ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of January 4, 2013 No. 3

About introduction of amendments to the Order of the Ministry of Health of Ukraine of August 26, 2005 No. 426 and recognition voided some orders of the Ministry of Health of Ukraine concerning registration of medicines

According to Item 2 of the Procedure for state registration (re-registration) of medicines approved by the resolution of the Cabinet of Ministers of Ukraine of May 26, 2005 No. 376, I ORDER:

1. Make changes to the Procedure for conducting examination of registration materials on medicines which move on state registration (re-registration), and also examinations of materials about modification of registration materials during action of the registration certificate, No. approved by the order of the Ministry of Health of Ukraine of August 26, 2005 426, registered on September 19, 2005 for No. 1069/11349, having been reworded as follows it which is applied the Ministry of Justice of Ukraine.

2. Approve Regulations on the Qualification commission of the Ministry of Health of Ukraine which are applied.

3. Recognize invalid:

the order of the Ministry of Health of Ukraine of November 01, 2001 No. 443 "About registration of some types of medicines", registered in the Ministry of Justice of Ukraine on November 20, 2001 for No. 975/6166;

The procedure for carrying out state registration (re-registration) for medical immunobiological supplies in Ukraine approved by the order of the Ministry of Health of Ukraine of December 06, 2001 No. 486, registered in the Ministry of Justice of Ukraine on February 28, 2002 for No. 204/6492;

the order of the Ministry of Health of Ukraine of April 17, 2007 No. 190 "About approval of the Procedure for carrying out additional testing of medicines when conducting examination of registration materials", registered in the Ministry of Justice of Ukraine on August 17, 2007 for No. 949/14216;

Procedure for conducting examination of registration materials on medicines which are made according to the approved copy-books, No. approved by the order of the Ministry of Health of Ukraine of December 17, 2008 754, registered in the Ministry of Justice of Ukraine on January 21, 2009 for No. 45/16061;

the order of the Ministry of Health of Ukraine of January 26, 2010 No. 55 "About approval of the Procedure for conducting examination of materials on medicines of limited application which move on state registration (re-registration)", registered in the Ministry of Justice of Ukraine on February 13, 2010 for No. 156/17451;

the order of the Ministry of Health of Ukraine of March 17, 2010 No. 236 "About approval of the Procedure for conducting check of production of medicines which move on state registration", registered in the Ministry of Justice of Ukraine on May 13, 2010 for No. 323/17618.

4. To the head of department of medicines and medical products (Konoshevich L. V.) provide provision of this order on state registration in the Ministry of Justice of Ukraine in accordance with the established procedure.

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

6. To impose control over the implementation of this order on the deputy minister - the chief of staff of Bogachyov R. M.

Approved by the Order of the Ministry of Health of Ukraine of August 26, 2005, No. 426

(in edition of the Order of the Ministry of Health of Ukraine of January 4, 2013 No. 3)

Procedure for conducting examination of registration materials on medicines which move on state registration (re-registration), and also examinations of materials about modification of registration materials throughout action of the registration certificate

I. General provisions

1.1. This Procedure is developed according to the Laws of Ukraine "About medicines" and "About protection of the population against infectious diseases", 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.

1.2. This Procedure for conducting examination of registration materials on medicines which move on state registration (re-registration) and also examinations of materials about modification of registration materials during action of the registration certificate (further - the Procedure) extends to active pharmaceutical ingredients, in bulk products, finished pharmaceutical products, including medical immunobiological supplies, substances or combinations of the substances containing in means of medical appointment which in the course of use arrive in system blood-groove, and also means which by determination of the Ministry of Health of Ukraine (further - MZ) are registered as medicines (further - medicines), such as:

means for disinfection of skin and mucous membranes of nasal and oral cavities and genitalia of the patient before diagnostic, operational manipulations or medical procedures;

means for disinfection of skin of hands of medical personnel before carrying out diagnostic and operational manipulations and contact with the infected and/or potentially infected material;

sticky dressings and others (tampons, gauze, napkins), impregnated antiseptic or disinfection with means, other medicines and packed for retail sale;

the means for extermination of insects and pincers having epidemiological value and intended for drawing on skin of the person and his appendages, and also repellent funds for direct drawing for skin of the person and his appendages;

medicinal cosmetics which together with cosmetic raw materials contain separate active ingredients or their mixes which are used for prevention and/or treatment of diseases of skin of the person and its appendages, mucous membrane of nasal and oral cavities, genitals of the patient and are made in the form of cream, milk, oil, mask, balm, gel, powder, lotion, shampoo, lipstick, extract for bathtubs, antiperspirant, toothpaste, elixir and so forth;

substances or the combinations of substances containing in means of medical appointment which in the course of use arrive in system blood-groove, in particular supportive applications for hemotransfusions and so forth.

1.3. This Procedure does not extend to the radio pharmaceutical medicines made according to instructions of the producer in usage time in accredited institutions of health care, is exclusive from licensed sources of radionuclides, radionuclide sets, precursors of radionuclides.

1.4. State registration (re-registration) of medicine is performed by MZ based on results of examination of registration materials (the registration file) on such means and the control of its quality which is carried out by the State MZ expert center (further - the Center).

ІІ. Determination of terms

In this Procedure the terms below are used in such values:

active pharmaceutical ingredient (medicinal substance, active ingredient, substance) (further - AFI or active ingredient) any substance or mix of substances which is held for use in production of medicine and during this use becomes its active ingredient. Such substances have pharmacological or other direct action on human body. As a part of ready forms of medicines they are applied to treatment, diagnostics or prevention of disease, to change of condition of structures or physiological functions of organism, to survey, processing and relief of symptoms.

AFI or active ingredient can be: compact, covered with cover, granulated, crushed to certain degree or processed some other way and under different names and forms (in particular in forms pelite, granules and so forth and other forms of release);

safety of medicine - the characteristic of medicine which is based on comparative assessment of advantage of its application and potential harm which can be caused to the patient in case of use of this medicine by it;

bioveyver - the procedure of carrying out the comparative researches in vitro based on biopharmaceutical classification system (further - BSK) with use of the Dissolution test for confirmation of equivalence of generic and reference medicines of system action in firm dosage form for oral application with immediate release for the purpose of registration of generic medicine without carrying out the researches in vivo;

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 of bioekvivalentna if they are pharmaceutical equivalent or pharmaceutical alternative and if their bioavailability after introduction in the same molar dose is similar to such degree that effects of these medicines concerning efficiency and safety will be in effect identical;

biological medicines - the medicines containing the active ingredients of biological origin received by way of production from biological source (animal, human, vegetable, microbic or biotechnological);

biopharmaceutical classification system - scientific classification system of active ingredients on the basis of their solubility in water solutions and extent of intestinal penetration;

producer of medicines - the subject of managing which is performing at least one of production phases of medicines and having the license (permission) to production of medicines (if the last is provided by the national legal system of the country in the territory of which there are production capacities of the producer);

production of medicines - the activities connected with serial release of medicines which include everything or at least one of stages of engineering procedure, including purchase of materials and products, packing, packaging and/or marking, storage, the corresponding control, issue of permission to release (realization), and also wholesale trade (distribution) by self-produced products;

conclusion of the State MZ expert center concerning efficiency, safety and quality of medicine, - the generalized result of examination (primary, and/or preliminary, and/or specialized) materials of the registration file on medicine with provision of recommendations concerning its state registration (re-registration), modification of materials of the registration file on medicine during action of the registration certificate or its new registration or concerning refusal in registration (re-registration), modification of materials of the registration file on medicine during action of the registration certificate;

the high-tech (biotechnological) medicinal sredstvalekarstvenny means containing the active ingredients received by means of methods of biotechnology, such as: genetically engineered technology, cellular engineering, gibridomny technologies, engineering enzimologiya and engineering immunology and so forth;

secondary package - packaging which medicine in primary package keeps within and which performs protective function in relation to medicine and primary package;

generic medicine (the generic interchanged) (далеегенерик) - medicine which has the same quantitative and high-quality composition of active ingredients and the same dosage form, as reference medicine and whose interchangeability with reference medicine is proved by the corresponding researches. Different salts, simple and esters, isomers, mixes of isomers, complexes or derivatives of active ingredient, are considered as the same active ingredient provided that they significantly do not differ from the point of view of safety and efficiency. Different dosage forms of oral application reckon with immediate release of active ingredient as the same dosage form;

genetically engineered medicines - the medicines received by technologies of recombinant DNA;

homeopathic medicine - any medicine made of products, substances or components which are called homeopathic raw materials according to the procedure of production of homeopathic medicine described in the State pharmacopeia of Ukraine (further - GFU), or the European pharmacopeia or - in case of lack of such description - in the German homeopathic pharmacopeia (GHP), the Homoeopathic pharmacopeia of the USA (HPUS), the British homeopathic pharmacopeia (BHP), the Homoeopathic pharmacopeia Schwab.

Homeopathic medicine also may contain more than one active ingredient;

the state re-registration of medicine - the procedure which is carried out according to requirements of the current legislation and this Procedure for the purpose of prolongation of term during which medicine is allowed for medical application in Ukraine;

state registration of medicine - the procedure which is carried out according to requirements of the current legislation and this Procedure for the purpose of the admission of medicine to medical application in Ukraine and its entering into the State register of medicines of Ukraine;

source of radionuclides - any system containing the fixed primary radionuclide of which secondary radionuclides which are extended by eluating or in a different way are formed and are used in radio pharmaceutical medicine;

active ingredients (biological agents) - biologically active agents, including biological agents (microorganisms, viruses, cages and tissues of the person, animals and their components) who can change condition and functions of organism or have preventive, diagnostic or medical action and are used as the main component(s) for production of finished pharmaceutical products;

well studied medical application - medical application acting substances which is (ят) part of medicine well studied, are acknowledged its efficiency and acceptable degree of safety (that is confirmed with detailed bibliographic references to the published data of rather postregistration, epidemiological researches and so forth), and there passed at least 10 years from the date of the first systematic and documentary use in Ukraine of operating substance as a part of medicinal means;

additional studying (testing) - researches which need is determined during conducting specialized examination and which allow to ensure creation of motivated conclusions concerning efficiency, safety and qualities of medicine in case of its registration and/or modification of registration materials;

equivalence research - the research determining equivalence between generic and reference medicine when using the researches in vivo and/or in vitro;

research of equivalence in vitro based on BSK - complex researches which are based on classification of active ingredient according to BSK and medicine dissolution and also include comparison of profiles of dissolution of generic and reference medicine in three circles with values рН 1,2, рН 4,5 and рН 6,8;

the expert in registration of the Center - the physical person having appropriate level of qualification and knowledge of the legislation of Ukraine, rules and regulations of the European Union, WHO recommendations in the field of drug circulation, provisions of the International conference on harmonization of technical requirements to registration of medicines for the person. At the same time the expert shall not perform function, including outside the Center, leading to conflict of interest;

examination of materials of the registration file on medicinal sredstvopredvaritelny and specialized examination of materials of the registration file and in need of materials of additional studying (testing) of medicine for the purpose of preparation of motivated conclusions and recommendations concerning decision making of possibility of its state registration (re-registration), modification of registration materials or concerning refusal in registration (re-registration), modification of registration materials for medicine;

efficiency of medicine - favorable diagnostic, medical or preventive effect of medicine on establishment of nature of disease, its course, duration or adjustment of condition or physiologic functions of human body, according to the indications to application specified in the instruction for medical application;

the commonly accepted name - the international unlicensed name (далееМНН) active ingredient, recommended by the World Health Organization (further - WHO), or in the absence of that the regular commonly accepted name;

the statement of the informed consent - the statement for state registration of the medicine similar registered provided that the owner of the registration certificate of the medicine registered earlier agrees to use its pharmaceutical, preclinical and clinical data for new registration of medicine with the same quantitative and high-quality composition of active ingredients in the same dosage form;

the statement on generic - the statement for state registration of medicine which contains the same active ingredient and in the same dosage form, as reference medicine;

the statement on medicine from in bulk products - the statement on state registration of ready medicine which production is performed by packing and/or final packaging and marking of products of in bulk;

the statement on the medicine having well studied medical application - the statement for state registration of the medicine containing the known operating substance(s), which medical application (which) it is well studied in Ukraine within at least 10 years and having the acknowledged efficiency and acceptable level of safety confirmed by detailed bibliographic data;

the statement on the fixed combination - the statement for state registration of the medicine containing the known active ingredients which were not used in this combination earlier, and also were not used in medical practice as separate medicines in the same dosage form, doses and the corresponding ratio earlier, as in the combined medicine;

the applicant (the owner of the registration certificate) (further - the applicant) legal entity or physical person which is responsible for efficiency, quality and safety of medicine, according to the procedure, determined by the current legislation and has resources for implementation of pharmakonadzor in Ukraine, and also is responsible for accuracy of the information, containing in the materials of the registration file provided to them;

changes which can take place during action of the registration certificate, - the changes offered by the applicant concerning the registered (re-registered) medicine;

the instruction for medical application of medicine (the instruction about use of medicine) (further - the instruction for medical application) - officially the approved information on medical application of medicine stated in connection therewith Rather accompanying ready medicine;

confidential registration information - scientific and technical information which contains in the statement for state registration (re-registration) of medicine and the statement for modification of materials of the registration file during effective period of the registration certificate and appendices to them including parts I, II, III and IV or modules 1, 2, 3, 4 and 5 materials of the registration file (except for information which is public, in particular about the name of medicine, composition of active ingredients, action force which are provided in instruction limits for medical application, packaging, about the applicant and/or producer of medicine, the instruction for medical application, information of rather dangerous properties of medicine which can do harm to the patient during application);

medicine of plant origin - any medicine containing exclusively operating substance(s) from one either more vegetable substances, or one or more vegetable medicines, or one or more vegetable substances in combination with one or more vegetable medicine;

medicine which is made according to the approved copy-book, - medicine which includes active ingredient with well studied medical application, with certain efficiency, satisfactory degree of safety on which copy-book is approved by MZ;

medicines of national production - medicines which are produced by the local (Ukrainian) producer; such medicines which passed only stages of packing and/or final packaging and marking are not considered as medicines of national production;

medicines which receive from blood or plasma of the person, medicines on the basis of blood components; such medicines include, in particular, albumine, factors of fibrillation and immunoglobulins of human origin;

the local (Ukrainian) producer - the subject of managing who performs all technological production phases of substances and/or finished pharmaceutical products on the production sites located in the territory of Ukraine and has the license for production of medicines;

medical immunobiological supplies (further - MIBP) - allergens, antigens, vaccines (anatoxins), cytokines, immunomodulators of bacterial origin, and also the medicines created on the basis of bodies and fabrics 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;

the name of medicine - the name given medicine which can be both the fictional applicant (producer), and commonly accepted or scientific that can be followed by the name of trademark or the name of the applicant (producer);

the independent expert - physical person which has appropriate level of qualification, special knowledge and by request of the applicant performs scientific or scientific and technical examination and justification of recommendations according to requirements of task of the applicant of conducting examination answers to the applicant for reliability and completeness of the analysis, and is not the author, the researcher of object of examination; which does not work as the expert in the institutions or the organizations officially determined as expert bodies of objects of scientific and scientific and technical activities concerning drug circulation; or otherwise connected with official expert organs, the central executive body providing forming of state policy in the field of health care or the bodies authorized by it; which is determined only by the applicant;

not intervention research - research in which medicines are appointed normally according to the approved instruction for 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;

unauthorized use of registration information concerning safety and efficiency of medicine - the reference or other use of information on efficiency and safety of the medicine registered according to the complete and independent statement, earlier than in 5 years from registration date of such medicine in Ukraine for filing of application about state registration of the appropriate generic medicine which moves for state registration according to the corresponding statement, except as specified, when the applicant according to the law acquired the right to refer and/or use registration information of reference/original medicine or submitted own complete registration information which meets the requirements to registration information of reference/original medicine.

These requirements do not interfere with the subject to perform the corresponding development of medicine during this period, including to conduct researches on equivalence between generic and reference medicines, for receipt of the registration certificate after the expiration of five years from registration date in Ukraine of the reference medicine determined in the previous paragraph;

original (innovative) medicine - medicine which for the first time in the world was registered based on complete documentation concerning its efficiency, safety and quality (the complete registration file);

patent medicine - medicine which arrives in the address under own name of the producer (applicant), the right to production (production) which realization and application it is protected by the legislation of Ukraine on protection of intellectual property rights;

primary package - the individual packaging which is directly contacting to medicine and promoting preserving its main properties;

the complete and independent statement (the autonomous statement) - the statement on state registration of medicine which new or known AFI or the active ingredient registered as a part of medicine in other dosage form enters;

similar biological medicine (биосимиляр) - the biological medicine similar relatively to efficiency, safety and qualities to the registered reference biological medicine which period of patent protection ended. Similarity of therapeutic efficiency, safety and quality of such medicine to reference shall be proved by the corresponding comparative preclinical and clinical trials;

the applicant's representative (the authorized person acting on behalf of the applicant) (further - the applicant's representative) - legal entity or physical person to which based on the relevant power of attorney the applicant granted the right to represent its interests when holding procedures of registration, re-registration and/or modification of registration materials in the territory of Ukraine and which is responsible for accuracy of the information, containing in the materials of the registration file provided to them in the Center;

radionuclide precursor - any radionuclide intended for introduction of radioactive tag in other substance before its application;

medicine of limited application (orphan medicine) - the medicine intended for diagnosis, prevention or treatment of rare disease, that is disease, the life-threatening or leading to disability no more than 5 people from each 10000 inhabitants for date of filing of application about state registration;

in bulk products - any medicine which passed all stages of engineering procedure, except for stages of packing and/or final packaging and marking;

copy-book (monograph) - information on structure, the production technology, quality control and use of medicine;

radionuclide set - any medicine which shall be connected or mixed with radionuclides in ready radio pharmaceutical medicine, as a rule, before its application;

radio pharmaceutical medicine - any medicine which contains one or several radionuclides (radioactive isotopes) entered into it with the medical purpose in condition, ready for application;

regularly updated report on safety of medicine (the regular report) - the written report which contains regularly updated information on safety of medicine according to the Procedure of supervision of collateral reactions of the medicines allowed for medical application, the approved order of the Ministry of Health of Ukraine of December 27, 2006 No. 898, registered in the Ministry of Justice of Ukraine on January 29, 2007 for No. 73/13340;

registration information - the scientific and technical information in any form and type kept on any carriers, including illustration (cards, charts, organogramma, drawings, schemes and so forth), photos and any other documented data which contain in the statement for state registration (re-registration) of medicine, the statement for modification of registration materials during action of the registration certificate and in registration files and determined as confidential according to the paragraph to the thirty ninth this Section;

the registration certificate on medicine - the document which contains information on the medicine registered in Ukraine and entered in the State register of medicines of Ukraine and the interdepartmental database about the medicines registered in Ukraine;

the registration certificate on medicine (medical immunobiological supply) - the document which contains information on the medical immunobiological supply registered in Ukraine and entered in the State register of medicines of Ukraine and the interdepartmental database about the medicines registered in Ukraine;

registration number - code mark which is appropriated to medicine in case of state registration and remains behind medicine invariable for the entire period of stay of medicine in the pharmaceutical market of Ukraine;

registration materials (materials of the registration file) - set of documents which are enclosed to the application for state registration (re-registration, modification of registration materials) medicine based on which it is possible to draw valid conclusion concerning its efficiency, safety and quality;

reference medicine - medicine to which generic medicine shall be compared and which first of all is original (innovative) medicine with the proved efficiency, safety and quality;

vegetable medicines - the medicines received as a result of processing of vegetable substances by extract, distillation, extraction, crushing, cleaning, concentration and fermentation. Here pounded or powdery vegetable substances, tinctures, extracts, essential oils, the wrung-out juice and the processed extracts enter;

vegetable substances - the whole, crushed or cut plants, parts of plants, seaweed, mushrooms, lichens in the raw, usually dried form, sometimes fresh. The certain extracts from plants (for example, pitches) which are not intended for treatment are also considered as vegetable substances. Vegetable substances are accurately determined by morphological part of plant which is used, and its botanical name according to binomial system (sort, type, version and source);

force of effect of medicine - content of active substance (substances) in quantitative expression per unit of dose, either unit of volume, or unit of mass, according to dosage form;

therapeutic equivalence - two medicines are considered therapeutic equivalent if they are pharmaceutical equivalent or pharmaceutical alternative medicines and after introduction to patients in the same way, in identical molar dose their effects concerning safety and efficiency in fact similar. It can be proved the corresponding researches: comparative pharmacokinetic researches, comparative phracodynamic researches, comparative clinical trials or researches of equivalence in vitro;

traditional medicine - medicine, in particular plant origin which answers such conditions:

medicine according to its structure and appointment is provided for application without observation of the doctor for the purpose of diagnostics, without addition or the recipe or without observation of treatment process;

medicine is applied in certain to concentration and dosage;

medicine is intended for oral, outside or inhalation application;

there is documentary confirmation of the fact that medicine was applied in medical practice at least 30 years in the world and at least 10 years in Ukraine;

there are enough data of rather traditional use of medicine (safety of application in case of usual conditions, the proved efficiency);

the generalizing report - the written report generalizing information on safety of medicine which contains in two or more regularly updated reports on safety of medicine;

pharmaceutical equivalence - medicines are pharmaceutical equivalent if they have identical dosage form, are entered in the same way, contain the same amount of the same active ingredient (the same active ingredients) in the same dosage forms, meet the requirements of the same or compared standards. Pharmaceutical equivalence provides therapeutic equivalence if the dosage form of medicine excludes possibility of influence on bioavailability of such factors as difference in excipients and/or the production technology, or other fluctuations which can influence the speed of dissolution and/or absorption of active ingredient of medicine;

pharmaceutical alternative medicines - the medicines containing identical molar amount of the same active ingredient, but differing on dosage form (for example, tablets in comparison with capsules) and/or chemical form (for example, other salts, other ethers). Alternative medicines deliver the same active ingredient in the same way of introduction, but is not pharmaceutical equivalent. They can be or can not be bioequivalent or therapeutic equivalent to reference medicine;

quality of medicine - set of the properties providing to medicine capability to satisfy consumers according to the appointment and meeting the requirements established by the legislation.

Other terms which are used in this Procedure are used in the values given in the legislation.

ІІІ. Procedure for conducting examination of registration materials on medicine which moves on state registration (re-registration)

3.1. Can precede conducting examination at the request of the applicant provision of free consultations by the Center concerning state registration (re-registration) of medicines.

3.2. For conducting examination the applicant gives to MZ by the principle of "single window":

the statement for state registration of medicine, including MIBP according to appendix 1 to this Procedure (in case of filing of application on multicomponent medicines in several variations of doses of active ingredients which change disproportionately the application is considered as on different medicines), and in case of traditional medicines and medicines which are made according to the approved copy-books the application for state registration (re-registration) of medicine in the form given in appendix 2 to this Procedure is submitted;

the statement for state registration (re-registration) of AFI or active ingredients in the form given in appendix 3 to this Procedure;

the statement for the state re-registration of medicine in the form given in appendix 4 to this Procedure, and in case of traditional medicines and medicines which are made according to the approved copy-books the application for state registration (re-registration) of medicine in the form given in appendix 2 to this Procedure is submitted.

At the request of the applicant registration of the ready medicine and active ingredient which is part of this medicine with provision of registration certificates about state registration of AFI, active ingredient and ready medicine provided that materials of the registration file move in format of the general technical document (further - OTD) which structure is given in appendix 5 to this Procedure can be carried out at the same time.

Information on the application submitted to MZ is entered in the electronic database.

Collection and processing of personal data are performed according to requirements of the Law of Ukraine "About personal data protection".

3.3. Conducting examination of medicine which moves on state registration (re-registration) includes such stages:

primary examination of the statement for state registration of medicine from the point of view of its belonging to prohibited to application in Ukraine and qualification like such statement for the purpose of scoping of registration materials according to requirements of this Procedure;

preliminary expert examination of completeness of materials of the registration file of medicine according to the type of the statement and requirements determined in Item 3.5 of this Section;

specialized expertize of materials of the registration file of medicine which is carried out for the purpose of creation of motivated conclusion concerning efficiency, safety and quality of medicine. The constituting specialized examination additional studying (additional testing) is (if necessary).

3.4. Procedure for conducting primary examination.

3.4.1. By results of consideration of the application of MZ within three working days sends to the Center the letter direction together with the copy of the application (as the statement, to certain applicant).

The letter direction for primary examination is introduced in the electronic database.

After receipt of the statement and the letter direction from MZ experts in registration of the Center till seven working days perform primary examination of the statement concerning possibility of registration of medicine from the point of view of its belonging to prohibited to application in Ukraine and qualification like such statement for the purpose of scoping of registration materials according to requirements of this Procedure.

By results of primary examination of the statement the Center within three working days submits in MZ the corresponding recommendations which are issued by conclusion of the Center of rather primary examination applications which within 5 working days are considered by the qualification commission of MZ according to the Regulations on the Qualification commission of the Ministry of Health of Ukraine approved by the order of the Ministry of Health of Ukraine of January 04, 2013 No. 3. Conclusion of rather primary examination of the statement is brought in the electronic database.

3.4.2. By results of consideration of MZ of conclusion of the Center of rather primary examination of the statement of MZ by the qualification commission within three working days provides to the applicant the written answer and in case of establishment of possibility of registration (re-registration) of the declared medicine draws up the letter direction for preliminary and specialized expert examination to the Center and recommends to the applicant to provide materials of the registration file in the Center for implementation of their examination. Pismonapravleniye for preliminary and specialized expert examination is brought by MZ in the electronic database.

Based on the prisoner between the Center and the applicant of the agreement expertize of the provided materials of the registration file is carried out.

If MZ by results of qualification of the statement determined that the applicant shall provide other statement, it is recommended to provide it together with materials of the registration file the new application determined in Item 3.2 of this Section and given in the corresponding appendices to this Procedure which is directed to the Center to start preliminary expert examination according to Item 3.5 of this Section.

In case of the applicant's disagreement concerning the recommended statement type the applicant has the right to address in MZ together with additional materials or to appeal the solution of MZ in the procedure established by the legislation.

3.4.3. Primary examination of the statement on the medicine given for the purpose of its state re-registration is not performed.

3.5. Procedure for conducting preliminary expert examination.

3.5.1. After receipt of the letter direction of MZ on conducting preliminary and specialized expert examination of materials of the registration file of medicine by the applicant after payment of the state registration fee (re-registration) of medicine and cost of expert works materials of the registration file taking into account recommendations of the qualification commission of MZ concerning type of the statement and requirements move in the Center:

Sections ІХ and the X this Procedure and appendix 5 to this Procedure - for registration;

the Section X ІІ this Procedure - for homeopathic medicines;

Sections X ІІІ and X_V of this Procedure - for traditional medicines or medicines which are made according to the approved copy-book;

Sections ІХ, X, ХІ this Procedure and appendix 6 to this Procedure - in case of registration of AFI or active ingredient.

Registration materials move according to requirements of the Section VІ of this Procedure.

In case of re-registration the set of materials of the registration file according to appendix 7 to this Procedure is provided. For traditional medicines or medicines which are made according to the approved copy-book the set of materials of the registration file according to appendix 8 to this Procedure is provided.

Registration materials for re-registration can move according to appendix 5 or 9 to this Procedure taking into account requirements of Sections VII, VII І, ІХ and the X this Procedure (depending on the format of materials of the registration file elected by the applicant).

In case of state registration (re-registration) of the medicines relating to group of medicines "Medical Gases" the application according to appendix 2 to this Procedure is submitted to MZ, materials of the registration file move according to the list given in appendix 6 to this Procedure added with the instruction for medical application taking into account requirements of the Section XVI of this Procedure.

The representative of the applicant shall guarantee accuracy of the information, provided in the provided materials of the registration file.

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