in testing. Do not apply supplementary diagnostic or monitoring procedures concerning patients, and for the analysis of collected data use epidemiological methods;

unpredictable collateral reaction - collateral reaction, nature or weight of which is not approved with the available information on medicine (for example, with the brochure of the researcher for the unregistered medicine or with the instruction for medical application / the short characteristic for the registered medicine);

the patient (the healthy volunteer) - person who can be attracted as the medicine researched to clinical testing;

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