FEDERAL LAW OF THE RUSSIAN FEDERATION

of December 22, 2014 No. 429-FZ

About introduction of amendments to the Federal law "About Drug Circulation"

Accepted by the State Duma on December 9, 2014

Approved by the Federation Council on December 17, 2014

Article 1

Bring in the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation" (The Russian Federation Code, 2010, No. 16, Art. 1815; No. 31, Art. 4161; No. 42, Art. 5293; No. 49, Art. 6409; 2011, No. 50, Art. 7351; 2012, No. 26, Art. 3446; No. 53, Art. 7587; 2013, No. 27, Art. 3477; No. 48, Art. 6165; 2014, No. 11, Art. 1098; No. 43, Art. 5797) following changes:

1) in Article 4:

a) state Item 2 in the following edition:

"2) pharmaceutical substance - medicine in the form of one or several active ingredients having pharmacological activity regardless of the nature of origin which is intended for production of production of medicines and determines their efficiency;";

b) add with Item 5.1 of the following content:

"5. 1) dosage - content of one or several active ingredients in quantitative expression per unit of dose, either unit of volume, or unit of mass according to dosage form or for some types of dosage forms amount of the active ingredient released from dosage form for unit of time;";

c) add with Items 6.1 and 6.2 of the following content:

"6. 1) orphan medicines - the medicines intended only for diagnostics or pathogenetic treatment (the treatment directed to the disease development mechanism) of rare (orphan) diseases;

6. 2) biological medicines - medicines which active ingredient is made or emitted from biological source and for determination of properties and which qualities the combination of biological and physical and chemical methods is necessary. The immunobiological medicines, medicines received from blood, plasma of blood of the person and animals (except for whole blood), biotechnological medicines, gene therapeutical medicines belong to biological medicines;";

d) state Item 7 in the following edition:

"7) immunobiological medicines - the medicines intended for forming of active or passive immunity or diagnostics of availability of immunity or diagnostics of the specific acquired change of the immunological answer to allergiziruyushchy substances. Vaccines, anatoxins, toxins, serums, immunoglobulins and allergens belong to immunobiological medicines;";

e) add with Items 7.1 and 7.2 of the following content:

"7. 1) biotechnological medicines - medicines which production is performed with use of bioengineering procedures and methods (including DNA-recombinant technology, technology of controlled expression of the genes coding biologically active proteins in prokariota and eukaryotes including the changed cages of mammals), gibridomny method and method of monoclonal antibodies;

7. 2) gene therapeutical medicines - medicines which pharmaceutical substance is recombinant nucleic acid or includes the recombinant nucleic acid allowing to perform regulation, reparation, replacement, addition or removal of the genetic sequence;";

e) state Items 11 and 12 in the following edition:

"11) reference medicine - medicine which is for the first time registered in the Russian Federation which quality, efficiency and safety are proved based on results of preclinical researches of the medicines and clinical trials of medicines conducted according to requirements of part 3 of article 18 of this Federal Law and which is used for assessment of bioequivalence or therapeutic equivalence, quality, efficiency and safety of the reproduced or bioanalog (biosimilar) medicine;

12) the reproduced medicine - medicine which has the same high-quality composition and quantitative composition of active ingredients in the same dosage form as reference medicine, and bioequivalence or therapeutic equivalence of which to reference medicine it is confirmed with the corresponding researches;";

g) add with Items 12.1 - 12.3 following of content:

"12. 1) therapeutic equivalence - achievement of clinically comparable therapeutic effect in case of use of medicines for medical application for the same group of patients on the same indications to application;

12. 2) bioanalog (biosimilar) medicine (bioanalogue) - the biological medicine similar in parameters of quality, efficiency and safety to reference biological medicine in the same dosage form and the having identical method of introduction;

12. 3) interchangeable medicine - the medicine with the proved therapeutic equivalence or bioequivalence concerning reference medicine having high-quality compositions and quantitative composition of active ingredients, composition of excipients, dosage form and method of introduction equivalent to it;";

h) state Item 15 in the following edition:

"15) homeopathic medicine - the medicine made or made of pharmaceutical substance or pharmaceutical substances according to requirements of general pharmacopoeian clauses to homeopathic medicines or according to requirements of pharmacopeia of the country of the producer of such medicine;";

i) in Item 16 of the word "name of pharmaceutical substance" shall be replaced with words "the name of active ingredient of pharmaceutical substance";

j) add Item 17 with words ", the holder or the owner of the registration certificate of medicine";

k) add with Item 17.1 of the following content:

"17. 1) the grouping name of medicine - the name of the medicine which does not have the international non-proprietary name, or combination of medicines, used for the purpose of their consolidation in group under the single name proceeding from identical composition of active ingredients;";

l) in Item 18 of the word "for medical application" to exclude;

m) in Item 19 of the word "for medical application" to exclude;

o) add with Items 19.1 and 19.2 of the following content:

"19. 1) standard samples - substances by means of comparison with which quality control of the researched medicines by means of physical and chemical and biological methods for the purpose of confirmation of conformity of medicines to the requirements of the regulating documentation established when implementing state registration and which are applied to calibration of standard samples of the producer of the medicines used for quality control and other purposes in case of drug circulation is exercised;

19. 2) pharmacopoeian standard sample - the standard sample made according to pharmacopoeian Article;";

o) add with Item 21.1 of the following content:

"21. 1) the general technical document - the set of documents and materials consisting of several Sections - documentation of administrative nature, chemical, pharmaceutical and biological documentation, pharmacological, toxicological documentation, clinical documentation and represented along with the statement for state registration of medicine for medical application in the format established by authorized federal executive body;";

p) add with Item 26.1 of the following content:

"26. 1) the holder or the owner of the registration certificate of medicine - developer of medicine, producer of medicines or other legal entity having right of possession the registration certificate which bear responsibility for quality, efficiency and safety of medicine;";

c) in Item 30 of the word", and also" shall be replaced with words "and (or)";

r) add with Item 31.1 of the following content:

"31. 1) the production site - territorially isolated complex of the producer of medicines intended for accomplishment of all production process of medicines or its certain stage;";

s) state Item 45 in the following edition:

"45) research of bioequivalence of medicine - type of clinical trial of medicine which carrying out is performed for determination of speed of absorption and removal of one or several active ingredients having pharmacological activity, amount of the medicine reaching system blood-groove and which results allow to draw conclusion on bioequivalence of the reproduced medicine in the determined dosage form and dosage, the corresponding form and dosage of reference medicine;";

t) add with Item 50.1 of the following content:

"50. 1) undesirable reaction - inadvertent adverse reaction of organism which can be connected using medicine;";

x) state Item 52 in the following edition:

"52) unexpected undesirable reaction - undesirable reaction of organism which is connected using medicine in the doses recommended in the protocol of its clinical trial, the brochure of the researcher or using medicine in the doses recommended in the instruction for its application for prevention, diagnostics, treatment of disease or medical rehabilitation of the patient, and essence weight or outcome of which does not correspond to information on medicine containing in the protocol of its clinical trial, the brochure of the researcher or in the instruction for use of medicine;";

v) add with Items 52.1 and 52.2 of the following content:

"52. 1) pharmakonadzor - the type of activity on monitoring of efficiency and safety of medicines directed to identification, assessment and prevention of undesirable effects of use of medicines;

52. 2) the risk management plan - the detailed description of the actions for pharmakonadzor directed to identification, assessment and prevention or risk minimization, connected with medicines including efficiency evaluation of these actions;";

w) add with Item 55 of the following content:

"55) complex assessment of medicine - assessment of the registered medicine including information analysis about comparative clinical efficiency and safety of medicine, assessment of economic effects of its application, studying of additional effects of use of medicine for the purpose of decision making about possibilities of inclusion of medicine in the list of vital and essential drugs, the regulatory legal acts and other documents determining procedure for delivery of health care, or its exception of the specified lists, acts and documents.";

2) in Article 5:

a) in Item 1 of the word "in the territory of the Russian Federation" shall be replaced with words "in the Russian Federation";

b) add Item 2 with words ", creation and maintaining the register of pharmacopoeian standard samples";

c) add Item 5 with words ", examinations of the documents submitted for determination of opportunity to consider medicine for medical application in case of state registration as orphan medicine";

d) add with Item 5.1 of the following content:

"5. 1) the organization of carrying out complex assessment of medicine for the purpose of decision making about possibilities of inclusion of medicine in the list of vital and essential drugs, the regulatory legal acts and other documents determining procedure for delivery of health care or its exception of the specified lists, acts and documents;";

e) state Item 8 in the following edition:

"8) the organization and (or) conducting inspection of subjects of drug circulation on compliance to rules of proper laboratory practice, to rules of proper clinical practice, rules of proper practice of storage and transportation of medicines, rules of proper distributor practice, rules of proper pharmaceutical practice;";

e) add with Items 8.1 and 8.2 of the following content:

"8. 1) the organization and (or) conducting inspection of subjects of drug circulation on compliance to requirements of rules of proper production practice, issue of the conclusions about compliance of the producer of medicines to requirements of rules of proper production practice;

8. 2) establishment of procedure for maintaining and maintaining the state register of the conclusions about compliance of the producer of medicines to requirements of rules of proper production practice;";

g) state Item 10 in the following edition:

"10) establishment of procedure for import of medicines to the Russian Federation and export of medicines from the Russian Federation;";

h) add with Items 10.1 and 10.2 of the following content:

"10. 1) issue, establishment of procedure for issue and the document form which confirms that production of medicine is performed according to requirements of rules of proper production practice and is subject to representation upon the demand of authorized body of the country into which medicine is imported;

10. 2) issue, establishment of the procedure for issue and the document form containing data on the stages of engineering procedure of production of medicine performed in the territory of the Eurasian Economic Union;";

i) state Item 14 in the following edition:

"14) implementation of pharmakonadzor;";

j) add with Items 18 - 24 following of content:

"18) approval of rules of proper laboratory practice, rules of proper clinical practice, rules of proper production practice, rules of proper practice of storage and transportation of medicines, rules of proper distributor practice, rules of proper pharmaceutical practice, rules of proper practice of pharmakonadzor of medicines for medical application;

19) establishment of procedure for forming of the registration file on medicine and requirements to documents in its structure;

20) approval of rules of the rational choice of names of medicines for medical application;

21) approval of the list of names of dosage forms;

22) forming of the register of standard instructions on medical application of interchangeable medicines;

23) approval of requirements to the instruction on medical application of medicines and to the instruction for veterinary use of medicines;

24) pre-judicial closing of the websites containing information on retail sale by remote method, the offer on acquisition by remote method, delivery by remote method and (or) transfer to physical person by remote method of the medicines, narcotic medicines and psychotropic medicines, except as specified, established by the Government of the Russian Federation.";

3) in Article 7:

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