It is registered
in the Ministry of Justice of Ukraine
June 23, 2011.
No. 757/19495
of May 23, 2011 No. 319
About introduction of amendments to the order MZ of Ukraine of 06.12.2001 No. 486
According to subitem 8.8 of the subitem 8 of item 4 of the Regulations on the Ministry of Health of Ukraine approved by the Presidential decree of Ukraine of 13.04.2011 of N 467, and Item 2 of the Regulations on control of compliance of immunobiological medicines which are applied in medical practice of 15.01.96 of N 73, I ORDER to requirements of the state and international standards, the Cabinet of Ministers of Ukraine approved by the resolution:
1. Approve Changes to:
To the procedure for carrying out state registration (re-registration) for medical immunobiological supplies in Ukraine approved by the order MZ of Ukraine of 06.12.2001 of N 486, registered in the Ministry of Justice of Ukraine 28.02.2001 for N 204/6492, which are applied;
To procedure of the state control of quality of medical immunobiological supplies which are used, made or offered to the application in medical practice in Ukraine approved by the order MZ of Ukraine of 06.12.2001 of N 486, registered in the Ministry of Justice of Ukraine 28.02.2002 for N 205/6493, which are applied.
2. To provide to department of regulatory policy in the field of drug circulation and products in health care system (V.V.'s Stetsiv) submission of this order in accordance with the established procedure on state registration in the Ministry of Justice of Ukraine.
3. This order becomes effective from the date of its official publication.
4. I reserve control over the implementation of this order.
Minister
O. V. Anishchenko
Approved by the Order of the Ministry of Health of Ukraine of May 23, 2011 No. 319
1. In Item 1.4 of Section 1 of the word "GP "Center of Immunobiological Medicines" shall be replaced with words "The state company "State Expert Centre of the Ministry of Health".
2. In Section 2:
2.1. State Item 2.1 in such edition:
"2.1. Medical immunobiological supplies (further - MIBP) are allergens, antigens, vaccines (anatoxins), cytokines, immunomodulators of bacterial origin, and also those which are created on the basis of bodies and fabrics, medicines which receive from blood and plasma of the person, immune serums, immunoglobulins (including monoclonal antibodies), probiotics, interferona, other medicines, held for use in medical practice for the purpose of treatment, specific prevention, diagnostics of condition of immunity (in vivo).
MIBP receive by cultivation of strains of microorganisms and cages of eukaryotes, extraction of substances from biological fabrics, including tissues of the person, animals and plants (allergens), applications of methods of genetic engineering, gibridomny technology, reproduction of living agents in embryos or animals.
MIBP can be made as ready dosage forms, biological agents (active ingredients), bulk immunobiological medicines and medicines in bolsheemkostny packaging (in bulk)".
2.2. State Item 2.2 in such edition:
"2.2. Biosimilar medical immunobiological supply - developed MIBP, characteristics of quality which safety and efficiency are similar to original (innovative) MIBP".
3. In Item 5.2 of Section 5 of the word of "MIBP-generic" to exclude.
4. In the text of this Procedure, except Item 2.14 undressed 2, the word of "MZ" shall be replaced with words "MZ of Ukraine".
5. To be reworded as follows appendix 5 to the Procedure which is applied.
Director of the department of regulatory policy
in the field of drug circulation and
products in health care system of V. V. Stetsiv
Appendix 5
to the Procedure for carrying out state registration (re-registration) for medical immunobiological supplies in Ukraine
(Государственный Герб Украины) МИНИСТЕРСТВО ЗДРАВООХРАНЕНИЯ УКРАИНЫ
CERTIFICATE
about state registration of medical immunobiological supply
N ______________ от "___" 20 года 1. Торговое название 2. Форма выпуска, доза-упаковка3. Международное непантенованное название
4. Наименование и местонахождение производителя (указать местонахождение основного и альтернативного производств) 5. Наименование и местонахождение заявителя 6. Медицинское назначение Сертификат подтверждает, что медицинский иммунобиологический препарат отвечает требованиям государственных стандартов и разрешен к медицинскому применению в Украине до "___" 20 года Руководитель уполномоченного подразделения МЗ Украины ______________________________________ (подпись) (фамилия, имя, отчество) М.П. Дата выдачи "___" ____________ 20 годаDirector of the department of regulatory policy
in the field of drug circulation and
products in health care system of V. V. Stetsiv
Approved by the Order of the Ministry of Health of Ukraine of May 23, 2011 No. 319
1. In Section 1:
1.1. State Item 1.2 in such edition:
"1.2. This Procedure establishes forms of the state control of quality of medical immunobiological supplies (further - MIBP) and its frequency which are used, made or offered to application in medical practice in Ukraine, including control of quality of MIBP in case of storage and transportation".
1.2. State Item 1.3 in such edition:
"1.3. MIBP of both domestic, and foreign production which are used, made or offered to application in medical practice in Ukraine by business entities irrespective of subordination and patterns of ownership, in the form of the state control of quality of MIBP and with frequency, determined by this Procedure are subject to the state control of quality all".
2. In Section 2:
2.1. State Item 2.3 in such edition:
"2.3. The state control of quality - set of the organizational and legal actions aimed at providing compliance of MIBP to requirements of the state and international standards which are performed by examination of materials of quality control (producer) of the MIBP series (protocols of quality control of series analytical reports), and also laboratory control of samples of MIBP, according to requirements of the analytical regulating documentation (further - the ANDES) (documentation which describes techniques of carrying out testing of immunobiological medicine establishes qualitative and quantitative indices of immunobiological medicine, their admissible limits, requirements to its packaging, marking, storage conditions, transportation, suitability term, etc.)".
2.2. To state subitems 2.3.2 and 2.3.3 of Item 2.3 in such edition:
"2.3.2. Continuous quality control - quality control of the MIBP series on all indicators of quality of MIBP according to the ANDES or to materials concerning MIBP methods of quality control;
2.3.3. Selective control of quality - quality control of the MIBP series on separate indicators of quality of MIBP according to the ANDES or to materials concerning MIBP methods of quality control".
2.3. Add the Section with new Item of such content:
"2.7. Control based on the producer - the complex of actions of MZ of Ukraine which is directed to check of indicators of quality of the MIBP series in case of monitoring procedure of quality of this series by the producer one of components of which is verification of protocols, reports and other documentation of inspection department of quality of the producer that gives the chance to draw conclusion on MIBP compliance to the quality indicators determined the ANDES".
3. In Section 3:
3.1. To state subitem 3.1.2 of Item 3.1 in such edition:
"3.1.2. The direction of documentation submitted the Applicant after its consideration MZ of Ukraine in expert organizations in time who does not exceed three working days from the date of receipt of data on the MIBP series from the Applicant".
3.2. State Item 3.3 in such edition:
"3.3. In case of establishment of discrepancy of the MIBP series to indicators of quality expert organizations submit the act of discrepancy of the MIBP series to indicators of quality to MZ of Ukraine and make the offer concerning phase-out, withdrawal from realization or neutralization of the MIBP series. In case of discrepancy of the MIBP series to indicators of quality of MZ of Ukraine in ten-day time considers question of review of form of the state control of quality of MIBP and its frequency.
Archive samples of the MIBP this series are subject to neutralization".
3.3. State Item 3.4 in such edition:
"3.4. Conclusion about MIBP series compliance to quality indicators (appendix 2) which availability is obligatory in case of realization and application of MIBP issues MZ of Ukraine within no more than three working days from the moment of receipt of the positive act of expert organizations, taking into account results of the state control of quality of MIBP and based on the positive act of the expert organizations and documents confirming capability of the Applicant to bear civil responsibility for compensation of the damage caused to life and health of patients (volunteers) as a result of application of MIBP (in case of their availability)".
4. In Section 5:
4.1. To state the name of the Section in such edition:
"5. Forms of the state control of quality of medical immunobiological supplies and its frequency".
4.2. State Item 5.1 in such edition:
"5.1. In form of the state control of quality of MIBP and frequency which is established by this Procedure MIBP of both domestic, and foreign production which are used, made or offered to application in medical practice in Ukraine are subject to the state control of quality of MIBP".
4.3. State Items 5.2 and 5.3 in such edition:
"5.2. Establishment of form of the state control of quality MIBP and its frequency are performed by MZ of Ukraine on the basis and taking into account:
availability of state registration of MIBP in Ukraine;
applications of MIBP in state programs, including in the program of carrying out preventive inoculations in Ukraine;
availability of the copy of the official document issued by authorized body of Ukraine or authorized body of Japan or the country which enters the international system of cooperation of pharmaceutical inspections (PIC/S), about production compliance to requirements of proper production practice (GMP);
data of monitoring of side and nonspecific effect of MIBP;
data on stability of indicators of quality of MIBP for usage time of medicine in medical practice in Ukraine;
risk degrees of negative impact of MIBP on human body (pharmakoterapevtichesky group, release form).
5.3. MIBP which are used, made or offered to application in medical practice in Ukraine undergo the procedure of the state control in the form of continuous and selective control with frequency which is established by MZ of Ukraine taking into account requirements of Item 5.2 of this Section, and is drawn up by the letter in form according to appendix 3. Quality control of MIBP is carried out by laboratory control and examination of the materials of quality control of the MIBP series (protocols of quality control of series, analytical reports) provided by the producer what the producer is informed by the above-mentioned letter on".
4.4. Add after Item 5.3 with new Items 5.4-5.6 of such content:
"5.4. For the innovative (original) MIBP made on technology of recombinant DNA, technology of monoclonal antibodies which carrying out the state quality control can be limited to lack of available control materials of standards, panels and in case of lack of hardware for ensuring accomplishment of laboratory control, monitoring procedure is possible based on the producer or by examination of the materials of quality control of the MIBP series (protocols of quality control of series, analytical reports) provided by the producer.
5.5. For MIBP of limited application (orphan medicine, that is the medicine intended for diagnostics, prevention or treatment of rare disease, that is disease which threatens life or leads to disability usually no more than five persons from each 10000 inhabitants at the time of submission of the statement for state registration), which is used, made or offered to application in medical practice in Ukraine, carrying out the state quality control is possible based on the producer or by examination of the materials of quality control of the MIBP series (protocols of quality control of series, analytical reports) provided by the producer.
5.6. In case of establishment of discrepancy of indicator(s) of quality of the MIBP series when carrying out the state control of quality the following three series of this MIBP are subject to continuous control.
In case of receipt continuous quality control of the MIBP series about which information arrived is carried out to MZ of Ukraine of information of rather serious collateral reaction which is not specified in the instruction about application which arose in case of application of MIBP in the territory of Ukraine and information on discrepancy of MIBP to indicators of quality. In case of confirmation of discrepancy of the MIBP series to indicators of quality for the following three MIBP series which are used, made or offered to application in medical practice in Ukraine continuous quality control is established.
In case of disagreement of the subject of managing with results of quality control of the MIBP series the subject of managing according to the legislation of Ukraine has the right to carry out repeated quality control of MIBP".
With respect thereto to consider Items 5.4-5.8 respectively Items 5.7-5.11.
4.5. State Item 5.8 in such edition:
"5.8. Quality control is model MIBP, their specialized assessment, examination, testing are performed by expert organizations in the MZ direction of Ukraine".
4.6. State Item 5.11 in such edition:
"5.11. The further address of MIBP, including its realization, is performed based on conclusion about MIBP compliance to quality indicators taking into account form of the state control of quality of MIBP and frequency which is determined by MZ of Ukraine in connection therewith the Section".
5. To exclude Item 6.2 of Section 6.
With respect thereto to consider Item 6.3 Item 6.2.
6. To be reworded as follows appendix 2 to the Procedure which is applied.
7. Add the Procedure with appendix 3, which is applied.
Director of the department of regulatory policy
in the field of drug circulation and
products in health care system of V. V. Stetsiv
Appendix 2
to the Procedure of the state control on quality of medical immunobiological supplies which are used, made or offered to application in medical practice in Ukraine
(Государственный Герб Украины) МИНИСТЕРСТВО ЗДРАВООХРАНЕНИЯ УКРАИНЫ НАЗВАНИЕ УПОЛНОМОЧЕННОГО ПОДРАЗДЕЛЕНИЯ МЗ УКРАИНЫ
The document ceased to be valid since November 18, 2014 according to Item 2 of the Order of the Ministry of Health of Ukraine of October 1, 2014 No. 698