RUSSIAN FEDERATION federal law on obraŝeniilekarstvennyh means Adopted March 24, 2010 GosudarstvennojDumoj year SovetomFederacii 31 March 2010 Approved (in red. Federal law dated July 27, 2010 N 192-FZ-collection of laws of the Russian Federation, 2010, N 31, art.
4161; Federal law dated October 11, 2010 N 271-FZ-collection of laws of the Russian Federation, 2010, N 42, art. 5293;
Federal law dated November 29, 2010 N 313-FZ-collection of laws of the Russian Federation, 2010, no. 49, St. 6409;
Federal law dated December 6, 2011 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351; harm.
Federal law dated June 25, 2012 N 93-FZ-collection of laws of the Russian Federation, 2012, N 26, art. 3446;
Federal law dated December 25, 2012 N 262-FZ-collection of laws of the Russian Federation, 2012, N 53, art. 7587;
Federal law dated July 2, 2013 N 185-FZ-collection of laws of the Russian Federation, 2013, N 27, art. 3477;
Federal law dated November 25, 2013 N 317-FZ-collection of laws of the Russian Federation, 2013, no. 48, art. 6165;
Federal law dated March 12, 2014 N 33-FZ-collection of laws of the Russian Federation, 2014, N 11, art. 1098;
Federal law dated October 22, 2014 N 313-FZ-collection of laws of the Russian Federation, 2014, N 43, St. 5797;
Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540;
Federal law dated March 8, 2015 N 34-FZ-collection of laws of the Russian Federation, 2015, N 10, art. 1404;
Federal law dated June 29, 2015 N 160-FZ-collection of laws of the Russian Federation, 2015, N 27, art. 3951;
Federal law dated July 13, 2015 N 233-FZ-collection of laws of the Russian Federation, 2015, N 29, art. 4359;
Federal law dated July 13, 2015 N 241-FZ-collection of laws of the Russian Federation, 2015, N 29, art. 4367;
Federal law dated July 13, 2015 N 262-FZ-collection of laws of the Russian Federation, 2015, N 29, art. 4388;
Federal law dated December 14, 2015 N 374-FZ-collection of laws of the Russian Federation, 2015, N 51, art. 7245;
Federal law dated December 29, 2015 N 389-FZ-collection of laws of the Russian Federation, 2015, N, St. ) Chapter 1. Article Obŝiepoloženiâ 1. Predmetregulirovaniâ 1 of this federal law. This federal law regulates relations arising in connection with the treatment of development, preclinical studies, clinical studies, examination, registration, standardization and quality control, production, manufacture, storage, transport, import, export to the Russian Federation from the Russian Federation, advertising, holiday, sales, transfer, use, destruction of drugs (as restated by federal law from December 2011 N 409-FZ collection zakonodatel′stvaRossijskoj Federation, 2011, N 50 , art. 7351). 2. This federal law supersede State regulation of safety, quality and efficacy of medicines in their treatment (as amended by the Federal law dated June 25, 2012 N 93-FZ-collection of laws of the Russian Federation, 2012, N 26, art. 3446). Article 2. Sferaprimeneniâ of this federal law NastoâŝijFederal′nyj law applies to relations arising upon the circulation of medicines in the territory of the Russian Federation.
Article 3 legislation on the treatment of drugs 1. Obobraŝenii medicines legislation consists of this federal law, other federallaws and other normative legal acts of the Russian Federation.
1-1. the law on circulation of medicines in respect of legal persons and individual entrepreneurs, carrying out activities on the territory of international medical cluster, apply with the specifications established by the Federal law "on international medical cluster, and amendments to certain legislative acts of the Russian Federation" (part 1-1 introduced by the Federal law dated June 29, 2015 N 160-FZ-collection of laws of the Russian Federation, 2015, N 27, art. 3951). 2. Action nastoâŝegoFederal′nogo for the treatment of narcotic drugs and psychotropic drugs, taking into account the characteristics established by the legislation of the Russian Federation on narcotic drugs, psychotropic substances and their precursors.
3. Action for the nastoâŝegoFederal′nogo treatment of pet medicines, taking into account the particularities, ustanovlennyhzakonodatel′stvom of the Russian Federation in the field of radiation safety.
4. If an international treaty of the Russian Federation stipulates other rules than those predusmotrenynastoâŝim federal law, rules of the international treaty shall apply.
5. In the Russian Federation in accordance with international treaties of the Russian Federation and (or) based on the principle of reciprocity, recognized the results of clinical trials of drugs for medical use, carried out outside the territory of the Russian Federation.
Article 4. The basic concepts used to prescribe those Federal′nomzakone for the purposes of this federal law uses the following concepts: 1) medicines-substances or combinations thereof in contact with human or animal body, penetrating the organs, tissues, human or animal, used dlâprofilaktiki, Diagnostics (except substances or combinations of nekontaktiruûŝih with the body of a human or animal), treatment, rehabilitation, preservation, prevention or abortion and obtained from the blood plasma, blood, organs, tissues, human or animal, plants, minerals or synthesis methods using biological technologies. The medicines include pharmaceutical substances and medicines;
2) farmacevtičeskaâsubstanciâ-remedy in the form of one or more active substances Pharmacology active regardless of origin, which is intended for the production, manufacture of medicines and determines their effectiveness (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
3) auxiliary substances-substances inorganic or organic origin used in the manufacturing process, manufacturing of drugs to give them the necessary physico-chemical properties;
4) medicines-medicines in the form of dosage forms that are used for prevention, diagnosis, treatment, rehabilitation, preservation, prevention or interruption of pregnancy;
5) dosage form-the status of the medicinal product, the appropriate methods of its introduction and implementation of iobespečivaûŝee achievement of desired therapeutic effect;
5-1) dosage-the content of one or more of the active substances expressed quantitatively per dosage, or unit volume, or per unit of mass in accordance with the dosage form or for certain types of dosage forms dosage form of a disposable amount of active substance per unit of time (para 5-1 was introduced by the Federal law dated 22dekabrâ, 2014. N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
6) perečen′žiznenno necessary and essential medicines annually approved by the Government of the Russian Federation a list of drugs for medical use, providing priority potrebnostizdravoohraneniâ for the prevention and treatment of diseases, including prevailing morbidity in the Russian Federation;
6-1) orphan drugs-drugs that are intended solely for diagnostic or pathogenetic treatment (treatment directed at the development of the disease) of rare (orphan) diseases (paragraph 6-1 was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art.
7540);
6-2) biological medicines-medicines, active substance which was vydelenoiz or biological source and to define the properties and quality of which requires a combination of biological and physico-chemical methods. Biological drugs include immunobiological medications, drugs derived from human blood plasma, blood and animals (except for whole blood), biotech drugs, genoterapevtičeskie lekarstvennyepreparaty (item 6-2 was introduced by the Federal law of December 22, 2014 N 429-FZ collection zakonodatel′stvaRossijskoj Federation, 2014, N 52, art.
7540);
7) immunobiologičeskielekarstvennye medicines-medicines intended for formation of active or
passive immunity or diagnose the existence of immunity or specific diagnostics acquired immunological response to changes allergiziruûŝie substances. The immunobiologičeskim drugs are vaccines, toxoids, toxins, serums and allergens, immunoglobulins (harm federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
7-1) biotech medicines-medicines, production of which is carried out using biotechnological processes and methods (including DNA recombinant technology, genes encoding kontroliruemojèkspressii biologically active proteins in prokaryotes and èukariotah, vklûčaâizmenennye cells of mammals), the gibridomnogo method, and the method of monoclonal antibodies (item 7-1 was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
7-2) genoterapevtičeskie medicines-medicines, pharmaceutical substance which is a recombinant nucleic acid or includes recombinant nucleic acid, allowing regulation, reparation, replace, add, or remove a genetic sequence (item 7-2 was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
8) Narcotic medications-medications and pharmaceuticals containing narcotic drugs and included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, in accordance with the zakonodatel′stvomRossijskoj Federation, meždunarodnymidogovorami of the Russian Federation, including the single Convention on Narcotic Drugs of 1961 years;
9) psychotropic medications-medications and pharmaceuticals containing psychotropic substances included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, in accordance with the zakonodatel′stvomRossijskoj Federation, the Russian Federation's international treaties, including the Convention on psychotropic substances of 1971 years;
10) radiofarmacevtičeskie medicines-medicines that contain a ready to use form a single radionuclide or more radionuclides (radioactive isotopes);
11) reference drug-a drug that vpervyezaregistrirovan in the Russian Federation, quality, efficacy and safety which are proven on the basis of the results of preclinical studies of drugs and clinical trials of drugs, carried out in accordance with the requirements of parts 6 and 7 of article 18 hereof with respect to drugs for medical use or in accordance with the requirements of article 12 of law nastoâŝegoFederal′nogo regarding medicinal products for veterinary use and that used to assess bioequivalence or therapeutic equivalence, quality, efficacy and safety, reproduced or bioanalogovogo (biopodobnogo) of the medicinal product (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540;
Federal law dated July 13, 2015 N 241-FZ-collection of laws of the Russian Federation, 2015, N 29, art. 4367);
12) reproduced a drug is a drug that has the same qualitative and quantitative composition the composition of the active ingredients in the same dosage form as the reference medicinal product, and whose therapeutic equivalence or bioequivalence REF. medicinal drug research podtverždenasootvetstvuûŝimi (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
12-1) therapeutic equivalence is to achieve clinically comparable therapeutic effect with primeneniilekarstvennyh drugs for medical use for the same group of patients with the same indications for use (para 12-1 was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art.
7540);
12-2), bioanalogovyj (biopodobnyj) a drug (bioanalog)-a biological drug, similar to parameters of quality, efficacy and safety with reference biological medicinal drug in the same dosage form and has the identical way of introduction (para 12-2 was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
12-3) vzaimozamenâemyjlekarstvennyj drug-a drug with proven therapeutic equivalence or bioèkvivalentnost′û in relation to the reference medicinal product, having equivalent quality and quantity of the active substances, sostavvspomogatel′nyh substances, lekarstvennuûformu and way of introduction (para 12-3 was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
13) lekarstvennoerastitel′noe raw-fresh or dried plants or parts thereof, used for the production of medicines organizations-manufacturers of medicinal products or manufacture drugs pharmacy organizations, veterinary pharmacy organizations, independent entrepreneurs, and to license them to pharmaceutical activities;
14) medicinal herbal drug-a drug that produced or manufactured from one kind of medicinal vegetative raw material or several types of such raw materials and pre-packed in the secondary (consumer);
15) homoeopathic drug-a drug that produced or manufactured from pharmaceutical substance or pharmaceutical substances in accordance with the requirements of common Officinal articles to homeopathic medicines or in accordance with the requirements of Pharmacopoeia producer countries such lekarstvennogopreparata (in red. Federal law ot22 December 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
16) international non-proprietary name of medicinal product-the name of the active ingredient of pharmaceutical substances, rekomendovannoeVsemirnoj Health Organization (in red. Federal zakonaot December 22, 2014 N 429-FZ collection zakonodatel′stvaRossijskoj Federation, 2014, N 52, art.
7540);
17) trade name of the medicinal product-the name of the medicinal product, assigned to its developer, the holder or the owner of the drug registration certificate (in red. Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
17-1) gruppirovočnoenaimenovanie drug-name lekarstvennogopreparata, has no international nepatentovannogo names, or combination of drugs used in an effort to unite them in name of podedinym Group on the basis of identical composition of active substances (para 17-1 was introduced by the Federal law of December 22, 2014 N 429-FZ collection zakonodatel′stvaRossijskoj Federation, 2014, N 52, art. 7540);
18) total, Pharmacopoeial article-a document approved by the authorized federal body of executive power and containing a list of quality indicators and (or) methods for monitoring the quality of a particular dosage form, raw vegetable matter, a description of the biological, biochemical, microbiological, physico-chemical, physical, chemical, and other methods of analysis of the medicinal product, as well as the requirements to be used in order to conduct this analysis, reagents, titrovannym solutions, indicators (in red. Federal′nogozakona from December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
19) Pharmacopoeial article-a document approved by the authorized federal body of executive power and containing a list of quality indicators and methods of quality control of medicinal products (as amended. Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
19-1) standartnyeobrazcy-posredstvomsravneniâ substances that were issleduemyhlekarstvennyh quality control means using physico-chemical and biological methods to confirm conformity of medicines requirements of normative documents, established during State registration, and which are used for calibration of standard samples of a manufacturer of medicines used for quality control and other purposes, with the circulation of medicines (para 19-1 was introduced by the Federal zakonomot December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation , 2014, N 52, art. 7540);
19-2) sample farmakopejnyjstandartnyj-standard sample in accordance with article Pharmacopeia (para 19-2 was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
20) regulatory documents-document listing based on appropriate expertises of the indicators of the quality of the drug for medical use, quality control methods and set its manufacturer;
21) instrument is a document that contains a list based on the relevant expertise of quality indicators and (or) control methods kačestvalekarstvennoj form, descriptions of biological, biochemical, microbiological, chemical, physical, chemical and drugihmetodov analysis of medicines for veterinary use, requirements to be used in order to conduct this analysis, reagents, titrovannym solutions, indicators and set its manufacturer;
21-1) common technical document-set of documents and materials, consisting of several sections of the documentation of an administrative nature, chemical, pharmaceutical and biological documentation, pharmacological, toxicological, and clinical documentation and documentation submitted simultaneously with the application for State registration of medicinal product for medical application in the format established by the authorized federal body of executive power (para. 21-1 was introduced by the Federal law of December 22, 2014
N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
22) the quality of the medicinal product-line medicine Pharmacopeia requirements article or in her absence of normative documents or instrument;
23) the safety of the medicinal product-characteristics of the medicinal product, based on a comparative analysis of efficiency and risk of injury to health;
24) efficacy of the medicinal product characteristic degree of positive influence drug natečenie, the duration of the illness or its prevention, rehabilitation, preservation, prevention or interruption of pregnancy;
25) a series of drug-količestvolekarstvennogo means, produced as a result of a single technological cycle of its manufacturer;
26) drug registracionnoeudostoverenie-document confirming the State registration of the medicinal product;
26-1), the holder or the owner of the registracionnogoudostovereniâ drug-drug developer, manufacturer of medicines or other legal person who holds the right of ownership registration certificate, which are responsible for the quality, efficiency, ibezopasnost′ drug (para. 26-1 entered Federal′nymzakonom from December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
27) registration number-kodovoeoboznačenie assigned to the medicinal drug in its State registration;
28) treatment medicines development, preclinical studies, clinical studies, expertise, State registration, standardization and quality control, production, manufacture, storage, transport, importation, exportation to the Russian Federation from the Russian Federation, advertising, sales, transfer, use, destruction of lekarstvennyhsredstv (in red. Federal law dated December 6, 2011 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art.
7351);
29) subjects of circulation of medicines-natural persons, including individual entrepreneurs, and legal entities performing activities in circulation of medicines;
30) developer of the drug-organization with rights to the results of the preclinical studies of the drug, clinical trials of the medicinal product and/or on the production technology of the medicinal product (as amended by the Federal law of December 22, 2014 N429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
31) manufacture of medicines-medicines production activities organizations-manufacturers of medicines on the one, several, or all stages of the process, as well as storing and sale of manufactured medicines;
31-1) proizvodstvennaâploŝadka-geographically isolated complex proizvoditelâlekarstvennyh funds prednaznačennyjdlâ perform the whole process of the production of medicines or its specific stage (para. 31-1 was introduced by the Federal zakonomot December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
32) manufacturer of medicines-the governing body of proizvodstvolekarstvennyh funds in accordance with the requirements of this federal law;
33) farmacevtičeskaâdeâtel′nost′-activities include wholesale trade in medicinal products, their storage, transport and (or) retail trade in drugs, their vacation, storage, transport, manufacture of lekarstvennyhpreparatov;
34) the Organization of wholesale trade in medicinal products-organization conducting wholesale trade in medicinal products, their storage, transport in accordance with the requirements of this federal law;
35) pharmacy Organization-Organization structural unit of medical organizations engaged in retail trade in drugs, storage, transport, production and release of drugs for medical use, in accordance with the requirements of this federal law (as amended. Federal′nogozakona from November 25, 2013 N 317-FZ collection zakonodatel′stvaRossijskoj Federation, 2013, N 48, art.
6165);
36) veterinary pharmacy Organization-Organization structural unit of veterinary organizations engaged in retail trade in drugs, storage, production and release of drugs for veterinary use in accordance with the requirements of this federal law;
37) fal′sificirovannoelekarstvennoe tool-medication accompanied by false informaciejo and (or) the manufacturer;
38) nedobrokačestvennoelekarstvennoe tool-medication, inappropriate, Pharmacopeia requirements article or if it is missing trebovaniâmnormativnoj documentation or instrument;
39) counterfeit drug-a drug that is in circulation with a violation of civil law;
40) preclinical study drug-biological, microbiological, immunological, toxicological, pharmacological, physical, chemical, and other studies of the drug through the application of scientific methods of evaluations in order to obtain evidence of safety, quality and efficacy of the medicinal product;
41) clinical trial drug-study of diagnostic, therapeutic, preventive, the pharmacological properties of the medicinal product in the process of its application in humans, animal, including processovvsasyvaniâ, distribution, modification and excretion by applying scientific methods of evaluations in order to obtain evidence of safety, quality and efficacy of the medicinal product, the data on unwanted reactions of the human body, an animal on the use of the medicinal product and of the effect of its interaction with other drugs and/or foods , animal feeds;
42) multicenter clinical study of medicine for medical applications-clinical study of the drug for medical use, carried out by the developer of the drug in two most medical organizations according to a single protocol clinical trial of the medicinal product;
43) International multicenter clinical trial of medicinal preparatadlâ medical applications-clinical study of the drug for medical use, carried out by the developer of the drug in different countries on a single protocol clinical trial of the medicinal product;
44) postregistracionnoe clinical trial of medicinal preparatadlâ medical applications-clinical study of the drug for medical use, carried out by the manufacturer of the medicinal product, which is over after the State registration, in order to further collect data on its safety and effectiveness, broadening indication for use of this drug, as well as the vyâvleniâneželatel′nyh reactions of patients for its action;
45) issledovaniebioèkvivalentnosti-a type of drug clinical trial of the medicinal product, which is carried out to determine the speed of absorption and excretion of one or more having pharmacological activity of active substances, the amount of drug reaching systemic blood flow and rezul′tatykotorogo
suggest bioequivalence reproduced in certain drug dosage form and dosage, the relevant form and dosage drug reference (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
46) issledovanieterapevtičeskoj equivalence of drugs-a type of clinical trial drugs, which is carried out to identify identical properties of drugs of a particular dosage form, as well as the availability of identical safety performance ièffektivnosti pharmaceuticals, identical clinical effects in their application;
47) drug clinical study protocol-a document which defines the objectives, forms of organization and kliničeskogoissledovaniâ methodology, statistical methods of processing results of such studies and measures to ensure the safety of the individuals involved in the clinical trial of the medicinal product;
48) brochure of the researcher-synthesis of results of pre-clinical drug research and clinical studies of the drug for medical use;
49) patient information sheet is a document containing information in accessible form concerning ongoing clinical trial of the medicinal product, and in writing the patient's informed consent to participate in a clinical study medication after consulting with the peculiarities of the clinical study, having a value for the expression of such consent;
50) side effects-reactions occurred in connection with the use of medication in the doses recommended in the instructions for its use, for the prevention, diagnosis, treatment or rehabilitation;
50-1) neželatel′naâreakciâ-unintentional adverse reactions that can be associated with the use of the medicinal product (para 50-1 was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
51) serious unwanted reaction-an undesirable reactions associated with the use of medication, leading to death, congenital abnormalities, or developmental disabilities or representing a threat to life, requiring hospitalization or resulting in persistent disability and (or) disability;
52) unexpected unwanted reaction-an undesirable reactions, kotoraâsvâzana with the use of medication in the doses recommended in the Protocol of its clinical studies brochure researcher, or with the use of medication in the doses recommended in the instructions onhis application for prevention, diagnosis, treatment zabolevaniâili medical reabilitaciipacienta, and essence, the severity or outcome of which is not consistent with the information on medication preparation contained in the Protocol of its clinical studies brochure Explorer or in the instructions for use of the medicinal product (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
52-1) pharmacovigilance-kind of activity to monitor the effectiveness and safety of drugs, aimed at identifying, assessing and preventing the undesirable consequences of applying lekarstvennyhpreparatov (para. 52-1 was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
52-2) management plan-a detailed description of pharmacovigilance activities aimed at identifying, assessing and preventing or minimizing the risks associated with drugs, including an assessment of the effectiveness of these activities (para. 52-2 was introduced by the Federal law of December 22, 2014 N 429-FZ collection zakonodatel′stvaRossijskoj Federation, 2014, N 52, art.
7540);
53) recipe nalekarstvennyj drug-drug designation in writing in the prescribed form issued by the medical or veterinary employee eligible to leave the medication or its manufacture and leave;
54) requirement of medical organizations, veterinary organizations document in the prescribed form, which discharged medical iliveterinarnym employee who ètopravo, and contains in writing specifying pharmacy organization on vacation medication or its manufacture and parental leave ensure treatment process in medical organizations, veterinary organization;
55) a comprehensive assessment of the medicinal product-rating registered drug, which includes analysis of information on comparative clinical effectiveness and safety of the medicinal product, assessment of the economic impact of its application, study dopolnitel′nyhposledstvij the use of the medicinal product with a view to taking decisions on the possible inclusion of a medicinal product in the list of essential medicines, normative acts and other documents governing the provision of medical assistance, iliisklûčeniâ it from the specified list of acts and documents (paragraph 55 was introduced by the Federal law of December, 2014 ot22. N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540). Chapter 2. Polnomočiâfederal′nyh executive bodies, executive bodies of the subjects of the Russianfederation when handling drugs Article 5. Polnomočiâfederal′nyh executive authorities priobraŝenii medicines to the powers of the federal bodies of executive power when handling drugs include: 1) in the Russian Federation edinojgosudarstvennoj policies for drugs of citizens in the Russian Federation (as amended by the Federal law of 22 dekabrâ2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
2) approval of General Officinal articles Officinal articles of the State Pharmacopoeia Edition, creation and maintenance of a roster of Officinal standard samples (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
3) osuŝestvleniegosudarstvennogo control (supervision) in the sphere of circulation of lekarstvennyhsredstv (in red. Between $ 25 million and federal law of June 2012 N 93-FZ-collection of laws of the Russian Federation, 2012, N 26, art. 3446);
4) licensing the production of medicines and pharmaceutical activities in accordance with the legislation of the Russian Federation;
5) Organization of expertise medicines, ethical examination of the possibility of conducting a clinical trial drug for medical use, examination of documents submitted to determine whether to consider the drug for medical use under the State registration as an orfannogolekarstvennogo drug (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
5-1) integrated assessment organizaciâprovedeniâ medicinal product with a view to taking decisions on the possible inclusion of a medicinal product in the list of essential medicines, normative acts and other documents governing the provision of health care or evicting it from the specified list of acts and documents (paragraph 5-1 was introduced by the Federal law of December 22, 2014 N429-FZ-collection of laws of the Russian Federation, 2014, N 52, art.
7540);
6) issuance of permits to conduct clinical trials of pharmaceuticals, maintaining the register of issued authorization to conduct clinical trials of medicines;
7) State registration of medicines, conducting the State Register of medicinal products;
8) Organization and/or carrying out inspektirovaniâsub″ektov treatment medicines on line pravilamnadležaŝej laboratory practice, good clinical practice rules, rules of good practice for storage and transportation of drugs, rules of good distribution practice, rules of good pharmacy practice (in red. Federal law dated December 22, 2014 N 429-FZ collection zakonodatel′stvaRossijskoj Federation, 2014, N 52, art. 7540);
8-1) Organization and/or carrying out inspection of drug entities for compliance with the requirements of the good manufacturing practices regulations, issuing opinions on the conformity of a manufacturer of medicines trebovaniâmpravil good manufacturing practices (para. 8-1 was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
8-2) establishing order and conducting the State Register of determinations of conformity manufacturer of medicines requirements of proper proizvodstvennojpraktiki (item 8-2 was introduced by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
9) State registration of established manufacturers of drugs limit selling prices for vital and essential medications and conducting the State Register of limit prices proizvoditelejna medicines included in the list of vital medicine and essential medicines;
9-1) the harmonization of the draft decisions of the executive authorities of the constituent entities of the Russian Federation to establish and/or change the size limit of wholesale and retail size limits allowances to actual cost prices set by manufacturers of pharmaceuticals, drugs and medicines included in the list of vital medicine and critical lekarstvennyhpreparatov (para 9-1 was introduced by the Federal law dated July 13, 2015 N 241-FZ-collection of laws of the Russian Federation, 2015, N 29 , art. 4367);
10) establishing the order of smuggling drugs in the Russian Federation and the export of medicines from the Russian Federation (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
10-1), establishing the procedures for issuing and form of the document, which confirms that the drug production carried out in accordance with good manufacturing practice regulations, and podležitpredstavleniû on demand of the authorized body of the country in which the medicinal product is imported (item 10-1 vvedenFederal′nym Act of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
10-2), establishing the procedures for issuing and form a document containing information about the stages of the technological process of production of the drug dlâmedicinskogo use, carried out in the territory of the Eurasian Economic Union (item 10-2 was introduced by the Federal law of 22 dekabrâ2014 g. N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540; in red. Federal law dated July 13, 2015 N 241-FZ-collection of laws of the Russian Federation, 2015, N 29, art. 4367);
11) creation of Councils on matters related to the circulation of medicines;
12) isertifikaciâ certification of professionals;
13) (para. 13 utratilsilu based on the Federal law dated July 2, 2013 N 185-FZ-collection of laws of the Russian Federation, 2013, N 27, art. 3477) 14) osuŝestvleniefarmakonadzora (in red. Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
15) part painted Equator Internetional cooperation;
16) receive, upon request, of the authorized federal′nogoorgana the Executive branch from the executive authorities of the constituent entities of the Russian Federation, as well as from subjects of circulation of medicines for medical application information on the establishment and application of drug prices inadbavok;
17) application of responsibility for violation of legislation of the Russian Federation;
18) adoption of the rules of good laboratory practice, good clinical practice rules, the rules of good manufacturing practice, rules of good practice for storage and transportation of drugs, rules of good distribution practice, rules of good pharmacy practice, rules of good praktikifarmakonadzora drugs for medical use (paragraph 18 was introduced by the Federal zakonomot December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
19) establishing the order of formation of the registration dossier for a medicinal product and documentary requirements in its composition (item 19 was introduced by the Federal law of December 22, 2014 N429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
20) adoption of the rules of rational choice medicinal drugs for medical use (paragraph 20 was introduced by the Federal law of December 22, 2014 N 429-FZ collection zakonodatel′stvaRossijskoj Federation, 2014, N 52, art.
7540);
21) perečnânaimenovanij dosage forms (paragraph 21 was introduced by the Federal law of December 22, 2014 N 429-FZ collection zakonodatel′stvaRossijskoj Federation, 2014, N 52, art.
7540);
22) formation of the register of model pomedicinskomu instructions application of interchangeable drugs (item was introduced by the Federal law dated 22 December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
23) approval requirements for instructions on medical use of drugs and to poveterinarnomu use of medication (paragraph added by federal law of 23 December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
24) pre-trial the closing of sites containing information about retail sales remotely, offer to purchase remotely, remote delivery method and (or) the transfer of an individual distancionnymsposobom drugs, narcotic drugs and psychotropic drugs, except in cases established by the Government of the Russian Federation (paragraph 24 was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). Article 5-1. Peredačaosuŝestvleniâ organovispolnitel′noj powers of federal authorities when handling medicines authorities of constituent entities of the Russian Federation the powers of federal bodies of executive power with the circulation of medicines prescribed by this federal law may be transmitted for the implementation of the executive bodies of subjects of the Russian Federation in decisions of the Government of the Russian Federation in the manner prescribed by the Federal law of October 6, 1999 N 184-ФЗ "about the common principahorganizacii of legislative (representative) and executive bodies of State power of the constituent entities of the Russian Federation (art. 5-1 introduced the Federal zakonomot July 13, 2015 N 233-FZ-collection of laws of the Russian Federation, 2015, N 29, art. 4359). Article 6. Executive Polnomočiâorganov entity Russianfederation when circulation of medicines to the powers of the executive authorities of the constituent entities of the Russian Federation when handling medicinal sredstvotnosâtsâ: 1) irealizaciâ development of regional programmes for the provision of drugs;
2) limit sizes wholesale and retail size limits allowances to actual cost prices, ustanovlennymproizvoditelâmi, drugs for medicines included in the list of vital medicine and essential medicines;
3) osuŝestvlenieregional′nogo of State control over the use of nalekarstvennye drugs prices included essential list of drugs, wholesale organizations, pharmacy organizations, independent entrepreneurs, and to license them to pharmaceutical activities (as amended by the Federal law dated June 25, 2012 N 93-FZ-collection of laws of the Russian Federation, 2012, N 26, art. 3446).
The head of the State Pharmacopoeia 3 Article 7. Development of iizdanie of the State Pharmacopoeia, razmeŝeniedannyh about it 1. Under the State pharmacopoeia is understood as a set of General Officinal articles and Officinal articles.
2. Development of common Officinal articles and Officinal articles, including Officinal articles on Pharmacopoeial standard samples, and turn on them in the State Pharmacopoeia shall be made in accordance with the procedure established by the authorized federal body of executive power (in red. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540). 3. Development of Pharmacopeia articles to reference medicinal product and incorporate it into the State Pharmacopoeia during the term of protection of the exclusive rights of the patent certified by the reference medicinal product, carried out with the consent of the developer (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540).
4. the State Pharmacopoeia published the authorized federal body of executive power at the expense of the federal budget and is pereizdaniâm not less than one times five years, between which the published application to the State Pharmacopoeia containing general stat′ii (or) Pharmacopoeial monographs approved since the publication or republication of the State pharmacopoeia.
5. the authorized federal body of executive power of the State Pharmacopoeia places data and applications knej on their official website on the Internet in accordance with the established procedure.
Chapter 4. State control when applying lekarstvennyhsredstv Article 8. licensing of production of medicines ifarmacevtičeskoj activity 1. Licensing the production of medicines and pharmaceutical activities are carried out in accordance with
the legislation of the Russian Federation.
2. A prerequisite for granting licenses for the production of lekarstvennyhsredstv is an annex to the statement of the license applicant list of dosage forms and (or) species of pharmaceutical substances, which the manufacturer intends to produce medicines.
3. If necessary, expanding the production of drugs at the expense of new dosage forms and kinds of pharmaceutical ingredients manufacturer of pharmaceuticals must obtain a new license for the production of medicines.
Article 9. State control (supervision) in the field of obraŝeniâlekarstvennyh means 1. State control (supervision) in the sphere of circulation of medicines includes: 1) licenzionnyjkontrol′ in the production of medicinal products and in the field of pharmaceutical activities;
2) Federal State supervision in the sphere of circulation of medicines;
3) selective 8.5.1 quality control of medicines (paragraph 3 was introduced by the Federal law of December 22, 2014 N 429-FZ collection zakonodatel′stvaRossijskoj Federation, 2014, N 52, art.
7540). 2. Licenzionnyjkontrol′ in the production of medicinal products and in the field of pharmaceutical activity is carried out by the authorized federal body of executive authorities and executive authorities of the constituent entities of the Russian Federation in accordance with their competence, in the manner prescribed by the Federal law of December 26, 2008 year N 294-FZ "on the protection of pravûridičeskih entities and individual entrepreneurs in the exercise of State control (supervision) and municipal control", taking into account the peculiarities of organization and carrying out of checks established by federal law May 4, 2011 year N99-ФЗ "about licensing separate kinds of activity".
3. Federal State supervision in the sphere of circulation of medicinal products is carried out by the authorized federal executive bodies (hereinafter State supervisory bodies) according to their competence, in the manner prescribed by the Government of the Russian Federation.
4. the Federal State supervision in the sphere of circulation of medicines includes: 1) organizing and conducting compliance audits of circulation of medicines prescribed entities nastoâŝimFederal′nym the law and adopted in accordance with it, other regulatory legal acts of the Russian Federation dokliniceski research requirements of medicines, clinical research of drugs, storage, transport, import into the Russian Federation, release, realization of medicines, use of medication, the destruction of drugs as well as compliance with the authorized bodies of the Executive power of the constituent entities of the Russian Federation approach to limit the size of the wholesale and retail size limits allowances to actual cost prices set by manufacturers of pharmaceuticals, drugs and medicines included in the list of essential medicines (hereinafter referred to as mandatory requirements);
2) organizing and conducting compliance audits of medical resources in civil circulation, the requirements to their quality;
3 iprovedenie) the Organization of pharmacovigilance;
4) application in the manner prescribed by the legislation of the Russian Federation, measures to eliminate the revealed violations of mandatory requirements and (or) eliminate the consequences of such violations, including the adoption of a decision about finding the drugs in circulation, issuing regulations on Elimination of revealed violations of mandatory requirements and bring to justice the perpetrators of such violations.
(Part 4 as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540) 5. Federal State supervision in the sphere of circulation of medicinal products is carried out in the manner prescribed by the Federal law of December 26, 2008 year N 294-FZ "Ozaŝite rights of legal entities and individual entrepreneurs priosuŝestvlenii of State control (supervision) and municipal control", taking into account the characteristics laid down in this article.
Preliminary agreement with prosecutors the timing of unscheduled inspection subjects of circulation of medicines, as well as advance notice of legal entities and individual entrepreneurs of the start of this test is not required. Prosecuting authorities are informed about holding unscheduled checks of subjects of circulation of medicines by sending relevant documents within three working days after the end of the ukazannojvneplanovoj validation (as amended by the Federal law of December 22, 2014 N429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540).
6. licaorgana State supervision in the manner prescribed by the legislation of the Russian Federation, have the right to: 1) to receive directly a motivated written requests from subjects of circulation of medicines, the executive authorities of the constituent entities of the Russian Federation and bodies of local self-government, the documents and information on the treatment of pharmaceutical products;
2 i.d. popred″âvlenii) and a copy of the order (orders) on the appointment of the State supervisory body inspection visit used by legal persons, individual entrepreneurs are sub″ektamiobraŝeniâ drugs, while carrying out its activities in the territory, buildings, premises and facilities to conduct monitoring activities;
3) to conduct sampling of medicinal products intended to be sold and implemented by subjects of circulation of medicines, to check their quality, research, testing, in accordance with the rules of otboraobrazcov, established by the authorized federal body of executive power;
4) issuing entities of circulation of medicines regulations on cessation of violations of mandatory requirements and on Elimination of revealed violations of the mandatory requirements;
5) send vupolnomočennye bodies materials related to violations of the mandatory requirements for the resolution of questions regarding the institution of criminal proceedings on grounds of crimes.
7. The selective quality control of medicinal products is carried out by the authorized federal body of executive power in accordance with the established procedure and includes: 1) handling information compulsorily granted to subjects of circulation of medicines, on the series, batches of drugs entering into civil circulation in the Russian Federation;
2) selection of subjects obrazcovlekarstvennyh circulation of medicines in order to conduct tests on their conformity to requirements of normative documents or instruments;
3) adoption porezul′tatam decisions on further tests civil circulation a corresponding medicinal product;
4) prinâtieupolnomočennym Federal Executive Body decision on the relocation of the medicinal product for selective poserijnyj quality control of medicines in case of non-repeated drug quality requirements and (optionally) subject oproverke circulation of medicines. Costs related to sampling poserijnogo the quality of medicines, shall be paid by the manufacturer of the medicinal product or the holder or the owner of the registration certificate of the medicinal product.
(Part 7 introduced the Federal law of 22 dekabrâ2014 g. N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540) (article 9 in the red. Federal law dated June 25, 2012 N 93-FZ-collection of laws of the Russian Federation, 2012, N26, art. 3446) Chapter 5. Development, preclinical studies, and clinical lekarstvennyhsredstv issledovaniâlekarstvennyh products for veterinarnogoprimeneniâ Article 10. Razrabotkalekarstvennyh means 1. Drug development includes sebâpoisk new pharmacologically active substances, further study of their medicinal properties, preclinical research, development of technologies for the production of pharmaceutical substances, developing formulations and technologies for the production of pharmaceuticals.
2. Financial support for the development of medicinal products is carried out through: 1) means federal′nogobûdžeta;
2) sredstvrazrabotčikov medicines;
3) sredstvproizvoditelej medicines when performing research works under the contract between the developer and the manufacturer of medicines medicines;
4) other not prohibited by the law of the Russianfederation sources.
3. the rights of the developer of the drug protected by civil law.
Article 11. Preclinical drug research dlâmedicinskogo application 1. Preclinical study of the drug for medical use is carried out by applying the naučnyhmetodov assessments in order to obtain evidence of safety, quality and efficacy of the medicinal product.
2. Preclinical study of the drug for medical use is carried out in accordance with the rules of good laboratory practice, approved by the authorized federal body of executive power (in red. Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 3. For the Organization and holding of dokliničeskogoissledovaniâ drug for medical use, developers of drugs may involve research institutions, educational institutions of higher education with the necessary material and technical base and skilled professionals in the relevant field of study (as amended by the Federal law dated July 2, 2013 N185-FZ-collection of laws of the Russian Federation, 2013, N 27, art. 3477).
4. Preclinical drug research for medical application held bystatements by the developer of the drug plan with the conduct of the study protocol and compiling a report that soderžatsârezul′taty of this study and the conclusion of the feasibility of a clinical study dlâmedicinskogo drug use.
5. Inspection of compliance with the rules of good laboratory practices and legal standards of animal use in conducting preclinical studies of drugs for medical use is carried out by the authorized federal body of executive power (in red. Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 6. Results of pre-clinical studies of the drug for medical use could be presented to the authorized federal body of executive power in accordance with the established procedure for the State registration of the medicinal product.
Article 12. Dokliničeskoeissledovanie drug ikliničeskoe drug preparatadlâ study veterinary use 1. Preclinical study of the medicinal product for veterinary use shall be carried out by applying scientific methods of evaluations in order to obtain evidence of safety, quality and efficacy of the medicinal product, including the definition of his removal from the body of the animal, in order to ensure the safety of products of animal origin after applying the appropriate medication.
2. Preclinical drug research and clinical study dlâveterinarnogo drug use, a specified medicine bioequivalence study are conducted in accordance with rules approved by the authorized federal body of executive power.
3. Preclinical drug research and clinical study dlâveterinarnogo drug use conducted by an approved razrabotčikomlekarstvennogo plan tools with complete protocols of these studies and drawing up reports containing the results of these studies.
4. To organize and conduct drug dokliničeskogoissledovaniâ and clinical study of the medicinal product for veterinary use razrabotčiklekarstvennogo may involve organizations with the necessary material and technical base and skilled professionals in the respective field of study.
5. Clinical trials of medicinal products for veterinary use shall take place at the veterinary organizations Yves organizations carrying out breeding, planting and maintaining animals, in order to: 1) establishing endurance drugs healthy animals;
2) selection of the optimal dosages of lekarstvennyhpreparatov and treatment on a particular group of animals with a particular disease;
3) ustanovleniâbezopasnosti and effectiveness of drug products, designed for the treatment of certain animal diseases, or effectiveness of the drug for prophylaxis of healthy animals;
4) izučeniâvozmožnostej expansion of indication for use of a registered drug and identify previously unknown side effects.
6. Clinical trial of the medicinal product for veterinary use shall be carried out at the expense of the developer of the drug.
7. Reports on the results of pre-clinical studies drug ikliničeskogo study of the medicinal product for veterinary use shall be prepared by the developer of the drug, taking into account the opinions of the organizations participating in organizing and conducting the research.
8. Monitoring of preclinical studies of drugs and clinical trials of medicinal products for veterinary use is carried out by the authorized federal body of executive power.
Chapter 6. Osuŝestvleniegosudarstvennoj lekarstvennyhpreparatov registration Article 13. State registration of medicinal products 1. In the Russian Federation permitted the production, manufacture, storage, transport, importation, exportation to the Russian Federation from the Russian Federation, advertising, sales, transfer, use, destruction of drugs if they are registered with the relevant authorized federal body of executive power (in red. Federal law dated July 13, 2015 N 241-FZ collection zakonodatel′stvaRossijskoj Federation, 2015, N 29, art. 4367). 2. Gosudarstvennojregistracii: 1) all lekarstvennyepreparaty, first to be issued in the Russian Federation;
2) medicines registered earlier, but made in the other dosage forms in accordance with the list of names in the new dosage forms, dosage in proving its clinical relevance and effectiveness;
3) new combinations of previously registered drugs.
3. State registration of medicinal products is carried out according to the results of the examination of drugs, and the State registration of orphan medicinal products is carried out according to the results of examination of documents submitted to determine whether to consider the drug for medical use during State registration as an orfannogo drug, and expert analyses of medicines.
4. the State registration of the medicinal product shall be administered by an appropriate authorized federal body of executive power in a period not exceeding one hundred and sixty working days from the date of adoption of the corresponding application for the State registration of the medicinal product. Within the specified period of time included time needed for re-examination of the medicinal product, in accordance with article 25 of this federal law. The deadline for State registration of medicinal product is calculated from the date of adoption of the relevant authorized federal body of executive power of the corresponding application for the State registration of the medicinal product with the application of the necessary documents on the day of issuance of the registration certificate of the medicinal product. The time required for the direction of the authorized federal body of executive power of the request for submission of required materials and presentation of the response to the request in accordance with articles 16, 19 and 23 of this federal law, shall not be counted in the calculation of the term of the State registration of the medicinal product.
5. Gosudarstvennojregistracii: 1) shall not be subject to medicinal preparations chemist's organizations, veterinary pharmacy organizations, individual entrepreneurs, who are also licensed to pharmaceutical activity, prescription medicines and medical organizations, veterinary requirements organizations;
2) lekarstvennyepreparaty purchased by individuals outside the Russian Federation and intended for personal use;
3) drugs imported to the Russian Federation for medical assistance for health pokazaniâmkonkretnogo a patient based on a permit issued by the authorized federal body of executive power;
4 lekarstvennyesredstva) imported into the Russian Federation on the basis of the report issued by the authorized federal body of executive power permits and designed to conduct clinical trials of drugs and (or) examination of medicines for the State registration of medicinal products;
5) farmacevtičeskiesubstancii;
6) radiofarmacevtičeskie medicinal preparations made directly in health organizations established by divested the authorized federal body of executive power;
7) lekarstvennyepreparaty produced for export.
6. do not dopuskaetsâgosudarstvennaâ registration: 1) drugs, which differ in the qualitative composition of active substances, under the same trade name;
2) of one drug, produced by a manufacturer under various trade names and submitted for State registration of two or more drugs.
7. On request (vèlektronnoj form or on paper) of the subject of circulation of medicines to the appropriate authorized federal executive body engaged in State registration of medicinal products, in accordance with the established procedure is carried out by scientific advice on issues related to provedeniemdokliničeskih studies, clinical research of drugs, examination of drug quality, efficacy and safety, with the implementation of the State registration of medicines. Counselling is carried out with the involvement of the Federal Government budgetary institutions under the jurisdiction of the federal body of executive power and is not involved in organizing the examination for the quality of medicines in order to implement their State registration in accordance with article 16 hereof, in the form of an answer in writing of the authorized federal body of executive power on request. Size per applicant fee shall be determined in accordance with the legislation of the Russian Federation to organize the provision of public and municipal services. Informaciâob implementation of scientific advice, including articles, reviews, reference materials and other information on the implementation of scientific advice, published on the official website of the authorized federal body of executive power in the Internet, in compliance with the restrictions laid down in the legislation on personal data, commercial and (or) State secrets.
8. State registration of medicinal products which are intended for use in war, emergencies, preventing and treating diseases and lesions, derived from adverse chemical, biological, radiological factors irazrabotany on the instructions of federal bodies of executive power, upolnomočennyhv area national defence and State security, realized in the manner prescribed by the Government of the Russian Federation.
(Article 13 as amended. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) article 14. Principyèkspertizy medicines 1. Èkspertizalekarstvennyh funds is based on the principles of the rule of law, respect for human and civil rights and freedoms, the rights of a legal person, the expert's independence, objectivity, comprehensiveness and completeness of research conducted with the use of modern achievements of science and technology, the responsibility of the Federal State budget Agency for the examination of drugs and experts for holding and quality examination.
2. examination of pharmaceuticals for medical use includes: 1) examination of the documents submitted to determine whether to consider the drug for medical use during State registration as orfannogo medicine;
2) examination of the proposed methods of quality control of medicinal products and the quality of the submitted samples of medicinal products using these methods (hereinafter referred to as the examination of the quality of medicines);
3) examination of the otnošeniâožidaemoj benefit to the possible risk of the medication.
3. examination of medicines for veterinary use includes an examination of the quality of the medicinal product and expertise relationships expected benefits to vozmožnomurisku the use of the medicinal product.
(Article 14 as amended. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) article 15. Federal′noegosudarstvennoe budgetary institution poprovedeniû examination of medicines Èkspertizalekarstvennyh funds held Federal State budgetary institution corresponding to the authorized federal body of executive power that is generated for the enforcement powers of the federal authority for issuing razrešenijna conducting clinical trials of drugs and (or) State registration of medicinal products (hereinafter referred to as an expert institution).
Article 16. Organizaciâprovedeniâ examination of medicines (name as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540) 1. Examination of the medicines Commission experts, expert institutions, appointed its leader, based on examination of job lekarstvennogosredstva, issued by the authorized federal body ispolnitel′nojvlasti.
Head of expert institutions ensures the proper examination of medicines in accordance with the job issued by the authorized federal body of executive power, iorganizuet preparation of a consolidated opinion of the Commission. He decision of the head of the Commission's expert institutions can be included in the kačestveèkspertov of a person who is not working in this expert facility if their special knowledge is necessary for examination and such there are no experts in this expert institution.
2. The expert to conduct èkspertizylekarstvennyh tools is a certified worker peer institutions, which has higher medical, pharmaceutical, veterinary, biological, or chemical education and examines the medicines in the performance of his duties (hereinafter expert).
3. During the examination of medicinal sredstvèkspert could not be located in any depending on the person, naznačivšegoètu, drug developer examination or others interested in the results of examination of persons.
4. During the examination of drugs is not permitted to claim from the claimant or other persons materials necessary for the examination. In slučaenedostatočnosti submitted materials to give expert opinions expert raises the question of submitting the necessary materials before the head of the expert agencies, which calls the appropriate request to the authorized federal body of executive power that issued the job on examination of the medicinal product. The specified federal organispolnitel′noj authorities within five working days from the date of receipt of the request of the head of expert institutions napravlâetzaâvitelû a request for the submission of required materials. This request may be forwarded to the authorized representative of the applicant personally, podraspisku, sent by registered mail or handed over in èlektronnojforme telecommunication liaison channels. In the case of napravleniâdannogo request by registered mail, it is deemed to have been received after six days of sdaty transmission of a registered letter (as amended by the Federal law of November 25, 2013 N 317-FZ-collection of laws of the Russian Federation, 2013, no. 48, art. 6165).
4-1. The claimant is required to submit a response to the request of the Commissioner of the Federal organaispolnitel′noj authorities in a period not exceeding 90 working days from the date of its receipt.
The authorized federal body issuing ispolnitel′nojvlasti job on the examination of the drug, within five working days from the dnâpostupleniâ from the applicant a reply to this query sends this response in expert institution. In case of failure on the expiry of ninety working days the applicant response to this request the authorized federal body of executive power that issued the job on examination of medicines within five working days, sends the expert agency notification of applicant response to a request of that body. Time from the date of the request the expert agencies in upolnomočennyjfederal′nyj the Executive authority before the date of receipt of the expert Agency respond to the request or notice of non-response nazapros is ignored in the calculation of the duration of the examination of the drug (part 4-1 vvedenaFederal′nym Act of November 25, 2013 N 317-FZ-collection of laws of the Russian Federation, 2013, no. 48, art. 6165). 5. The expert when carrying out entrusted to him by the head of the expert examination of the drug agency is obliged to: 1) hold polnoeissledovanie objects, materials submitted to it, give an informed and objective opinion on raised before it or a reasoned conclusion about the impossibility of its examination of the drug, if the questions go beyond the expertise of the expert, the objects of research and insufficient or unsuitable materials for research and conclusion or the current level of development of science is not to answer the questions;
2) not razglašat′svedeniâ, which became known to him in connection with the conduct of the examination of the drug, and takžesvedeniâ,
constituent state, commercial or other secrets protected by law;
3) obespečit′sohrannost′ presented the research objects and materials.
6. the expert may not: 1) èkspertizulekarstvennogo tools for the treatment directly to the organizations or individuals;
2) samostoâtel′nosobirat′ materials for evaluation of medicinal products;
3) provodit′èkspertizu of the drug as a nongovernmental expert.
7. In the case of neobhodimostièkspert has the right to apply to the head of expert institutions of the medicine examination of other experts.
8. Each expert, Member of the Commission of experts, which is responsible for expert examination of the medicinal product, independently and independently conducts research, evaluates the results obtained by them personally and other experts, iformuliruet conclusions regarding the issues raised within its specialized knowledge.
9. the results of the examination of the medicinal product shall be formalised by the conclusion of the Commission of experts. In the opinion of the Commission of experts, identifies a list of studies conducted by each expert studies volume set each of them the facts and made as a result of research findings. Expert opinion which does not coincide with the decision of the Commission of experts shall have the right to express their opinions in writing, which is attached to the conclusion of the Commission of experts.
10. Experts of the Commission, warned on liability in accordance with the legislation of the Russian Federation for having opinions, containing unsubstantiated or false conclusions, as they provide a subscription.
11. Definition of urovnâprofessional′noj training of experts and testing them for the right to carry out examination of medicines carried out expert qualification commissions in the manner prescribed by the respective authorized federal body of executive power. The level of training of experts specified commissions be reviewed not less often than once every five years.
12. rules for the examination of drugs and particularly the examination of certain types of medications (medications reference reproduced drugs, biologičeskihlekarstvennyh preparations bioanalogovyh (Biosimilar) medicines (bioanalogov), homeopathic medicines, medicinal herbal preparations, combinations of drugs), form conclusions of the Commission of experts ustanavlivaûtsâsootvetstvuûŝim the authorized federal body of executive power (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation , 2014, N 52, art. 7540). Article 17. Submission of application for State irassmotrenie registraciilekarstvennogo drug for veterinary use 1. Dlâgosudarstvennoj the registration of the medicinal product for veterinary use, the developer of such drug or an official authorized by him or another legal person (hereinafter in this article-the applicant) is the authorized federal body of executive power responsible for the State registration of medicines for veterinary use, in electronic form or on paper a statement of State registration of medicinal product for veterinary use, as well as in the manner prescribed by the respective authorized federal body of executive power in electronic form or to bumažnomnositele the necessary documents from which to generate registracionnoedos′e for a medicinal product for veterinary use.
2. the statement of State registration of medicinal product for veterinary use shall contain the following: 1) the name and address of the applicant, a developer and manufacturer of the medicinal product for veterinarnogoprimeneniâ and the address of the place of manufacture of the medicinal product for veterinary use (in the case of several participants in the production process, you must specify each of them);
2) name of the medicinal product for veterinary use (International Nonproprietary or generic name, or chemical and commercial names);
3) dejstvuûŝihi list of excipients included in the medicinal product for veterinary use, together with an indication of the number of each of them;
4) dosage form, dosage, ways of introduction and implementation, srokgodnosti medicine for veterinary use;
5) pharmacotherapeutic group;
6) neobhodimost′primeneniâ accelerated examination procedure, drugs for State registration of the medicinal product;
7) copies of the documents certifying the payment of State duty: a) for provedenieèkspertizy the quality of the medicinal product and examination of the relationship of the expected benefits to the possible riskuprimeneniâ of the medicinal product for veterinary use when its State registration;
b) for the issuance of the registration certificate of the medicinal product;
8) consent, under paragraph 7 of this article, if from the moment of registration the reference medicinal product for veterinary use less than čemšest′ (in red. Federal zakonaot July 13, 2015 N 241-FZ-collection of laws of the Russian Federation, 2015, N 29, art. 4367). 3. Registracionnoedos′e for the purposes of examination of the medicinal product for veterinary use shall be formed of the following documents: 1) a copy of the document narusskom language, issued by the competent authority of the country of the manufacturer for each production site registered medicinal product for veterinary use (including the manufacturer of the pharmaceutical substance), certified in the prescribed manner and confirming the compliance of the manufacturer of the registered lekarstvennogopreparata for veterinary use the requirements of the rules of good manufacturing practice, or a copy of the licence to produce medicines for veterinary use for Russian manufacturers;
2) a copy of the opinion on the compliance of the manufacturer of the medicinal product for veterinary use good manufacturing practice regulations issued by the authorized federal body of executive power dlâkaždoj production site registered medicinal product for veterinary use (including the manufacturer of the pharmaceutical substance), or a copy of the licence to produce medicines for veterinary use for Russian manufacturers;
3) normativnogodokumenta project for a medicinal product for veterinary use;
4) document that contains the following information about the pharmaceutical substance or pharmaceutical substances that are part of the medicinal product for veterinary use: a) the name of the pharmaceutical substance, its structure, General properties;
b) name and adresproizvoditelâ;
) tehnologiâproizvodstva with a description of the stages of production and control methods at all stages of production;
g) information oprimesâh;
d) specification nafarmacevtičeskuû substance;
e) description metodikkontrolâ quality;
f) results analizaserij pharmaceutical substance;
w) list standartnyhobrazcov or the substances used in the implementation of quality control;
and opisanieharakteristik and properties) packaging and crating;
to) data stability;
l) expiration date, storage conditions;
5) report on the results of pre-clinical studies of medicinal products for veterinary use;
6) report on the results of a clinical trial of the medicinal product for veterinary use for each species identified in veterinary use;
7) draft guidelines for veterinary use of the medicinal product, containing the following information: a) name of the medicinal product for veterinary use (International Nonproprietary, iligruppirovočnoe, or chemical and commercial names);
b) dosage form indicating the names and composition of active substances and excipients kačestvennogosostava;
in) description the appearance of medicinal product for veterinary use;
g) pharmacotherapeutic group medicinal product for veterinary use or indication "homeopathic medicinal product";
d) pharmacodynamics and pharmacokinetics (except for pharmacokinetics of homeopathic medicines and herbal medicines) or description of immunobiological properties of the medicinal product;
(e)) dlâprimeneniâ;
f) contraindications dlâprimeneniâ;
w) merypredostorožnosti in the application;
and possibilities) an indication of the characteristics of the pregnant animal, animals in the lactation period, the offspring of animals;
k) the dosage, route of administration and use, if necessary, while taking medicine for veterinary use, the duration of treatment;
l) possible side effects, unwanted reactions when use of the medicinal product for veterinary use;
m) symptoms of overdose, measures to assist in overdose;
n) interaction with other drugs and (or) animal feeds;
on the vypuskalekarstvennogo form) of the drug for veterinary use;
n) (if needed) features the action of the medicinal product for veterinary use when opening reception or when its abolition;
r) description (if applicable) action veterinarian (Veterinary Medical Assistant), a specialist in oblastiveterinarii, the owner of an animal when I miss taking one or more doses of medicine for veterinary use;
c) shelf life and prohibition of the use of the medicinal product for veterinary use after the expiry date;
t) storage conditions;
u) naneobhodimost′ storage of the medicinal product for veterinary use of the reach of children;
s) indication (if necessary) special precautions when unused drugs for veterinary use;
x) possible use of products of animal origin after the introduction of animal medicinal preparatadlâ veterinary use;
TS) terms;
h) name and address of the manufacturer's production sites of the medicinal product for veterinary use;
w) name, adresorganizacii, authorized by the holder or the owner of the drug registration certificate on acceptance of the claims from the consumer;
8) projects maketovpervičnoj packaging and secondary packaging of the medicinal product for veterinary use;
9) the following information about the medicinal product for veterinary use: a) description and composition of the medicinal product for veterinary use;
b) opisaniefarmacevtičeskoj;
in) description processaproizvodstva and its control;
g) description of the control of critical stages of production and intermediate products;
d) iadresa name of the developer, the holder or the owner of the drug product registration certificate manufacturing sites of the manufacturer of the medicinal product for veterinary use (as restated by federal law 13iûlâ, 2015. N 241-FZ-Sobraniezakonodatel′stva Russian Federation, 2015, N 29, art. 4367);
(e)) farmacevtičeskaâsovmestimost′;
f) mikrobiologičeskieharakteristiki;
w) material balance for the production of a series of finished product;
and opisanieharakteristik and properties) packaging and crating;
k) dokumental′noepodtverždenie (validation) processes and (or) assessment thereof;
l) kkačestvu auxiliary substances (certificate specification for excipients and their rationale);
m) analytical techniques used in implementing quality control of excipients;
h) documentary evidence (validation) of analytical methods used in quality control of excipients;
o) information on the use of excipients of human or animal origin;
p) information obispol′zovanii new auxiliary substances;
r) requirements for the quality of the medicinal product for veterinary use (certificate specification nalekarstvennyj medication and their rationale);
c) analytical techniques used in monitoring the quality of the medicinal product for veterinary use;
t) documentation (validation) of analytical methods used in quality control of medicinal product for veterinary use;
) a document certifying the quality of Medicine three industrial series (Protocol analysis or certificate of analysis), one series which must coincide with a series of sample medication, filed for registration;
s) harakteristikaprimesej;
x) list of standard designs used in the quality control of medicinal product for veterinary use;
TS) data on the stability of the medicinal product for veterinary use;
10) a copy of the document containing information about the presence or absence of facts, the registration of the medicinal product for veterinary use outside of the Russian Federation;
11) consent in writing referred to in paragraph 7 of this article, in the case of the registration of the medicinal product (reproduced as amended by the Federal law dated July 13, 2015 N 241-FZ-Sobraniezakonodatel′stva Russian Federation, 2015, N 29, art. 4367);
12) copy in the Russian language, certified in the prescribed manner and confirming the legality of application for the State registration of the medicinal product for veterinary use (power of attorney).
4. in conducting the expedited procedure for the examination of the medicinal product for veterinary use with a view to its registration information may be obtained when conducting clinical trials of the medicinal product and published in specialized publications, as well as documents containing the results of the bioequivalence study of the medicinal product for veterinary use.
5. The èkspertizurazličnyh dosage forms of the same medicinal product for veterinary use the applicant submits a separate statement and the registration dossier for each dosage form. Subject to simultaneous filing naèkspertizu one dosage form with different dosage, concentration, volume, the claimant is one application and dossier with application packaging layouts for each dosage every concentration of each volume and the number of doses each per pack.
6. The applicant shall be entitled to deliver, on its own initiative, together with the statement of State registration of medicinal product for veterinary use documents certifying payment of the State fee specified in paragraph 7 of part 2 of this article. In the event of their failure to submit the appropriate authorized federal executive authority verifies that the payment of the State fee by the applicant through the use of information concerning payment of the State fee contained in the public information system of the State and municipal payments, based on evidence produced by the claimant copies of documents certifying the payment of State duty.
7. no commercial use of information on the results of the preclinical studies of drugs and clinical trials of medicinal products for veterinary use, provided by the applicant for the State registration of medicines without his consent within six years from the date of State registration of medicinal product results in the Russian Federation.
(Article 17 as amended. Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540, part 3, paragraph 2 shall enter into force from 1 January 2017goda) article 18. Filing irassmotrenie application for the State registration of medicinal preparatadlâ medical application (name as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540) 1. For State registration of medicinal product for medical use legal person acting in their own interest or authorized to represent the interests of the other entity and drug claims for State registration (hereinafter referred to in this article is on the applicant) shall submit to the authorized federal body of executive power responsible for the State registration of drugs for medical use, in electronic form and on paper a statement of State registration of medicinal product for medical use as well as in the manner prescribed by the authorized federal body of executive power, vèlektronnoj form and required documents on paper, of which registracionnoedos′e is generated for a medicinal product for medical use (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540).
2. in the statement on State registraciilekarstvennogo of the drug for medical use: 1) the name and address of the applicant and manufacturer of the drug for medical use and the address of the place of its production (in the case of several participants in the production process, you must specify each party in accordance with the stage production);
2) name of the medicinal product for medical use (International Nonproprietary, iligruppirovočnoe, or chemical and commercial names);
3) dejstvuûŝihi list of excipients included in the composition of the drug for medical use, with the number of each of them;
4) dosage form, dosage, ways of introduction and implementation, the shelf life of dlâmedicinskogo drug use;
5) pharmacotherapeutic group, code
anatomical therapeutic chemical classification recommended by the World Health Organization, made use of the drug for medical use;
6) no need to provide a report on the results of clinical studies, bioequivalence studies medicinal product authorized for medical use in the Russian Federation for more than twenty years, with an indication of regulatory legal acts, confirming the term of use;
7) neobhodimost′oformleniâ import into the Russian Federation specific party registered and/or unregistered medicines intended for evaluation of medicines in celâhgosudarstvennoj registration;
8) need for examination of the documents submitted to determine whether to consider the drug for medical use during State registration as an orfannogo drug;
9) neobhodimost′primeneniâ accelerated examination procedure, drugs for State registration of the medicinal product;
10 kopiidokumentov), verifying the payment of the State fee: a) for examination of documents submitted to determine whether to consider the drug for medical use during State registration as an orfannogo drug;
b) for provedenieèkspertizy the quality of the medicinal product and examination of the relationship of the expected benefits to the possible riskuprimeneniâ medicinal product authorized for medical use in the Russian Federation for more than twenty years, in carrying out the State registration of the medicinal product;
in) for provedenieèkspertizy the quality of the medicinal product and examination of the relationship of the expected benefits to the possible riskuprimeneniâ medicine for medical applications at its State registration;
g) for provedenieèkspertizy the quality of the medicinal product and examination of the relationship of the expected benefits to the possible riskuprimeneniâ drug for medical use, in respect of which international multicentric clinical studies, some of which are held in the Russian Federation, in carrying out the State registration of the medicinal product;
11) availability of drug soglasiâproizvoditelâ, which is carried out outside the Russian Federation, to conduct an inspection of the manufacturer for compliance with the requirements of the rules of good manufacturing practices;
12) naličiesoglasiâ, under section 18 of the present article;
13) vidalekarstvennogo drug submitted for registration (reference medicinal product contained a drug, biologic drug, bioanalogovyj (biopodobnyj) a drug (bioanalog), homeopathic medicine, medicinal herbal preparation).
(Part 2 as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540) 3. Dossier on the drug for medical use is in the form of document obŝegotehničeskogo (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540). 4. Section dokumentaciiadministrativnogo nature includes: 1) statement of State registration of the drug for medical use in electronic form and on paper;
2) a copy of the document in Russian language, certified in the prescribed manner and confirming the eligibility of the applicant to file an application for the State registration of the medicinal product for medical use (power of attorney);
3) a copy of the license naproizvodstvo medicines or a copy of the opinion on the compliance of the manufacturer lekarstvennyhsredstv the good manufacturing practice regulations issued by the authorized federal body of executive power, incase, if drug production is carried out in the Russian Federation;
4) a copy of the vydannojupolnomočennym authority of the country of the manufacturer of the drug production licenses and its translation to Russian language, certified in the prescribed manner, and a copy of the opinion on the compliance of a manufacturer of medicines good manufacturing practice regulations issued by the authorized federal body of executive power, incase if the manufacture of the medicinal product takes place outside of the Russian Federation;
5) draft instructions pomedicinskomu the use of the medicinal product, containing the following information: a) name of the medicinal product (International Nonproprietary or generic name, or chemical and commercial names);
b) dosage form indicating the names and composition of active substances and excipients kačestvennogosostava (if necessary, quantitative composition of excipients);
in) description the appearance of the drug for medical use;
g) the physico-chemical properties (for radiopharmaceutical drugs);
d) pharmacotherapeutic group, the code of the medicinal product for medical use on the anatomical therapeutic chemical classification recommended by the World Health Organization, or the words "homeopathic medicinal product";
e) pharmacodynamics and pharmacokinetics (except for pharmacokinetics of homeopathic medicines and herbal medicines);
f) indications dlâprimeneniâ;
w) contraindications dlâprimeneniâ;
and merypredostorožnosti) in the application;
the capabilities and features of) the indication of the use of the drug for medical use by pregnant women, breastfeeding women, children, adults with chronic illnesses;
l) dosing regime, ways of introduction and implementation, if necessary while taking medicine for medical use, duration of treatment, including in children before and after one year;
m) possible unwanted reactions when applying the drug for medical use;
h) symptoms of overdose, measures to assist in overdose;
about) interaction with other drugs and (or) food;
p) forms vypuskalekarstvennogo of the drug;
r) indication (if necessary) features the action of the medicinal product for medical use when opening reception or when its abolition;
c) description (if applicable) action (paramedic) and (or) patient when I miss taking one or more doses of the drug for medical use;
t) possible vliânielekarstvennogo of the drug for medical use on the ability to drive vehicles, mechanisms;
shelf life) and prohibition of the use of the medicinal product for medical use after the expiry date;
f) storage conditions;
x) to specify storage naneobhodimost′ medicine for medical use in places inaccessible to children;
TS) indication (if necessary) special precautions when unused drugs for medical use;
h) conditions of leave;
w) name and address of the manufacturer's production sites liposomal;
щ) name, adresorganizacii, authorized by the holder or the owner of the registration certificate of the drug for medical use on the adoption of the consumer;
6) medical application instructions or a brief description of the drug, approved in the country of the producer;
7) projects maketovpervičnoj packaging and secondary packaging of the medicinal product for medical use;
8) normativnojdokumentacii project or instrument for a medicinal product for medical use or to specify appropriate Pharmacopeia articles;
9) document soderžaŝijinformaciû about the presence or absence of facts, the registration of the medicinal product for medical use outside of the Russian Federation;
10) copies of the documents certified in the prescribed manner and confirming the registration of the medicinal product in foreign States as drug orfannogo;
11) management plan for biological drugs for medical use;
12) document on the sistemefarmakonadzora holder or holder of the registration certificate of the medicinal product;
13) document, confirming the quality of Medicine three industrial series (Protocol analysis or certificate of analysis), one series which must coincide with a series of sample medicine for medical applications submitted for State registration.
(Part 4 in red. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) 5. Section of the chemical, pharmaceutical and biological
documentation includes the documents containing information on pharmaceutical substances and medicinal product for medical use, production process and quality control methods, including: 1) a copy of the document that contains the following information about the pharmaceutical substance or pharmaceutical substances that are part of the medicinal product: a) the name of the pharmaceutical substance, its structure, General properties;
b) name and adresproizvoditelâ;
) tehnologiâproizvodstva with a description of the stages of production and control methods at all stages of production;
g) description razrabotkiprocessa production;
d) description of the control of critical stages of production and intermediate products;
(e)) dokumental′noepodtverždenie (validation) processes and (or) assessment thereof;
f) properties and strukturadejstvuûŝih substances;
w) harakteristikaprimesej;
and pharmaceutical substance) specification and its rationale;
c) analytical techniques used in the quality control of pharmaceutical substances;
l) documentary evidence (validation) of analytical methods used in quality control of pharmaceutical substances;
m) analizaserij results of the pharmaceutical substance;
n) list standartnyhobrazcov or the substances used in the implementation of quality control;
opisanieharakteristik and properties of) packaging and crating;
p) data on stabil′nostifarmacevtičeskoj substances;
r) expiry date;
2) document that contains the following information about the medicinal product for medical use: a) description and sostavlekarstvennogo of the drug for medical use;
b) opisaniefarmacevtičeskoj (substantiation of choice of composition, primary packaging and other);
) tehnologiâproizvodstva with a description of the stages of production and control methods at all stages of production;
g) kontrolâkritičeskih description of the stages of the production process and intermediate products;
d) name and address of the place of manufacture of the medicinal product for medical use (if there are several participants in the production process, you must specify each of them);
(e)) farmacevtičeskaâsovmestimost′;
f) mikrobiologičeskieharakteristiki;
w) material balance for the production of a series of finished product;
and opisanieharakteristik and properties) packaging and crating;
c) documentary proof (validation) of production processes and (or) assessment thereof;
l) kkačestvu auxiliary substances (certificate specification for excipients and their rationale);
m) analytical techniques used in implementing quality control of excipients;
h) documentary evidence (validation) of analytical methods used in quality control of excipients;
o) information on the use of excipients of human or animal origin;
p) information obispol′zovanii new auxiliary substances;
r) requirements for the quality of medicine for medical application (certificate specification for a medicinal product and the reasons therefor);
c) analytical techniques used in monitoring the quality of the drug for medical use;
t) documentation (validation) of analytical methods used in quality control of medicinal product for medical use;
u) test results of batches of the drug for medical use;
s) harakteristikaprimesej;
x) list of standard designs used in the quality control of medicinal product for medical use;
TS) data on the stability of the drug for medical use.
(Part 5 in red. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) 6. Section pharmacological, toxicological documentation includes reports on the results of the preclinical studies of the drug for medical use, including: 1) report ofarmakodinamičeskih research;
2) report ofarmakokinetičeskih research;
3) report on toksikologičeskihissledovaniâh.
(Part 6 introduces the Federal law of 11, oktâbrâ2010. N 271-FZ-collection of laws of the Russian Federation, 2010, N 42, art. 5293; in red. Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540) 7. Kliničeskojdokumentacii section includes reports on the results of the clinical issledovanijlekarstvennogo drug for medical use, including: 1) research reports bioavailability and bioequivalence research establishing a correlation of results obtained in vitro and in vivo;
2) reports ofarmakokinetičeskih research;
3) reports ofarmakodinamičeskih research;
4) reports on clinical studies of efficacy and safety;
5) report opostregistracionnom experience (if any).
(Part 7 of the Act of December 22, 2014 vvedenaFederal′nym N 429-FZ collection zakonodatel′stvaRossijskoj Federation, 2014, N 52, art. 7540) 8. Information requirements provided in the composition of the registration dossier, for certain types of drugs for medical use are set by the authorized federal body of executive power (part 8 introduced the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art.
7540). 9. Against drugs, permitted for medical use in the Russian Federation for more than twenty years (except for biological medicinal products), allowed the inclusion of section pharmacological, toxicological and clinical documentation section documentation instead of the developer's report on the results of the preclinical studies of their own drugs and clinical trials of pharmaceuticals for medical use obzoranaučnyh works on the results of the preclinical studies of medicines and clinical research data lekarstvennyhpreparatov including experience with their postregistracionnogo application (part 9 introduced the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art.
7540). 10. When State registration reproduced drugs for medical use permitted the inclusion of section pharmacological, toxicological and clinical documentation section documentation instead of the developer's report on the results of the preclinical studies of its own medicines review scientific papers on the results of preclinical studies: lekarstvennogopreparata and view instead of clinical studies in full, prescribed by the section of clinical documentation, report on the results of the bioequivalence studies reproduced drug for medical use. Not required to submit a report on the results of the bioequivalence studies reproduced medicine for medical use if registered reproduced drugs for medical use, which: 1) are intended for parenteral (subcutaneous, intramuscular, intravenous, vnutripolostny, intraocular, intra-articular, vnutrikoronarnogo) introduction and represent aqueous solutions;
2 sobojrastvory) for oral use;
3) are produced in the form of powder or freeze-dried products for preparation of solutions;
4) are gases;
5) are ušnymiili eye medicines produced in the form of water solutions;
6) local applications are designed and prepared in the form of water solutions;
7) topics aqueous solutions for use in the form of inhalations using the nebulizer or as nasal sprays applied using similar devices.
(Part of the vvedenaFederal′nym Act of 10 December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) 11. For the cases referred to in paragraphs 1-3, 5-7 part 10 of this article, reproduced a drug for medical use must contain the same excipients in the same quantities, as the reference drug product. If convoys excipients are different, the claimant must provide evidence that are used in these concentrations of excipients do not affect the safety and/or efficacy of the medicinal product for medical use. If the applicant is unable to produce such proof of age and (or) does not have access to relevant information, it should undertake appropriate research to prove the lack of influence of different excipients or assistive devices on the safety and/or efficacy of the medicinal product for medical use in the manner prescribed by the authorized federal body of executive power (part 11 introduced by the Federal law of December 22, 2014 N 429-FZ collection
the legislation of the Russian Federation, 2014, N 52, art. 7540). 12. At the State registration of combinations of previously registered drugs for medical use permitted the inclusion of section pharmacological, toxicological and clinical documentation section documentation instead of the developer's report on the results of own preclinical studies of medicinal sredstvobzora research papers on the results of the preclinical studies of reference drugs comprising combinations of drugs, and the lack of their interaction with water dosage form (part 12 of the Federal law was introduced December, 2014 ot22. N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 13. The èkspertizurazličnyh dosage forms of the same drug for medical application the applicant submits a separate statement and the registration dossier for each dosage form. Subject to simultaneous filing naèkspertizu one dosage form srazličnymi dosage, concentration, volume, the claimant is one application and dossier with the layout application packages on každuûdozirovku each concentration, each ob″emi each number of doses per Pack (Part 13 introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 14. When gosudarstvennojregistracii drug orfannogo the applicant submits the information needed to form a section of clinical documentation, in the amount established by the authorized federal body of executive power (part 14 introduced the Federal law of 22 dekabrâ2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540).
15. When registraciibiologičeskogo drug derived from blood, human blood plasma, in the registration dossier for a medicinal product for medical use should be submitted Additionally: 1) in the documentation section of the administrative nature of the document that contains the information about the treatment of donor blood and its components, about where the donation was carried out (blood and/or blood plasma), as well as data on infectious diseases transmitted through parenteral information about the treatment of donor blood and its components, subject to verification of donor blood and its components;
2) in the chemical, pharmaceutical and biological documentation: (a) criteria for the selection of isposoby), transportation and storage of donor blood and its components;
b) rezul′tatyissledovanij selected blood and/or blood plasma and pools for the presence of pathogens of infections, including information on research methods used in the case study of plasma pools results documenting (validation) of the used methodologies;
in the technical data for the selection of the packaging) of blood and/or blood plasma, including information on anticoagulants solutions used.
(Part of the vvedenaFederal′nym Act of 15 December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540) 16. Clinical studies of the drug for medical use with a view to its registration in the Russian Federation are held in order, ustanovlennomstat′âmi 38-44 of this federal law. Research report is included in the section of clinical documentation of the registration dossier for a medicinal product for medical use. For drugs for medical use, in respect of which as a result of the èkspertizydokumentov submitted to determine whether to consider the drug for medical use as a orfannogo drug, this possibility is recognized and in respect of which the provedenykliničeskie studies outside the Russian Federation, in accordance with the rules of good laboratory practice and the rules of nadležaŝejkliničeskoj practice, allowed the inclusion of the section of clinical documentation instead of the account of the results of clinical trials of the drug for medical use provedennyhv, Russian Federation, a report on the results of clinical studies, vypolnennyhza outside of the Russian Federation (part 16 introduced by the Federal law of December 22, 2014 N429-FZ-collection of laws of the Russian Federation, 2014, N 52, art.
7540). 17. Zaâvitel′vprave provide, on its own initiative, together with the statement of State registration of the drug for medical use documents certifying payment of the State fee specified in paragraph 10 of part 2 of this article. In the event of their failure to submit the appropriate authorized federal executive authority verifies that the applicant State duty through the use of information concerning payment of the State fee contained in the public information system of the State and municipal payments, based on evidence produced by the claimant copies of documents certifying payment of the State duty (part 17 introduced by the Federal law of December, 2014 ot22. N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 18. You may not use the information for commercial purposes on the results of the preclinical studies of drugs and clinical trials of drugs for medical use, provided by the applicant for the State registration of medicinal product without his consent within six years from the date of State registration of medicinal product results in the Russian Federation (part 18 introduced the Federal law of December 22, 2014 N 429-FZ collection zakonodatel′stvaRossijskoj Federation , 2014, N 52, art.
7540). 19. The holder or the owner of the registration certificate of the medicinal product in biotechnology or medical product orfannyj must provide on a reimbursable basis the reference medicinal product samples to the applicants to conduct clinical research. The cost of the medication obrazcareferentnogo, included in the list of essential drugs, should not exceed the selling price limit on registered reference drug product or the price of the drug from the manufacturer (Part 19 introduced the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540).
20. a statement of the gosudarstvennojregistracii reproduced medicine for medical use may be filed with the authorized federal body of executive power responsible for the State registration of medicinal products, on the expiry of four years from the date of State registration of medicinal product results in the Russian Federation (part 20 introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540).
21. Statement of State registration bioanalogovogo (biopodobnogo) medication (bioanaloga) can be filed with the authorized federal body of executive power responsible for the State registration of medicinal products, on the expiration of three years from the date of State registration of medicinal product results in the Russian Federation (part of the vvedenaFederal′nym Act of 21 December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540).
22. The holder or the owner of the registration certificate of the medicinal product represents the authorized federal body of executive power that exercises control and supervisory functions in the areas of health, report on results of pharmacovigilance once every six months for two years after the State registration of the medicinal product in the Russian Federation, annually over the next three years and thereafter every five years (part 22 introduced by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation , 2014, N 52, art. 7540). Article 19. Adoption of extradition expert job agency SolutionsAbout naprovedenie examination of medicinal products 1. Within desâtirabočih days from the date of adoption of the Declaration on the State registration of the corresponding medicinal product authorized federal executive body inspects the completeness, accuracy and validity of the documents submitted registration dossier for a medicinal product and shall decide whether to conduct job: 1) examination of documents submitted to determine whether to consider the drug for medical use during State registration as orfannogo medicine;
2) examination of the drug in parts of medicinal product quality examination and examination of the relationship of the expected benefits to the possible risk of the medicinal product for medical use;
3) examination of the drug in parts of medicinal product quality examination and examination of the relationship of the expected benefits to the possible risk of medicine for medical application in the accelerated procedure of examination of medicines in accordance with article 26 of this federal law;
4) examination of the medicinal product in respect of the medicinal product for veterinary use.
2. the authorized federal body of executive power shall notify electronically or on paper zaâvitelâi expert institution of the decision on the extradition of jobs on valuations provided by part 1 nastoâŝejstat′i, and, if necessary, the authorization to import into the Russian Federation to a particular party, the series registered and/or unregistered medicines or on refusal to conduct expert examinations envisaged together with the reasons for such denial.
3. In case of absence or authenticity of the information contained in the documents submitted by the applicant, the authorized federal body of executive power shall send to the applicant a request for clarification of this information (hereinafter referred to as the request of the authorized federal body of executive power) that can be transmitted by an authorized representative of the applicant personally against receipt, sent by registered mail or transmitted in electronic form on telecommunication liaison channels. In the case of a request of the authorized federal body of executive power by registered mail, it is deemed to have been received after six days from the date of dispatch of a registered letter.
4. The applicant is obliged to submit a response to the request of the authorized federal body of executive power in a period not exceeding 90 working days from the date of its receipt. Term specified in part 1 of this article shall be suspended, from the date of the applicant request the authorized federal body of executive power until the day of receipt of the appropriate response.
5. Grounds for refusal in the Organization of examinations provided by paragraph 1 of this article is to present the necessary to carry out examinations of incomplete documents or failure by the claimant in response to the request of the authorized ustanovlennyjsrok Federal organaispolnitel′noj authorities, as well as the introduction of documents that do not contain an exhaustive list of the necessary information.
(Article 19 in red. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) article 20. Èkspertizadokumentov to the opredeleniâvozmožnosti consider a drug for medical primeneniâpri implementation of public registraciiv as orfannogo medicine 1. Examination of documents submitted to determine whether to consider the drug for medical use during State registration as orfannogo medication, drafting komissiejèkspertov opinion on the possibility or impossibility of considering a drug for medical use during State registration as an orfannogo medication and direction of this conclusion in the authorized federal body of executive power are carried out within a period not exceeding thirty working day of receiving the dnejso expert job agency authorized federal body of executive power and electronic formeili on paper documents required referred to in paragraphs 1, 2, 5, 6, 10 part 4 and part 7 of article 18 hereof.
2. The documents contained in the registration dossier for a medicinal product and received in paper form in the expert Agency for the implementation of their examination to determine the possibility of considering a drug for medical use as a orfannogo drug, should be returned to the authorized federal body of executive power at the same time with relevant expertise.
(Article 20 as amended. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) article 21. Decision ovozmožnosti considered a drug in implementing gosudarstvennojregistracii as a orfannogolekarstvennogo preparation 1. In the neprevyšaûŝij period of five working days from the receipt of the report specified in subsection 1 of article 20 of this federal law, an authorized Federal Executive Body assesses the resulting conclusion to determine its compliance with the instructions of the appropriate expertise and shall notify the applicant in electronic form or on paper nositeleo the findings of the examination with the application a copy of the expert opinion (preserving the confidentiality of the information on the composition of the Expert Commission) and on the possibility or impossibility of considering a drug for medical use during State registration as a orfannogo medication.
2. If the expert conclusion on the possibility of vyneseniikomissiej consider the drug for medical use during State registration as an orfannogo drug authorized federal body of executive power in a period not exceeding five working days after receipt of the opinion, shall decide whether the job on the examination of the quality of medicinal expertise into the relationship of the expected benefits to the possible riskuprimeneniâ medicine for medical application in the accelerated procedure of examination of the medicinal product, in accordance with article 26 of this federal law.
3. In the slučaeprinâtiâ decision of impossibility of considering a drug for medical use under the State registration as an orfannogo drug authorized federal body of executive power shall terminate the procedure of State registration of the medicinal product. The applicant may apply to the Registrar a statement of State registration of the specified medicinal product in accordance with article 18 of this federal law.
(Article 21 as amended. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) article 22. (Repealed based on Federal′nogozakona from December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540) Article 23. Èkspertizakačestva medicine and èkspertizaotnošeniâ of the expected benefits to the vozmožnomurisku use of medicinal preparatadlâ medical applications 1. Examination of kačestvalekarstvennogo tools and expertise relationships expected benefits to the possible risk of medicine for medical applications, drafting commissions of experts opinions on the results of the examinations and direction of these findings to the authorized federal body of executive power are carried out within a period not exceeding one hundred and ten working days after receipt of the appropriate job agency experts authorized federal body of executive power and the necessary documents vèlektronnoj form or on paper.
2. Within ninety days from the date of receipt of the decision of the authorized federal body of executive power of the examinations provided by paragraph 1 of this article, the applicant submits in the expert Agency for the examination of the quality of the medicinal product drug samples for medical use, in accordance with the requirements of experimental-industrial and (or) the industrial regulations and approved rukovoditelemproizvoditelâ medicines, as well as, where appropriate, samples of the pharmaceutical substance test-strains of microorganisms, cell cultures, samples of substances used for quality control of medicinal products by comparing them with the investigational drug, in quantities needed to play methods of quality control.
3. upon receipt of samples of medication and pharmaceutical substances expert institution shall issue to the applicant a document confirming the receipt of these specimens, and in a period not exceeding three (3) working days shall notify electronically or on paper of the authorized federal body of executive power.
4. Specified in parts 2 and 3 of this article, the time limit for submission of applicant drug samples and pharmaceutical substance and the deadline to inform the expert agency on paper the authorized federal body of executive power are not included in the duration of examinations provided by paragraph 1 of this article.
5. documents received by the expert Agency for the conduct of examinations, provided by paragraph 1 of this article shall be returned to the authorized federal organispolnitel′noj
authorities simultaneously with the findings obtained by results of relevant expertise.
(Article 23 as amended. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) article 24. Èkspertizakačestva medicine and èkspertizaotnošeniâ of the expected benefits to the vozmožnomurisku use of medicinal preparatadlâ veterinary use 1. Examination of kačestvalekarstvennogo tools and expertise relationships expected benefits to the possible risk of the medicinal product for veterinary use, drafting commissions èkspertovzaklûčenij based on the results of these examinations and the direction of such opinions in the authorized federal body of executive power are carried out within a period not exceeding one hundred and ten working days from the date of receipt of the expert učreždeniemzadaniâ authorized federal body of executive power with the documents specified in part 3 of article 17 nastoâŝegoFederal′nogo Act (as amended by the Federal law of October 22, 2014 N 313-FZ-collection of laws of the Russian Federation , 2014, N 43, St.
5797; Federal law dated July 13, 2015 N 241-FZ-collection of laws of the Russian Federation, 2015, N 29, art. 4367). 2. Within fifteen working days from the dnâpolučeniâ resolution of the authorized federal body of executive power on the holding referred to in paragraph 1 of this article, èkspertizzaâvitel′ is the expert Agency for the examination of the quality of the drug obrazcylekarstvennogo drug for veterinary use produced in accordance with the requirements of technological regulations, approved by the head producer of medicines, as well as a sample of the pharmaceutical substance in quantities necessary for playback quality control methods.
3. upon receipt of samples of medication and pharmaceutical substances expert institution shall issue to the applicant a document confirming the receipt of these specimens, and in a period not exceeding three (3) working days, notifies in writing of the authorized federal body of executive power.
4. term of the fifty applicant drug samples and pharmaceutical substance and the deadline to inform the expert agency in writing of the authorized federal body of executive power listed in the parts 2 or 3 of this article, are not included in the dates referred to in paragraph 1 of this article.
5. documents received by the expert Agency for the conduct referred to in paragraph 1 of this article, the examinations are to be returned to the authorized federal body of executive power simultaneously with conclusions based on the results of these examinations.
Article 25. Povtornoeprovedenie examination of medicines (name as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540) 1. In cases of insufficient substantiation or incompleteness of the conclusion of the Commission of experts, the presence of protivorečivyhdannyh, falsification of findings examination of the drug, concealing from the authorized federal body of executive power of the grounds for disqualification of the expert as a result of egozainteresovannosti in the results of the expertise, availability of data on direct or indirect interference in the process of sootvetstvuûŝejèkspertizy persons not participating in it, but affecting the process and results of its implementation, the authorized federal body of executive power shall be re-reviewing drug and (or) the ethical examination (as amended by the Federal law of 22 December, 2014. N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 2. Repeated èkspertizalekarstvennogo funds takes into account results of earlier examination within the period established by the authorized federal body of executive power and no more than 30 working days after receiving the expert agency job to conduct re-examination of the medicinal product (harm. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540). 3. Finansovoeobespečenie job execution to conduct re-examination of the medicinal product is not carried out (in red. Federal law ot22 December 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). Article 26. Uskorennaâprocedura examination of drugs 1. Uskorennaâprocedura examination of medicines for the State registration of medicinal products applies in respect of orphan drugs, the first of the three drugs that are registered in the Russian Federation as reproduced drugs, the sequence of which shall be determined in accordance with the date and number of incoming applications for the State registration of medicines as part of an international drug names nepatentovannogo or gruppirovočnogo names, medication and drugs intended solely for the use of minors by the citizens (as restated by federal law dekabrâ2014, 22. N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540; Federal law dated July 13, 2015 N 241-FZ-collection of laws of the Russian Federation, 2015, N 29, art.
4367). 2. Uskorennaâprocedura examination of medicines for the State registration of medicinal products does not apply to: 1) bioanalogovyh (Biosimilar) medicines (bioanalogov);
2) reference medications (except for orphan drugs);
3) vosproizvedennyhlekarstvennyh drugs (except the first three registered in the Russian Federation as reproduced in medicines and medicinal products intended solely for the use of minors by the citizens);
4) new combinations of previously registered drugs;
5) drugs registered earlier, but produced in other dosage forms in accordance with the list of names in the new dosage forms and dosage.
(Part 2 in red. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) 3. Expedited procedure for the examination of drugs is carried out by decision of the relevant body of executive power upolnomočennogofederal′nogo on the basis of the application of zaâvitelâv period not exceeding eighty days. When ètomèkspertiza registracionnomdos′e to the documents contained in the medicinal product, shall be carried out remains, not exceeding ten working days, forensics tools and kačestvalekarstvennogo examination of the relationship of the expected benefits to the possible risk of the medicinal product shall be held not more than šestidesâtirabočih days (in red. Federal′nogozakona from December 22, 2014 N 429-FZ collection zakonodatel′stvaRossijskoj Federation, 2014, N 52, art.
7540.) 3-1. With regard to orphan medicinal preparatovmogut be presented the results of the preclinical studies of drugs and clinical trials of drugs for medical use, performed outside the Russian Federation, in accordance with the rules of good laboratory practice and good clinical practice rules (part 3-1 introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art.
7540). 4. Expedited procedure for the examination of drugs shall be conducted in the manner prescribed by articles 17-20, 23 and 24 of this federal law and does not mean lowering the trebovanijk safety, quality and efficacy of medicines.
Article 27. Decision ogosudarstvennoj drug registration 1. In time, neprevyšaûŝij ten working days from the date of receipt of the conclusions of the Commission of experts on the results of the examination of the quality of the medicinal product and examination of the relationship of the expected benefits to the possible risk of the medicinal product, corresponding to the authorized federal body of executive power (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540): 1) places nasvoem the official website of the Internet relevant conclusions of the Commission of experts and carries out evaluation to determine whether the job for these examinations ( in red. Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
2) takes the decision on the State registration of the medicinal product or the refusal of State registration of the medicinal product;
3) makes when taking a decision on the State registration of medicinal product data of the registered drug medication, including pharmaceutical substances included in the medicinal product, in the State Register of medical products and issues to the applicant a certificate of registration of the medicinal product, the form kotorogoutverždaetsâ
the authorized federal body of executive power, agreed normative documentation, normative document, the instructions for use of the medicinal product and primary packaging layouts and secondary (consumer) packages with indication of them drug registration certificate numbers and dates of its State registraciiili in the event of a decision to refuse the drug gosudarstvennojregistracii notifies in writing the zaâvitelâob indicating pričintakogo failure. For vydačuregistracionnogo drug identity is levied in accordance with the laws of the Russianfederation on taxes and fees (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540).
2. Reason for refusal in State registration of the medicinal product concerned is an authorized federal executive body, that the quality and (or) the effectiveness of the drug registriruemogolekarstvennogo not supported by data or that the risk of harm zdorov′ûčeloveka or animal as a result of drug intake exceeds the effectiveness of egoprimeneniâ (in red. The Federal law from October 2010 N 271-FZ-collection of laws of the Russian Federation, 2010, N 42, art. 5293). 3. Povtornoepredstavlenie to the appropriate authorized federal body of executive power of the medicinal product in respect of which the refusal in State registration and which was subsequently changing its composition, is regarded as a new drug submission to his State registration regardless of saving its primary name (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540). Article 27-1. Porâdokopredeleniâ interchangeability of pharmaceuticals for medical use 1. Interchangeability of pharmaceuticals for medical use is determined in accordance with the procedure established by the Government of the Russian Federation, on the basis of the following parameters: 1) equivalence (bioanalogovyh (Biosimilar) medicines (bioanalogov)-comparable) quantitative and qualitative characteristics of pharmaceutical substances (use different salts, esters, isomers, complexes, crystalline forms and other derivatives of the same active substance is not an obstacle to the interchangeability of medicinal preparations If in conducting bioequivalence studies of the medicinal product or in case of impossibility to conduct this study, the therapeutic equivalence study medication proven lack of clinically important differences in pharmacokinetics and (or) security and èffektivnostilekarstvennogo of the drug for medical use);
2) equivalence of dosage form (under equivalent dosage forms refers to different dosage forms that have the same route of administration and usage possessing comparable pharmacokinetics characteristics and pharmacological action and to achieve desired clinical effect differences dosage forms are not an obstacle for their interchangeability, if in conducting bioequivalence studies lekarstvennogopreparata or in case of impossibility to conduct this study, the therapeutic equivalence study medication proven lack of clinically important differences in pharmacokinetics and (or) the safety and efficacy of the medicinal product for medical use);
3) equivalence of ilisopostavimost′ composition of auxiliary substances of the medicinal product for medical use (differences of composition of auxiliary substances of the medicinal product for medical use is not âvlâûtsâprepâtstviem for their interchangeability, if in conducting bioequivalence studies medicine for medical use or in case of impossibility to conduct ètogoissledovaniâ the therapeutic equivalence study drug for medical use proven lack of clinically important differences in pharmacokinetics and (or) the safety and efficacy of the drug for medical use. The distinction composition excipients should not lead to risk of serious
unwanted reactions in certain groups of patients or increase the frequency of their occurrence);
4) identity sposobavvedeniâ and application;
5) no clinically significant differences in conducting bioequivalence studies of the medicinal product or in case of impossibility to conduct this study, the absence of clinically relevant differences in safety performance and effectiveness of the drug in a study of therapeutic equivalence. This option does not apply to reproduction of medicines indicated in paragraph 10 of article 18 hereof. Regarding bioanalogovyh (Biosimilar) medicines (bioanalogov) information about the absence of clinically relevant differences in safety, efficacy and immunogenicity the medication according to the results of clinical studies are available in the manner prescribed by this part;
6) compliance of the manufacturer of the drug good manufacturing practices requirements.
2. Comparison of parameters of registered pharmaceuticals for medical use is carried out by the Commission of experts, expert agencies during the examination of such drugs in their gosudarstvennojregistracii.
The experts ' findings about the interchangeability or nevzaimozamenâemosti drugs for medical use, made as a result of this comparison, are issued as an annex to the opinion of Experts approved by the authorized federal body of executive power.
3. the provisions of this article shall not apply to reference medicinal drugs medicinal herbal products, homeopathic medicines and drugs that are permitted for medical use in the Russian Federation for over twenty years and in respect of which it is impossible to study their bioequivalence.
(Article 27-1 vvedenaFederal′nym Act of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540) article 28. drug registration certificate 1. Registracionnoeudostoverenie drug with indication of dosage forms and dosage is granted indefinitely, except for drug registration certificate is issued with a validity of five years, for the first time registered in the Russian Federation: medicinal preparations.
2. Upon the expiration of the specified part 1 nastoâŝejstat′i term issued indefinite drug registration certificate subject to confirmation of its State registration.
3. If, in accordance with articles 30 and 31 of this federal law changes contained in the registration dossier drug nazaregistrirovannyj documents zatragivaûŝihsvedeniâ, as reflected in the registration certificate of the medicinal product, the authorized federal body of executive power shall issue a new certificate of registration of the medicinal product, containing the made changes (soit part 3 introduced the Federal law of 22 dekabrâ2014 N 429-FZ-collection of laws of the Russian Federation , 2014, N 52, art. 7540). 4. In the case of loss of or damage to the drug registration certificate upon application in writing to the owner or holder of the registration certificate of the medicinal product or another entity they duplicate registracionnogoudostovereniâ medicinal product authorized federal body of executive power in a period not exceeding 10 working dnejso of receipt of an application, issue a duplicate registration certificate of the medicinal product. For issuance of a duplicate registration certificate medicinal preparatavzimaetsâ State duty in accordance with the legislation of the Russian Federation on taxes and fees (part 4 introduced the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). Article 29. reaffirmation of the State registration of medicinal product 1. Confirmation of State registration of medicinal product is performed when granting indefinite drug registration certificate in case specified in part 2 of article 28 of this federal law in a period not exceeding 90 working days from the date of polučeniâsootvetstvuûŝim the authorized federal body of executive power of the Declaration on the commitments of the State registration of the drug for medical use, in accordance
Part 2 of article 18 hereof, libozaâvleniâ for confirmation of State registration of medicinal product for veterinary use, issued in accordance with part 2 of article 17 of the present Federal Act (as amended by the Federal law dated July 13, 2015 N 241-FZ-collection of laws of the Russian Federation, 2015, N 29, art. 4367). 2. Confirmation of State registration of medicinal product is carried out by the results of the examination of the relationship of the expected benefits to the possible risk of the medicinal product, as well as examination of kačestvalekarstvennogo funds, carried out in the event of changes in the normative documentation or normative document (harm. Federal law dated November 29, 2010 N 313-FZ-Sobraniezakonodatel′stva Russian Federation 2010, N 49, St. 6409). 3. The statement on the confirmation of State registration of medicinal product for medical use are attached a document certifying payment of the State fee for confirming the State registration of the drug for medical use, a document containing the results of the monitoring bezopasnostilekarstvennogo medicine for medical application held by the claimant in the form established by the relevant authorized federal′nymorganom Executive, document, translated into the Russian language, confirming that the manufacturer of the medicinal product for medical use good manufacturing practice regulations issued by the competent authority of the country of the manufacturer of the drug for medical use and certified in accordance with the established procedure, document, translated into the Russian language, confirming that the manufacturer of the pharmaceutical substance requirements of the good manufacturing practices regulations, issued by the competent authority of the country of the manufacturer of the pharmaceutical substance, certified in the prescribed manner and containing the pharmaceutical substance name (International Nonproprietary or chemical name itorgovoe), naimenovaniei address of the manufacturer of the pharmaceutical substance, the shelf life of pharmaceutical substances (as amended by the Federal law of December 29, 2015 (N) 389-FZ-collection of laws of the Russian Federation, 2015, N, St. ).
3-1. the application for confirmation of the State registration of medicinal product for veterinary use shall be accompanied by proof of payment of the prescribed State fee for confirming state registration of medicinal product for veterinary use, a document containing the results of the monitoring of drug safety held by the claimant in the form established by the relevant authorized federal body of executive power, as well as the documents referred to in paragraph 1 and subparagraphs "a", "b", "k", "l" item 4 of part 3 of article 17 hereof (part 3-1 introduced by the Federal law dated July 13, 2015 N 241-FZ-collection of laws of the Russian Federation, 2015, N 29, art. 4367.) 3-2. Normativnaâdokumentaciâ or normative document, draft regulations on application of medicinal preparation, draft primary packaging layouts and secondary (consumer) drug packaging attached to the application for confirmation of the State registration of medicinal product once again only if they make changes (part 3-2 introduced by the Federal law dated July 13, 2015 N 241-FZ-collection of laws of the Russian Federation, 2015, N 29, art. 4367). 4. Within ten working days from the date of adoption of the Declaration on the commitments of the State registration of the medicinal product and the necessary documents corresponding to the upolnomočennyjfederal′nyj Executive Body: 1) verifies the completeness and accuracy of the information contained in the materials submitted by the applicant;
2 oprovedenii) makes a decision or refusal to engage in examining the relationship of the expected benefits to the possible riskuprimeneniâ of the medicinal product, as well as examination of the quality of the drug, conducted in slučaevneseniâ changes in the normative documentation or normative document (as amended by the Federal law of November 29, 2010 N 313-FZ-collection of laws of the Russian Federation, 2010, no. 49, St. 6409);
3) notifies the applicant form vpis′mennoj of the decision or, in the case of adoption of a decision on refusal of vprovedenii examination with reasons for such denial.
4-1. In the case of vyâvleniânedostovernosti the information contained in the materials submitted by the applicant, the authorized federal body of executive power shall send to the applicant a request for clarification of the specified information. This request may be forwarded to the authorized representative of the applicant personally against receipt, sent by registered mail or handed over in èlektronnojforme telecommunication liaison channels. In the case of napravleniâdannogo request by registered mail, it is deemed to have been received after six days from the date of dispatch of a registered letter (čast′4-1 introduced by the Federal law dated November 25, 2013 N 317-FZ-collection of laws of the Russian Federation, 2013, no. 48, art.
6165). 4-2. The applicant is required to submit a response to the request of the authorized federal body of executive power in a period not exceeding 90 working days after receipt of the request. Term specified in part 4 of this article, shall be suspended from the day the applicant request the authorized federal body of executive power until the day of receipt of the response to this request, and is not counted when calculating the period confirm the State registration of the medicinal product (part 4-2 introduced Federal′nymzakonom from November 25, 2013 N 317-FZ collection zakonodatel′stvaRossijskoj Federation, 2013, N 48, art. 6165). 5. The reason dlâotkaza in examining the relationship of the expected benefits to the possible risk of the medication and (or) examination of the quality of the medicinal product is the submission of documents referred to in paragraphs 1 and 3 of this article, vnepolnom volume nepredstavleniezaâvitelem in response to the deadline specified in part 4-1 nastoâŝejstat′i request of the authorized federal body of executive power, as well as the lack of comprehensive information in the submitted documents, which must be reflected in them (in red. Federal law dated November 29, 2010 313 N-FZ-collection of laws of the Russian Federation, 2010, no. 49, St. 6409; Federal law dated November 25, 2013 N 317-FZ-collection of laws of the Russian Federation, 2013, no. 48, art. 6165). 6. Examination of the relationship of the expected benefits to the vozmožnomurisku use of drug and (or) medicinal product quality examination in order to confirm the State registration of the medicinal product shall be conducted on the basis of the documents referred to in paragraph 3 of this article, in the manner prescribed by the parts 5-8 of article 23 and article 24 of this federal law (harm. Federal law dated November 29 N 313-FZ-collection of laws of the Russian Federation, 2010, no. 49, St. 6409). 7. In the period provedeniâprocedury confirmation of State registration of medicinal product its civil circulation is carried out on the territory of the Russian Federation.
8. Grounds for refusal of confirmation of State registration of the medicinal product concerned is authorised, of the Federal organaispolnitel′noj authorities that the quality and (or) the efficacy of the medicinal product have not been confirmed this information, or that the risk of harm zdorov′ûčeloveka or animal as a result of drug intake exceeds the effectiveness of its application (part 8 introduced the Federal law of October 22, 2014 N313-FZ-collection of laws of the Russian Federation , 2014, N 43, St.
5797). Article 30. Vnesenieizmenenij in the documents contained in the registration dossier for registered drug for medical use 1. To amend the documents contained in the registration dossier for registered drug for medical use, the applicant submits the authorized federal body of Executive vlastizaâvlenie about changes in form, ustanovlennojupolnomočennym federal body of executive power and the enclosed changes in these documents as well as documents confirming the need for such changes. Decision ovnesenii of such changes or obotkaze in their making is done in a period not exceeding 90 working days from the date of adoption by the authorized executive federal′nymorganom request for the recording of such change.
2. examination of medicines in parts of medicinal product quality examination and (or) examination of the relationship of the expected benefits to the possible risk of medication for medicinskogoprimeneniâ is held in case of modification of the documents contained in the registration dossier for registered medical product, in respect of: 1) information ukazannyhv medical application instructions of the medicinal product: a) dosage form indicating the names and composition of active substances and kačestvennogosostava
auxiliary substances (if necessary, quantitative composition of excipients);
b) pharmacodynamics and pharmacokinetics (except for pharmacokinetics of homeopathic medicines and herbal medicines);
in dlâprimeneniâ);
d) Contra dlâprimeneniâ;
d) predostorožnostipri;
e) capabilities and features of the application of the drug for medical use by pregnant women, breastfeeding women, children, adults with chronic illnesses;
f) dosing regime, ways of introduction and implementation, if necessary, while taking the medication, duration of treatment, including in children before and after one year;
w) possible pobočnyedejstviâ and unwanted reactions when applying medication;
and) symptoms of overdose, measures to assist in overdose;
k) interaction with other drugs and (or) food;
l) medication release forms;
m) indication (if necessary) features the first drug action or when its abolition;
n) information about vozmožnomvliânii drug for medical use on the ability to drive vehicles, mechanisms;
o) expiry date and a reference to the prohibition of the use of the medicinal product after the expiry date;
p) conditions of storage;
r) terms;
2) composition of the drug for medical use;
3) change mestaproizvodstva medicine for medical use;
4) izmeneniâpokazatelej the quality of the medicinal product for medical use and (or) drug quality control methods for medical use;
5) changes the expiration date of the drug for medical use;
6) information about the need for other changes in the medical application of medicinal preparation, as well as in other documents contained in the registration dossier for registered medical product. The decision on an examination of the quality of medicines and (or) examination of the relationship of the expected benefits to possible drug riskuprimeneniâ for medical primeneniâprinimaetsâ in accordance with approved by the authorized federal body of executive power classification changes to documents contained in the registration dossier for registered medical product.
(Part 2 in red. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) 3. Ovnesenii a statement of changes to the documents contained in the registration dossier for registered drug for medical use, together with the documents specified in part 1 of this article, the applicant predstavlâetkopii the documents confirming payment of the State fee for recording of the documents contained in the registration dossier for registered drug for medical use, changes that require examination of medicines in parts of medicinal product quality examination and (or) examination of the relationship of the expected benefits kvozmožnomu risk of medicine for medical use the State fee for recording of the documents contained in the registration dossier for registered drug for medical use, changes that do not require an examination of the drug, or has the right to submit indicated documents on its own initiative. In case of non-submission of the authorized federal body of Executive vlastiproverâet the fact of payment of State fees the applicant through the use of information concerning payment of the State fees contained in the public information system of the State and municipal payments on the basis of evidence produced by the claimant copies of documents certifying payment of the State fee (in red. Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 4. Within desâtirabočih days from the date of receipt of the amount specified in part 1 of this article, statements and documents required the authorized federal body of executive power: 1) verifies the completeness and accuracy of the information contained in the materials submitted by the applicant;
2) decides on the holding referred to in paragraph 2 of this article of the relevant expertise of the medicinal product or refusal;
3) shall notify electronically or in writing the applicant of the decision or, in the case of a decision on refusal to conduct an appropriate examination of the reasons for such refusal (as amended by the Federal law of December 22, 2014 N 429-FZ collection zakonodatel′stvaRossijskoj Federation, 2014, N 52, art. 7540).
4-1. In the case of vyâvleniânedostovernosti the information contained in the materials submitted by the applicant, the authorized federal body of executive power shall send to the applicant a request for clarification of the specified information. This request may be forwarded to the authorized representative of the applicant personally against receipt, sent by registered mail or handed over in èlektronnojforme telecommunication liaison channels. In the case of napravleniâdannogo request by registered mail, it is deemed to have been received after six days from the date of dispatch of a registered letter (čast′4-1 introduced by the Federal law dated November 25, 2013 N 317-FZ collection zakonodatel′stvaRossijskoj Federation, 2013, N 48, art.
6165). 4-2. The applicant is required to submit a response to the request of the Commissioner of the Federal organaispolnitel′noj authorities in a period not exceeding 90 working days after receipt of the request. Term specified in part 4 of this article, shall be suspended from the day the applicant request the authorized federal body of executive power until the day of receipt of the response to this request, and is not counted when calculating the duration of the decision amending vdokumenty, contained in the registration dossier for registered drug for medical use (part 4-2 introduced by the Federal law dated November 25, 2013 N 317-FZ-collection of laws of the Russian Federation, 2013, no. 48, art.
6165). 5. The reason dlâotkaza in conducting specified in part 2 of this article, the examinations is submitting documents listed in parts 1 and 3 of this article, in full, the claimant's failure to reply within the prescribed time naukazannyj part 4-1 of this article, request the authorized federal body ispolnitel′nojvlasti, as well as the absence of vpredstavlennyh documents sufficient evidence of the need to amend, iliotsutstvie evidence of the fact of payment of the State fees referred to in part 3 nastoâŝejstat′i (in red. Federal law dated November 25, 2013 N 317-FZ-collection of laws of the Russian Federation, 2013, no. 48, art.
6165; Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 6. Referred to in part 2nastoâŝej article examination carried out in accordance with article 23 of the present Federal′nogozakona.
7. in time, neprevyšaûŝij ten working days from the date of receipt of the conclusions of the expert commissions based on the results referred to in paragraph 2 of this article, the expertise, the authorized federal body of executive power (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540): 1) shall decide on amendments to the documents contained in the registration dossier for registered drug for medical use, or refuse these changes;
2) introduced the vgosudarstvennyj registry of medicines on the basis of a decision on amendments to the documents contained in the registration dossier for registered drug for medical use, the necessary changes and return them to the claimant;
3) gives the applicant a new certificate of registration of the medicinal product in the event of a change in the information contained therein (paragraph 3 was introduced by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540). 8. Grounds for refusing to amend vdokumenty, contained in the registration dossier for registered drug for medical use, is the conclusion of the authorized federal body of executive power on the possibility of reducing the safety, quality and efficacy of the medicinal product in the event of such changes.
9. Permitted treatment drugs for medical use before the expiration date, during the hundred vos′midesâtidnej produced after the date of adoption of the authorized federal body of executive power of decision on amendments to the documents contained in the registracionnomdos′e, in accordance with the information contained in the documents of the registration dossier for a medicinal product prior to the date of adoption of
such a decision (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540).
Article 31. Vnesenieizmenenij in the documents contained in registracionnomdos′e to the registered drug for veterinary use 1. To amend the documents contained in the registration dossier for registered drug for veterinary use, the holder or the owner of the drug registration certificate or an official authorized by him or another legal person (hereinafter applicant nastoâŝejstat′e) is the authorized federal body of executive power statement about such changes in accordance with the form established by the authorized federal body of executive power and the enclosed documents changes as well as documents proving the neobhodimost′vneseniâ of such changes. A decision on changes in their refusal to iliob making is done in a period not exceeding 90 working days from the date of the adoption of upolnomočennymfederal′nym Executive authority statements about these changes (in red. Federal zakonaot July 13, 2015 N 241-FZ-collection of laws of the Russian Federation, 2015, N 29, art. 4367). 2. In case of modification of vdokumenty contained in the registration dossier for registered drug for veterinary use, with regard to the information referred to in subparagraphs "e", "f", "k", "l", "n", "c", "x" item 7 of part 3 of article 17 hereof, modify and/or supplement the production site of the drug product, as well as in the case of changes in the quality of the medicinal product for veterinary use and (or) methods of quality control of medicinal product for veterinary use examination of the medicinal product for veterinary use. In case of need by making other changes to the documents contained in the registration dossier for registered drug for veterinary use, èkspertizalekarstvennogo funds for veterinary use is not performed (as amended by the Federal law of October 22, 2014 N 313-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 43, St. 5797; Federal law dated 22 dekabrâ2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 3. Ovnesenii a statement of changes to the documents contained in the registration dossier for registered drug for veterinary use, together with the documents specified in part 1 of this article, documents certifying payment of the State fee for recording of the documents contained in the registration dossier for registered drug for veterinary use, changes that require examination of a medicinal product for veterinary use, or changes that do not require an examination of the drug for veterinarnogoprimeneniâ (in red. Federal law dated October 22, 2014 N 313-FZ-collection of laws of the Russian Federation, 2014, N 43, St. 5797). 4. In a period not exceeding 10 working days from the date of receipt of the representation of the part 1 of this article, the statements and the necessary documents, the authorized federal body of executive power: 1) verifies the completeness and accuracy of the information contained in the documents submitted by the applicant;
2) Decides to hold a èkspertizylekarstvennogo funds for veterinary use or reject it;
3) notifies the applicant form vpis′mennoj of the decision or, in the case of adoption of a decision on refusal of vprovedenii examination of the medicinal product for veterinary use, together with an indication of the reasons for such denial.
5. Grounds for refusal of an examination of the medicinal product for veterinary use is the submission of documents referred to in paragraphs 1 and 3 of this article, incomplete or lack the documents submitted sufficient evidence of the need to make changes.
6. examination of the medicinal product for veterinary use vneseniâizmenenij in the documents contained in the registration dossier for registered medical product for veterinary use shall be carried out in accordance with article 24 of this federal law.
6-1. in time, neprevyšaûŝij five working days from the date of receipt of the opinion of the Committee of experts on the results specified in part 2 of this article, the examination, the authorized federal body of executive power: 1) shall decide on amendments to the documents contained in the registration dossier for registered drug for veterinary use, or refuse these changes;
2) introduced the vgosudarstvennyj registry of medicines on the basis of a decision on amendments to the documents contained in the registration dossier for registered drug for veterinary use, the necessary changes and returns those documents to the applicant.
(Part 6-1 vvedenaFederal′nym Act of October 22, 2014 N 313-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 43, art. 5797)
7. The grounds for the refusal to amend vdokumenty, contained in the registration dossier for registered drug for veterinary use, is the conclusion of the authorized federal body of executive power on the possibility of reducing the safety, quality and efficacy of the medicinal product for veterinary use in case of modification of the documents.
8. treatment of medicines for veterinary use before the expiration date recorded within one hundred and eighty days after the date of adoption of the authorized federal body of executive power of decision on amendments to the documents contained in the registration dossier for a medicinal product, in accordance with the information contained in the documents of the registration dossier for a medicinal product before the date of the adoption of such a decision (in red. Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). Article 32. Otmenagosudarstvennoj registration decision on drug otmenegosudarstvennoj drug registration and deletion of registry izgosudarstvennogo medication drugs taken authorized federal body of executive power in the case of: 1) presentation of the relevant authorized federal body of executive power of detention of the risk or the threat to health, life, human or animal when applying medication, exceeding its effectiveness, according to the results of its monitoring of the safety of the medicinal product;
2) filing the registration certificate holder or holder of the medicinal product or an authorized legal entity imdrugim statements on the abolition of the State registration of the medicinal product (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
3) rejecting the State registration of the drug upon expiry of the registration certificate issued for a period of five years;
4) claimant's failure to provide information which may entail the need to make changes to the documents contained in the registration dossier for registered medical product within thirty working days from the date of the onset of these changes;
5) of State registration of the medicinal product under torgovymnaimenovaniem previously registered under the trade name of the medicinal product, different qualitative composition of active substances (as amended. Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
6) osuŝestvleniâgosudarstvennoj registration by the applicant of the same drug under various tradenames;
7) a decision of the Court regarding the violation of the intellectual property pravpravoobladatelâ in obraŝeniilekarstvennyh means;
8) absence of drug in circulation in the Russian Federation for three years or more (item 8 was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
9) failure of an owner or holder of the registration certificate of the medicinal product or another entity authorized by them measures to ensure the safety of drugs, established by the authorized federal body of executive power in accordance with parts 3 and 64 4stat′i hereof, within the framework of the implementation of pharmacovigilance (item 9 was introduced by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
10) refusal of the holder or the owner of the registration certificate of the medicinal product or their authorized
other entity from making amendments to the instruction on application of medicinal preparation for new data confirmed that the risk of harm to human health or animal as a result of drug intake exceeds the effectiveness of its application (paragraph vvedenFederal′nym of the Act of 10 December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540).
Article 33. State Register of medicinal products 1. State registry of medicines contains a list of drugs that have passed the State registration, list of pharmaceutical substances, included in medicines, and the following information: 1) otnošeniilekarstvennyh drugs: a) name of the medicinal product (International Nonproprietary or generic name, or chemical and commercial names) (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
b) drug drug dosage indication formas and its quantity in consumer packaging;
in holder or owner) name registration certificate (in the redaction of the medication. Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
g) name and address of the manufacturer of the medicinal product;
d) farmakoterapevtičeskaâgruppa drug code on the anatomical therapeutic chemical classification recommended by the World Health Organization (in red. Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
e iprotivopokazaniâ) to the use of the medicinal product;
f) side dejstviâlekarstvennogo product;
w) term godnostilekarstvennogo drug;
and hraneniâlekarstvennogo) conditions of the drug;
to otpuskalekarstvennogo) conditions of the drug;
l) number farmakopejnojstat′i or in case of its lack of room standard documentation or instrument;
m) date of gosudarstvennojregistracii medication and its registration number, date of registration certificate replacement medication for indefinite drug registration certificate, datapodači of the Declaration on the commitments of the State registration of the medicinal product, otmenygosudarstvennoj date of registration of the medicinal product (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
n) quality and quantity of the active substances and the quality of auxiliary substances of the medicinal product (subparagraph "h" vvedenFederal′nym Act of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
about) information about all types of permitted secondary (consumer) packing (subparagraph vvedenFederal′nym of the Act of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
p) date of adoption of the decision on the possibility of considering a drug for the State registration as an orfannogo drug ("p" vvedenFederal′nym Act of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
r) availability of the medicinal product in the list of essential medicines ("r" was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art.
7540);
with the product vlekarstvennom) the availability of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, in accordance with the zakonodatel′stvomRossijskoj Federation, international treaties the Russianfederation, including the single Convention on Narcotic Drugs of 1961 and the Convention on the psihotropnyhveŝestvah year 1971 year (paragraph "c" was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
t) information on whether the drug reference medication (sub-item "t" was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
) for information about applying for amendments to the documents contained in the registration dossier for a medicinal product ("y" was introduced by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
f) information about the drug interchangeability (sub-item "s" was introduced by the Federal law dated 22dekabrâ, 2014. N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
x) the term vvedeniâlekarstvennogo drug in the civil circulation (item "x" was introduced by the Federal law dated 22dekabrâ, 2014. N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
2) otnošeniifarmacevtičeskih substances: a) the name of the pharmaceutical substance (International Nonproprietary or generic name, or chemical and commercial names) (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
b) name and address of the manufacturer of the pharmaceutical substance;
in) godnostifarmacevtičeskoj substances;
g) conditions of hraneniâfarmacevtičeskoj substances;
d) room farmakopejnojstat′i or in case of its lack of room standard documentation or instrument;
e) naličiefarmacevtičeskoj substance in the list of narcotic drugs, psychotropic substances and their precursors, podležaŝihkontrolû in the Russian Federation, in accordance with the legislation of the Russian Federation, international treaties of the Russian Federation, in the čisleEdinoj Convention on Narcotic Drugs of 1961 year and the Convention on psychotropic substances of 1971 year (sub-item "e", was introduced by the Federal law of December 22, 2014 N429-FZ-collection of laws of the Russian Federation, 2014, N 52, art.
7540). 2. Farmacevtičeskaâsubstanciâ produced forimplementation may be included vgosudarstvennyj registry of medicines on the basis of the application developer or manufacturer of medicinal sredstvalibo their authorized legal person subject to such of the pharmaceutical substance examination quality pharmaceutical substance in accordance with article 34 of the present Federal law. In respect of pharmaceutical substances, produced for the implementation, in the public registry of medicines contain the following information: 1) the name of the pharmaceutical substance (International Nonproprietary , or combination, or chemical and commercial names);
2) name and address of the manufacturer of the pharmaceutical substance;
3) godnostifarmacevtičeskoj substances;
4) conditions of hraneniâfarmacevtičeskoj substances;
5) number farmakopejnojstat′i or if it is not the number of normative documents or instrument;
6) naličiefarmacevtičeskoj substances in the list of narcotic drugs, psychotropic substances and their precursors, podležaŝihkontrolû in the Russian Federation, in accordance with the legislation of the Russian Federation, international treaties of the Russian Federation, including the single Convention on Narcotic Drugs of 1961 year and the Convention on psychotropic substances of 1971 years;
7) date of inclusion in the State Register of pharmaceutic drugs date changes in the documents of the pharmaceutical substance, the date of the exception of the pharmaceutical substance from the State registry of medicines.
(Part 2 in red. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) 3. Procedure of maintenance of the State Register of drugs for medical use and the procedure for maintenance of the State Register of medicinal products for veterinary use shall be approved by the relevant authorized federal body of executive power.
Article 34. Enable vgosudarstvennyj drugs register and exclusion from State Register of medicines pharmaceutical substance produced forimplementation (name as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540) 1. For the inclusion of pharmaceutical substances, produced for the implementation in the State Register of lekarstvennyhsredstv, carrying out an assessment of its quality (as amended by the Federal law of December 2014 ot22 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540).
2. Examination of kačestvaukazannoj in part 1 of this article of the pharmaceutical substance, preparation by the Commission of experts opinions on the results of this examination and their direction in the authorized federal body of executive power shall be implemented within the period neprevyšaûŝij sixty working days from the date of receipt of the expert agency appropriate job
the authorized federal body of executive power and the following documents: 1 a copy of the license) naproizvodstvo medicines or a copy of the opinion on the compliance of the manufacturer lekarstvennyhsredstv the good manufacturing practice regulations issued by the authorized federal body of executive power, incase, if drug production is carried out in the Russian Federation;
2) copy issued by the notified body stranyproizvoditelâ licenses for the production of the drug and its translation to Russian language, certified in the prescribed manner, and a copy of the opinion on the compliance of a manufacturer of medicines requirements pravilnadležaŝej manufacturing practices issued by the authorized federal body of executive power, incase if the manufacture of the medicinal product takes place outside of the Russian Federation;
3) document soderžaŝijsleduûŝie information about pharmaceutical substances: a) the name of the pharmaceutical substance, its structure, General properties;
b) name and adresproizvoditelâ;
) tehnologiâproizvodstva with a description of the stages of production and control methods at all stages of production;
g) description razrabotkiprocessa production;
d) description kontrolâkritičeskih stages of the production process and intermediate products;
e) documentary proof (validation) processes and (or) assessment thereof;
f) properties and strukturadejstvuûŝih substances;
w) harakteristikaprimesej;
and pharmaceutical substance) specification and its rationale;
c) analytical techniques used in the quality control of pharmaceutical substances;
l) documentary evidence (validation) of analytical methods used in quality control of pharmaceutical substances;
m) analizaserij results of the pharmaceutical substance;
n) list standartnyhobrazcov or the substances used in the implementation of quality control;
opisanieharakteristik and properties of) packaging and crating;
p) data on stabil′nostifarmacevtičeskoj substances;
r) shelf life.
(Part 2 in red. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) 3. For the examination of the quality specified in part 1 of this article of the pharmaceutical substance zaâvitel′predstavlâet in the authorized federal body of executive power: 1) the request for the inclusion in the State Register of medicinal products the pharmaceutical substance;
2) a copy of the document certifying payment of the State fee for inclusion in the State Register of lekarstvennyhsredstv pharmaceutical substance manufactured for sale, either on its own initiative, the specified document. In case of failure by the claimant to an authorized federal executive body verifies that the payment of gosudarstvennojpošliny by the applicant with information on State tax payment contained vGosudarstvennoj information system on State and municipal payments, based on the information supplied by the applicant of a copy of the document certifying payment of the State fee (harm. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
3) documents referred to in paragraph 2 of this article (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
4) application for authorization to import into the Russian Federation specific party unregistered medicinal product intended for the examination (item 4 was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art.
7540). 4. Within ten working days from the date of acceptance of the application for the inclusion of specified in part 1 of this article of the pharmaceutical substance in the State registry of medicines and the documents listed in part 1 and paragraph 2 of part 3 of this article, the authorized federal body of executive power (in red. Federal law ot22 December 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540): 1) verifies the completeness and accuracy of the data contained in the documents submitted by the applicant (as amended by the Federal law of November 25, 2013 N 317-FZ-collection of laws of the Russian Federation, 2013, no. 48, art. 6165);
2) makes a decision about the direction of the expert agency job on the examination of the quality specified in part 1 of this article, farmacevtičeskojsubstancii or denial in this regard;
3 vèlektronnoj or) notifies the applicant in writing of the decision or, in the case of refusal, with reasons for such refusal (as amended by the Federal law of December 22, 2014 N 429-FZ collection zakonodatel′stvaRossijskoj Federation, 2014, N 52, art. 7540).
4-1. In the case of vyâvleniânedostovernosti the information contained in the materials submitted by the applicant, the authorized federal body of executive power shall send to the applicant a request for clarification of the specified information. This request may be forwarded to the authorized representative of the applicant personally against receipt, sent by registered mail or handed over in èlektronnojforme telecommunication liaison channels. In the case of napravleniâdannogo request by registered mail, it is deemed to have been received after six days from the date of dispatch of a registered letter (čast′4-1 introduced by the Federal law dated November 25, 2013 N 317-FZ collection zakonodatel′stvaRossijskoj Federation, 2013, N 48, art.
6165). 4-2. The applicant is required to submit a response to the request of the Commissioner of the Federal organaispolnitel′noj authorities in a period not exceeding 90 working days after receipt of the request. Term specified in part 4 of this article, shall be suspended from the day the applicant request the authorized federal body of executive power until the day of receipt of the response to this request, and is not counted when calculating the period of examination of the quality of the pharmaceutical substance, unused in the production of drugs (čast′4-2 introduced by the Federal law dated November 25, 2013 N 317-FZ collection zakonodatel′stvaRossijskoj Federation, 2013, N 48, art.
6165). 5. Ground dlâotkaza in the direction of the expert agency job on the examination of the quality specified in part 1 of this article of the pharmaceutical substance is the failure to submit the documents specified in part 2 of this article, the lack of evidence to support the fact of uplatygosudarstvennoj inclusion fees pharmaceutical substance, proizvedennojdlâ, implementation in the State Register of medicines, failure to reply within the prescribed time-limit the applicant naukazannyj part 4-1 of this article, request the authorized federal body of executive power or the submission of documents does not contain an exhaustive list of the required information (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 6. Within pâtnadcatirabočih days from the date of receipt of the decision of the authorized federal body of executive power of expert institution job on the examination of the quality specified in part 1 of this article of the pharmaceutical substance the applicant submits in the expert Agency for the examination of samples of the pharmaceutical substance in a quantity required for playback quality control methods. Expert institution upon receipt of specimens specified in part 1 of this article of the pharmaceutical substance shall issue to the applicant a document confirming the receipt of the samples, and in a period not exceeding three (3) working days shall notify in electronic or written formeob the authorized federal body of executive power. These terms are not included in the period of the dannojèkspertizy (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 7. Documents received by the expert Agency for the examination of the quality specified in part 1 nastoâŝejstat′i of pharmaceutical substances, shall be surrendered to the authorized federal body of executive power at the same time szaklûčeniâmi on the results of the examination.
8. In a period not exceeding five working days from the date of receipt of the opinion of the Committee of experts on the examination results of the quality specified in part 1 of this article, the farmacevtičeskojsubstancii, the authorized federal body of executive power: 1) assesses such detention to determine its compliance with the specification;
2 ovklûčenii) makes a decision specified in part 1 of this article of the pharmaceutical substance in the State Register of medicines or refusal in such inclusion;
3) introduced in prinâtiirešeniâ the inclusion specified in part 1 of this article of the pharmaceutical substance in the State Register of medicinal products provided for in paragraph 2 of part 1 of article 33 of this federal law and the uvedomlâetob information in electronic or written form of the applicant (as amended by the Federal law of December 22, 2014 N 429-FZ collection
the legislation of the Russian Federation, 2014, N 52, art. 7540). 9. Grounds for refusal to include specified in part 1 of this article of the pharmaceutical substance in the State Register of medical products is a decision of the relevant authorized federal body of executive power that the quality of the pharmaceutical substance not confirmed findings (part 9 introduced the Federal law of October 22, 2014 N 313-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 43, art. 5797).
10. May not be included in the State Register of medicines a pharmaceutical substance, produced for sale and produced by the same manufacturer as dvuhi more registered entries (part 10 introduced the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art.
7540). 11. Changes to documents on pharmaceutical substance manufactured for sale and included in the State Register of medical products, is carried out in the manner prescribed by articles 30 and 31 of this federal law, the payment of the State fee provided for by the legislation of the Russian Federation on taxes and dues (part11 introduced by the Federal law of December 22, 2014 N 429-FZ collection zakonodatel′stvaRossijskoj Federation, 2014, N 52, art.
7540). 12. Allowed the appeal of pharmaceutical substances, produced for the implementation, within one hundred and eighty dnejdo and after the adoption of the authorized federal body of executive power of decision on amending documents for pharmaceutical substance manufactured for sale and included in the State Register of medical products (part 12 was introduced by the Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540).
13. The decision on the removal from the State registry of medicines pharmaceutical substance, produced for implementation, was adopted by the authorized federal body of executive power in the case of: 1) presentation of the relevant authorized federal body of executive power of detention of the risk or threat to the life or health of a person or animal with the use of the medicinal product;
2) filing by the developer of the medicinal product or a manufacturer of medicinal products or their other entity declarations on exclusions from the State registry of medicines pharmaceutical substance manufactured for sale;
3) otsutstviâfarmacevtičeskoj substances, produced for the implementation in the Russian Federation for a period of three years or more.
(Part of the vvedenaFederal′nym Act of 13 December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) article 35. (Repealed based on Federal′nogozakona from December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540) article 36. Obžalovanierešeniâ refusing permissions naprovedenie clinical trial of the medicinal product, the decision on refusal of registration of medicine vgosudarstvennoj, conclusions of the Commission of experts, èkspertnogoučreždeniâ or Rešeniesootvetstvuûŝego of the Board of ethics of the authorized federal body of executive power to grant or deny the authorization to conduct a clinical trial of the medicinal product, the decision specified the federal body of executive power of refusal in State registration of medicinal product, the conclusion of the Commission of experts, expert agencies or zaklûčeniesoveta of ethics may be appealed in the manner established by the legislation of the Russian Federation. Expert's opinion, issued on the outcome of the examination in order to identify the registered drug interchangeability may be appealed by the holder or the owner of the registration certificate of the medicine in a Commission of experts, expert agencies. Opinion of the Commission of experts, expert institutions, arranged according to the results of reconsidering the conclusion of expert, may be contested by the holder or the owner of the registration certificate of the medicinal product or a person authorized by them in the order ustanovlennomzakonodatel′stvom of the Russian Federation. When the appeal against the decision of the authorized federal body of executive power, the conclusions of the expert or a Commission of experts expert agencies, the conclusion of the Board of ethics holder or holder of the registration certificate of the medicinal product or person authorized by them may submit the medicinal product, the results of the examination protocols obtained by accredited testing laboratories (centers) of the results of research trials (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014 N 52, art. 7540). Article 37. Information related to the implementation of the State registration of medicines, information on registered drugs and medicinal preparations excluded from public reestralekarstvennyh funds 1. Corresponds to the authorized federal body of executive power available on its official site on the Internet for information related to the implementation of the State registration of medicinal products, including the conduct of the examination (including the results of its implementation), information on registered drugs and medicines, which are excluded from the public registry of medicines, not later than five working days from the date of receipt of the relevant authorized executive federal′nymorganom application for the State registration of the medicinal product (as amended by the Federal law of December 22, 2014 N 429-FZ- Collection of laws of the Russian Federation, 2014, N 52, art. 7540). 2. Terms and order of the specified včasti 1 of this article, the information shall be established by the authorized federal body of executive power. The information referred to in part 1 of this article, is open and available to the public and is available to interested persons in accordance with the legislation of the Russian Federation (in red. Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). Chapter 7. Kliničeskieissledovaniâ medicines dlâmedicinskogo application, agreement on its conduct, the rights of patients enrolled in these studies Article 38. Kliničeskieissledovaniâ of medical preparatovdlâ of medical application 1. Clinical trials of drugs for medical use, uncounted international multicentric, multicentric, postmarketing, are held in one or several medical organizations in accordance with the rules of good clinical practice, approved by the authorized federal body of executive power, respectively, in the following order (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540): 1) establishing the safety of medicines for healthy volunteers and (or) the portability of their healthy volunteers except for such studies of drugs manufactured outside of the Russian Federation;
2) selection of the optimum dosages of medication and treatment for patients with a certain disease, optimal doses of vaccination schemes and immunobiological drugs healthy volunteers;
3) establishing safety and effectiveness of the drug for patients with a certain disease, prophylactic effectiveness of immunobiological drugs for healthy volunteers;
4) explore the possibility of expanding indications for medical use and identify previously unknown side effects registered drugs.
2. otnošeniivosproizvedennyh medical primeneniâprovodâtsâ medical products for bioequivalence studies and (or) therapeutic equivalence in the manner prescribed by the authorized federal body of executive power.
3. Organization for clinical trials of the drug for medical use is entitled to: 1) drug developer or upolnomočennoeim person;
2) educational institutions of higher education, supplementary professional education (as amended by the Federal law dated July 2, 2013 N 185-FZ-collection of laws of the Russian Federation, 2013, N 27, art. 3477);
3) research organization.
4. Clinical trials of the drug for medical use are carried out on the basis of the authorization to conduct a clinical trial of the medicinal product issued by the authorized federal body ispolnitel′nojvlasti.
The authorized federal body of executive power vedetreestr permits the conduct of clinical trials of the medicinal product, containing an indication of their purpose or goal, in the manner prescribed by that authority (as amended by the Federal zakonaot December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540; The Federal law from July, 2015. N 241-FZ-Sobraniezakonodatel′stva Russian Federation, 2015, N 29, art. 4367). 5. (Part 5 repealed based on Federal′nogozakona from December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540) 6. To the Organization and conduct of clinical trials of the drug for medical use of the drug developer preparatamogut involve legal entities of any organizational-legal form, subject to ensure that these research requirements of this federal law.
7. Clinical trials of pharmaceuticals for medical use are carried out in health organizations accredited by the authorized federal body of executive power in the manner prescribed by the Government of the Russian Federation.
8. The list of medical organizations with the right to conduct clinical trials of drugs for medical use, and reestrvydannyh authorization to conduct clinical trials of drugs are published and posted the authorized federal body of executive power in the prescribed procedure on its official website vseti.
Article 39. Decision oprovedenii clinical trial drug for medical use 1. Clinical study of the drug for medical use is carried out on the basis of the authorization to conduct a clinical trial of the medicinal product issued by the authorized federal body of executive power by the results of the examination of documents required to obtain authorization to conduct a clinical trial of the medicinal product and ethical expertise.
2. in order to obtain authorization to conduct a clinical trial drug for medical application the applicant submits the authorized federal body of executive power: 1 vydačerazrešeniâ) to conduct a clinical trial of the medicinal product for medical use;
2) copies of the documents certifying payment of the State fee for the conduct of ethical examination, examination of documents for a medicinal product to obtain authorization to conduct a clinical study dlâmedicinskogo drug use, for issuing authorization to conduct a clinical trial of the medicinal product for medical use, for examination of the documents for a medicinal product to obtain a permit for conducting international multi-centre clinical study dlâmedicinskogo drug use, for issuing a permit to conduct an international multi-center clinical trial of the medicinal product for medical use for ethical examination, examination of documents for a medicinal product to obtain authorization to conduct a clinical study postregistracionnogo drug for medical use, for issuing authorization to conduct a clinical study postregistracionnogo drug dlâmedicinskogo application, or on its own initiative, the specified documents. In case of failure by the applicant to the instruments referred to an authorized federal executive body verifies the fact that payment of the State fee with ispol′zovanieminformacii on State duty payment contained in the public information system of the State and municipal payments, based on copies of the documents submitted by the applicant;
3) protokolkliničeskogo studies of the drug for medical use;
4) brošûruissledovatelâ;
5) informacionnyjlistok of the patient;
6) opyteraboty information researchers on relevant professions and their experiences in the conduct of clinical trials;
7) information on medical organizations in which a clinical trial drug for medical use (full and abbreviated name, legal form, location and place of activity, phone, fax, e-mail address of each medical organization);
8) information opredpolagaemyh timing of clinical trial drug for medical use;
9) a copy of the dogovoraobâzatel′nogo insurance entered into in accordance with the model rules of compulsory insurance, with an indication of the number of authorized patients participating in the clinical trial drug for medical use;
10) information on the composition of the drug for medical use;
11) document prepared by the manufacturer of the drug for medical use and containing parameters (specifications), as well as information about the medicinal product for medical use, produced for the conduct of clinical trials;
12) a copy of the license to manufacture medicines in case drug production realized in the Russian Federation, or a copy of the opinion on the compliance of the manufacturer of the medicinal product good manufacturing practice regulations issued by the competent authority of the country of the manufacturer authorised medicinal product.
3. in time, neprevyšaûŝij five working days from the date of acceptance referred to in paragraph 1 of part 2 of this article, the statements and the necessary documents, the authorized federal body of executive power: 1) verifies the completeness and accuracy of the information contained in the documents submitted by the applicant;
2) Decides to oprovedenii examination of documents for obtaining authorization to conduct a clinical trial of the medicinal product for medical use and ethical examination or refusal in conducting those examinations;
3) notifies the vèlektronnoj form or on paper of the applicant of the decision or, in the case of adoption of a decision on refusal of indicating the reasons for such refusal;
4) prepares and shall forward to the expert agency and Ethics Council set to conduct the relevant examinations.
4. In the case of incomplete and/or authenticity of the information contained in the documents submitted by the applicant, the authorized federal body of executive power shall send to the applicant a request for clarification of the information. This request may be forwarded to the authorized representative of the applicant personally against receipt, sent by registered mail or transmitted in electronic form on telecommunication liaison channels. If the direction of this request by registered mail, it is deemed to have been received after six days from the date of dispatch of a registered letter. The applicant is required to submit a response to the request of the authorized federal body of executive power in a period not exceeding 90 working days from the date of its receipt. Term specified in part 3 of this article, shall be suspended from the day the applicant request the authorized federal body of executive power until the day of receipt of the corresponding otvetai not taken into account when calculating the period of adoption authorized Federal Executive Body decision on the examination of documents for obtaining authorization to conduct a clinical study dlâmedicinskogo drug use.
5. dlâotkaza in examination of documents for obtaining authorization to conduct a clinical trial of the medicinal product for medical use and ethical examination is representation of the documents provided by paragraph 2 of this article, in full, the failure by the applicant to reply within the prescribed time-limit specified in part 4 of this article, request the authorized federal body of executive power or the absence of an exhaustive list of the documents submitted required information or information that should be reflected in them, as well as lack of information evidencing payment of the State fee for the conduct of ethical examination, examination of documents for a medicinal product to obtain authorization to conduct a clinical trial of the medicinal product for medical use, for issuing authorization to conduct a clinical trial of the medicinal product for medical use, zaprovedenie examination of documents for a medicinal product to obtain a permit for conducting international multi-centre clinical study dlâmedicinskogo drug use , for issuing a permit to conduct an international multi-center clinical trial drug for medical applications for ethical examination, examination of documents for a medicinal product to obtain authorization to conduct a clinical study postregistracionnogo drug for medical use,
for issuing authorization to conduct a clinical study postregistracionnogo drug dlâmedicinskogo application.
6. documents Provedenieèkspertizy to obtain authorization to conduct a clinical trial of the medicinal product for medical use and ethical expertise, preparation of the Commission of experts and the Ethics Council conclusions on vozmožnostiili inability to conduct such clinical research and direction of these findings to the authorized federal body of executive power are carried out within a period not exceeding thirty working days from the date of receipt of the expert agency set the authorized federal body of Executive vlastis application documents referred to in paragraphs 3, 4, 10 and 11 of part 2 of this article, and the Ethics Council set the authorized federal body of executive power with the application documents referred to in paragraphs 3-6, 8 and 9 of part 2 of this article.
7. in time, neprevyšaûŝij five working days from the date of receipt of the opinions referred to in paragraph 6 of this article, the authorized federal body of executive power: 1) implements ocenkupostupivših opinions to determine their consistency with the tasks on relevant expertise;
2) decides on the authorization to conduct a clinical study dlâmedicinskogo drug use or to refuse to grant the specified permission;
3) issues a permission naprovedenie a clinical study drug for medical use or rešenieob deny specified permissions indicating the reasons for rejection.
8. dlâotkaza authorization to conduct a clinical study dlâmedicinskogo drug use is the presence of the conclusions of the expert or opinion of the Board of ethics of the impossibility of carrying out a clinical trial of the medicinal product for medical use based on the results of examinations provided by paragraph 6 of this article.
9. The decision on refusal of vprovedenii examination of documents for obtaining authorization to conduct a clinical trial of the medicinal product for medical use and ethical examination and authorization to conduct a clinical trial of the medicinal product for medical use may be appealed in accordance with the legislation of the Russian Federation.
(Article 39 as amended. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) article 39-1. Ètičeskaâèkspertiza 1. Ethical èkspertizaprovoditsâ Council on ethics, which was established in the manner prescribed by the authorized federal body of executive power, with a view to issuing opinions on the ethical validity of the possibility of conducting a clinical trial drug for medical use.
2. Experts from the Council of ethics may include representatives of medical organizations, academic organizations, educational organizations, higher education, and predstaviteliobŝestvennyh organizations, religious organizations and funds massovojinformacii.
These experts should not be in any drugs, depending on the developers and others interested in the results of the ethical examination.
3. payment of uslugèkspertov Board of ethics is carried out on the basis of the contract concluded between the authorized federal body of executive power which created the Council on ethics, and the expert Board of ethics, budget appropriations provided for authorized federal agency, which created the Council on ethics, in the federal budget for the relevant year on ensuring of its activity, the amount established by the Government of the Russian Federation.
4. the Council of Experts on the ethics of responsibility in accordance with the legislation of the Russian Federation.
5. The composition of the Board the poetics of the Council, its activities, the qualifications and experience of the expert assessment of the scientific, medical and ethical aspects of clinical trials of drugs for medical use, applicable to the experts of the Council of ethics, the procedure for the Organization and conduct of ethical expertise, form the conclusion of the Board of ethics establishes the authorized federal body of executive power. Medicinskihorganizacij the number of representatives shall not exceed one half of the total number of experts of the Council of ethics.
6. sostavesoveta information on ethics, its working plans and ongoing activities is posted on the official website of the authorized federal body of executive power on the Internet in accordance with the established procedure.
(Art. 39-1 vvedenaFederal′nym Act of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540) article 40. Provedeniekliničeskogo studies of the drug for medical use 1. The head of the medical organization that conducts a clinical issledovanielekarstvennogo drug for medical use, naznačaetissledovatelâ, responsible zaprovedenie this study and a medical specialty that corresponds to an ongoing clinical study of the drug, with experience of clinical research programme drugs not meneečem three years, and at his suggestion, appoints soissledovatelej from among doctors that medical organizations (in red. Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 2. The researcher chooses patients who for medical reasons may be involved in clinical issledovaniilekarstvennogo drug for medical use.
3. the investigator and soissledovateli must be acquainted with the results of pre-clinical studies of the drug contained in the brochure of the researcher, the draft Protocol clinical study dlâmedicinskogo drug use, developed by drug developer or another legal entity contracted to organize a clinical study dlâmedicinskogo drug use, and other material of the study.
3-1. the head of the medical organization in a period not exceeding three (3) working days from the date of the beginning of the provedeniâkliničeskogo the study drug for medical use, notify the vupolnomočennyj Federal Executive authority, which issued the razrešeniena of such a study, on the prescribed form (part 3-1 introduced by the Federal law on November 29, 2010. N313-FZ-collection of laws of the Russian Federation, 2010, no. 49, St. 6409). 4. Organizations hosting a clinical study dlâmedicinskogo drug use and the 3 včasti article 38 hereof, if necessary amending Protocol clinical study dlâmedicinskogo drug use reported by the authorized federal body of executive power that issued the permit to conduct such a study, on the prescribed form (in the redaction of Federal′nogozakona from October 11, 2010 N 271-FZ-collection of laws of the Russian Federation, 2010, N 42, art. 5293.) 4-1. Form reports on amendments to the Protocol clinical trial drug for medical use must contain the following information: 1) name, identification number and date of clinical research;
2) Insert date changes in the clinical trial protocol;
3) name and location of the applicant;
4) name of organization contracted by the developer of the drug to the Organization and conduct of the clinical trial (if available);
5) name and location of medical organizations in which clinical research is conducted;
6) date of issue of the authorization to conduct a clinical study and the number of the authorization;
7) changes, vnosimyev clinical study protocol.
(Part 4-1 vvedenaFederal′nym Act of October 11, 2010 N 271-FZ-collection of laws of the Russian Federation, 2010, N 42, art. 5293)
5. Within thirty working days from the date of receipt of the amount specified in part 4 of this article posts, authorized federal executive body considers this message by a procedure established by a statute and decide on amendments to the Protocol kliničeskogoissledovaniâ medicine for medical use or denial of such changes. When considering reports of the need to amend the Protocol clinical trial drug for medical primeneniâv to assess the reasonableness of the proposed changes and determine the degree of risk to patients participating in clinical studies, the authorized federal body of executive power may be experts Ethics Council (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 6. Clinical study of the drug for medical use may byt′priostanovleno or discontinued,
If in the process of the vote found a danger to life, health of patients. In the case of opasnostidlâ life, health of the patient participating in a clinical study of the drug for medical use, researchers are required to inform the head of the medical institution and organization under the authorized federal body of executive power in organizaciûprovedeniâ clinical trial of the medicinal product. The decision to suspend the clinical trial drug for medical use take the head of the medical institution and (or) organization that has been granted authorized federal body of executive power in the Organization of a clinical trial drug for medical use, the decision to prekraŝeniitakogo research takes the authorized federal body of executive power based on messages in pis′mennojforme head of the medical institution or organization receiving the authorized federal body of executive power in the Organization of a clinical trial drug for medical use.
7. in time, neprevyšaûŝij five working days from the date of completion, suspension or termination of a clinical trial drug for medical use, the message is sent to the organizations listed in part 3 of article 38 of this federal law, the authorized federal body of executive power in the prescribed form.
8. form completion messages, suspension or termination of kliničeskogoissledovaniâ medicine for medical application must contain: 1) information on medical organizations or medical organizations carrying out the study;
2) description dannogoissledovaniâ;
3) Explorer data (surname, name, patronymic, place of work, position, profession, work experience programmes, clinical research of drugs, list of clinical trials of drugs, which he attended (periods) as a researcher or soissledovatelâ) (as amended by the Federal law of October 11, 2010 N 271-FZ-collection of laws of the Russian Federation, 2010, N 42, art. 5293);
4) result dannogoissledovaniâ (completion, suspension or termination of the study, together with their causes and impact assessment egorezul′tatov, an overall assessment of the risk of iožidaemoj benefit from the use of the investigational medicinal product, as well as projected further action).
8-1. when identifying federal body ispolnitel′nojvlasti, performing the functions of control and supervision in the field of health, violations of rules nadležaŝejkliničeskoj practices when conducting clinical research drug affecting the completeness and/or accuracy of the clinical study, ukazannyjfederal′nyj Executive authority suspends the clinical study and makes medical organization, which conducted the clinical study, regulation on Elimination of revealed violations. Prineustranenii medical organization revealed violations within the prescribed period of vpredpisanii the specified federal executive authority makes a decision on discontinuation of clinical drug studies and directs the Federal Executive authority which carries out the functions of the formulation and implementation of State policy and normative-legal regulation in the sphere of health, conclusion on identification in the clinical studies of violations of rules of good clinical practice in order to make a decision about the cancellation of permission fororganization the clinical study from the date of adoption of the decision on suspension of carrying out a clinical trial of the medicinal product (part 8-1 entered Federal′nymzakonom from December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540; in red. The Federal law from July 2015 N 241-FZ collection zakonodatel′stvaRossijskoj Federation, 2015, N 29, art. 4367). 9. An authorized federal executive body publishes and makes available on its official website on the Internet "message on completion, suspension or termination of a clinical study dlâmedicinskogo drug use in time neprevyšaûŝij the five workdays from the date of its receipt, in accordance with the established procedure.
10. the authorized federal body of executive power carries out maintenance of the register of researchers conducting or carrying out clinical trials of drugs for medical use, in accordance with the approved IM rules and places it on their official website on the Internet in accordance with the established procedure. The register contains the information prescribed in paragraph 3 of part 8 of this article.
11. report on the results of clinical studies of the drug for medical use is compiled organization referred to in part 3 of article 38 of this federal law, on the basis of medical organizations, conducted the study and is the authorized federal body of executive power that issued the permit to conduct this study, within a period not exceeding three months from the date of its completion, suspension or termination, in the manner prescribed by the authorized federal body of executive power.
12. Violation of the rules of good clinical practice, falsification of research rezul′tatovkliničeskogo medicine for medical applications entail liability in accordance with the legislation of the Russian Federation (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540). 13. When conducting clinical issledovaniâlekarstvennogo drug for medical use is allowed to fence upacientov biological material (samples of body fluids, tissues, secretions and excreta, physiological and pathological bleeding strokes, scrapes, swabs, microorganisms, biopsijnyjmaterial) for their study in the Russian Federation and (or) outside the Russian Federation (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 14. The order of import vRossijskuû Federation and exit from the Russian Federation obtained biological materials when conducting clinical drug studies for medical applications, shall be established by the Government of the Russian Federation (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540). Article 41. Contract clinical study oprovedenii drug for medical use 1. Clinical study of the drug for medical use is in accordance with the Treaty on conducting clinical issledovaniâlekarstvennogo drug for medical use, concluded between the Organization to receive the authorized federal body of executive power for the Organization of such a study, imedicinskoj organization, carrying out such a study.
2. Agreement on carrying out clinical drug studies for medical application must contain: 1) conditions and srokiprovedeniâ of the study;
2 obŝejstoimosti programme), the definition of the study showing the amount to vyplatissledovatelâm, soissledovatelâm;
3) presentation of results of the study to the authorized federal body of executive power.
Article 42. Finansovoeobespečenie clinical trial drug for medical use Finansovoeobespečenie clinical trial drug for medical primeneniâosuŝestvlâetsâ by: 1) means federal′nogobûdžeta;
2) of organisations have been granted permission to organize the study, in accordance with the terms of the Treaty;
3) other zapreŝennyhzakonodatel′stvom the Russian Federation sources.
Article 43. Pravapacientov participating in clinical issledovaniilekarstvennogo drug for medicinskogoprimeneniâ 1. Participation of patients vkliničeskom the study drug for medical use is voluntary.
2. the patient or his legal representative shall be informed in writing: 1) on medication the drug for medical use and clinical research entity of the medicinal product;
2) about the safety of dlâmedicinskogo drug use, its expected effectiveness and the degree of risk to the patient;
3) on usloviâhučastiâ patient in the clinical trial drug for medical use;
4) about the purpose or purposes and the duration of the clinical trial drug for medical use;
5) about the actions of the patient in case of unforeseen effects of the influence of the drug for medical use on his State of health;
6) on the conditions of compulsory insurance life, health of the patient;
7) privacy safeguards patient participation in clinical study of the drug for medical use.
3. Dobrovol′noesoglasie the patient to participate in a clinical study dlâmedicinskogo drug use is confirmed by his signature or his legal representative's signature on the patient leaflet.
4. the patient or his legal representative has the right to refuse participation in clinical issledovaniilekarstvennogo drug for medical use at any stage of such a study.
5. the conduct of a clinical trial drug for medical use, with the participation of children as patients is allowed only with the written consent of their parents, adoptive parents formeih. Children can be considered as potential patients of such research only if it is necessary to improve children's health or prevention of infectious diseases in childhood, or if the purpose of this study is to obtain data onailučšej dosage of medication for the treatment of children. In these cases, such exploration should be preceded by a clinical study dlâmedicinskogo drug use on adult citizens, except if the study drug for medical use is solely intended for use by minors citizens (as restated by federal law oktâbrâ2014, 22. N 313-FZ-collection of laws of the Russian Federation, 2014, N 43, St. 5797). 6. It is prohibited to conduct a clinical trial of the medicinal product for medicinskogoprimeneniâ with the participation of as patients: 1) orphans and children deprived of parental care;
2) pregnant women, breastfeeding women, except cases, if a clinical trial of the medicinal product intended for these women, subject to the need for information only during appropriate kliničeskihissledovanij and take all necessary measures to eliminate the risk of naneseniâvreda a woman during pregnancy, during breastfeeding woman, foetus or child;
3) soldiers, except for cases of clinical trial of the medicinal product, specially designed for use in war, emergencies, preventing and treating diseases and lesions, derived from adverse chemical, biological, radiation factors. Clinical study of such medicine may be carried out with the participation of troops as patients, except for soldiers performing military service conscripts ssoblûdeniem requirements established by this federal law for civilians;
4) sotrudnikovpravoohranitel′nyh bodies;
5) otbyvaûŝihnakazanie persons in places of deprivation of liberty, and also persons in custody at pre-trial detention facilities.
7. it is allowed to conduct clinical studies of the drug for medical use, designed for the treatment of mental illness, involving spsihičeskimi persons as patients of diseases declared in the manner prescribed by the legislation of the Russian Federation. Clinical study of the drug in this case is carried out with the consent in writing of the legal representatives of the above-mentioned persons.
Article 44. Obâzatel′noestrahovanie life, health of the patient participating in clinical issledovaniilekarstvennogo drug for medicinskogoprimeneniâ 1. Organization that has been granted permission to the Organization of clinical issledovaniâlekarstvennogo drug for medical use, must as strahovatelâstrahovat′ risk of causing harm to life, body or health of the patient as a result of a clinical trial drug for medical use, at his own expense by the conclusion of the contract of obligatory insurance.
2. the object of compulsory insurance is a property interest of the patient, svâzannyjs damage to his life or health as a result of the clinical trial drug for medical use.
3. The insured event under the contract of compulsory insurance is the death of a patient or deterioration in his health, including entailing the establishment of a disability, in the presence of a causal link between the onset of the event and the participation of the patient in a clinical trial of the medicinal product.
4. claims for compensation for harm caused to life or health of the patient, are brought within the time frames established by civil legislation iskovojdavnosti.
5. Amount of indemnity under the contract of compulsory insurance is: 1) in the case of smertipacienta two million roubles for each patient who vkliničeskom the study drug;
2) when the patient's uhudšeniizdorov′â: a) resulting in invalidity of I group sobojustanovlenie, one million five hundred thousand rubles per each patient participating in the clinical trial of the medicinal product;
b) which led to the establishment of invalidity of II group, one million rubles to each patient participating in the clinical trial of the medicinal product;
in) resulting in disability group III sobojustanovlenie, five hundred thousand rubles per each patient participating in the clinical trial of the medicinal product;
g) not resulting in ustanovleniâinvalidnosti, not more than three hundred thousand rubles per each patient participating in the clinical trial of the medicinal product on the basis of regulations otražaûŝihharakter and the degree of damage to health, as well as the patient actually incurred costs caused by damage to health, medical assistance, medicines (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540). 6. (Part 6 utratilasilu on the basis of the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540) 7. Term of contract of compulsory insurance shall not be less than the duration of the clinical issledovaniâlekarstvennogo drug.
8. conditions of dogovoraobâzatel′nogo insurance, including insurance tariffs for compulsory insurance, perečen′neobhodimyh of documents for carrying out of insurance payouts, the procedure for establishing the strahovatelemindividual′nogo patient identification code, how to inform the insurer of the insured subject to clinical study lekarstvennogopreparata patients for medical use, the order of payment of insurance premium, modalities for implementation of this federal law and other federal laws the rights and obligations of the parties under the contract of compulsory insurance as well as regulations to reflect the nature and extent of damage to health, establishes the obâzatel′nogostrahovaniâ model regulations (as amended. Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 9. In the case of pričineniâvreda the life of the patient involved in the clinical trial of the medicinal product, the beneficiaries under the contract of compulsory insurance are citizens with the right to reparation in the event of death in accordance with civil legislation, in the absence of such citizens, parents, spouse, children of the deceased patient who vkliničeskom study of the medicinal product, in the case of smertipacienta involved in the clinical trial of the medicinal product and which had not had an independent income, citizens dependent on which he was in otnošeniivozmeŝeniâ funeral expenses of the patient involved in the clinical trial of the medicinal product, the person who has suffered such costs.
10. Insurance payment for the harm caused to the life of the patient involved in the clinical trial of the medicinal product, shall be distributed among beneficiaries proportionally to their number in ravnyhdolâh.
11. in the case of nastupleniistrahovogo the patient who participated in a clinical trial of the medicinal product, the beneficiary is entitled to file a claim for neposredstvennostrahovŝiku damage. Indemnity is paid by the insurer within thirty days from the date of submission of the required documents. The patient who participated in a clinical trial of the medicinal product, or the beneficiary shall notify the insurer to carry on insurance payouts to individual patient identification code established by the insured in accordance with the model rules of compulsory insurance.
12. To fully determine the size of recoverable injury insurer according the patient involved in
clinical study of the drug, or statement of a beneficiary may exercise a portion of the indemnity that corresponds in fact to a particular part of the injury.
13. Indemnity in accordance with the contract of compulsory insurance is performed regardless of the payments due on other types of insurance.
14. do not dopuskaetsâučastie patient in conducting a clinical trial of the medicinal product, in the absence of a contract of compulsory insurance.
15. monitoring the performance of the Organization, which has received authorization for the organization conducting the clinical trial drug for medical use, established by this article acting on compulsory insurance life, health of the patient involved (involved) in the clinical trial of the medicinal product, is carried out by the authorized federal enforcement authority which issued the permit to conduct clinical trials of drugs for medical use.
(Article 44 as amended. Federal law dated November 29, 2010 N 313-FZ-collection of laws of the Russian Federation, 2010, no. 49, St. 6409) Chapter 8. Production of imarkirovka medicines Article 45. Proizvodstvolekarstvennyh means 1. Proizvodstvolekarstvennyh funds must comply with the rules of good manufacturing practice approved by the authorized federal body of executive power. Features of transition production of certain medicines to their production in accordance with GMP regulations ustanavlivaûtsâPravitel′stvom of the Russian Federation. Issuing opinions on the conformity of a manufacturer of medicines trebovaniâmpravil good manufacturing practices is carried out according to the results of the inspection of manufacturers of medications as prescribed by the Government of the Russian Federation. The fee for the issuance of the opinion on the compliance of a manufacturer of medicines good manufacturing practice regulations shall be established by the Government of the Russian Federation. Procedure for the Organization and conduct of inspection of manufacturers of medicinal products for compliance with the requirements of pravilnadležaŝej manufacturing practices set Pravitel′stvomRossijskoj Federation (as amended by the Federal law dated June 25, 2012 N 93-FZ-collection of laws of the Russian Federation, 2012, N 26, art. 3446; federal law dated October 22, 2014 N 313-FZ-collection of laws of the Russian Federation, 2014, N 43, art. 5797; federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation , 2014, N 52, art. 7540). 2. Production of pharmaceuticals in the Russian Federation is carried out by manufacturers of drugs licensed for the production of medicines. Confirmation of compliance of the licensee the rules of good manufacturing practice shall be carried out under license control in accordance with the legislation of the Russian Federation, taking into account the characteristics referred to in paragraph 1 of this article (as amended by the Federal law of October 22, 2014 N 313-FZ-collection of laws of the Russian Federation, 2014, N 43, St. 5797;
Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 3. Manufacture of medicinal products is carried out in compliance with the requirements of the industrial regulations, which shall be approved by the head producer of medicines and includes a list of Pharmaceutical Excipients substanciji indicating the number of each of them, information about the equipment, process description and control methods at all stages of the production of medicines.
4. When medications used pharmaceutical substances included in the State Register of medicinal products, with the exception of pharmaceutical substances produced to conduct clinical studies and for export. The process of production of pharmaceutical substances include any stages of the technological process to the finished product, corresponding to the trebovaniâmfarmakopejnoj article, in čislefermentaciâ, extraction, purification, extraction, recrystallization, drying, grinding (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540.) 4-1. List of drugs for medical use, in respect of which the requirements kob″emu packaging, packaging ikomplektnosti, list of lekarstvennyhpreparatov for veterinarnogoprimeneniâ in respect of kotoryhustanavlivaûtsâ packaging requirements, as well as packaging requirements, packaging and komplektnostilekarstvennyh drugs for medical use, kob″emu requirements of the packaging of medicinal products for veterinary use shall be determined by the relevant authorized federal executive authorities in the manner prescribed by the Government of the Russian Federation (part 4-1 introduced by the Federal law of December 22, 2014 N 429-FZ collection zakonodatel′stvaRossijskoj Federation, 2014, N 52, art.
7540; in red. Federal law dated December 14, 2015 N374-FZ collection zakonodatel′stvaRossijskoj Federation, 2015, N 51, art.
7245). 5. Zapreŝaetsâproizvodstvo: 1) of drugs not included in the State Register of medicinal products, with the exception of lekarstvennyhsredstv, produced to conduct clinical studies and for export;
2) fal′sificirovannyhlekarstvennyh means;
3) medicines without a licence to manufacture pharmaceutical products;
4) drugs in violation of the rules of organization of production and quality control of medicines.
6. When you enter the drugs into civil circulation by the manufacturer of the drugs carries out conformity assessment of medicines requirements established in ihgosudarstvennoj registration and guarantees čtolekarstvennye means manufactured in accordance with the requirements of pravilnadležaŝej manufacturing practices (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 7. Upolnomočennymlicom manufacturer of medicines is his employee, certified in ustanovlennomupolnomočennym by the Federal Executive Body in the order and has worked for not less than five years in the production and (or) quality control of medicines, higher education, respectively, one of the specialties and (or) one of the directions of training: biology, biotechnology, veterinary medicine, clinical medicine, radiation, chemical and biological protection, pharmacy, basic medicine, chemical engineering , chemistry (in red. Federal′nogozakona from October 22, 2014 N 313-FZ-collection of laws of the Russian Federation, 2014, N 43, St.
5797). 8. Pharmaceuticals manufacturers may sell medicines or pass them in the manner prescribed by the legislation of the Russian Federation: 1) other producers of medicines for pharmaceutical products manufacturing;
2) organizations of optovojtorgovli drugs;
3) aptečnymorganizaciâm, a veterinary aptečnymorganizaciâm, individual entrepreneurs, licensed or licensed distribution for medical activity;
4) research organizations for scientific research;
5) medical organizations, veterinary organizations;
6) organizations involved in breeding, planting and maintaining animals.
Article 46. Markirovkalekarstvennyh means 1. Medications, except for medicinal products manufactured aptečnymiorganizaciâmi, veterinary pharmacy organizations, independent entrepreneurs, and to license them to pharmaceutical activities, should be issued if: 1) on their pervičnojupakovke (except for the primary packaging of medicinal vegetative preparations) horošočitaemym font name specified in Russian medicine (International Nonproprietary or generic name, ilihimičeskoe, or trade name), serial number, date of issue (for immunobiological drugs), shelf life dosage or concentration, volume, active in edinicahdejstviâ or the number of doses (as amended by the Federal law of October 11, 2010 N 271-FZ-collection of laws of the Russian Federation, 2010, N 42, art. 5293; federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
2) on their secondary (consumer) upakovkehorošo readable typeface in Russian are indicated the name of the medicinal product (International Nonproprietary or generic name, or chemical and commercial names), the name of the manufacturer of the medicinal product, the serial number, manufacturing date (for immunobiological drugs), registration certificate number, expiry date, method of use, dosage or concentration, volume, active in edinicahdejstviâ
or the number of doses in the packaging, pharmaceutical form, terms, storage conditions, warning labels (as amended by the Federal law of October 11, 2010 N 271-FZ-collection of laws of the Russian Federation, 2010, N 42, art. 5293;
Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). 2. Farmacevtičeskiesubstancii should be issued, if their primary packaging good readable font name specified in Russian pharmaceutical substances (International Nonproprietary or generic name, or chemical and commercial names), the name of the manufacturer of the pharmaceutical substance, serial number and date of manufacture, the amount of packaging and unit number, srokgodnosti and storage conditions (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation , 2014, N 52, art. 7540). 3. Medicines as serums should be issued indicating the animal from the blood plasma, blood, organs and tissues in which they are received.
4. Secondary (consumer) the packaging of medicinal products derived from blood plasma, blood, organs and tissues of human origin, should nanosit′sânadpis′: "antibodies to HIV-1, HIV-2, HCV and hepatitis b virus surface antigen missing."
5. at the primary and secondary packaging (consumer) radiopharmaceutical medicinal products must bear the mark of the radiation hazard.
6. at the secondary (consumer) homeopathic medicines must bear the inscription: "Homeopathic".
7. at the secondary (consumer) packaging of medicinal vegetative preparations shall bear the inscription: "the products have passed the radiation control.
8. On the primary packaging (unless there is a technical possibility) and secondary (consumer) packaging drugs intended for clinical research, shall bear the inscription: "for clinical research" (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540). 9. Packaging of medicines intended for export shall be in accordance with the requirements of the importing country.
10. The shipping container, which is not intended for consumers and pushed remedy, shall bear the name, information about the medicinal product series, release date, the number of secondary (consumer) packages of the drug, the manufacturer of the medicinal product, together with an indication of the name and location of the manufacturer of the medicinal product (address, including country and (or) production site of the drug product), as well as the shelf life of the medicinal product and the conditions of its storage and transport required warning labels and positioning marks.
11. at the primary and secondary packaging (consumer) the packaging of medicinal products for veterinary use shall bear the inscription: "for veterinary use".
12. at the secondary (consumer) drug product packaging barcode is applied.
Chapter 9. Vvozlekarstvennyh funds in the Russian Federation ivyvoz medicines from Russianfederation (name in red. Federal law dated December 6, 2011 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351) article 47. Porâdokvvoza drugs in RossijskuûFederaciû and exportation of medicines izRossijskoj Federation (name of harm. Federal law dated 6 dekabrâ2011 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351) 1. Importation of medicines in the Russian Federation is carried out is okay, established by the Pravitel′stvomRossijskoj Federation, in accordance with the customs legislation of the Customs Union within the Eurasian Economic Community (hereinafter referred to as the Customs Union) and (or) the legislation of the Russian Federation on Customs Affairs (ed. The Federal law from December, 2011. N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351). 2. Imported into the Russian Federation drugs should be included in the State Register of lekarstvennyhsredstv (in red. Federal law dated December 6, 2011 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art.
7351). 3. Allowed import of vRossijskuû Federation of particular party registered and/or unregistered medicines going for clinical trials of drugs, medicines for examination of public registraciilekarstvennyh drugs or medical aid for health reasons the individual patient based on a permit issued by the authorized federal body of executive power according to the persons referred to in article 48 of this federal law. Consideration of such a Declaration and the adoption of a decision to grant permission to import a particular party registered and/or unregistered drugs intended for clinical trials of drugs, medicines for examination of State registration of pharmaceuticals or medical aid for health pokazaniâmkonkretnogo the patient or on refusal to issue the specified razrešeniâproizvodâtsâ in a period not exceeding five working days. A fee is not charged for the specified permission (as restated by federal law from December 2011 N 409-FZ-Sobraniezakonodatel′stva Russian Federation, 2011, N 50, art. 7351).
4. In the Russian Federation can import medicines quality kotoryhpodtverždeno manufacturer's certificate certifying conformity of medicines imported medicines requirements Officinal articles or in case of their absence of normative documents or regulatory instrument (as amended by the Federal law of December 6, 2011 N409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351).
5. it is prohibited to import into the Russian Federaciûfal′sificirovannyh medicines, adulterated medicines, counterfeit medicines (in red. Federal law dated December 6, 2011 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351). 6. Falsified medicines, unsafe medicines subject to seizure and subsequent destruction or removal from the Russian Federation, counterfeit drugs-seizure and subsequent destruction. The destruction or removal from the Russian Federation falsified medicines, adulterated medicines, counterfeit medicines are paid for by the person who imports. The order of destruction of seized counterfeit medicines, adulterated medicines, counterfeit medicinal products shall be established by the Government of the Russian Federation (as amended by the Federal law of December 6, 2011 N409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351).
7. Persons carrying out import into the Russian Federation of falsified medicines, adulterated medicines, counterfeit medicines are liable in accordance with the customs legislation of the Customs Union and (or) law Russianfederation on Customs Affairs (as amended by the Federal law of December 6, 2011 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351).
8. Export of medicines from the Russian Federation is carried out without the use of restraints, ustanovlennyhtamožennym legislation of the Customs Union and (or) the legislation of the Russian Federation on the public regulirovaniivnešnetorgovoj activities (as amended by the Federal law of December 6, 2011 N 409-FZ-Sobraniezakonodatel′stva Russian Federation, 2011, N 50, art. 7351; Federal law dated November 25, 2013 N 317-FZ collection zakonodatel′stvaRossijskoj Federation, 2013, N 48, art.
6165; Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). Article 48. Ûridičeskielica allowed the importation of medicines in RossijskuûFederaciû (name of harm. Federal law dated 6 dekabrâ2011 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351) Medicinal sredstvav Russian Federation may bring (in red. The Federal law from December, 2011. N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351): 1) manufacturers of drugs for the purposes of own manufacture of medicines;
2) foreign developers of drugs and foreign manufacturers of medicines or other legal persons of the drug developer poporučeniû to conduct clinical trials of the medicinal product, the implementation of State registration lekarstvennogopreparata, inclusion of the pharmaceutical substance in State register
drugs, quality control of medicines with the permission of the authorized federal body of executive power for the import of a particular batch of drugs;
3) optovojtorgovli drugs;
4) research organizations, educational institutions of higher education, producers of medicines to develop, research, monitoring of safety, quality, effectiveness of drugs with the permission of the authorized federal body of executive power (in red. Federal′nogozakona of July 2, 2013 N 185-FZ collection zakonodatel′stvaRossijskoj Federation, 2013, N 27, art.
3477);
5) other medical organizations, referred to in paragraphs 1-4 of this article the Organization for providing medical pomoŝipo health reasons the individual patient with the permission of the Commissioner of the Federal organaispolnitel′noj authorities on the import of a particular batch of medicinal product issued in the prescribed manner in the form of an electronic document signed by the enhanced qualified electronic signature (as amended by the Federal law of March 12, 2014 N 33-FZ-collection of laws of the Russian Federation, 2014, N 11, art. 1098). Article 49. Documents submitted to the Customs authorities upon importation of the Russianfederation medicines vRossijskuû Federation (name of harm. Federal law dated 6 dekabrâ2011 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351) 1. When vvozelekarstvennyh funds in the Russian Federation to the Customs authorities of the Russian Federation, together with the documents, which provided the customs legislation of the Customs Union and (or) the legislation of the Russian Federation on customs, the following documents shall be presented (as amended by the Federal law of December 6, 2011 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351): 1) certificate of the manufacturer of the medicinal product, certifying that the imported medicinal product, Pharmacopeia requirements article or in her absence of normative documents or instrument;
2) authorized federal body of executive power for the import of a particular party drug in cases stipulated by part 3 of article 47 of the Federal law.
2. the documents referred to in paragraphs 1 and 2časti 1 of this article shall be submitted to the Customs authorities of the Russian Federaciipri arrival of pharmaceuticals in the Russian Federation (as amended by the Federal law of December 6, 2011 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351).
Article 50. Vvozlekarstvennyh drugs in Russian Federaciûdlâ inyhnekommerčeskih own use and purposes as well as for use at the international medicinskogoklastera (name of harm. Federal law dated 6 dekabrâ2011 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351; Federal law dated June 29, 2015 N 160-FZ-collection of laws of the Russian Federation, 2015, N 27, art.
3951) 1. Lekarstvennyepreparaty can be imported into the Russian Federation without taking into account the requirements of parts 1-4 of article 47, articles 48 and 49nastoâŝego federal law if they are designed for (as restated by federal law dekabrâ2011 6 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351): 1) for personal use by individuals who arrived in the Russian Federation (as amended by the Federal law of December 6, 2011 N 409-FZ-collection of laws of the Russian Federation 2011, N, 50, art. 7351);
2) use by the diplomatic corps or representatives of international organizations accredited in the Russian Federation;
3) treatment of passengers and crew members transportnyhsredstv, train crews and drivers of vehicles arrived in the Russian Federation (as amended by the Federal law of December 6, 2011 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351);
4) treatment of participants in international cultural and sports activities and participants of international expeditions;
5) treatment konkretnyhživotnyh in zoos, as well as the animals imported into the Russian Federation for participation in sports and entertainment activities (as amended by the Federal law of December 6, 2011 N 409-FZ-Sobraniezakonodatel′stva Russian Federation, 2011, N 50, art. 7351);
6) use on the territory of international medical cluster (paragraph vvedenFederal′nym of the Act of 6 June 29, 2015 N 160-FZ-collection of laws of the Russian Federation, 2015, N 27, art. 3951). 2. In the cases provided by paragraph 1 of this article, it is allowed to import drugs into the Russian Federation, Russian Federation are not registered (as amended by the Federal law of December 6, 2011 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351);
3. Lekarstvennyepreparaty, intended for humanitarian aid (assistance) or assistance in emergency situations, are imported to the Russian Federation in the manner prescribed by the Government of the Russian Federation. It is prohibited to import into the Russian Federation unregistered medicines intended for humanitarian aid (assistance) or assistance in emergency situations (as amended by the Federal law of December 6, 2011 N409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351).
Article 51. cooperation of the federal body of executive power in the area, tamožennogodela Commissioner and other Commissioners Executive federal′nyhorganov 1. Authorized federal executive bodies provide a federal body of executive power, authorized in the field of customs, the State Register of medicines, as well as information on issued import authorizations for specific party drugs in cases ustanovlennyhčast′û 3 of article 47 of the Federal law.
2. the federal authorities organispolnitel′noj Commissioner in the area of customs, shall inform referred to in part 1nastoâŝej article authorised federal bodies of executive power on the importation of pharmaceuticals in the Russian Federation and the export of medicines from the Russian Federation according to the form and order, established by the Government of the Russian Federation (as amended by the Federal law of December 6, 2011 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50 , art. 7351). Chapter 10. Pharmaceutical activities Article 52. implementation of the pharmaceutical activities 1. Farmacevtičeskaâdeâtel′nost′ is carried out by the organizations of wholesale trade of medicines, pharmacy organizations, veterinary pharmacy organizations, independent entrepreneurs, and to license them to pharmaceutical activities, medical organizations, licensed to the pharmaceutical activities, and their separate units (units, fel′dšerskimi and feldsher-obstetric points, centres (offices) general medical practice (family)), located in rural settlements, which no pharmaceutical organizations, and veterinary organizations licensed to pharmaceutical activities (as amended by the Federal law of November 25, 2013 N 317-FZ-collection of laws of the Russian Federation 2013, N, 48, art. 6165). 2. Individuals can carry out pharmaceutical activities in the presence of higher or srednegofarmacevtičeskogo education and specialist certificate, higher or secondary education certificate and veterinary specialists, as well as higher or secondary medical education specialist certificate and additional professional education včasti retail drugs provided ihraboty in separate units of the medical institutions specified in part 1 of this article (in red. Federal′nogozakona of July 27, 2010 N 192-FZ-Sobraniezakonodatel′stva Russian Federation 2010, N 31, art. 4161). Article 53. Sale, transfer drugs wholesale organizations drugs Organizaciioptovoj drug trade can sell medicines or pass them in the manner prescribed by the legislation of the Russian Federation: 1) other organizations of wholesale trade in medicinal products;
2) proizvoditelâmlekarstvennyh tools for the production of drugs;
3) aptečnymorganizaciâm and veterinary pharmacy organizations;
4) research organizations for scientific research;
5) individuals licensed to pharmaceutical activities or license for medical activity;
6) medicinskimorganizaciâm, veterinary organizations;
7) organizations involved in breeding, planting and maintaining animals.
Article 54. Pravilaoptovoj trade drugs wholesale drugs is carried out by manufacturers of medicines and wholesale organizations
trafficking in drugs according to the rules of good distribution practice and rules of good practice storage transport of medicines approved by the respective authorised federal bodies of executive power (damage the Federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540). Article 55. Porâdokrozničnoj trade in drugs 1. Retail sale of medicinal preparations in the quantities necessary to perform medical (nurse) assignments or assignments of specialists in the field of veterinary medicine, pharmacy, veterinary organizations implemented pharmacy organizations, individual entrepreneurs, imeûŝimilicenziû on pharmaceutical activity, medical organizations, licensed to the pharmaceutical activities, and their separate units (units, fel′dšerskimi and feldsher-obstetric points, centres (offices) general medical practice (family)), located in rural settlements, which no pharmacy organizations and veterinary organizations licensed to pharmaceutical activities. Razrešenarozničnaâ trade only medicines registered in the Russian Federation or made drugstore organizations, veterinary pharmacy organizations, individual entrepreneurs, imeûŝimilicenziû for pharmaceutical activities. Retail torgovlâlekarstvennymi drugs is carried out according to the rules of good pharmacy practice, approved by the authorized federal body of executive power (as restated by federal law No. 25, noâbrâ2013 317-FZ-collection of laws of the Russian Federation, 2013, no. 48, art. 6165; federal law dated December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540).
2. Types of pharmacies and rules leave drugs for medical use pharmacy organizations, independent entrepreneurs, and to license them to pharmaceutical activities, as well as rules leave drugs for medical organizations, medicinskogoprimeneniâ imeûŝimilicenziû for pharmaceutical activities, and their separate units (units, fel′dšerskimi and feldsher-obstetric points, centres (offices) general medical practice (family)), located in rural settlements, which no pharmaceutical organization, approved by the authorized federal body of executive power (in red. Federal′nogozakona from November 25, 2013 N 317-FZ collection zakonodatel′stvaRossijskoj Federation, 2013, N 48, art.
6165). 3. The rules leave of narcotic drugs and psychotropic substances, zaregistrirovannyhv as drugs, medicines containing narcotic drugs and psychotropic substances, approved by the authorized federal body of executive power in consultation with the federal body of executive power executing the functions of State policy, normative-legal regulation, control and supervision in the field of narcotic drugs, psychotropic substances and their precursors, as well as to counter their illicit trafficking.
4. Medicinal products for veterinary use shall be subject to the release of veterinary pharmacy organizations, veterinary organizations, independent entrepreneurs, and to license them to pharmaceutical activities. Pravilaotpuska medicinal preparatovdlâ veterinary use approved by the authorized federal body of executive power.
5. The list of medical organisations licensed to pharmaceutical activities, and their separate units (clinics, nursing and midwifery units, centres (offices) general medical practice (family)), located in rural settlements, where there are no pharmaceutical organization, as well as a list of medications (except for narcotic and psychotropic drugs lekarstvennyhpreparatov), which can be accessed by the organizations and their separate units are established by the Executive authority of the Federation sub″ektovRossijskoj (as amended by the Federal law of November 25, 2013 N317-FZ-collection of laws of the Russian Federation 2013, N, 48, art.
6165). 6. Pharmaceutical organizations, individual entrepreneurs, licensed to pharmaceutical activities are obliged to ensure that the Government of the Russian Federation and generated by a procedure established by a minimum assortment of drugs required for medical care (in red. Federal′nogozakona from November 25, 2013 N 317-FZ-collection of laws of the Russian Federation, 2013, no. 48, art.
6165). 7. Pharmaceutical organizations, individual entrepreneurs, licensed to pharmaceutical activities, along with the drugs have the right to acquire and sell medical devices, disinfectants, and personal hygiene items, utensils, objects and purposes dlâmedicinskih funds intended for the care of the sick newborn, and children under the age of three years, completed the optics and her care, mineral waters, therapeutic products, children's and dietary food biologically active additives, perfume ikosmetičeskie tools, medical and sanitary-educational pečatnyeizdaniâ, designed to promote a healthy lifestyle (as amended by the Federal law dated July 27, 2010 N 192-FZ-collection of laws of the Russian Federation, 2010, N 31, art. 4161;
Federal law dated November 25, 2013 N 317-FZ-collection of laws of the Russian Federation, 2013, no. 48, art. 6165). 8. The activities of Pharmacy organizations of the armed forces of the Russian Federation, other troops, military formations and organs in which the legislation of the Russian Federation provides for military service or the federal public service related to law enforcement, is governed by this federal law and approved by the relevant federal authorities regulations organamiispolnitel′noj. Monitoring of compliance with pharmacy organizations specified provisions of this federal law shall be carried out by the relevant federal bodies of executive power (damage. Federal law dated July 13, 2015 N 262-FZ-collection of laws of the Russian Federation, 2015, N 29, art. 4388). Article 56. Izgotovleniei leave drugs 1. Manufacture of pharmaceuticals, veterinary organizations drugstore pharmacy organizations, independent entrepreneurs, and to license them to pharmaceutical activities are recipes for medicines, potrebovaniâm medical organizations, veterinary organizations in accordance with the rules of manufacturing and dispensing of medicines approved by the authorized federal body of executive power.
2. In the manufacture of medicines pharmacy organizations, veterinary pharmacy organizations, independent entrepreneurs, and to license them to pharmaceutical activities, use pharmaceutical substances included respectively in the State Register of pharmaceuticals for medical use igosudarstvennyj registry of medicines for veterinary use in accordance with the established procedure. Not allowed manufacturing chemist's organizations, veterinary pharmacy organizations, independent entrepreneurs, and to license them to pharmaceutical activities, drugs, registered in the Russian Federation.
3. marking of medicines manufactured drugstore organizations, veterinary pharmacy organizations, independent entrepreneurs, and to license them to pharmaceutical activities, making such preparatovdolžny and conform to the rules specified in part 1 of this article.
4. Pharmaceutical organizations, veterinary aptečnyeorganizacii, individual entrepreneurs, licensed to pharmaceutical activities, responsible for the non-compliance of the rules making and holiday lekarstvennyhpreparatov in accordance with the legislation of the Russian Federation.
Article 57. Zapreŝenieprodaži falsified medicines, adulterated medicines, counterfeit medicines the sale of adulterated medicines, adulterated medicines, counterfeit medicines is prohibited.
Article 58. Hranenielekarstvennyh means 1. Storage of medicinal products is carried out by manufacturers of medicinal products, wholesale trade in medicinal products organizations, pharmacy organizations, veterinary pharmacy organizations, independent entrepreneurs, and to license them to pharmaceutical activities or the license for medical practice, medical organizations, veterinary organizations iinymi organizations providing treatment medications. Storage
medicines dlâveterinarnogo application of the organizations and individual entrepreneurs in cases, if they are used exclusively for breeding, cultivation, maintenance and treatment of animals may be carried out without obtaining a license for pharmaceutical activities (as amended by the Federal law of October 22, 2014 N 313-FZ-collection of laws of the Russian Federation, 2014, N 43, St. 5797). 2. Rules for storing medicines approved by the relevant authorized federal′nymorganom Executive.
3. Hranenienarkotičeskih drugs, psychotropic drugs, radiopharmaceutical medicinal products is carried out in accordance with the legislation of the Russian Federation.
Article 58-1. Subject-the quantification of medicinal techniques medical application 1. Perečen′lekarstvennyh funds for medical use, to be subject-quantifiable, alleged the authorized federal body of executive power.
2. The order of the vklûčeniâlekarstvennyh funds for medical application in the list of drugs for medical use, to be domain-specific, quantifiable sets the authorized federal body of executive power in consultation with the federal authority, ispolnitel′nojvlasti, exercising the functions of State policy, normative-legal regulation, control and supervision in the field of narcotic drugs, psychotropic substances and their precursors, as well as to counter their illicit trafficking.
3. Subject-the quantification of pharmaceuticals for medical use are leading manufacturers of medicinal products, wholesale trade in medicinal products, pharmaceutical organizations, individual entrepreneurs, licensed to pharmaceutical activities or license to medical activities and medical organizations, carrying out treatment drugs for medical use, by registering any associated with their treatment operations, in which changes their quantity and (or) State journals operations related to the treatment of drugs for medical use (hereinafter referred to as the special magazines).
4. rules of registration of operations related to the treatment of drugs for medical use, included in the list of drugs for medical use, to be subject-quantifiable, in specialty magazines and rules of storage and special interest magazines approved by the authorized federal body of executive power.
5. Monitoring of compliance with the rules for the registration of transactions related to the treatment of drugs for medical use, included in the list of drugs for medical use, to be subject-quantifiable, in special magazines, as well as the rules on the maintenance and retention of specialized magazines is imposed on authorized federal executive authorities and executive authorities of the constituent entities of the Russian Federation exercising licensing the production of medicines, pharmaceutical and medical activities and is being implemented within the framework of the licensing control.
(Article 58-1 vvedenaFederal′nym Act of December 25, 2012 N 262-FZ-collection of laws of the Russian Federation, 2012, N 53, article 7587) Chapter 11. Uničtoženielekarstvennyh means of Article 59. Reason iporâdok destruction medicines 1. Unsafe medicines, counterfeit medicines are subject to removal from circulation and destroy in order ustanovlennomPravitel′stvom of the Russian Federation. The reason for the destruction of drugs is drugs, rešenievladel′ca decision of the relevant authority or organaispolnitel′noj the Commissioner of the Federal Court decision (harm. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540). 2. Kontrafaktnyelekarstvennye funds shall be seized and destroyed by order of a court. The order of destruction of counterfeit medicinal products shall be established by the Government of the Russian Federation (as amended by the Federal law of 22 dekabrâ2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540).
3. costs associated with the destruction of counterfeit medicines, adulterated medicines, counterfeit medicines are reimbursed by their owner.
4. The owner of the drugs must submit to the authorized federal body of executive power dokumentili duly certified copy confirming the destruction of drugs.
5. the authorized federal body of executive power, ordered the destruction of the drugs, monitors their destruction.
6. the destruction of drugs is made by the organizations, imeûŝimisootvetstvuûŝuû license, on specially equipped sites, landfills and vspecial′no equipped facilities in compliance with the requirements of environmental protection Wednesday in accordance with the legislation of the Russian Federation.
7. the Narcotic Drugs, psychotropic drugs radiofarmacevtičeskie drugs are destroyed in accordance with the zakonodatel′stvomRossijskoj Federation.
Chapter 12. State regulation of prices for medicines dlâmedicinskogo application of Article 60. State regulation of prices for drugs for medical use Gosudarstvennoeregulirovanie prices for medicines for medical use is carried out through: 1) endorsement by the Government of the Russian Federation list of essential medicines, which is formed by a procedure established by a statute on the basis of kompleksnojocenki drugs, including analizsvedenij on comparative clinical effectiveness and safety of the medicinal product , assessment of economic impacts of lekarstvennogosredstva and explore further the implications of the use of the medicinal product (as amended by the Federal law of December 22, 2014 N429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
2) approval of the methodology for establishing the manufacturers of drugs limit selling prices for medicines included essential list of drugs, as well as the introduction of reference pricing systems mehanizmovformirovaniâ (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
3) State registration of established manufacturers of drugs limit selling prices for medicines included in the list of essential medicines;
4) maintenance of the State Register of marginal prices of manufacturers of medicines included in the list of essential medicines;
5) the approval of the metodikiustanovleniâ bodies of the Executive power of the constituent entities of the Russian Federation razmerovoptovyh limits and size limits retail allowances to actual cost prices set by manufacturers of pharmaceuticals, drugs and medicines included in the list of essential medicines;
6) establish limits of wholesale and retail size limits allowances to actual cost prices, ustanovlennymproizvoditelâmi, drugs for medicines included in the list of vital medicine and essential medicines;
7) approval of the procedure of issuing prescriptions executive authorities of the constituent entities of the Russian Federation on the privedeniiv line with the legislation of the Russian Federation, decisions on establishing the limits of wholesale and retail size limits allowances to actual cost prices set by manufacturers of pharmaceuticals, drugs and medicines included in the list of vital medicine and essential medicines if they were snarušeniem the legislation of the Russian Federation, in the manner prescribed by the Government of the Russian Federation;
8) direction of the authorized federal body of executive power bodies of executive power of the constituent entities of the Russian Federation requirements on the approximation of the laws of the Russian Federation adopted in violation of the legislation of the Russian Federation of the decisions on the establishment of limits of wholesale and retail size limits price premiums for medicines, vklûčennyev list of essential lekarstvennyhpreparatov;
9) osuŝestvleniâfederal′nogo of State supervision in the sphere of circulation of medicines and regional State monitoring of prices for medicines respectively authorized by the Federal organamiispolnitel′noj authorities and executive authorities of the constituent entities of the Russian
Federation in accordance with their competence, in the manner prescribed by the Government of the Russian Federation (in red. Federal law dated June 25, 2012 N 93-FZ-collection of laws of the Russian Federation, 2012, N 26, art. 3446);
10) the application of the measures stipulated by legislation of the Russian Federation responsibility for violation of the rules of pricing for essential and essential medicines.
Article 61. State registration set by the manufacturers of medicinal products predel′nyhotpusknyh prices for medicines included in the list of vital neobhodimyhi essential medicines (name of harm. Federal law dated March 8, 2015 N 34-FZ-collection of laws of the Russian Federation, 2015, N10, art. 1404) 1. Medicines manufacturers install limit selling prices for medicines included in the list of essential lekarstvennyhpreparatov, are subject to state registration in the order established by the Government of the Russian Federation (in red. Federal law dated March 8, 2015 N 34-FZ-collection of laws of the Russian Federation, 2015, N 10, art. 1404). 2. On the basis of submitted before 1 October each godazaâvleniâ manufacturer of medicines included in the list of essential medicines, the registered maximum sale price for a medicinal product may byt′pereregistrirovana once in a calendar year in the order ustanovlennomPravitel′stvom of the Russian Federation (in red. Federal law dated March 8, 2015 N 34-FZ-collection of laws of the Russian Federation, 2015, N 10, art. 1404.) 2-1. (Part 2-the Act of October 11, 2010 vvedenaFederal′nym 1 N 271-FZ-collection of laws of the Russian Federation, 2010, N 42, art. 5293; void on the basis of the Federal law 8 March, 2015. N 34-FZ-collection of laws of the Russian Federation, 2015, N 10, art. 1404) 2-2. (Part 2-2 vvedenaFederal′nym Act of October 11, 2010 N 271-FZ-collection of laws of the Russian Federation, 2010, N 42, art. 5293; void on the basis of the Federal law 8 March, 2015. N 34-FZ-collection of laws of the Russian Federation, 2015, N 10, art. 1404) 3. Calculation of limit selling prices referred to in paragraphs 1 and 2 of this article, when their State registration or re-registration shall be carried out in accordance with the methodology approved by the Government of the Russian Federation and takes into account, inter alia: 1) balancing the interests of consumers of medicines included in the list of essential medicines, and manufacturers of medicines included in the list of essential medicines;
2) faktičeskuûotpusknuû price for pharmaceuticals in the Russian Federation, the price of smuggling drugs in the Russian Federation, as well as the prices for similar drugs in circulation in the Russian Federation;
3 drug manufacturer) costs of production and sales of the medicinal product;
4) price nalekarstvennyj product of a foreign proceeding, its price from the manufacturer, and in countries where the drug is registered and (or) that is supplied by a foreign manufacturer.
(Part 3 as amended by the Federal law of March 8, 2015 N 34-FZ-collection of laws of the Russian Federation, 2015, N 10, art. 1404)
4. implementation and are not allowed leave medicines included in the list of essential medicines that manufacturers of medicines not registered maximum sale price, sale and vacation lekarstvennyhpreparatov manufacturers at prices prevyšaûŝimzaregistrirovannye limit selling prices for medicines, as well as implementation and leave drugs wholesale and retail organizations trafficking drugs at prices which, taking into account the limit and maximum allowance wholesale retail allowance exceeds the size of the actual selling price (part 4 introduced by the Federal law dated 8 March, 2015. N 34-FZ-collection of laws of the Russian Federation, 2015, N 10, art. 1404). 5. Features of State regulation of limit prices for medicines included in the list of essential medicines, depending on economic and/or social criteria (conditions porâdkai production cost of medicines, the use of new forms, methods and means of State regulation of prices nalekarstvennye drugs, including through the mechanism of reference pricing, changes the order of medical assistance, and other modifications) shall be established by the Government of the Russian Federation (part 5 introduced the Federal zakonomot March 8, 2015 N 34-FZ-collection of laws of the Russian Federation, 2015, N 10, art. 1404). Article 62. State Register of limit prices for medicines manufacturers included vital list and važnejšihlekarstvennyh drugs 1. Registered marginal prices for medicines included in the list of vital medicine and essential medicines should be included in the State Register of limit selling prices of manufacturers of medicines included in the list of vital medicine and essential medicines.
2. State Register limit selling prices of manufacturers of medicines included in the list of essential medicines, contains the following information: 1 the holder or owner) name registration certificate, the name of the drug product manufacturer of the medicinal product, the location of production sites involved in the manufacturing process of the medicinal product, together with an indication of the stage of the production process (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation , 2014, N 52, art. 7540);
2) name of the medicinal product (International Nonproprietary, iligruppirovočnoe, or chemical and commercial names) (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
3) number of the registration certificate of the medicinal product;
4) dosage form with indication of dozirovkilekarstvennogo drug and its number of secondary (consumer) package, as well as completeness (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
5) zaregistrirovannaâpredel′naâ sale price in rubles;
6) date and nomerprikaza of the authorized federal body of executive power of State registration, re-registration of the ultimate selling price for a medicinal product included in the list of essential medicines (as amended by the Federal law of December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540);
7) bar code printed on the secondary (consumer) drug packing (item 7 was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540);
8) code of the medicinal product on the anatomical therapeutic chemical classification recommended by the world organizaciejzdravoohraneniâ (item 8 was introduced by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540).
3. State registration of limit prices for medicines included in the list of vital medicine and essential medicines, conducting the State Register of marginal prices of manufacturers of medicines included in the list of essential drugs, shall be made in accordance with the procedure established by the Government of the Russian Federation.
Article 63. Ustanovlenieorganami Executive sub″ektovRossijskoj Federation of razmerovoptovyh limits and size limits rozničnyhnadbavok to actual cost prices set by manufacturers of medicines, medicinal preparatydlâ medical applications 1. Organyispolnitel′noj authorities of subjects of the Russian Federation set limits of wholesale and retail size limits allowances to actual cost prices set by manufacturers of pharmaceuticals, drugs and medicines included in the list of vital medicine and essential medicines, in accordance sutverždennoj in the manner prescribed by the Government of the Russian Federation, the methodology for establishing executive bodies of subjects of the Russian Federation limits wholesale retail size limits and allowances allowances to actual cost prices , ustanovlennymproizvoditelâmi medicines,
medicines included in the list of vital medicine and essential medicines. Draft decisions of the executive authorities of the constituent entities of the Russian Federation on establishing and (or) changing optovyhnadbavok size limits and size limits retail allowances to actual cost prices, ustanovlennymproizvoditelâmi, drugs for medicines included in the list of vital medicine and essential medicines, subject to agreement with the Federal Executive Body authorized to carry out the legal regulation in the sphere of State regulation of prices (tariffs) for goods (services) in the order established by the Government of the Russian Federation (as amended by the Federal law dated July 13, 2015 N 241-FZ-collection of laws of the Russian Federation, 2015, N 29, art. 4367). 2. The Organization of optovojtorgovli and (or) pharmacy organizations, individual entrepreneurs, licensed to pharmaceutical activities, implement of medicines included in the list of essential drugs, at prices, the level of which does not exceed the sum of the actual selling price determined by the manufacturer of the drugs and not exceeding registered ultimate selling price, and the size of the wholesale allowance and (or) size retail allowance not exceeding respectively razmerapredel′noj wholesale allowance and (or) size limit retail allowances established in the constituent entities of the Russian Federation.
3. Organyispolnitel′noj power of subjects of the Russian Federation is placed on the Internet or publish information on registered ultimate selling price for medicines included in the list of essential medicines, installed in the constituent entities of the Russian Federation amounting to limit wholesale allowance and (or) size limit retail allowances to producers of drugs the actual cost prices for medicines included in the list of vital medicine and essential medicines and about the specified in part 2 of this article. The information required by this part, must be also in pharmacy organizations accessible to all interested persons form and updated as its publication.
4. snarušeniem the legislation of the Russian Federation Adopted decision of the executive authorities of the subject of the Russianfederation establishment of limit sizes wholesale and retail size limits allowances to registered marginal cost prices for medicines included in the list of essential medicines are subject to cancellation by judicial procedure.
Chapter 13. Monitoringèffektivnosti and security lekarstvennyhpreparatov in circulation Russian Federation (name as amended by the Federal law of December 22, 2014 N 429-FZ collection zakonodatel′stvaRossijskoj Federation, 2014, N 52, art. 7540) article 64. Pharmacovigilance 1. Drugs in circulation in the Russian Federation shall be subject to the monitoring of the effectiveness and safety of negativnyhposledstvij in order to identify potential for applying them, intolerances, preventing health workers, veterinary specialists, patients or the owners of the animals and their protection from the use of such drugs.
2. Pharmacovigilance osuŝestvlâetsâsootvetstvuûŝim authorized federal body of executive power in accordance with the established procedure by the analysis provided by the subjects of circulation of medicines, information on side effects, unwanted reactions, serious adverse reactions, unforeseen undesirable reactions when applying medications about hypersensitive, the lack of effectiveness of medicines, as well as other facts and circumstances, represent a threat to human life or health or animal when applying medications ivyâvlennyh at all stages of circulation of pharmaceuticals in the Russian Federation and other States.
3. subjects of circulation of medicines in the manner prescribed by the authorized federal body of executive power are required to report to the authorized federal body of executive power of side effects, neželatel′nyhreakciâh, serious adverse reactions, unforeseen undesirable reactions when applying medication, obindividual′noj, lekarstvennyhpreparatov efficiency intolerances, as well as other facts and circumstances, represent a threat to human life or health or animal when applying medications and identified at all stages of circulation of pharmaceuticals in the Russian Federation and other States.
4. Holders or holders of registration certificates of medicines, legal person in whose name the issued authorization to conduct clinical research in the Russian Federation or their authorized other legal persons under security of drugs in the manner prescribed by the respective authorized federal body of executive power, are obliged to carry out reception, recording, processing, storage and analysis coming at them from the subjects of circulation of medicines and public vlastisoobŝenij about side effects unwanted reactions, ser′eznyhneželatel′nyh and unexpected unwanted reactions when applying medications on the peculiarities of their interaction with other drugs, individual′nojneperenosimosti, as well as other facts and circumstances that threaten the life or health of a person or animal, or have an influence on the change of attitude of the expected benefits to the possible risk of drugs.
5. When vyâvleniiinformacii of serious adverse reactions and unexpected unwanted reactions when applying medications on the peculiarities of their interaction with other drugs, individual′nojneperenosimosti, as well as other facts and circumstances that affect the changing attitudes of the expected benefits to the possible risk of pharmaceuticals, holders or holders of registration certificates of medicines, legal person in whose name the permit kliničeskihissledovanij issued in the Russian Federation or their authorized other legal persons are obliged to take measures to eliminate the negative effects of such medications, prevention of harm to the life or health of a person or animal, to protect them from the use of such drugs, additional data collection on the effectiveness and bezopasnostitakih of medicines.
6. For failure to disclose or concealing information under part 3 of this article, holders or holders of registration certificates of medicines, legal person in whose name the permit kliničeskihissledovanij issued in the Russian Federation or their authorized other juridical persons, as well as the officials of that information has become known in the course of their professional activities, shall be liable in accordance with the legislation of the Russian Federation.
7. upon receipt of the authorized federal body of executive power in the fulfilment of pharmacovigilance evidence of lack of medication prescribed requirements or to obtain information about data on the efficacy and safety of medication medication medication data contained in the instructions for use (čislevyâvlennyh in the course of the implementation of pharmacovigilance control and supervisory authorities of foreign States), the authorized federal body of executive power by a procedure established by considering the suspension of the use of such medication.
(Art. 64 as amended. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) Article 65. Suspension of the application of medicinal preparation 1. To obtain information about unwanted reactions when applying medication, not mentioned in the instructions for use of the medication, serious adverse reactions, on the peculiarities of its interactions with other drugs that may be of ugrozužizni or the health of a person or animal, as well as data on the efficacy and safety of medication medication medication data contained in instrukciipo its application, including the authorized bodies of foreign States exchanged in accordance with agreements between the authorized federal body of executive power and the authorized bodies of foreign States, the authorized federal body of executive power is considering the possibility of the suspension of the drug obraŝeniâtakogo in the order established by the authorized federal body of executive power.
2. When neispolneniiili improper performance by the holders or holders of registration certificates of medicines, legal persons in whose name the issued authorization to conduct clinical research in, or their authorized Russianfederation other duties prescribed entities parts 3 and 4 of article 64 of this federal law, or in cases of sootvetstvuûŝimupolnomočennym by the Federal Executive Body in the opinion on the authenticity of the results of clinical studies of the drug for medical use based on the results of check of medical organization, which conducted the specified clinical trial in violation of the rules of good clinical practices, and result in inaccurate results or in the event of failure to comply with a precept issued by the authorized federal body of executive power of selective drug quality control, the authorized federal body of executive power by a procedure established by considering the suspension of the use of such medication.
(Art. 65 as amended. Federal law dated December 22, 2014 N 429-FZ-Sobraniezakonodatel′stva Russian Federation, 2014, N 52, art. 7540) article 66. Information orezul′tatah pharmacovigilance (name as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540) Upolnomočennyjfederal′nyj executive body, performing the pharmacovigilance, in circulation in the Russian Federation, according to the results of the pharmacovigilance places on their official website on the Internet information oprinâtyh decisions on amendments to the instruction on application of medicinal preparation, opriostanovlenii use of drug , on the retirement of the medicinal product or to renew the use of the medicinal product (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540).
Chapter 14. Information olekarstvennyh products Article 67. Information olekarstvennyh products 1. Information on medicines, prescription for a medicinal product must contain only in specialized publications intended for the medical, pharmaceutical, veterinary workers. Information on medicines for professionals in the field of circulation of medicines can contain monographs, reference books, scientific articles, reports on congresses, conferences, symposia, research councils, as well as the instructions for use of the drugs.
2. the information on pharmaceuticals, prescription for a medicinal product can appear in publications and media announcements, specialized and General publications, instructions on the use of medicines, other editions of subjects of circulation of medicines. Promotional material product otpuskaemom the medication without a prescription for a medicinal product must comply with the instructions for use of the medicinal product.
3. you are allowed to use any material carriers to keep, share and use information on medicines without distortion.
Chapter 14-1. Restrictions imposed on organizations involved in treatment drugs (Chapter 14-1 introduced by the Federal law dated November 25, 2013 N 317-FZ-collection of laws of the Russian Federation, 2013, no. 48, art. 6165) article 67-1. Restrictions in carrying out activities in the sphere of circulation of medicines 1. Organizations involved in the development, production and (or) implementation of drugs for medical use, institutions with rights to use the trade name of the medicinal product for medical use, organization lekarstvennymisredstvami wholesale, pharmaceutical organizations (or their representatives, and other individuals and entities operating on behalf of those organizations) for medical providers and managers organizations do not have the right to: 1) handing gifts to pay cash (except remuneration under contracts when conducting clinical trials of pharmaceuticals for medical use rewards, associated with the implementation of medical professional teaching and (or) scientific activities), including paying for entertainment, recreation, travel to a place of rest, as well as to engage in recreational activities conducted at the expense of own funds;
2) conclude agreements regarding the appointment or recommendation of patients drugs for medicinskogoprimeneniâ (except for contracts about conducting clinical trials of pharmaceuticals for medical use);
3) provide samples of drugs for medical use for handing patients (with the exception of cases relating to the conduct of clinical trials of drugs for medical use);
4) predostavlât′nedostovernuû and (or) incomplete information on pharmaceuticals for medical use;
5) visit them during working hours at the workplace, except for cases related to the conduct of clinical trials of drugs for medical use, with the participation, in the manner prescribed by the head of the medical institution, medical staff meetings and other activities aimed at improving their professional′nogourovnâ or to provide information related to the implementation of the safety monitoring of medicines;
6) encouraged to vypisyvaniû drugs for medical use in forms that contain advertising information, as well as of prescription forms, on which is printed in advance the name of the drug for medical use.
2. The organizations referred to in paragraph 1 of section 1 of this article and their representatives regarding pharmaceutical workers and leaders pharmacies may not: 1) handing gifts to pay money, including paying for entertainment, recreation, travel to a place of rest and engage in recreational activities conducted at the expense of own funds;
2) provide samples of drugs for medical use for the population;
3) enclose the soglašeniâo proposal to the population of certain drugs for medical use;
4) predostavlât′nedostovernuû and (or) incomplete information on pharmaceuticals for medical use, including having the same International Nonproprietary name.
(Article 67-1 introduced by the Federal law dated November 25, 2013
N 317-FZ-collection of laws of the Russian Federation, 2013, no. 48, art. 6165) Art. 67-2. Requirements relating to the Organization and conduct of scientific activities, other activities aimed napovyšenie professional grade health workers or to provide information related to the implementation of safety monitoring of drugs 1. At carrying out of scientific events, other events aimed at raising the professional level of medical workers or to provide associated with monitoring the safety of medicines information organized by the organizations referred to in the first paragraph of part 1 of article 67-1 of this federal law, their representatives and (or) funded by these organizations and their representatives, it is forbidden to interfere with the participation in those activities of other organizations that produce or implement drugs for medical use with a similar mechanism of pharmacological action or create discriminatory conditions for participants in comparison with other participants, namely: 1) predostavlât′različnoe amount of time for presentations, various on the size of the footprint places to showcase samples of drugs for medical use or promotional materials on lekarstvennyhpreparatah for medical use in exhibits, stands, except if such conditions are enshrined in the agreements of these organizations, their representatives on the financing of these activities and the different costs of participants to their organization;
2) ustanavlivat′razmer fee for participants of the activities referred to in the first subparagraph of this paragraph, the excess summuzatrat on the Organization of these activities and lead to unjustified restriction of the number of participants.
2. The organizations referred to in paragraph 1 of section 1 of article 67-1 of this federal law, their representatives engaged in the Organization and/or financing of the activities referred to in časti1 of this article, are obliged to provide access to information about the date, place and time of carrying out these activities, plans, programmes of conducting these activities and topics planned
to review, the composition of their participants by posting the relevant information on their official websites on the Internet no later than two months before the start of these activities.
3. information oprovedenii events, listed in part 1 of this article within the period stipulated in part 2 of this article shall be forwarded to the Federal Executive Body, performing the functions of control and supervision in the field of health, for posting it on the official site of this body on the Internet.
(Art. 67-2 introduced by the Federal law dated November 25, 2013
N 317-FZ-collection of laws of the Russian Federation, 2013, no. 48, art. 6165) Chapter 15. Responsibility for violation of legislation when handling the Russianfederation lekarstvennyhsredstv and compensation for harm caused to health graždanvsledstvie primeneniâlekarstvennyh drugs Article 68. Responsibility for violation of legislation when handling the Russianfederation medicines 1. Violation of the legislation of the Russian Federation to the circulation of medicines involves itself in accordance with the legislation of the Russian Federation (as amended by the Federal law of December 22, 2014 N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540).
2. For failure to provide information and/or data provided for in this federal law, subjects of circulation of medicines shall bear responsibility in accordance with the legislation of the Russian Federation (part 2 of the Act of December 22, 2014 vvedenaFederal′nym N 429-FZ-collection of laws of the Russian Federation, 2014, N 52, art. 7540).
Article 69. Vozmeŝenievreda caused to health of citizens vsledstvieprimeneniâ drugs 1. The manufacturer of the medicinal product shall be obliged to compensate the damage caused to health of citizens as a result of the medication if it is shown that: 1) a drug used for its intended purpose in accordance with the instruction on application of medicinal preparation and of the harm caused was entering into civil circulation of defective medicinal product;
2) harm zdorov′ûpričinen due to incorrect information contained in the operating instructions lekarstvennogopreparata, published by the manufacturer of the medicinal product.
2. If personal injury graždanpričinen as a result of medication, unserviceable as a result of infringement of regulations concerning the storage of medicinal products, wholesale trade in medicines regulation, the rules of holiday pharmaceuticals, manufacturing rules and dispensing medicines, compensation is carried out according to the Organization of wholesale trade in medicinal products, pharmaceutical organization individual′nympredprinimatelem licensed nafarmacevtičeskuû activities or license for medical practice, medical organization, licensed to pharmaceutical activities (its separate subdivision (dispensary fel′dšerskim, ifel′dšersko-obstetric points, Centre (Office) general medical practice (family)), located in sel′skomnaselennom paragraph in which there is no pharmacy organization), dopustivšimi or leave such lekarstvennogopreparata (in red. Between $ 25 million and federal law of November, 2013. N317-FZ-collection of laws of the Russian Federation, 2013, no. 48, art. 6165). 3. Vozmeŝenievreda caused to health graždanvsledstvie the use of drugs or commit illegal acts of subjects of circulation of medicines shall be carried out in accordance with the legislation of the Russian Federation.
Chapter 16. final provisions Article 70. The priznaniiutrativšimi effect of certain legislative acts (provisions of legislation) to recognize: utrativšimisilu 1 the Russianfederation) Federal law dated June 22, 1998, N 86-FZ "on medicines" (collection of laws of the Russian Federation, 1998, N 26, art. 3006);
2) the Federal law of January 2, 2000 year N5-FZ "on amendments and additions to the Federal Act" on medicines "(Sobraniezakonodatel′stva of the Russian Federation, 2000, N 2, art. 126);
3) article 40 of the Federal law dated January 10, 2003 N 15-FZ "on amendments and additions to some legislative acts of the Russian Federation in connection with adoption of the Federal law" on licensing of certain vidovdeâtel′nosti "(collection of laws of the Russian Federation, 2003, N 2, art. 167);
4) article 31Federal′nogo of the law of June 30, 2003 N 86-FZ "on amendments and additions to the nekotoryezakonodatel′nye acts of the Russian Federation, repealing certain legislative acts of the Russian Federation, granting certain guarantees employees of internal affairs bodies, bodies for monitoring the trafficking of narcotic drugs and psychotropic veŝestvi abolished the federal tax police bodies in connection with the implementation of measures to improve public administration" (collection of laws of the Russianfederation , 2003, no. 27, art. 2700);
5) Article 101 22avgusta 2004 federal law N 122-FZ "on changes in the legislative acts of the Russian Federation and repealing certain legislative acts of the Russian Federaciiv connection with the adoption of the Federal law on amendments and additions to the Federal law on general principles of organization of legislative (representative) and executive bodies of State power of the constituent entities of the Russian Federation" and "on general principles of organization of local self-government in the Russian Federation" (collection of laws of the Russian Federation , 2004, no. 35, St. 3607);
6) article 28Federal′nogo of the law of December 18, 2006 year N 231-FZ "on the entry into force of part four of the Civil Code of the Russian Federation (collection of laws of the Russian Federation, 2006, no. 52, p. 5497).
Article 71. The managed entry of this federal law 1. This federal law shall enter into force on the 1sentâbrâ 2010 year.
2. Medicinal products registered prior to the date of entry into force of this federal law, shall be included in the State registers of medicines with the incorporation referred to in paragraph 1 of article 33 of this federal law, information about these medicines bezprohoždeniâ again the procedure of State registration of medicines.
3. State registration of medicinal products, with the exception of medicines dlâmedicinskogo application submitted on specified registration prior to the date of entry into force of this federal law, shall be carried out in accordance with this federal law on the basis of the documents and the data submitted prior to the date of entry into force of this federal law (as amended by the Federal law of October 11, 2010 N 271-FZ-collection of laws of the Russian Federation 2010 , N 42, art.
5293.) 3-1. public registraciâlekarstvennyh drugs for medical use, presented at registration prior to the date of entry into force of this federal law and gosudarstvennaâregistraciâ drugs for medical use, presented at èkspertizulekarstvennyh funds prior to the date of entry into force of this federal law, with a view to their subsequent State registration osuŝestvlâûtsâna the basis of the documents and the data submitted prior to the date of entry into force of this federal law, as well as the application for State registration of medicinal product submitted by the manufacturer of the drugs or his representative in accordance with this federal law to the authorized federal body of Executive vlastido March 1, 2011 year beztrebovaniâ payment of the State fee provided for by the legislation of the Russian Federation on taxes and fees (part 3-1 introduced by the Federal law of October 11, 2010
N 271-FZ-collection of laws of the Russian Federation, 2010, N 42, art. 5293; in red. Federal law dated November 29, 2010 313 N-FZ-collection of laws of the Russian Federation, 2010, no. 49, St. 6409.) 3-2. Podtverždeniegosudarstvennoj registration of drugs for medical use, submitted for State registration confirmation prior to the date of entry into force of this federal law, and confirmation of the State registration of drugs for medical use, represented at the examination of drugs prior to the date of entry into force of this federal law for subsequent confirmation of their State registration shall be made on the basis of the documents and the data submitted prior to the date of entry into force of this federal law as well as the Declaration on the commitments of the State registration of medicinal product submitted by the manufacturer of the drugs or his representative in accordance with this federal law to the authorized federal body of executive power until March 2011 year, without requiring payment of the State fee provided for by the legislation of
Russian Federation on taxes and fees (part 3-2 introduced by the Federal law of October 11, 2010 N 271-FZ-collection of laws of the Russian Federation, 2010, N 42, art. 5293; harm.
Federal law dated November 29, 2010 313 N-FZ-collection of laws of the Russian Federation, 2010, no. 49, St. 6409.) 3-3. A decision on amendments to the documents contained in the registration dossier for registered drug for medical use ipredstavlennye prior to the date of entry into force of this federal law, iprinâtie a decision on amendments to the documents contained in the registration dossier for registered drug for medical use and submitted for examination of drugs prior to the date of entry into force of this federal law, shall be carried out on the basis of documents and data submitted prior to the date of entry into force of this federal law, as well as statements on amendments to the documents contained in the registration dossier for registered drug for medical use, submitted by the manufacturer or its authorized persons into the lekarstvennyhpreparatov accordance with this federal law to the authorized federal body of Executive vlastido March 1, 2011 year beztrebovaniâ payment of the State fee provided for by the legislation of the Russian Federation on taxes and fees (part 3-3 introduced the Federal law of October 11, 2010
N 271-FZ-collection of laws of the Russian Federation, 2010, N 42, art. 5293; in red. Federal law dated November 29, 2010 313 N-FZ-collection of laws of the Russian Federation, 2010, no. 49, St. 6409.) 3-4. Issuance of razrešenijna conducting clinical trials of pharmaceuticals for medical application pozaâvleniâm filed prior to the date of entry into force of this federal law, as well as on applications filed after the date of entry into force of this federal law based on examinations conducted prior to the date of entry into force of this federal law, shall be carried out in accordance with this federal law on the basis of the documents and the data submitted or obtained dodnâ the entry into force of this federal law as well as on the basis of a copy of the preliminary contract obâzatel′nogostrahovaniâ life zdorov′âpacientov involved in the kliničeskomissledovanii drug for medical use, or a copy of the contract of compulsory insurance life, health of patients participating in a clinical study of medicinal preparatadlâ medical applications or provided copies of the compulsory insurance contract concluded in accordance with the model rules of compulsory insurance, with an indication of the number of authorized patients participating in the clinical trial drug for medical use , without requiring payment of the State fee provided for by the legislation of the Russian Federation on taxes and fees (part 3-4 introduced by the Federal law of October 11, 2010 N 271-FZ-zakonodatel′stvaRossijskoj Federation, Meeting 2010, N 42, art.
5293; in red. Federal law dated November 29, 2010 N 313-FZ-collection of laws of the Russian Federation, 2010, no. 49, St.
6409.) 3-5. Zaregistrirovannyev foreign currency prior to the date of entry into force of this federal law limit selling prices of foreign producers of medicines, vklûčennyev list of essential lekarstvennyhpreparatov are subject to recalculation into rubles at the rate of the Central bankaRossijskoj of the Federation on the date set by the Government of the Russian Federation, without filing a request for a recalculation of the price svneseniem the appropriate changes in the State Register of limit selling prices of manufacturers of medicines included in the list of essential drugs (part 3-5 introduced the Federal law of October 11, 2010 N 271-FZ-Sobraniezakonodatel′stva Russian Federation 2010, N 42, art. 5293). 3-6. Zaregistrirovannyedo the date of entry into force of this federal law limit the selling prices of the Russian manufacturers of medicines included in the list of essential medicines, subject to indexation since November 1, 2010 year on the basis of projected inflation, established by federal law from 2 December 2009 N 308-FZ "on the federal budget for the year 2010 and 2011 and 2012 planning period years" for the year 2011 (part 3-6 introduced by the Federal law of October 11, 2010 N 271-FZ-collection of laws of the Russian Federation, 2010, N 42, art. 5293.) 3-7. After March 1, 2011 year are not allowed to manufacture and import into the Russian Federation drugs in packages labeled, which was applied prior to the date of entry into force of this federal law. After expiration of data on medications can be sold, transferred, and apply until their expiry date (part 3-7 was introduced by the Federal law of October 11, 2010 N 271-FZ-collection of laws of the Russian Federation, 2010, N 42, art.
5293; in red. Federal law dated November 29, 2010 N 313-FZ-collection of laws of the Russian Federation, 2010, no. 49, St.
6409; Federal zakonaot December 6, 2011 N 409-FZ-collection of laws of the Russian Federation, 2011, N 50, art. 7351). 4. From the date of entry into force of this federal law and managed by April 30, 2011 year allowed examination of the drugs experts expert institution before passing their certification in the manner prescribed by the authorized federal body of executive power.
5. From the date of entry into force of this federal law and by December 31, 2013 inclusive transition to drug manufacture in accordance with the rules of organization of production and quality control of lekarstvennyhsredstv specified in part 1 of article 45 of this Federal′nogozakona, in full. Srokiperehoda the production of medicines to their production in accordance with the specific requirements of these rules, including the srokiattestacii authorized persons referred to in paragraphs 6 and 7 of article 45 of this federal law, shall be established by the Government of the Russian Federation.
6. License naproizvodstvo of drugs issued prior to January 1, 2014 year operate after January 1, 2014 year within the term of their validity provided that licensee's rules for the production and quality control of lekarstvennyhsredstv, mentioned in paragraph 1 of article 45 of this federal law.
7. the formation of the State job on the examination to the federal public budget medicines agency for the examination of drugs and financial support of this job are carried out is okay, installed Federal′nymzakonom from January 12, 1996 year N 7-FZ "on non-commercial organizations" (part 7 has been introduced by the Federal law dated November 29, 2010 N 313-FZ-zakonodatel′stvaRossijskoj Federation, Meeting 2010, N 49, St.
6409). President of the Russianfederation d. Medvedev Kremlin, Moscow April 12, 2010 year N 61-FL
