On Amendments To The Federal Law "on Circulation Of Medicines"
Original Language Title: О внесении изменений в Федеральный закон "Об обращении лекарственных средств"
Subscribe to a Global-Regulation Premium Membership Today!
Key Benefits:
- Unlimited Searches
- Weekly Updates on New Laws
- Access to 5,345,848 Global Laws from 110 Countries
- View the Original Law Side-by-Side with the Translation
Subscribe Now for only USD$40 per month.
RUSSIAN FEDERATION FEDERAL LAW On Amendments to the Federal Act on the Treatment of Drugs adopted by the State Duma on 9 December 2014 Approved by the Federation Council on December 17, 2014 08.03.2015 N 34-FZ; dated 13.07.2015. N 241-FZ) Article 1 of the Russian Federation. 1815; N 31, est. 4161; N 42, sect. 5293; N 49, sect. 6409; 2011, N 50, sect. 7351; 2012, N 26, est. 3446; N 53, sect. 7587; 2013, N 27, est. 3477; N 48, sect. 6165; 2014, N 11, sect. 1098; N 43, sect. The following changes: 1) in Article 4: (a) Paragraph 2 should be amended to read: " (2) A pharmaceutical substance is a drug in the form of one or more pharmaceutical substances of active substances, irrespective of the nature of origin, which is intended for production, manufacture of medicines and determines their effectiveness; "; b) to supplement paragraph 5-1 as follows: " 5-1) dosage-content of one or more active substances in quantity per unit of dose, or unit of volume, or unit of mass according to the medicinal form, or for certain types of medicinal forms the quantity of the substance released from the effective substance per unit time; "; in) to supplement 6-1 and 6-2 as follows: " 6-1) Spelling medications-Drugs intended solely for diagnosis or pathogenetic treatment (treatment, (a) (b) (c), (c), (c). 6-2) Biological drugs are drugs whose current substance is produced or isolated from a biological source and whose properties and qualities are necessary to combine biological and Physico-chemical methods. Biological drugs include immunobiological drugs, drugs derived from blood, human and animal blood plasma (other than whole blood), biotechnological drugs, generic drugs; "; , paragraph 7 restated: " 7) immunobiological drugs-drugs intended to form an active or passive drug immunity or diagnosis of the existence of immunity or diagnosis A specific acquired change in the immunological response to allergizing substances. immunobiological drugs include vaccines, anatoxins, toxins, serums, immunoglobulins and allergens; "; (7-1) and 7-2, reading: " 7-1) Biotechnology medicine drugs, which are manufactured using biotechnological processes and techniques (including DNA recombinant technology, controlled gene expression technologies, which encode biologically active proteins in the caries and eukaryots, including modified cells ), mammalian), hybrids and monoclonal antibodies; 7-2) gene therapeutics, the pharmaceutical substance of which is recombinant nucleic acid, or includes Recombinant nucleic acid, which allows for the regulation, reparation, replacement, addition or removal of genetic sequence; "; e), paragraphs 11 and 12, as follows: " 11) reference Drug drug, which is a drug that for the first time in the Russian Federation, the quality, effectiveness and safety of which has been proved by the results of pre-clinical studies of medicinal products and clinical studies of medicinal products carried out in the Russian Federation in accordance with the requirements of article 18, paragraph 3, of this Federal Act, which is used to evaluate bio-equivalence or therapeutic equivalence, quality, efficiency and safety of the reproduced or bianalogue (biocomparable); 12) produced medicinal drug, which has the same qualitative composition and quantity of existing substances in the same medicinal form as the reference drug, and bioequivalence or therapeutic Equivalence of which the reference drug is confirmed by the relevant research; "; ) to supplement paragraphs 12-1-12-3 as follows: " 12-1) therapeutic equivalence-achievement of a clinically comparable therapeutic effect in the application of Medicinal drugs for medical use for the same group of patients for the same testimony to use; 12-2) bioanalog (biocomparable) drug (bioanalog) is a biological drug, similar to the quality, efficacy and safety of the reference biological drug in the same medicinal form that has an identical way of introducing; 12-3) a fungible drug- Therapeutic-therapeutic medicine bioequivalence with respect to a reference drug that has an equivalent qualitative composition and a quantity of active substances, the composition of the subsidiary substance, the pharmaceutical form and the method of introduction; "; z) Paragraph 15 should read as follows: " 15) homeopathic drug, produced or manufactured from a pharmaceutical substance or pharmaceutical substance, as required by the general public pharmacopoeic articles for homeopathic drugs or in accordance with the requirements of pharmacopoeia of the country of the manufacturer of such a drug; "; and, in paragraph 16, the words" the name of the pharmaceutical substance "should be replaced by the words" the name of the substance in the pharmaceutical medium ". substations "; c) add the words", holder or owner of the drug registration certificate "; l) to supplement paragraph 17-1 as follows: " 17-1) Grouped name pharmaceutical drug-name of drug a drug that does not have an international generic name or a combination of drugs used to group them under the same name, based on the same composition of active substances; "; m) in Paragraph 18 of the words "for medical use", delete; (19) in paragraph 19 of the word "for medical use", delete; o) to supplement paragraphs 19-1 and 19-2 as follows: "19-1) standard samples". substances by which quality control is carried out the use of physical-chemical and biological methods to confirm the compliance of medicines with the requirements of the regulatory documentation established in the implementation of State registration, and which are used to calibrating standard samples of the manufacturer of medicines used for quality control and other purposes for the treatment of medicines; 19-2) the pharmacopoeia standard sample-a standard specimen, produced under pharmacopoeia; "; p) supplement paragraph 21-1 as follows: " 21-1) General technical document-a set of documents and materials consisting of several sections-administrative, chemical, pharmaceutical and biological documentation Documents, pharmacological, toxicological documentation, clinical documentation, and submitted simultaneously with the application for state registration of medicinal products in the format established by the Commissioner by the federal executive; "; (p) To supplement paragraph 26-1 as follows: "26-1) holder or holder of a drug registration certificate-a drug developer, a pharmaceutical manufacturer or other legal entity" A person with possession of the registration certificate, who is responsible for the quality, efficiency and safety of the drug; "; c) in paragraph 30 of the word" and "shall be replaced by the words" and (or) "; T) add the following: " 31-1) manufacturing site-a territorially distinct set of medicines manufacturer, intended for the execution of the entire process of production of medicines or of its certain stage; "; y". as follows: " 45) study of the bioequivalence of a drug-the type of clinical study of a drug that is carried out to determine the speed of suction and withdrawal of one or more of a number of pharmacological activities in force substances, the amount of medicinal products that reach the system blood flow, and the results of which suggest the bioequivalence of the remanufactured drug in certain medicinal forms and dosages form and dosage of a reference drug; "; f) to supplement paragraph 50-1 as follows: " 50-1) Undesirable reaction-unintended adverse reaction of an organism that can be associated with Drug use; "; x) para. 52 The following wording: " (52) unintended undesirable reaction is an unwanted reaction of the body, which is associated with the use of the drug in the doses recommended in the protocol of his clinical trial, the brochure the researcher, or with the use of medication in doses recommended in the instructions for its application for prevention, diagnosis, treatment of the disease or medical rehabilitation of the patient, and the nature, the seriousness or outcome of which is not is consistent with the drug information contained in the protocol. a clinical trial, a research booklet or instructions for the use of a drug; "; c) to supplement paragraphs 52-1 and 52-2 of the following content: " 52-1) pharmacopoesupervision-type of monitoring activity The effectiveness and safety of medicines, aimed at identifying, evaluating and preventing the undesirable effects of drug use; 52-2) a risk management plan-a detailed description of the activities Pharmaceusurveillance aimed at identifying, assessing and preventing or Minimize the risks associated with drugs, including the evaluation of the effectiveness of the output; "; h) to supplement paragraph 55 with the following: " 55) Integrated assessment of the drug-evaluation of a registered drug including an analysis of information about comparative clinical efficacy and safety of the drug, assessment of the economic consequences of its application, study of additional consequences the use of medication for decision-making on the possibility of the inclusion of a drug in the list of essential and essential medicines, regulations and other documents defining the procedure for the provision of medical assistance, or of removing it from the list, acts and "; (2) in article 5: (a) in paragraph 1, the words" in the territory of the Russian Federation "should be replaced by the words" in the Russian Federation "; "; in paragraph 5, in addition to the words", In order to determine the possibility to consider a drug for medical use in State registration as an orphan drug; g) to supplement paragraph 5-1 with the following content: " 5-1) organization of an integrated assessment of the drug for the purpose of making decisions about the possibility of including a drug in the list of essential and essential drugs, regulatory legal Acts and other documents defining the medical procedure to assist or to exclude it from the said list, acts and documents; "; (8) paragraph 8 should read as follows: " 8) the organization and (or) conduct of inspections of drug operators The rules of good laboratory practice, the rules of good clinical practice, the rules of good practice for the storage and carriage of medicines, the rules of good distribution practice, the rules of the proper pharmacy practice; " (e) to supplement paragraphs 8 to 1 and 8 to 2 as follows: " 8-1) organization and (or) conduct of inspections of medicines to meet the requirements of the rules of good production practices, issuance of opinions on the conformity of the pharmaceutical manufacturer with the requirements Rules of good production practice; 8-2) establishing procedures for maintaining and maintaining a state register of opinions on the conformity of the pharmaceutical manufacturer with the requirements of good production practices; " (g) Paragraph 10 should be redrafted to read: "10) the establishment of procedures for the importation of medicines into the Russian Federation and the export of medicines from the Russian Federation;"; c) to supplement paragraphs 10-1 and 10-2 as follows: " 10-1) extradition, establishment The procedure for the issuance and form of a document which confirms that the manufacture of the drug has been carried out in accordance with the requirements of the rules of good production practice and is to be submitted at the request of the competent authority of the country, medicine; 10-2) extradition, establishment of procedures for the issuance and form of a document containing information on the stages of the technological process of production of medicines carried out in the territory of the Eurasian Economic Union; "; and) paragraph 14 should be set out in as follows: "14) Pharmacosupervision;"; c) supplement paragraphs 18 to 24 with the following: " 18) Adoption of rules of good laboratory practice, rules of good clinical practice, rules of good practice, rules of The practice of storage and transport of medicines, rules of good distribution practice, rules of good pharmacy practice, rules of good practice of pharmacosurveillance of medicines for medical use; 19) Establishing a procedure for the establishment of a drug registration file and the requirements for documents in its composition; (20) approval of the rules for the rational selection of medicinal products for medical use; 21) approval of a list of drug names forms; 22) Development of a model instruction registry for the medical use of fungible drugs; 23) approving guidelines for the medical use of drugs and instructions on veterinary use of drugs; 24) pre-trial closure of sites containing information about the retail sale in remote mode, offer of remote acquisition, delivery by remote means, and (or) Transmit to a physical person remotely medicines, narcotic drugs and psychotropic drugs, except as provided by the Government of the Russian Federation. "; 3) in article 7: (a), part 2, after the words" and Pharmacopoeine articles ", including pharmacopoeic articles on pharmacopoeic standard samples,"; b) in Part 3, replace "original drug" with "reference medicine"; 4) in Article 9: a) Part 1 to supplement paragraph 3 of the following the content: "3) Selectable quality control of medicines."; b) of Part 4 and 5, as follows: " 4. Federal State supervision in the circulation of medicines includes: 1) the organization and conduct of inspections of compliance by subjects of medicines prescribed by this Federal Law and adopted in In accordance with other legal acts of the Russian Federation, the requirements for pre-clinical studies of medicinal drugs, clinical studies of medicinal products, storage, transport, import into the Russian Federation, leave, Drug Enforcement, Drug Enforcement OF THE PRESIDENT OF THE RUSSIAN FEDERATION The actual selling prices of medicines, which are included in the list of essential and essential drugs (hereafter required); 2) The organization and conduct of drug conformity checks, (a) Application of measures to prevent and combat trafficking in persons in accordance with the requirements of their quality; (3) organization and conduct of pharmacosurveillance; 4) detected breaches of the mandatory requirements and (or) the consequences of such violations, including the decision to find medicines in circulation, issuance of regulations for the elimination of detected breaches of mandatory requirements, and The perpetrators of such violations are brought to justice. 5. Federal State supervision of the circulation of medicines is carried out in accordance with the procedure established by the Federal Law No. 294-FZ of 26 December 2008 on the protection of the rights of legal persons and individual entrepreneurs in the implementation of the law. Control and municipal control ", taking into account the characteristics set out in this article. Preliminary agreement with the Public Prosecutor's Office on the timing of unscheduled inspections of drug operators, as well as prior notification of legal persons and individual entrepreneurs to initiate this check. is not required. The procuratorial authorities shall be informed of the unscheduled inspection of drug circulation subjects by means of the relevant documents within three working days from the end of the specified exceptional check. "; in) to be supplemented with Part 7, as follows: " 7. Selective control of the quality of medicines is carried out by the authorized federal executive authority in the prescribed manner and includes: 1) the processing of information, which is obligatory Subjects of drug use, series, shipments of medicines to civil turnover in the Russian Federation; (2) the selection of samples of medicines from drug operators for purposes of their compliance with the requirements of the regulatory documentation or Normative documents; 3) adoption of a decision on further civilian traffic of the appropriate medicine; (4) acceptance by the federal executive authority Decisions to transfer medicines to serial quality control of the quality of medicines if the quality of the drug is detected again, and (if necessary) to verify the subject Treatment of medicines. The costs associated with serial quality control of medicines are paid by the pharmaceutical manufacturer or by the holder or the owner of the drug registration certificate. "; 5) in Article 11: (a) Part 2 after the word "rules" add the word "appropriate"; b) Part 5, after the word "rules", add the word "appropriate"; 6) Article 13 should read: " Article 13. State registration of drugs preparations 1. Drugs are being introduced in the Russian Federation (including production, manufacture, storage, transport, import into the Russian Federation, export from the Russian Federation, advertisement, leave, sale, transfer, use, destruction), If they are registered by the competent federal executive authority. 2. State registration is subject to: 1) all medicines for the first time in circulation in the Russian Federation; (2) medicines previously registered but produced in other medicines forms, in accordance with the list of names of medicinal forms, in the new dosage, with evidence of its clinical relevance and effectiveness; 3) new combinations of previously registered medicines. 3. State registration of medicines is carried out according to the results of expert examination of medicines, and the state registration of Spelling Drugs is carried out according to the results of expert examination of documents submitted for Determination of the possibility to consider a medicinal product for the state registration as a spinal medicine, and on the results of the examination of medicines. 4. State registration of the drug is carried out by the relevant authorized federal executive authority within a period not exceeding one hundred and sixty working days from the day of the adoption of the relevant State declaration. the registration of a drug. The time required for the re-examination of the drug in accordance with article 25 of this Federal Law shall be included. The period of state registration of the drug is calculated from the date of acceptance by the relevant authorized federal executive body of the relevant application on state registration of the drug with the application the necessary documents on the day of the issuance of the registration certificate of the drug. The time required to request the competent federal executive authority to submit the necessary materials and to submit a response to the request in accordance with articles 16, 19 and 23 of this Federal The law is not taken into account in the calculation of the period of state registration of the drug. 5. State registration is not subject to: 1) medicines manufactured by pharmacy organizations, veterinary pharmacies, individual entrepreneurs who are licensed for pharmaceutical activities, Prescription drugs and requirements of medical organizations, veterinary organizations; 2) medicines purchased by natural persons outside the Russian Federation for personal use use; 3) medicines imported into Russian Federation to provide medical assistance on the life course of a particular patient on the basis of a permit issued by the authorized federal executive; 4) medicines imported to the Russian Federation The Federation, on the basis of the authorization granted by the authorized federal executive authority, for the conduct of clinical studies of medicinal products and (or) carrying out an expert examination of medicines for the implementation of the State registration of medicines; 5) Pharmaceutical substations; 6) radiopharmaceutical medicinal products made directly in medical organizations in the manner prescribed by the authorized federal executive; 7) medicines produced for export. 6. State registration is not allowed: 1) of medicines, which differ from each other by the qualitative composition of existing substances, under the same trade name; (2) of one drug, produced by the manufacturer under different trade names and submitted for state registration in the form of two or more drugs. 7. On request (in electronic form or on paper), the subject of the circulation of medicines by the relevant authorized federal executive authorities carrying out state registration of medicines, in Scientific advice on the conduct of pre-clinical research, clinical studies of drugs, examination of the quality of medicines, efficiency and safety is provided to them the State registration of medicines drugs. Advice is provided through federal State budgetary institutions under the authority of the Federal Executive and not participating in the organization of the evaluation of the quality of drugs in the country. The purpose of the exercise of their State registration under article 16 of this Federal Act is in the form of a reply in written form of the authorized federal executive authority to the request. The fee charged to the applicant is determined in accordance with the legislation of the Russian Federation on the organization of the provision of public and municipal services. Information on the implementation of scientific advice, including articles, reviews, background materials and other information on the implementation of scientific advice, is posted on the official website of the authorized federal executive body. authorities on the Internet, subject to restrictions established by law on personal data, commercial and/or state secrets. 8. State registration of medicines that are intended for use in conditions of war, emergency situations, prevention and treatment of diseases and injuries resulting from adverse chemical effects, "Biological, radiological and radiological factors have been developed under the procedure established by the Government of the Russian Federation for the task of the federal executive authorities, which are authorized to defend the country and the security of the State." (7) Article 14 should read as follows: " Article 14. Principles of Drug Expertise 1. The examination of medicines is based on the principles of legality, observance of human and civil rights and freedoms, the rights of the legal person, the independence of the expert, objectivity, comprehensiveness and comprehensiveness of the studies carried out using of modern science and technology, the responsibility of the federal state budget agency for carrying out expert examinations of medicines and experts for carrying out and quality of expertise. 2. The examination of medicinal products includes: 1) the examination of documents submitted for the determination of the possibility to consider a drug for medical use in the application State registration as an orphan drug; (2) examination of proposed methods of quality control of medicinal products and the quality of samples submitted using these methods (hereafter referred to as the examination of the quality of the drug); 3) the examination of the expected benefit to the possible risk of the use of the drug. 3. The examination of veterinary drugs for veterinary use includes the examination of the quality of the drug and the examination of the relation of the expected benefit to the possible risk of the drug use. "; 8) in article 16: (a) The title should read: " Article 16. Organization of expert examination of medicinal means "; b) Part 12 should be redrafted to read: " 12. Rules for the examination of medicines and the specifics of the examination of certain types of medicinal products (reference drugs, reproduced medicines, biological drugs, bioanalog drugs) (biocomparable) medicines (bioanalogues), homeopathic drugs, medicinal herbal medicines, combinations of drugs), forms of expert commission reports are established by the relevant commissioners The federal executive branch. "; 9) Article 17 should read: " Article 17. Apply and consider a state registration of a drug for veterinary use 1. For the State registration of a drug for veterinary use, the developer of the drug or other legal entity authorized by him (hereinafter referred to in this article-the applicant) shall submit to the Commissioner Federal executive branch, which performs state registration of medicinal products for veterinary use, in electronic form or on paper form, application for state registration of a drug for of veterinary use, as well as in accordance with the procedure established by the The competent federal authority of the executive branch, in electronic form or on paper, the necessary documents from which the registration file for veterinary medicine for veterinary use is made. 2. The state registration of the drug for veterinary use indicates: 1) the name and address of the applicant, the developer and manufacturer of the veterinary drug for veterinary use, and the address of the place The production of a drug for veterinary use (if there are several participants in the production process it is necessary to specify each); 2) the name of the drug for veterinary medicine Application (international generic, or grouping, or chemical and trade names); (3) a list of the existing and subsidiary substances of the veterinary drug with the quantity of each; 4) form, dosage, methods of introduction and use, shelf life of a drug for veterinary use; 5) pharmacotherapy group; 6) the need to apply an accelerated procedure for the examination of medicinal drugs State registration of a drug; 7) copies of the state duty documents: (a) for the examination of the quality of the drug and the examination of the relation of the expected benefit to the possible risk of the use of the drug for veterinary use in its state registration; b) for the issuance of a registration certificate of the drug; 8) the consent given in part 6 of this article if from the time of registration veterinary drug for veterinary medicine It has been less than six years. 3. The registration file for the examination of a drug for veterinary use is formed from the following documents: 1) a copy of the document in Russian issued by the competent authority of the producing country for each The production site of the registered drug for veterinary use (including for the manufacturer of a pharmaceutical substance), certified in accordance with the established procedure and confirming the conformity of the manufacturer of the registered drug veterinary medicine a copy of the opinion on the conformity of the manufacturer of the drug for the production of veterinary drugs for Russian producers; or Veterinary application of the requirements of good production practices issued by the authorized federal executive authority for each production site of the registered drug for veterinary use (including for the pharmaceutical producer) Sub-stations) or a copy of the license for the production of veterinary drugs for Russian producers; (3) the draft regulatory document for veterinary drugs for veterinary use; 4) A document containing the following information about the pharmaceutical substance or pharmaceutical substations that are part of the drug for veterinary use: a) the name of the pharmaceutical substance, its structure, general properties; b) the name and address of the manufacturer. in) production technology describing production stages and control methods at all stages of production; g) information about the prime10; d) specification for a pharmaceutical substance; e) description quality control techniques; g) results of the analysis of the pharmaceutical substance series; z) list of standard samples or substances used in the implementation of quality control; and) description of characteristics; and properties of packaging materials; c) stability data; L) shelf life, storage conditions; 5) a report on the results of the pre-clinical study of the drug for veterinary use; 6) a report on the results of the clinical trial A drug for veterinary use in each animal species specified in the veterinary use instruction; 7) a draft instruction on veterinary use of a drug containing the following information: (a) the name of the drug for Veterinary application (international non-patented, or group, or chemical and trade names); b) medicinal form with the names and quantity of the current substance and quality composition A description of the appearance of the drug for veterinary use; g) pharmacotherapeutic group of a drug for veterinary use or the indication of " homeopathic medicine "; de) pharmacodynamics and Pharmacokinetics (except pharmacokinetics of homeopathic drugs and herbal medicines) or a description of the drug's immunobiological properties; e) readings for use; c) Precaution for use; , and) Precautions and Precautions in Pregnant Animals, Animals during Laktation, Animal Children; c) dosing mode, mode of introduction and application, time required of the medication for veterinary use, duration of treatment; l) possible side effects, undesirable reactions to the use of a drug for veterinary use; m) symptoms overdose, assistance measures for overdose; n) interaction with other drugs and/or fodder; (o) the form of the veterinary drug for veterinary use; p) (if necessary) of the effects of the drug of the veterinary medicine (if necessary) the description (if necessary) of the veterinary surgeon (veterinary medical assistant), another specialist in veterinary medicine, the owner of the animal at the pass The acceptance of one or more doses of veterinary drug for veterinary use; c) the expiry date and the ban on the use of the veterinary drug upon expiry of the shelf life; t) storage conditions; u) indicate that storage is required A drug for veterinary use in places not accessible to children; (if necessary) special precautions for the destruction of unused drugs for veterinary use; x) the period of possible use of animal products after the introduction of an animal drug for veterinary use; c) conditions of leave; h) of the name and address of the production Pharmacopoiads for the manufacture of Veterinary application; h) the name, address of the organization authorised by the holder or the holder of the drug registration certificate to accept claims from the consumer; 8) layout projects of the primary packaging and secondary packaging of a drug for veterinary use; 9) the following information about the veterinary drug for veterinary use: a) description and composition of a drug for veterinary medicine use; b) a description of the pharmaceutical development; in) description of the production process and its control; g) description of control of production and intermediate products; d) name and address of manufacturer's production sites veterinary medicine; e) pharmaceutical compatibility; microbiological characteristics; z) material balance for production of the finished product series; and) Description of the characteristics and characteristics of the packaging and the perverse (c) Documentary validation (validation) of processes and (or) their evaluation; L) quality requirements for substances (certificate, supporting material specification and justification); m) Analytical techniques used in the implementation of the quality control of the supporting substances; (s) documentary evidence (validation) of analytical methodologies used in the control of the quality of the supporting substances; o) information on the use of secondary substances of human and animal origin; p) information on the use of new auxiliary substances; p) quality requirements for veterinary drugs (certificate, specification for (c) analytical methodologies used in the monitoring of the quality of the drug for veterinary use; T) document validation (validation) the analytical methods used in the implementation of quality control of a drug for veterinary use; y) a document confirming the quality of the pharmaceutical product of three industrial episodes (analysis protocol or certificate of analysis), one series of which must match the series of samples a drug filed for registration; f) impurity characteristic; x) list of standard samples used in the monitoring of the quality of the drug for veterinary use; c) data on the stability of the drug for Veterinary application; 10) copy of the document containing information about the presence or absence of facts of the registration of a drug for veterinary use outside the Russian Federation; 11) consent in The written form provided for in Part 6 of this article, in case of the registration of the manufactured drug; 12) copy of the document in Russian, certified in accordance with the established procedure and confirming the validity of the application on the State registration of the drug for Veterinary application (power of attorney). 4. In the accelerated procedure for the examination of a drug for veterinary use for the purposes of State registration, information obtained from clinical trials of the drug may be provided. published in specialized publications, as well as documents containing the results of the study of the bioequivalence of a drug for veterinary use. 5. For the examination of the various medicinal forms of the same drug for veterinary use, the applicant submits separate applications and registration files for each drug form. Subject to the simultaneous submission of a single dose-dosing, concentration, volume, the applicant shall submit one application and the registration file with the application of the packages of the packages for each dose, each Concentration, each volume and each number of doses in the package. 6. The applicant is entitled to submit, on his own initiative, together with a statement on the state registration of a drug for veterinary use, the documents confirming the payment of the State duty, as set out in Part 2, paragraph 7 of this article. If they are not provided, the competent federal executive authority shall verify that the State duty is paid by the applicant by means of the payment of the State duty contained in the State Tax Act. State information system on state and municipal payments, on the basis of copies of documents submitted by the applicant eviding payment of the State duty. 7. Information on the results of pre-clinical studies of medicinal products and clinical research on veterinary drugs submitted by the applicant for public use is not permitted for commercial purposes. Registration of medicines without its consent within six years from the date of the State registration of the reference drug in the Russian Federation. "; editions: " Article 18. To submit and consider the application for state registration of a drug preparation for medical use "; b), Part 1, as follows: " 1. For the State registration of medicines for medical use a legal person acting in his or her own interest or authorized to represent the interests of another legal person and declares a drug to be medicinal The State registration (hereinafter referred to as the applicant) shall be submitted to the authorized federal executive authority conducting the State registration of medicines for medical use in electronic form and the paper claim form of State registration Medicinal drugs, as well as in the procedure established by the federal executive authority, electronically and in hard copy, of the necessary documents from which the registration is made A dossier on medicinal products for medical use. "; in) Part 2 should read: " 2. The state registration of medicines for medical use state: 1) the name and address of the applicant and the pharmaceutical manufacturer for medical use and the address of the place of implementation Production (if there are several participants in the production process it is necessary to state each participant according to the stage of production); 2) the name of the drug for medical use (international generic, or grouping, or Chemical and trade names); (3) a list of active and supporting substances in the medicinal product, indicating the number of each; 4) the drug form, dosage, methods of introduction and use, shelf life of the medical drug for medical use; 5) Pharmaceutical Group, Code of Anatomy and Chemical Classification, recommended by the World Organization health care claims for the use of drugs Medical treatment; 6) no need for a report on the results of a clinical trial, a study of the biometequivalence of a drug authorized for medical use in For the Russian Federation for more than 20 years, with an indication of the normative legal acts attesting to this date of application; 7) the need to issue a permit for the import into the Russian Federation of a specific lot of registered and (or) Unregistered medicines to be used for the examination of medicines for State registration; 8) the need to review documents submitted for determination of the possibility to consider a drug for medical use Implementing State registration as an orphan drug; (9) the need to apply an accelerated procedure for the examination of medicines for the purposes of state registration of a drug; 10) copies of documents attesting to payment State duty: (a) for the examination of documents submitted for the determination of the possibility to consider a drug for medical use in State registration as a spell-like state medicine; b) for the examination of the quality of the drug and the examination of the expected benefit to the possible risk of the use of a drug authorized for medical use in the Russian Federation THE RUSSIAN FEDERATION the registration of a drug; in) for carrying out an expert examination of the quality of the drug and the examination of the relation of the expected benefit to the possible risk of the use of a drug for medical use in the drug State registration; g) for the examination of the quality of the drug and the examination of the expected benefit to the possible risk of the use of a pharmaceutical drug for which international multi-center clinical trials, part of in the Russian Federation, in the case of the State registration of a drug; 11), the consent of the manufacturer of a drug that is manufactured outside the Russian Federation Federation, to carry out inspections of the producer for compliance with the requirements of good production practices; 12) the consent given in part 18 of this article; 13) indication of the type of drug submitted for registration (referenceable) Drugs, a medicinal drug, a biological drug, a bioanalog drug (biocomparable), a homeopathic drug, a medicinal herbal drug). "; In Part 3-6, amend to read: " 3. The registration file for medical treatment is provided in the form of a general technical paper. 4. The administrative section of the documentation includes: 1) a statement on the state registration of a medical application for medical use in electronic form and on paper; 2) a copy of the document Russian, certified in accordance with the established procedure and the applicant's authority to apply for a state registration of a medicinal product (power of attorney); 3) copy of the licence to production of medicines or a copy of a certificate of compliance The manufacturer of medicinal requirements for the requirements of the rules of good production practice issued by the authorized federal executive authority, if the manufacture of the drug is carried out in the Russian Federation; (4) a copy of the license issued by the authorized body of the country of manufacture of the drug and its translation into the Russian language, certified in accordance with the prescribed procedure, and a copy of the opinion on the conformity of the pharmaceutical manufacturer the requirements of the rules of good industrial practice, issued by the authorized federal executive body, in the event that the manufacture of a drug is carried out outside the Russian Federation; 5) the draft guideline on medical use of medicines a drug containing the following information: a) the name of the drug (international generic, or group, or chemical and trade names); b) a pharmaceutical form with names and the quantity of current substances and of the quality of the composition of the Substance (s) (if necessary quantity of auxiliary substances); in) description of the appearance of the medical drug for medical use; g) physico-chemical properties (for (c) d) Pharmaceutical group, code of medicine for medical applications for anatomy and chemical classification recommended by the World Organization Health care, or the indication of "homeopathic medicine"; Pharmacy dynamics and pharmacokinetics (except pharmacokinetics of homeopathic drugs and herbal medicines); ) evidence for use; (c) contraindication for use; and) Precautions in Application; to) indicate the possibility and characteristics of the use of a medication for the medical application of pregnant women, women during breastfeeding, children, Adults with chronic diseases; L) dosing, methods of introduction and use, where necessary, the time of medication for medical use, duration of treatment, including for children before and after one year; m) possible undesired reactions The use of a drug for medical use; n) symptoms of overdose, relief measures at overdose; (o) interaction with other drugs and/or food products; p) the form of the drug; p) indication (if necessary) of the effects of the drug for medical use at first acceptance or cancellation; c) the description (if necessary) of the physician's actions (medical assistant) and (or) of the patient at the time of admission One or more doses of medicines for medical use; (t) the possible impact of a drug for medical use on the ability to control vehicles, mechanisms; y) Fitness and indication of prohibition of the use of a drug for Medical use upon expiry of shelf life; (f) storage conditions; x) an indication of the need to keep a medicinal product for medical use in places that are not accessible to children; c) (if necessary) special precautions for the destruction of unused medical products for medical use; h) condition of leave; c) name and address of manufacturer's production sites medication; c) name, address An organization authorized by the holder or the holder of the medical application for medical application for the acceptance of a claim from the consumer; 6) a medical application or a brief Characteristics of the drug approved in the country of manufacture; 7) of the primary packaging and secondary packaging designs for medical use; 8) draft regulatory documentation or regulatory instrument for medicines for health care Apply or specify the relevant pharmacopoe; 9) a document containing information about the presence or absence of facts of the registration of a drug for medical use outside the Russian Federation; 10) copies of documents certified in accordance with the established procedure and supporting the registration of a drug in foreign countries as a prescribed drug; 11) a risk management plan for biological agents Medicinal products for medical use; 12) document on the pharmaceutical supervision system of the holder or owner of the drug registration certificate; 13) document confirming the quality of the pharmaceutical product of three industrial episodes (protocol of analysis or a certificate of analysis), one series of which must coincide with a series of medicinal products submitted for state registration. 5. The section of the chemical, pharmaceutical and biological documentation includes documents containing information on the pharmaceutical substance and the drug for medical use, the process of its production and the methods of quality control, including: 1) a copy of the document containing the following information about the pharmaceutical substation or pharmaceutical substations of the drug: a) the name of the pharmaceutical substance structure, general properties; b) name and address producer; in) production technology describing production stages and control methods at all stages of production; g) description of the production process; d) description of the control of critical stages production and intermediate products; (e) Documentary validation (validation) of processes and (or) their assessment; properties and structure of active substances; (s) impurities; and) Specification for the pharmaceutical substance and its justification; c) Analytical techniques used in the control of the quality of the pharmaceutical substance; L) document validation (validation) of analytical techniques used in the control of the quality of the pharmaceutical industry Sub-stations; m) the results of the analysis of the pharmaceutical substance series; n) list of standard samples or substances used in the implementation of quality control; (o) description of packaging characteristics and properties materials and tools; p) data on the stability of the pharmaceutical substance; p) shelf life; 2) a document containing the following information about the medical prescription for medical use: a) description and composition of the drug for medical application; b) a description of the pharmaceutical development (justification of selection, primary packaging and other); in) production technology describing the stages of production and methods of control at all stages production; g) description of control of the critical stages of the process production and intermediate products; d) the name and address of the place of manufacture of the medical product for medical use (in the case of multiple participants in the production process it is necessary to specify each) of them); e) pharmaceutical compatibility; microbiological characteristics; z) material balance for production of a finished product series; and) description of packaging characteristics and properties Materials and tools; c) documentary validation (validation) of production processes and (or) their evaluation; L) quality requirements (certificate, substance specification and justification); m) analytical techniques; used in the implementation of the quality control of the assisents; , document validation (validation) of analytical techniques used in the control of the quality of the sub-substances; o) information on the use of human and animal accessories origin; p) information on the use of new support substances; p) quality requirements for medicinal use (certificate, drug specification and justification); (c) the analytical techniques used in the implementation of the quality control of the medicinal product; T) documentation validation (validation) of analytical methodologies used in the implementation quality control of the drug for Medical application; ) results of medical application tests for medical use; f) impurity characteristic; x) list of standard samples used in monitoring the quality of the medication for medical use; c) data on the stability of medicinal products. 6. The section of pharmacological, toxicological documentation includes reports on the results of pre-clinical studies of medicinal products, including: 1) report on pharmacodynamic research; 2) Report on pharmacokinetic studies; 3) report on toxicological studies. "; d) to supplement 7 to 22 reading: " 7. The section of the clinical documentation includes reports on the results of clinical studies of medicinal products, including: 1) reports on bioavailability and bio-equivalence, research, correlating results obtained in in vitro and in vivo; 2) reports on pharmacokinetics; 3) reports on pharmacodynamic research; 4) reports on clinical studies efficiency and security; 5) report on Post-register application (if any). 8. The requirements for the volume of information provided as part of the registration file for certain types of medicines for medical use are established by the authorized federal executive authority. 9. In the Russian Federation for more than 20 years (with the exception of biological drugs), it is possible to include pharmacological, toxicological and pharmaceutical products for medical use in the Russian Federation for more than 20 years. the documentation and the section of the clinical documentation instead of the developer's report on the results of their own pre-clinical studies of medicines and clinical studies of medicinal products for the medical application of the review of scientific works and the results of pre-clinical studies of drugs and of clinical trials of drug data, including the experience of their post-registration application. 10. In the case of the state registration of the medicinal products reproduced for medical use, it is permissible to include in the section of the pharmacological, toxicological documentation and the section of clinical documentation instead of the developer's report of the results of their own pre-clinical research on the scientific work on the results of the pre-clinical research of the referee drug and the submission instead of clinical studies in full scope in the clinical documentation section, the results report Research on the bioequivalence of the medicinal product that has been reproduced. There is no need for a report on the results of studies on the bioequivalence of the medicinal product that has been reproduced, if the medicinal products reproduced for medical use are recorded: 1) is intended for parenteral (subcutaneous, intramuscular, intravenous, intra-ocular, intravenous, intravenous) introduction and is aqueous solutions; 2) are solutions for oral use; 3) were produced in the form of powders or lifizates for the preparation of solutions; 4) are gases; 5) are ear or eye medicinal products produced in the form of aqueous solutions; 6) are intended for local use and prepared in the form of aqueous solutions; 7) are aqueous solutions for use in the form of inhalation with the help of a neoulder or as nazed spray with similar devices. 11. For the cases referred to in paragraphs 1 to 3, 5 to 7 of Part 10 of this Article, the medication produced for medical use shall contain the same assistive substances in the same quantities as the reference drug. Where the composition of the supporting substances is different, the applicant must provide evidence that the supporting substances used in these concentrations do not affect the safety and/or the effectiveness of the medical drug application. In the event that the applicant is unable to provide such evidence and (or) has no access to the relevant data, he or she is required to conduct studies to demonstrate that there is no influence on the supporting substances or accessories. Safety devices and (or) the effectiveness of the medication for medical use in accordance with the procedure established by the authorized federal executive authority. 12. In the case of state registration of combinations of previously registered medicines for medical use, it is permissible to include in the section of pharmacological, toxicological documentation and a section of clinical documentation instead of Report by the developer on the results of his own pre-clinical studies of medicinal products of the scientific work on the results of the pre-clinical research of the reference drugs included in the combination of drugs, and on the results of the drug combination Their lack of interaction in a single drug form. 13. In order to review the various medicinal forms of the same drug for medical use, the applicant submits separate applications and registration files for each drug form. Subject to the simultaneous submission of a single dose-dosing, concentration, volume, the applicant shall submit one application and the registration file with the application of the packages of the packages for each dose, each Concentration, each volume and each number of doses in the package. 14. In the case of the State registration of the prescribed drug, the applicant submits the information necessary for the formation of a section of the clinical documentation in the amount established by the authorized federal executive authority. 15. When registering a biological drug derived from blood, blood plasma, the registration file for medical use has to be additionally provided: 1) in Document containing information on the subject of blood donations and (or) components thereof, where the domina (blood and (or) blood plasma) was carried out, as well as data on infectious diseases, transmitted by ferry routes, information on the subject of donor The blood and (or) components of the blood and (or) components of its components; (2) in the chemical, pharmaceutical and biological documentation section: (a) the criteria and manner of selection, transportation and storage of donor blood and (or) its components; b) results of studies of selected donor blood and (or) blood plasma and pools for infectious agents, including information on used methods and in the case of a study of the blood plasma pools, the results of the documentary Validation (validation) of the methods used; in) the technical characteristics of the package for the selection of blood and blood plasma, including information on the anti-coagulant solutions used. 16. Clinical studies of medicinal products for the purposes of State registration are carried out in the Russian Federation in accordance with the procedure established by articles 38 to 44 of this Federal Law. The research report is included in the clinical document section of the registration file for medical use. For medicinal products for which, as a result of the examination of documents submitted for determination of the possibility to consider a drug for medical use as a spell-like medicine, of the drug, such a possibility is recognized and in respect of which clinical studies have been carried out outside the Russian Federation in accordance with the rules of good laboratory practice and the rules of due process practice, it is permissible to include in the section of clinical documentation In lieu of a report on the results of clinical trials of medicinal application conducted in the Russian Federation, a report on the results of clinical studies carried out outside the Russian Federation. 17. The applicant is entitled to submit, on his own initiative, together with the application for the State registration of a medicinal product, the documents confirming the payment of the State duty, as set out in paragraph 10 of Part 2 of this article. If they are not provided, the competent federal executive authority shall verify that the State fee is paid by the applicant by means of the payment of the State duty contained in State information system on state and municipal payments, on the basis of copies of documents submitted by the applicant eviding payment of the State duty. 18. Information on the results of pre-clinical studies of medicines and clinical research on medicinal products submitted by the applicant for public use is not permitted for commercial purposes. Registration of a drug without its consent within six years from the date of the State registration of the reference drug in the Russian Federation. 19. The holder or owner of a drug registration certificate for a biotechnological or spell-aid drug is required to provide samples of a reference drug to the applicants for application on a reimbursable basis Clinical research. The value of the reference drug included in the list of essential and essential drugs should not exceed the registered limit price of the reference drug or the price of the reference drug pharmaceutical drug in the country of manufacture. 20. An application for a state registration of a medically reproduced drug for medical use may be submitted to the authorized federal executive authority conducting the State registration of medicinal drugs. OF THE PRESIDENT OF THE RUSSIAN FEDERATION 21. An application for state registration of a bioanalog (biocomparable) medicine (bioanalogue) can be submitted to the authorized federal executive authority, which performs state registration of medicines, On the expiry of three years from the date of the State registration of the reference drug in the Russian Federation. 22. The holder or owner of the drug registration certificate is represented by the authorized federal executive body exercising control and oversight functions in the field of health care, the report on results Every six months of pharmacosurveillance within two years after the state registration of the drug in the Russian Federation, each year for the next three years and thereafter every five years. "; 11) Article 19 Amend the text as follows: " Article 19. { \cs6\f1\cf6\lang1024 } Expert { \cs6\f1\cf6\lang1024 } { \b } { \b } { \b } { \b } Within ten working days from the date of acceptance of the application for state registration of the drug, the respective federal executive body performs a check on the completeness, validity and correctness of the registration of the documents of the registration file on the drug and decides whether to issue: 1) examination of documents submitted for determination of the possibility to consider a drug for Medical application in the implementation of State registration in the the quality of the orphologic drug; (2) expertise of the drug in the quality of the drug examination and the examination of the relation of the expected benefit to the possible risk of the use of the drug for the drug Medical application; 3) expert examination of the quality of medicine and examination of the relation of the expected benefit to the possible risk of the use of a drug for medical use in procedures for the accelerated procedure for the examination of drugs in the (a) The examination of a drug for veterinary use in accordance with article 26 of this Federal Law; 4). 2. The Commissioner of the federal executive branch shall notify the applicant and the expert body, in electronic form or on paper, of the decision taken to issue the expert examinations provided for in Part 1 of this article, and The need to issue a permit for the importation into the Russian Federation of a specific party, a series of registered and (or) unregistered medicines, or refusal to carry out the required expertise, indicating the reasons for such refusal. 3. Where there is no information contained in the documents submitted by the applicant, the authorized federal executive authority sends a request for clarification of this information to the applicant (hereinafter referred to as the request for information). The authorized representative of the federal executive branch), who may be handed over to the authorized representative of the applicant personally, by registered mail or transmitted in electronic form via telecommunications channels. In the event of a request made by an authorized federal executive authority by registered mail, it shall be deemed to have been received after six days from the date of the delivery of the registered letter. 4. The applicant is obliged to submit a response to the request of the authorized federal executive body within a period not exceeding ninety working days from the date of receipt. The period specified in part 1 of this article shall be suspended from the day the applicant has been requested by the authorized federal executive authority until the day of receipt of the corresponding reply. 5. The grounds for refusal of the organization of the expertise provided for in Part 1 of this article shall be the provision of incomplete or incomplete documents required for the evaluation of documents to be carried out by the applicant within a specified period of time. at the request of the authorized federal executive body, as well as the submission of documents that do not contain an exhaustive list of necessary information. "; 12), article 20 should read as follows: " Article 20. { \b } { \b } { \b } { \b } { \b } { \b } { \b } { \b } { \b } { \b a drug drug 1. Review of the documents submitted for the determination of the possibility to consider a drug for medical use in the state registration as a spell-aid drug, drafting by a commission Experts of the opinion on the possibility of or inability to consider a drug for medical use in the exercise of State registration as a spell-capable drug and the transmission of this opinion in The authorized federal executive authority shall be executed on time, not exceeding thirty working days from the date of receipt by the expert body of the task of the authorized federal executive authority and in electronic form or on paper copies of the necessary documents referred to in paragraphs 1, 2, 5, 6, 10 Part 4 and article 18, paragraph 7, of this Federal Act. 2. Documents contained in the drug dossier and on paper to the expert institution to conduct their expertise to determine the possibility to consider a medicinal drug The use of an orphan drug as a spell is to be returned to the authorized federal executive body at the same time as the relevant expert reports. "; 13), amend article 21 to read as follows: " Article 21. The decision about the possibility to consider a medicinal product while implementing the state registration as of an misspelled drug 1. Within a period not exceeding five working days from the date of receipt of the opinion referred to in article 20, paragraph 1, of this Federal Act, the authorized body of the federal executive authorities shall evaluate the determination of the opinion received. Compliance of the task with the relevant expertise and notifies the applicant in electronic form or on paper of the results of the expert examination conducted with the copy of the expert opinion (with the confidentiality of the information kept confidential) on the composition of the expert commission) and on the possibility or impossibility consider the medicinal product for the implementation of state registration as an orphan drug. 2. When an expert commission makes an opinion on the possibility of considering a drug for medical use in the exercise of State registration as a spell-aid drug, the authorized federal authority The executive branch shall, within a period not exceeding five working days from the date of receipt of the opinion, decide on the issue of the task of carrying out an expert examination of the quality of the drug and the examination of the relation of the expected benefit to the possible risk Medical treatment for medical use in the accelerated procedure for the examination of a drug under article 26 of this Federal Act. 3. In the event of a decision on the impossibility of considering a drug for medical use in the state registration as a spell-aid drug, the authorized federal executive body will terminate The procedure of state registration of a drug. The applicant has the right to apply to the registering body for the State registration of the drug in accordance with article 18 of this Federal Law. "; 14) Article 22 is declared void; (15) Article 23 should read as follows: " Article 23. Test of the quality of the drug and examination of the ratio of expected benefits to possible risk of drug use medicine 1. Expertise of the quality of the drug and examination of the relation of the expected benefit to the possible risk of the use of a drug for medical use, drafting expert opinions on the results of expert examinations and These opinions shall be sent to the competent federal executive body within a period not exceeding one hundred and ten working days from the date of receipt by an expert body of the relevant task of the authorized federal body the executive branch and the necessary documents in electronic form or Paper media. 2. Within ninety days from the date of receipt of the decision of the authorized federal executive body to carry out the examinations provided for in Part 1 of this article, the applicant shall submit to the expert institution for expert examination The quality of medicinal products for medical use produced in accordance with the requirements of the industrial and (or) industrial regulations approved by the head of the pharmaceutical manufacturer and, where appropriate, pharmaceutical samples Substations, test-strain of microorganisms, cell cultures, samples of substances used to control the quality of a drug by comparing them with the studied medicine, in the quantities necessary for the reproduction of the methods quality control. 3. When receiving samples of a drug and a pharmaceutical substance, the expert institution shall issue to the applicant a document confirming receipt of the said samples and shall notify the applicant in electronic form or in a period not exceeding three working days. This is a paper copy of this approved federal executive body. 4. The period specified in paragraphs 2 and 3 of this article for the submission of samples of the drug and pharmaceutical substance and the period of notification by the expert agency to the authorized federal authority The executive shall not be included in the period of examination provided for in part 1 of this article. 5. The documents submitted to the expert institution for carrying out the examinations provided for in Part 1 of this article are to be returned to the authorized federal executive body at the same time as the findings of the results obtained. Relevant expertise. "; 16) in article 25: (a) the title should read: Article 25. Re-conducting examination of medicinal funds; b) in Part 1 of the word "or the board of ethics" and the words "and (or) an ethical expertise" delete; in) in Part 2 after the words " Re-examination of a drug The term "supplement" is "supplemented by the words" in accordance with the results of the expert review ", the word" forty "replaced by the word" thirtieth ", the words", the re-examination of the ethical review shall not exceed fifteen working days from the date of receipt by the Council of The ethics of the mission to conduct a second ethical review " delete; In Part 3, the words "and the funds previously listed for carrying out such examinations shall be returned to the federal budget" delete; 17) in article 26: (a) of Part 1 to read: " 1. The accelerated procedure for the examination of medicines for the State registration of medicines is applied to the spellical drugs, the first three drugs registered in the Russian Federation in the Russian Federation. the quality of remanufactured medicines and medicines that are intended solely for the use of minors. 2. The accelerated procedure for the examination of medicines for the purposes of state registration of medicines does not apply to: 1) bioanalog (biocomparable) medicines (bioanalogues); 2) Reference medicines (except for orspelled drugs); 3) reproduced medicines (except for the first three registered drugs in the Russian Federation) medicines and medicinal products intended for exclusively for the use of minors); 4) new combinations of previously registered medicines; 5) medicines previously registered but produced in others Medical forms in accordance with the list of names of medicinal forms and in the new dosage. 3. The accelerated procedure for the examination of medicines is carried out by decision of the relevant authorized federal executive authority on the basis of the applicant's application within a period not exceeding 80 working days. At the same time, the examination of the documents contained in the registration file on the drug is carried out within a period not exceeding 10 working days, examination of the quality of the drug and examination of the relation of the expected benefit to the possible risk The use of medication shall be carried out within a period not exceeding sixty working days. "; b) to be completed with Part 3-1, reading: " 3-1. The results of pre-clinical studies of medicinal products and clinical research on medicines for medical use performed outside the Russian Federation can be presented with regard to the spellbound medicine Federation in accordance with the rules of good laboratory practice and rules of good clinical practice. "; 18) in article 27: (a) in Part 1: in the first paragraph of the first word" 5 "to read" 10 "; 1 should be redrafted to read " 1) on its official website on the Internet, the relevant conclusions of the expert commission and their assessment to determine whether the task is in conformity with these assessments; "; in paragraph 3, the word" refusal "should be replaced with the words" refusal. The State duty is charged for the issuance of a registration certificate in accordance with the laws of the Russian Federation on taxes and fees. "; b) Part 3 should be redrafted to read: " 3. Re-submission to the appropriate authorized federal executive of the drug in respect of which the refusal of the State registration has been refused and subsequently subjected to change in its composition, is considered as a presentation of a new drug for its state registration, irrespective of the preservation of its primary name. "; 19) to supplement article 27-1 as follows: Article 27-1. How to determine the interchangeability of medical medications 1. The interchangeability of medicines for medical use is determined in accordance with the procedure established by the Government of the Russian Federation, based on the following parameters: (1) equivalence (for bioanalogue (bionic)) Pharmaceutical substances (bioanalogues)-compatibility of the qualitative and quantitative characteristics of pharmaceutical substances (use of different salts, esters, complexes, isomers, crystalline forms and other derivatives of the same The current substance is not an impediment to interchangeability medication, if a study of the bioequivalence of a drug or if it is not possible to carry out this study in the study of therapeutic equivalence of the drug, has been proven The lack of clinically relevant differences in pharmacokinetics and (or) the safety and efficacy of the drug for medical use); (2) the equivalence of the medicinal form (equivalent to medicinal forms is understood different forms of medicinal forms that have the same way Introduction and use, with comparable pharmacokinetic characteristics and pharmacological effects, which also provide the necessary clinical effects. The differences in medicinal forms are not an obstacle to their interchangeability, if a study of the bioequivalence of a drug or the impossibility of carrying out the study The lack of clinically relevant differences in pharmacokinetics and (or) the safety and efficacy of a drug for medical use); (3) equivalence, or Comparability of formulations of auxiliary substances of medicinal drugs for Medical applications (differences in the composition of the medical drug for medical use are not an obstacle to their interchangeability, if the bioequivalence of the drug is conducted in the case of Medical application or if it is not possible to carry out this study when a therapeutic equivalence study is carried out, the lack of clinically relevant differences has been demonstrated for medical use Pharmacokinetics and (or) the safety and efficacy of medicines Medical treatment. In this case, the differences in the composition of the supporting substances should not lead to the risk of serious undesirable reactions from certain groups of patients or an increase in the frequency of their occurrence; 4) the identity of the way of introduction and application; 5) the lack of clinically relevant differences in the study of the biometrics of the drug, or if the study is not feasible, the absence of clinically relevant differences in safety and security measures The effectiveness of the drug in the study Therapeutic equivalence. This parameter does not apply to the medicinal products reproduced in article 18, paragraph 10, of this Federal Act. In relation to bioanalog (biocomparable) drugs (bioanalogues), data on the absence of clinically relevant differences in the safety, efficacy and immunogenicity of a drug based on clinical studies are provided in the manner prescribed by this Part; 6) conformity of the pharmaceutical manufacturer with the requirements of good production practices. 2. Comparing the parameters of the registered medicines for medical use is carried out by a commission of experts of the expert agency when carrying out the examination of such drugs in the process of their state registration. The conclusions of the experts on the interchangeability or irremovability of medicines for medical use made as a result of this comparison are prepared in the form of an annex to the opinion of the experts on the form approved by the Commissioner. by the federal executive branch. 3. The provisions of this article do not apply to reference medicines, medicinal herbal medicines, homeopathic drugs and medicines, which are authorized for medical use in the Russian Federation. For more than 20 years and for which it is not possible to conduct a study of their biometers. "; 20), article 28 is supplemented by Parts 3 and 4 as follows: " 3. In the case of an amendment to articles 30 and 31 of this Federal Act, the records contained in the registered drug file that affect the information reflected in the registration form The certificate of the drug, authorized by the federal executive authority, issues a new registration certificate of the drug containing the changes made to it. 4. In case of loss of or damage to the registration certificate of the drug by application in writing, the holder or the holder of the registration certificate of the drug or other legal person authorized by them The issuance of a duplicate registration certificate of a drug by an authorized federal executive authority within a period not exceeding ten working days from the date of receipt of the application, issues a duplicate registration certificate medication. The State fee is charged for issuing a duplicate registration certificate in accordance with the laws of the Russian Federation on taxes and charges. "; " Article 29. Confirting the state registration of the drug 1. The confirmation of the state registration of the drug is carried out at the time of issue of the indefinite registration of the drug in the case referred to in Article 28 (2) of this Federal Law, on time, not exceeding 60 working days from the date of receipt by the appropriate federal executive authority of a declaration of confirmation of the state registration of the drug. There is no confirmation of the State registration of a drug that has not been in circulation in the Russian Federation for three years or more, and for a remedy that has been violated The requirements set out in article 71, paragraphs 3 to 7, of this Federal Act. 2. An application for confirmation of the state registration of a drug is submitted to the relevant authorized federal executive body no earlier than one hundred and eighty days before the expiry of the registration period of a drug. 3. The confirmation of the state registration of the drug is carried out on the results of the examination of the relation of the expected benefit to the possible risk of the use of the drug based on the results of the monitoring of effectiveness and the safety of the drug carried out by the holder or the holder of the registration certificate of the drug or by their authorized legal entity, and also by the duly authorized federal executive body Authorities in accordance with the requirements of article 64 of this Federal of the law. 4. The document containing the results of the monitoring of the effectiveness and safety of the drug carried out by the holder or the owner of the registration is attached to the application for confirmation of the state registration of the drug The certificate of the drug or by a legal person authorized by them, in the form approved by the appropriate federal executive authority; a copy of the pharmaceutical production licence or a copy of the opinion on the conformity of the manufacturer with the requirements The rules of good production practice issued by the authorized federal executive authority, if the manufacture of the drug is carried out in the Russian Federation or a copy issued by the authorized body of the country the manufacturer of the drug production licence and its translation into the Russian language, certified in accordance with the established procedure, and a copy of the opinion on the conformity of the pharmaceutical manufacturer with the requirements of the rules of the proper production for the enforcement of the authorities, if the manufacture of a drug is carried out outside the borders of the Russian Federation. For veterinary drugs, the documents referred to in subparagraphs (a), (b), (c) and (l) of article 17 (4) of this Federal Act are additionally provided. In relation to biological drugs, the applicant additionally presents the results of the activities in accordance with the risk management plan approved by the authorized federal executive State registration of a drug. With a statement on the confirmation of the state registration of the drug, the applicant submits a copy of the document confirming the payment of the state fee for the confirmation of the state registration of the drug, or to the right (e) To submit, on its own initiative, the document. In the event of non-submission of the said document, the authorized federal executive body shall verify that the State fee is paid by the applicant by the use of the information on the payment of the State duty contained in the State information system on state and municipal payments, on the basis of a copy of the document confirming the payment of the State duty. 5. Within ten working days from the date of acceptance of the declaration of confirmation of the state registration of the drug and documents containing the results of the monitoring of the effectiveness and safety of the drug carried out by the holder or by the owner of the registration certificate or the legal entity authorized by them, the authorized federal executive body: 1) shall verify the completeness of the information contained in the submitted by the applicant; 2) makes a decision about conducting or refusing to conduct an examination of the expected benefit to the possible risk of the use of a drug based on the results of the monitoring of the effectiveness and safety of the drug held by the holder or by the owner of the registration certificate or by a legal person authorized by them, and by the federal executive authority in accordance with the requirements of article 64 of this Federal Law; 3) notifying in electronic form or in writing of the applicant and the expert The institution of the decision, or in the event of a decision not to carry out an examination, shall indicate the reasons for the refusal. 6. In the event that the information contained in the documents submitted by the applicant is not sufficient and (or) insufficient information is available, the authorized federal executive authority shall submit a request to the applicant for clarification of the information provided. A request by the authorized representative of the Federal Executive may be submitted to the authorized representative of the applicant in person under receipt, by mail by registered mail or transmitted in electronic form via telecommunications channels. In the event of a request made by an authorized federal executive authority by registered mail, it shall be deemed to have been received after six days from the date of the delivery of the registered letter. 7. The applicant is obliged to submit a response to the request of the authorized federal executive body within a period not exceeding ninety working days from the date of receipt. The period specified in part 5 of this article shall be suspended from the day the applicant has been requested by the authorized federal executive authority until the day of receipt of the corresponding response and is not taken into account in the calculation of the period of confirmation. State registration of a drug. 8. The basis for the refusal to conduct an examination of the expected benefit to the possible risk of the drug is the submission of documents containing the results of the monitoring of the effectiveness and safety of the drug, and (or) With regard to biological medicines, the results of activities in accordance with the risk management plan approved by the federal executive authority in the exercise of State registration Incomplete, non-exhaustive Information proving the payment of the State fee for the confirmation of the State registration of the drug or the failure of the applicant to submit a request within the prescribed period of reply to the request referred to in paragraph 6 of this article The competent federal authority of the executive branch, as well as the lack of information in these documents, which should be reflected in them. 9. Expert-agency commission of experts within a period of not more than 40 is expected to carry out the examination of the expected benefit to the possible risk of the drug use in order to confirm the state registration of the drug working days. 10. In case of insufficient input from the expert to give an opinion, the expert calls upon the head of the expert institution to provide him with the necessary materials. The head of the expert institution addresses the relevant request to the authorized federal executive authority, which issued the task to conduct an expert examination of the expected benefit to the possible risk of the use of the drug The drug is based on a document containing the results of the monitoring of the effectiveness and safety of the drug. Within five working days from the request of the head of the expert agency, the Federal Executive Office sends a request to the applicant for the submission of the necessary materials, which may be transmitted to the Commissioner The complainant's representative is personally under receipt, sent by post by registered mail or transmitted in electronic form via telecommunications channels. In the event of a request made by an authorized federal executive authority by registered mail, it shall be deemed to have been received after six days from the date of the delivery of the registered letter. 11. The applicant is obliged to submit a response to the request of the authorized federal executive body within a period not exceeding sixty working days from the date of receipt of the request. The Commissioner of the federal executive authority who has given the task of carrying out the examination of the expected benefit to the possible risk of the use of the drug based on the document containing the results of the performance monitoring and The safety of the drug, within five working days from the day of the applicant's response to the request of the authorized federal executive body, sends this response to an expert institution. In the event of a failure to submit a response to the request at the end of sixty working days by the complainant, the authorized federal executive authority issuing the assignment for the examination of the expected benefit to possible risk The application of a drug based on a document containing the results of the monitoring of the effectiveness and safety of the drug, within five working days, sends a notification to the expert institution that the applicant does not submit a notification A response to a request from the specified body. The time from the request of the expert institution to the authorized federal executive body until the day of receipt by the expert agency of the response to the request or the notification of non-response to the request is not taken into account in the calculation The duration of the examination of the relationship of the expected benefit to the possible risk of the drug use on the basis of a document containing the results of the monitoring of the effectiveness and safety of the drug. 12. Within a period not exceeding ten working days from the date of receipt of the opinion of the commission of experts on the results of the examination of the expected benefit to the possible risk of the use of the drug, the authorized federal authority 1) carries out an assessment of this opinion in order to determine its conformity with the specified expertise; 2) decides on the approval of the State registration of the drug or refusal of confirmation of a State registration medication; (3) makes a decision on the confirmation of state registration of a drug in the state register of medicines and gives the applicant an indefinite registration a drug licence. 13. The grounds for refusal to confirm the state registration of the drug are the decision of the respective federal executive authority that the risk of causing harm to human or animal health The medication is more effective than its use. 14. During the period of the procedure of confirmation of state registration of a drug, his appeal to the Russian Federation is not suspended. 15. It is permissible to use medicines for medical use before expiry of the shelf life produced within a hundred and eighty calendar days after the date of acceptance by the authorized federal executive authority of the decision on Confirmation of State registration, in accordance with the information contained in the documents of the drug registration file before the date of the decision. "; 22) in article 30: (a) Part 1 next revision: " 1. In order to amend the documents in the registration file for the registered medical application, the holder or the holder of the drug registration certificate; or The other legal entity authorized by him (hereinafter referred to as the applicant) shall submit to the authorized federal authority of the executive branch an application for such changes in the form established by the authorized federal authority and the changes thereto in the documents, as well as documents confirming the need to make such changes. If necessary, amend the records of the registration file on the registered drug requiring expert examination of the quality of drugs and (or) expertise of the expected benefit to possible risk Application of a drug for medical use, the applicant additionally submits to the authorized federal executive authority a copy of the pharmaceutical production licence or a copy of the certificate of compliance of the manufacturer of medicines to the requirements of the regulations In the case of a production of medicinal products carried out in the Russian Federation or a copy issued by the authorized body of the country of manufacture, Licenses for the production of medicines and its translation into Russian, certified in accordance with the prescribed procedure, and a copy of the opinion on the conformity of the pharmaceutical manufacturer with the requirements of the rules of good production practice issued by the federal executive authority, in the case of If the manufacture of the medication is carried out outside the Russian Federation. The decision to make changes or to refuse them is carried out in case of need to carry out expert examination of the quality of medicines and (or) expertise of the expected benefit to the possible risk of drug use Medical treatment for a period not exceeding ninety working days and, in other cases, not to exceed thirty working days from the date of acceptance by the designated federal executive authority of such application. changes. "; (In the wording of Federal Law dated 13.07.2015 N 241-FZ b) Part 2 should be redrafted to read: " 2. The examination of medicines in the part of the examination of the quality of the drug and (or) the examination of the relation of the expected benefit to the possible risk of the drug for medical use is carried out if changes are made to the drug Documents contained in the register of registered drug in relation to: 1) the information specified in the medical procedure of the drug: a) medicinal form with of substances and the quantity and quality of the substances Qualitative composition of subsidiary substances (as required by the quantity of subsidiary substances); b) pharmacokodynamics and pharmacokinetics (except pharmacokinetics of homeopathic drugs and plant products). ); in) evidence for use; g) contraindication for use; y) precautionary measures in use; e) indication of the possibility and characteristics of drug use Medical treatment of pregnant women women, women during breastfeeding, children, adults with chronic diseases; ) dosing regime, ways to introduce and apply, if necessary, the time of the medication, duration Treatment, including for children before and after one year; (s) possible side effects and unwanted reactions in the use of a drug; and) symptoms of overdose, relief measures at overdose; (c) Interactions with other drugs and (or) L) the form of the drug; m) indication (if necessary) of the effects of the drug at the first time or at the time of cancellations; n) information on possible influence Medicinal product for the ability to control vehicles, mechanisms; o) shelf life and to prohibit the use of a drug upon expiry of the shelf life; p) storage conditions; p) conditions of leave; 2) medical treatment; 3) changes in the production of medicinal products for medical use; (4) changes in the quality of medicinal products Application of and (or) methods of quality control for medical use; 5) changing the shelf life of a drug for medical use; 6) Changes in the medical prescription of the drug of the drug, as well as in other documents contained in the registration file of the registered drug. At the same time, the decision to review the quality of medicines and (or) expertise of the expected benefit to the possible risk of the use of a drug for medical use is taken in accordance with the approved The authorized federal executive branch of the classification of changes to the documents contained in the registration file of the registered drug. "; in) Part 3 should read as follows: " 3. The applicant shall submit copies of the documents contained in the registration file for the registered medical drug for medical use, together with the documents referred to in Part 1 of this Article. documents confirming the payment of the state fee for the registration of documents contained in the registration file for the registered drug for medical use, changes requiring examination of medicinal drugs medicines and (or) examination of the expected benefit to the possible risk of the use of a drug for medical use, the state duty for the submission of documents contained in the registered file on the registered drug for medical use, changes that do not require the examination of a drug or have the right to submit those documents on their own initiative. In the event of their failure, the authorized federal executive body shall verify the payment of State duties by the applicant by means of information on the payment of the State duties contained in the State Tax Code. Information system on state and municipal payments, on the basis of copies submitted by the applicant of the documents confirming the payment of the State duty. "; g), paragraph 3 of Part 4, after the words" notifies the " "electronic or"; d) Part 5 with words ", or lack thereof Information demonstrating the payment of the State duties specified in part 3 of this article; e) in Part 7: in the first paragraph of the first word "5" to read "10"; to be added by paragraph 3 of the following The content: "3) gives the applicant a new registration certificate for the drug if the information contained in it has changed."; , Part 9, amend to read: " 9. It is permissible to use medicines for medical use before expiry of the shelf life produced within 100 days after the date of acceptance by the federal executive authority of the decision to make changes to the documents in the registration file, in accordance with the information contained in the document of the registration file prior to the date of the decision. "; 23) in article 31: a) in Part 2 of the words "referred to in subparagraphs"-"e", "l", "m", "p", "(e)" of part 3, paragraph 16 18 "replace" with ",", "c", "L", "H", "c", "c", "x" of article 17, paragraph 7, ", after the words" of the Federal Act, "to be supplemented with the words" changes and (or) additions to the production site of the drug, "; (b) Part 8 should read: " 8. It is permissible to use medicines for veterinary use before expiry of the shelf life produced within a hundred eighty days after the date of acceptance by the authorized federal executive authority of the decision to make changes to the documents in the registration file of the drug according to the information contained in the document of the registration file for the drug before the date of the decision. "; 24) in the article 32: a) in paragraph 2 of the word "drug developer" Replace the words "by the holder or holder of the drug registration certificate"; b) with the words "of the quality of the existing substances"; in) to supplement paragraphs 8 to 10 the following: " 8) the absence of a drug in the Russian Federation for three years or more; 9) failure by the holder or the holder of the drug registration certificate by other legal entities authorized by them The safety of medicines prescribed by the authorized federal executive authority in accordance with article 64, paragraphs 3 and 4, of this Federal Act, as part of the implementation of pharmacosupervision; 10) the holder or owner of the registration certificate of the drug or other legal person authorized by them to amend the instructions for the use of the drug concerning new confirmed evidence that Risk of harm to human or animal health caused by reception "; 25) in article 33: (a) in Part 1: in point 1: subparagraph" a "after" international generic "with the words", or Grouped, "; indent as follows: " in) the name of the holder or the holder of the drug registration certificate; "; subparagraph" d " should read: " (e) Pharmaceutical group, drug code by anatomo-Therapy-chemical classification recommended by the World Health Organization; "; " m "add", date of replacement of registration certificate of a drug for an indefinite registration period. the certificate of medicine, the date of the application for confirmation of the state registration of the drug, the date of the withdrawal of the state registration of the drug "; to be added to the following subparagraphs: content: ") qualitative composition and quantity of active substances and the quality of auxiliary substances of the drug; o) information about all permitted types of secondary (consumer) packaging; p) the date of the decision on The ability to treat a drug in state registration as a spinal medicine; p) availability of a drug in the list of essential and essential drugs; (c) availability of narcotic drugs, of psychotropic substances and their precursors subject to control 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 and the Convention on Psychotropic Substances of 1971; (t) information on whether the drug is a reference drug; (y) in the registration file of the drug; irremovability of a drug; x) the period of introduction of a drug in the civil turnover; "; , in paragraph 2: subparagraph (a), after the words" international generic ", add the words", or the grouping, "; to add to the following subparagraph: " (e) the presence of a pharmaceutical substance in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, of the Russian Federation of the Russian Federation, including the Single Convention on Narcotic Drugs of 1961 and the Convention on Psychotropic Substances of 1971. "; A pharmaceutical substance produced for sale may be included in the state register of medicines on the basis of a declaration made by the developer or manufacturer of a drug or a legal entity authorized by them The conditions for testing the pharmaceutical substance of the pharmaceutical substance, in accordance with the procedure established by article 34 of this Federal Law. For pharmaceutical substances produced for sale, the state register of medicines contains the following information: 1) the name of the pharmaceutical substance (international generic, or Grouped, or chemical and trade names); 2) the name and address of the pharmaceutical substance manufacturer; 3) the shelf life of the pharmaceutical substance; 4) the storage conditions of the pharmaceutical substations; 5) the number of the pharmacopoine article, or in the case of lack of a normative documentation number or a normative document; 6) the presence of a pharmaceutical substance in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, in accordance with of the Russian Federation, international treaties of the Russian Federation, including the Single Convention on Narcotic Drugs of 1961 and the Convention on Psychotropic Substances of 1971; 7) date of inclusion of pharmaceutical Substations in the state register of medicines, date the modification of documents of the pharmaceutical substance, the date of exclusion of the pharmaceutical substance from the public register of medicines. "; 26) in article 34: (a) the name should be redrafted to read: " Article 34. The inclusion in the public register of medicines and the exclusion from of the state drug register of the pharmaceutical substation produced for implementation "; b) in Part 1 of the word "unused in the production of medicines" should be replaced by the words "made for sale"; in Part 2, as follows: " 2. The examination of the quality specified in part 1 of this article of the pharmaceutical substance, the commission of expert opinions on the results of this examination and their transmission to the authorized federal executive authority shall be carried out in the following way: A term not exceeding sixty working days from the date of receipt by the expert body of the relevant task of the authorized federal executive authority and the following documents: 1) copy of the pharmaceutical production licence or a copy of the manufacturer's compliance report Pharmacopoeia for the requirements of the rules of good production practice issued by the authorized federal executive authority, in the event that the manufacture of the drug is carried out in the Russian Federation; 2) A copy of the license issued by the authorized body of the country of manufacture of the pharmaceutical means and its translation into the Russian language, certified in accordance with the established procedure, and a copy of the opinion on the conformity of the manufacturer Requirements for appropriate production and A practice issued by the authorized federal executive authority, in the event that the production of the pharmaceutical funds is carried out outside the Russian Federation; (In the wording of the Federal Law dated 13.07.2015. N 241-FZ) 3) a document containing the following information about the pharmaceutical substance: a) the name of the pharmaceutical substance, its structure, general properties; b) the name and address of the manufacturer; in) production technology describing production stages and control methods at all stages of production; g) description of the production process; d) description of the control of the critical stages of the process production and intermediate products; (e) documentary validation (validation) of processes and (or) their assessment; properties and structure of active substances; (s) impurities; and) the specification for the pharmaceutical substance and its justification; c) Analytical techniques used in the control of the quality of the pharmaceutical substance; L) document validation (validation) of analytical techniques used in the control of the quality of the pharmaceutical industry substations; m) results of the series analysis a pharmaceutical substance; n) list of standard samples or substances used in the implementation of quality control; (o) description of packaging material characteristics and properties; p) data on the stability of the pharmaceutical substance; p) shelf life. "; g) in Part 3: paragraph 2 restated: " 2) a copy of the document confirming the payment of the state duty for Inclusion in the State register of medicines a pharmaceutical substance produced for implementation or on its own initiative. In the event of his failure to provide the complainant, the authorized federal executive body verifies the payment of the State fee by the applicant using information on the payment of the State duty contained in the State Tax Code. Information system on state and municipal payments on the basis of the claimant's copy of the payment of the state duty; "; , paragraph 3 of the words" in article 18, paragraphs 4 to 7, of article 18 The Federal Act "shall be replaced by the words" in Part 2 of this Article "; to supplement paragraph 4 with the following: "(4) an application for authorization to import into the Russian Federation a particular consignment of unregistered drug intended for the said examination."; d) In Part 4: in the first word "5" should be replaced with "10"; paragraph 3 after "notifies in" with the words "electronic or"; e) Part 5 should read: " 5. The reason for refusing to submit to the expert body a task for the examination of the quality of the pharmaceutical substance in Part 1 of this article is the failure to submit the documents referred to in Part 2 of this article, lack of Information demonstrating the payment of the State duty for the inclusion of a pharmaceutical substance produced for sale in the State register of medicines, the failure of the applicant to submit a response to the prescribed period of time part 4-1 of this article request by an authorized federal authority the executive branch or the submission of documents that do not contain an exhaustive list of necessary information. "; f) Part 6, after the words" notifies in "with the words" electronic or "; h), paragraph 3 of Part 8, after the words "shall notify the" in "to be supplemented by the words" electronic or "; and) to be supplemented with parts 10 to 13 as follows: " 10. It is not permitted to include one pharmaceutical substance in the state register of medicines produced for sale and produced by the same producer, in the form of two or more registry records. 11. Changes to the documents for the pharmaceutical substance produced for sale and incorporated in the State register of medicines shall be effected in the manner prescribed by articles 30 and 31 of this Federal Law, with payment OF THE PRESIDENT OF THE RUSSIAN FEDERATION 12. Pharmaceutical substations produced for sale are allowed to be addressed within 100 days before and after the authorized federal executive authority decides to amend documents for pharmaceutical products. A substance produced for sale and included in the state register of medicines. 13. The decision to exclude a pharmaceutical substance from the public register of medicines produced for sale is made by the authorized federal executive authority in the case of: 1) of the submission The competent federal executive authority to report on the risk or threat to the life or health of a person or animal in the use of the drug; 2) by the developer of the drug or by the manufacturer of the medication The legal entity of the application to exclude from the state register of pharmaceutical substances produced for sale; 3) the lack of a pharmaceutical substance produced for sale in the of the Russian Federation for three or more years. "; 27) Article 35 to declare invalid; 28) Article 36 should read as follows: " Article 36. To appeal against the decision not to grant permission to conduct a clinical trial of a drug, a decision to refuse the state registration of a drug the conclusion of an expert commission of an expert institution or advice on ethics a clinical trial of a drug, a decision of the drug The federal executive authority to refuse the state registration of the drug, the expert commission's opinion or the conclusion of the ethics council may be appealed in accordance with the procedure established by the law. OF THE PRESIDENT OF THE RUSSIAN FEDERATION The expert's opinion on the results of the examination to determine the interchangeability of a registered drug can be appealed by the holder or the owner of the drug registration certificate to the commission Experts of the expert agency. The expert commission's opinion of an expert institution following the review of an expert's appeal may be challenged by the holder or the holder of the registration certificate or by an authorized person OF THE PRESIDENT OF THE RUSSIAN FEDERATION On appeal against the decision of the Commissioner of the Federal Executive, the opinion of an expert or expert commission of an expert institution, the conclusion of the board of ethics, the holder or the holder of the registration certificate of the drug or an authorized person is entitled to present the results of the examination of the drug, the protocols of the accredited testing laboratories (centres) of the results of the studies, the tests. "; 29) in article 37: (a) Part 1 after the words "expertise of medicines" to be supplemented by the words "(including the results of its conduct)"; b) Part 2, to be supplemented with the following sentence: " The information referred to in Part 1 of this Article shall be open and public and shall be made available to the persons concerned in in accordance with the legislation of the Russian Federation. "; 30) in article 38: (a) in the first part of paragraph 1 of the words" for the State registration of medicines and other purposes ", delete, after the word" rules " with the word "appropriate"; b) , to read: " 4. Clinical studies of medicinal products are carried out on the basis of authorization to conduct a clinical trial of a drug issued by an authorized federal executive body in the for the purposes specified in Part 1 of this Article. The authorized body of the federal executive branch shall maintain a register of authorizations for the conduct of clinical studies of a drug containing an indication of their purpose or purpose, in accordance with the procedure established by that body. "; Part 5 of recognizing lapel; 31) Article 39 should read: " Article 39. The decision to conduct a clinical trial of a drug for medical use 1. The clinical study of the medical drug for medical use is carried out on the basis of permission to conduct a clinical trial of a drug issued by the authorized federal executive body The results of the examination of the documents necessary for obtaining permission to conduct a clinical study of the drug and ethical expertise. 2. In order to obtain permission to conduct a clinical trial of a drug for medical use, the applicant submits to the authorized federal executive body: 1) an application for a permit Conducting a clinical trial of a medical drug for medical use; (2) copies of documents confirming the payment of the state duty for carrying out an ethical review, examination of documents for medicines for authorization to conduct a clinical trial Medical treatment for medical use, authorization to conduct a clinical study of medicinal products, for carrying out expert examination of documents for medical treatment Authorization for the conduct of an international multi-centre clinical study of medicinal products, for granting permission to conduct an international multi-centre clinical study of the drug for medical use, for conducting an ethical review, the examination of documents for the approval of a post-registration clinical trial of a medical drug for medical application, for issuing a permit to conduct a post-registration a clinical trial of a drug for medical use, or on his own initiative. In the event that the complainant does not submit these documents, the authorized federal executive body verifies the payment of the State duty using information on the payment of the State duty contained in the State Tax Code. Information system on state and municipal payments based on copies of documents submitted by the applicant; 3) the clinical trial protocol for medical use; 4) Explorer; 5) information sheet a patient; 6) knowledge of the experience of researchers in relevant specialties and their experience in conducting clinical studies; 7) information on medical organizations that are expected to be conducted clinical study of medicinal product (full and abbreviation, organizational and legal form, location and location of activity, telephone, telefax, email address of each Medical organization); 8) estimated time frame (a) A copy of the contract of compulsory insurance concluded under the model rules of compulsory insurance, with a limit on the use of a medical certificate for medical use; 9) the number of patients participating in a clinical trial for medical use; 10) information on the composition of the medical drug for medical use; 11) compiled by of the pharmaceutical product for medical use and Containing indicators (characteristics), as well as information on a pharmaceutical drug for clinical research; 12) a copy of the drug production licence in the event that Production of a drug is carried out in the Russian Federation, or a copy of the opinion on the conformity of the pharmaceutical manufacturer with the requirements of the rules of good production practice issued by the competent authority the country of the drug producer. 3. Within a period not exceeding five working days from the date of adoption of Part 2, paragraph 1, of this article and the necessary documents, the authorized federal executive authority: 1) shall verify the completeness and validity. the information contained in the documents submitted by the applicant; 2) decides to review the documents to obtain permission to conduct a clinical study of the medical drug for medical use; and The ethical review or refusal to conduct these examinations; 3) notifies the applicant in electronic form or paper of the decision taken, or in the event of a decision to refuse also giving reasons for such refusal; 4) prepares and forwards to the expert agency and The board of ethics is the task of carrying out the relevant examinations. 4. In the event that the information contained in the documents submitted by the applicant is incomplete and (or) unreliability, the authorized federal executive authority sends a request for clarification to the applicant. The request may be submitted to the authorized representative of the applicant personally under receipt, by mail by registered mail, or transmitted in electronic form via telecommunications channels. If the request is made by registered mail, it shall be deemed to have been received after six days from the date of the registered letter. The applicant is obliged to submit a response to the request of the authorized federal executive body within a period not exceeding ninety working days from the date of receipt. The period specified in part 3 of this article shall be suspended from the day the applicant has been requested by the authorized federal executive authority until the day of receipt of the corresponding reply and is not taken into account in the calculation of the period of acceptance The authorized federal executive authority of the decision to carry out expert examination of documents for obtaining permission to conduct a clinical trial of a medical drug for medical use. 5. The basis for refusal of the examination of the documents to obtain a permit to conduct a clinical trial of a drug for medical use and an ethical evaluation is the submission of the documents provided for in the document. Part 2 of this article, which is incomplete, does not provide the applicant with a request within a specified period of time for a response to the request of the authorized federal executive body referred to in part 4 of this article, or the absence of a request in the documents submitted an exhaustive list of the necessary information or information to be provided to be reflected in them, as well as the lack of information substantiating the payment of a state duty for carrying out an ethical review, expert examination of documents for a drug to obtain permission to conduct a clinical trial Medical treatment for medical use, authorization to conduct a clinical study of medicinal products, for carrying out expert examination of documents for a drug to obtain a permit for the International Centre for the a study of a medical drug for medical use, for granting permission to conduct an international multi-centre clinical study of medicinal products, for conducting an ethical review, the examination of documents for the approval of a post-registration clinical trial of a medical drug for medical application, for issuing a permit to conduct a post-registration clinical study of medicinal medication application. 6. Review the documents to obtain permission to conduct a clinical study of medicinal and ethical medicine, draw up a commission of experts and advise on the ethics of opinions about the possibility of or The impossibility of conducting such a clinical trial and sending these findings to the authorized federal executive authority shall be carried out within a period not exceeding thirty working days from the date of receipt by the expert body of the task Authorized Federal Executive Office The application of the documents referred to in paragraphs 3, 4, 10 and 11 of Part 2 of this Article and the Ethics Council for the task of the authorized federal executive authority with the annex of the documents referred to in paragraphs 3 to 6, 8 and 9 of Part 2 of this Article. 7. Within a period not exceeding five working days from the date of receipt of the opinions referred to in part 6 of this article, the authorized federal executive authority: 1) shall evaluate the findings of the findings to determine them. (b) Compliance with the relevant expertise; 2) decides whether to authorize the clinical study of the medical drug for medical use or refusal to issue the said permissions; 3) authorize a clinical trial Medical treatment for medical use or refusal to issue the permit with reasons for refusal. 8. The grounds for refusing permission to conduct a clinical trial for medical use are the opinion of a commission of experts or an opinion of the Ethics Council on the impossibility of holding a clinical trial A study of a drug for medical use based on the results of expert examinations provided for in Part 6 of this Article. 9. Decision on refusal to conduct expert examination of documents to obtain permission to conduct a clinical trial of a drug for medical use and ethical review and for authorization to conduct clinical trials. The study of medicinal products for medical use can be appealed in accordance with the procedure established by the law of the Russian Federation. "; 32) to supplement article 39-1 as follows: " Article 39-1. Ethical expertise 1. Ethical expertise is conducted by an ethics council established in accordance with the procedure established by the authorized federal executive authority to issue an opinion on the ethical grounds for conducting a clinical trial medication for medical use. 2. Representatives of medical organizations, scientific organizations, educational institutions of higher education, as well as representatives of public organizations, religious organizations and mass media may be experts of the board of ethics. The experts should not be dependent on drug developers and others interested in the results of the ethical review. 3. The fee for the services of the experts of the ethics board is based on a contract concluded between the Commissioner of the Federal Executive for which the Ethics Council is established, and the expert of the ethics council, from the budget appropriations, The competent federal executive authority, which has been set up by the board of ethics, in the federal budget for the corresponding year to ensure its activity, in the amount set by the Government of the Russian Federation. 4. The experts of the ethics board are responsible in accordance with the legislation of the Russian Federation. 5. Composition of the board of ethics, regulation of this council, its conduct of work, qualification requirements and experience of expert assessment of scientific, medical and ethical aspects of clinical studies of medicinal products Experts of the board of ethics, organization and conduct of ethical review, the form of the opinion of the board of ethics shall be established by the competent federal executive authority. The number of representatives of medical organizations may not exceed half of the total number of experts of the board of ethics. 6. Information on the composition of the board of ethics, its work plans and current activities is posted on the official website of the authorized federal executive authority over the Internet in the established order. "; 33) in article 40: (a) In Part 1, replace "at least five years" with "at least three years"; b) Part 5, add the following sentence: " When considering a communication on the need for changes to the protocol clinical study of medicinal medicinal use for evaluation purposes The validity of the proposed changes and the degree of risk to patients participating in the clinical studies, authorized by the federal executive authority may be drawn by the experts of the ethics board. "; in) to supplement 8-1 as follows: " 8-1. Clinical study of the medical drug for medical use may be suspended or terminated upon submission by the competent federal executive authority of a clinical trial. Research on the violation of the rules of good clinical practice based on the results of an inspection of the activities of one or more medical organizations that conduct clinical trials of medicinal drugs application. The decision to conduct a clinical trial for medical use is to be abolished by the registering body when it is submitted to the federal executive authority exercising control and supervision functions in the sphere Health care resulting from the review of one or more medical organizations that conduct clinical studies of medicinal products, findings on the detection of medical treatment clinical trial of drug violations of good clinical practice affecting the completeness and/or reliability of clinical trials. "; ) Part 12, after the word" rules ", add the word" appropriate "; (d) in Part 13 of the phrase" in the territory of the Russian Federation; and (or) outside the territory "shall be replaced by the words" in the Russian Federation and (or) outside "; (e) in part 14 the words" to the territory of the Russian Federation and to export beyond the territory of the territory "to read" the Russian Federation and the export of limits "; 34) in article 44: (a) of paragraph 2 of Part 5 The following wording should be worded as follows: " (g) not resulting in disability, no more than three hundred thousand roubles per patient who participated in the clinical trial of the drug, based on norms reflecting The nature and extent of the damage to health, as well as the patient's actual costs resulting from damage to health, to medical care, to the purchase of drugs. "; b) part 6 of the void; in) Part 8, after the words "under the contract of compulsory insurance" In the words "as well as standards reflecting the nature and extent of damage to health,"; 35) in article 45: (a), in Part 1, replace the words "rules of production and quality control of medicines" with the words "requirements of the rules of good production practice", the words "rules of organization of production and quality control of medicines" to be replaced by the words "the requirements of good production practices", supplemented by the following proposals: Content: " Issuance of certificates of compliance of the manufacturer of medicines The requirements of the rules of good production practice are carried out on the basis of inspections of manufacturers of medicines in accordance with the procedure established by the Government of the Russian Federation. The amount of the fee for issuing the opinion on the conformity of the pharmaceutical manufacturer with the requirements of the rules of good production practice is established by the Government of the Russian Federation. The procedure for organizing and conducting inspections of manufacturers of medicines to meet the requirements of the rules of good production practice shall be established by the Government of the Russian Federation. "; b) in Part 2 of the word" Replace the words "the rules of the organization of production and quality control of medicines" with the words "the rules of good production practice"; in Part 4) be supplemented with the words ", the elimination of pharmaceutical substances produced for in the conduct of clinical trials and for export ", add the following sentence:" The pharmaceutical substance production process includes any stage of the process that allows to obtain a finished product, Relevant requirements of a pharmacopoopine article, including fermentation, extraction, purging, excursion, drying, shredding. "; g) to be completed with Part 4-1: " 4-1) Volume Requirements packaging, packaging, packaging of individual drugs are established by the Government of the Russian Federation. "; d) in Part 6, the words" production and quality control of medicines "are replaced by the words" requirements of good production practices "; 36) Article 46: (a) in Part 1: paragraph 1, after the words "international generic", add ", or group"; , paragraph 2, after the words "international generic", add ", or group,"; b) Part 2 after "international generic" should be supplemented by the words ", or grouped,"; in) Part 8 after the words "primary packaging" with the words "(if there is a technical capability)"; 37) in Part 8 of Article 47, the second sentence should be deleted; In article 54, after the word "rules", article 54 should be supplemented with the words "appropriate distribution practices and rules of good practice for the storage and transport of medicines"; Table of contents: " The retail drug trade is carried out in the following way: the rules of the appropriate pharmacy practice approved by the authorized federal executive authority. "; 40) in article 59: (a) in Part 1 of the word" civil revolution "should be replaced by the word" address "; b) in Part 2; The words "civil turnover" should be replaced by the word "address"; 41) in article 60: (a) paragraph 1 should read: " (1) by the Government of the Russian Federation Drugs that has been developed in the prescribed manner on the basis of an integrated assessment of drugs, including an analysis of the comparative clinical efficacy and safety of the drug, the assessment of the economic impact of the use of the drug, and the study of additional drugs the effects of the use of the drug; "; b) paragraph 2, in addition to the words" as well as the introduction of mechanisms for the formation of reference prices "; 42) (Deleted-Federal Law dated 08.03.2015 N 34-FZ) 43) in article 62 (2): (a) paragraph 1 should read: " 1) the name of the holder or the holder of the registration certificate of the drug, the name of the manufacturer the drug, the location of the production sites involved in the process of production of the drug, with an indication of the stage of the production process; "; b), paragraph 2, after the words" international generic " with the words ", or the grouping,"; in paragraph 4, add Paragraph 6 should read as follows: " 6) the date and number of the order of the authorized federal executive branch of the executive branch of state registration, re-registration of the the selling price of the medication included in the list of essential and essential drugs; "; y) to supplement paragraphs 7 and 8 reading: " 7) bar code applied to secondary (consumer) packaging of the drug; 8) anatomo-chemical classification recommended by the World Health Organization. "; 44) in the title of Chapter 13, after" Monitoring ", add the words" effectiveness and ", the words" at For the Russian Federation to replace the words "in the Russian Federation"; 45), article 64 should read as follows: " Article 64. Pharmacosurveillance 1. Medicines in circulation in the Russian Federation are subject to monitoring of efficiency and safety in order to identify possible adverse effects of their use, individual intolerance, and prevention of medical treatment. workers, veterinary specialists, patients or animal owners and their protection against the use of such drugs. 2. The pharmacosurveillance is carried out by the relevant authorized federal executive authority in the prescribed manner by analysing the information provided by the subjects of drug treatment information on side effects, unwanted reactions, serious undesired reactions, unanticipated unwanted reactions in the use of drugs, individual intolerance, lack of efficacy of drugs, and other facts and circumstances, A threat to the life or health of an individual or an animal The use of drugs and drugs identified at all stages of drug treatment in the Russian Federation and other States. 3. Drug circulation actors in the manner prescribed by the authorized federal executive authority are obliged to inform the authorized federal executive body about side effects, undesirable reactions, and serious unwanted reactions, unanticipated undesired reactions in the use of drugs, individual intolerance, lack of efficacy of medicines, and other facts and circumstances threatening life or health of a person or an animal in the application of OF THE PRESIDENT OF THE RUSSIAN FEDERATION 4. Holders or owners of registration certificates of medicines, legal entities whose name has been authorized to conduct clinical research in the Russian Federation or other legal entities authorized by them within the framework of Ensuring the safety of medicines, in accordance with the procedure established by the competent federal executive authority, is obliged to receive, register, process, analyse and store incoming traffic from entities the Treatment of Drugs and Public Authorities by-actions, unwanted reactions, serious unwanted and unanticipated unwanted reactions in the use of drugs, the peculiarities of their interaction with other drugs, individual intolerance, and Other facts and circumstances that pose a threat to the life or health of a person or animal or affect the changing relationship of the expected benefit to the possible risk of the use of drugs. 5. When identifying information about serious unwanted reactions and unanticipated undesirable reactions in the use of drugs, the specifics of their interaction with other drugs, individual intolerance, and Other facts and circumstances affecting the change in relation of the expected benefit to the possible risk of the use of drugs, holders or owners of drug registration certificates, legal entities whose name is had been granted permission to conduct clinical studies in the Russian Federation. The Federation, or other legal entities authorized by them, are obliged to take measures to eliminate the negative consequences of the use of such drugs, to prevent harm to the life or health of a person or an animal, to protect them from the use of such drugs, to collect additional data on the effectiveness and safety of such drugs. 6. For non-reporting or concealment of information provided for in part 3 of this article, holders or owners of registration certificates, legal entities authorized to conduct clinical studies in OF THE PRESIDENT OF THE RUSSIAN FEDERATION 7. When the authorized federal executive authority receives evidence of non-compliance with the prescribed requirements, or in obtaining information on the lack of conformity of the data, The effectiveness and safety of the drug in the drug data contained in the instructions for its use (including those identified in the implementation of pharmacosurveillance by the regulatory authorities of foreign States); The Commissioner of the Federal Executive (c) The question of the suspension of the use of such medication. "; 46) Article 65 should be amended to read: Article 65. Suspension of the application of a drug preparation 1. When receiving information about unwanted reactions in the use of a drug not specified in the instructions for the use of a drug, serious undesirable reactions, the peculiarities of its interaction with other drugs of drugs that may pose a threat to the life or health of a person or an animal, as well as the lack of data on the efficacy and safety of the drug in the drug data contained in its instructions the exchange of information, including the exchange of information, which is carried out in accordance with the agreements between the authorized federal executive body and the authorized bodies of foreign states, the authorized body of the federal executive authority is considering the question of The possibility of suspending the circulation of such medication in accordance with the procedure established by the authorized federal executive authority. 2. In case of non-performance or improper execution by holders or owners of registration certificates of medicines, legal entities under whose name they have been granted permission to conduct clinical studies in the Russian Federation, or by their other legal entities under article 64, paragraphs 3 and 4, of this Federal Act, or in the case of submission by the competent federal authority of the executive the lack of credibility of the clinical trial of the drug Medical treatment, which is based on the findings of a medical organization that conducted the clinical trial in violation of the rules of good clinical practice, and resulted in unreliable results, or in the event of failure to comply with a regulation issued by the authorized federal executive authority following a sample of the quality of the medication, authorized by the federal executive authority in the consideration of the question of suspension of the use of such a drug. "; 47) in article 66: (a) in the name of the word" drug safety monitoring "should be replaced by the word" pharmacosurveillance "; b) the words" safety monitoring "in the territory of the Russian" replaced by "in the Russian", the word "monitoring" should be replaced by the word "pharmacosurveillance"; 48) in article 68: (a) replace by the words "1". Breach of the law "; b) is supplemented by Part 2, reading: " 2. For failure to submit information and (or) data provided for by this Federal Law, the subject of the circulation of medicines is liable in accordance with the legislation of the Russian Federation. ". Article 2 Recognize: 1) Article 1, paragraph 2 of Federal Law of October 11, 2010 N271-FZ " On introducing changes to Federal Act on the Treatment of Drugs OF THE PRESIDENT OF THE RUSSIAN FEDERATION 5293); 2) paragraph 3 and paragraph 14 of Article 13 of the Federal Law of 29 November 2010 No. 313-FZ " On introducing changes to OF THE PRESIDENT OF THE RUSSIAN FEDERATION 6409); 3) article 54, paragraph 5, of the Federal Law of 25 November 2013, No. 317-FZ " On amendments to selected legislative acts OF THE PRESIDENT OF THE RUSSIAN FEDERATION 6165). Article 3 1. The determination of the interchangeability of medicines for medical use registered before the day of the entry into force of this Federal Law is carried out by a commission of experts of the federal state budget institution on Conducting an expert examination of medicinal drugs for medical use in the examination of the quality of the drug and (or) the examination of the relation of the expected benefit to the possible risk of use Medical treatment on the basis of a mission The relevant authorized federal executive body of the, including a declaration issued by the holder or the holder of the drug registration certificate, until 31 December 2017. (In the wording of Federal Law No. N 241-FZ) 2. Holders or owners of drug registration certificates may apply for the definition of interchangeability of medicines for medical use in accordance with the procedure established by article 30 of the Federal Law dated April 12, 2010 N 61-FZ "On the Treatment of Drugs" (as amended by this Federal Law), until December 31, 2016. 3. Information on the irremovability of medicines for medical use is to be included in the state register of medicines from January 1, 2018. 4. The use of the results of the determination of interchangeability of medicines for medical use is permitted from 1 January 2018. 5. The Commissioner of the federal executive authority is obliged to issue a task to the federal state budget agency for the evaluation of medicinal products for 2015 -2017 For medical applications registered before the day of entry into force of this Federal Law. 6. Until January 1, 2016, for the purposes of the Federal Law of 12 April 2010, No. 61-FZ "On appeal of medicines" (in the wording of this Federal Law) as a reference drug is considered original medication. (Part of the addition is the Federal Law of 13 July 2015. N 241-FZ)7. State registration of medicines submitted to the authorized federal executive authority prior to the day of entry into force of this Federal Law shall be carried out as required Legislation on the treatment of medicines in force before the day of the entry into force of this Federal Act. (Part of the addition is the Federal Law of 13 July 2015. N 241-FZ) 8. Applications for the resumption of the State registration of a drug, the examination of the quality of the drug, and the examination of the relation of the expected benefit to the possible risk of the use of the drug for the drug Medical applications submitted to the federal executive authority before the day of the entry into force of this Federal Act are considered in accordance with the requirements of the legislation on the circulation of medicines, in force until the day of the entry into force of this Federal Act. (Part of the addition is the Federal Law of 13 July 2015. N 241-FZ) Article 4 1. This Federal Act shall enter into force on 1 July 2015, with the exception of the provisions for which this article establishes a different time frame for their entry into force. 2. Subparagraph 2 (d), subparagraphs (d) and (d) of paragraph (10), subparagraph (b), subparagraph (b), subparagraph (c), of article 1, paragraph 26, of this Federal Act shall enter into force on 1 January 2016. 3. Paragraph 21, paragraph 21, subparagraph (a) of article 1, paragraph 22, subparagraph (a), of this Federal Act shall enter into force on 1 January 2017. President of the Russian Federation Vladimir Putin Moscow, Kremlin December 22, 2014 N 429-FZ
Search Translated Laws of Russia
