pharmaceutical regulation
Russian Laws

The new Amendments of July 2019 to
Federal Law 61
"On circulation of medicines"

The legal document below was translated into Russian by CEG or a translation company on behalf of CEG.
This translation may contain inaccuracies. For all issues related to law enforcement practice, please contact the authorities of Russia / the EAEU and CEG company.
These amendments have not yet entered into force.
GOVERNMENT
OF THE RUSSIAN FEDERATION
to
STATE DUMA OF THE FEDERAL ASSEMBLY
OF THE RUSSIAN FEDERATION

On the submission of the draft federal law "On Amendments to the Federal Law" On the Circulation of Medicinal Products" and to the Federal Law" On Amendments to the Federal Law "On the Circulation of Medicinal Products" regarding the improvement of the procedure for determining the interchangeability of medicinal products for human use"
July 2, 2019
No. 5973п-П12
MOSCOW
In accordance with Article 104 of the Constitution of the Russian Federation, the Government of the Russian Federation submits for consideration by the State Duma of the Federal Assembly of the Russian Federation the draft federal law "On Amendments to the Federal Law" On the Circulation of Medicinal Products" and to the Federal Law" On Amendments to the Federal Law "On the Circulation of Medicinal Products" regarding the improvement of the procedure for determining the interchangeability of medicinal products for human use".

Attachment:
1. Draft federal law on 35 sheets.
2. Explanatory note to the draft law on 4 sheets.
3. The financial and economic justification on 1 sheet.
4. The list of federal laws subject to invalidation, suspension, amendment or adoption in connection with the draft law, on 1 sheet.
5. The list of regulatory legal acts of the President of the Russian Federation, the Government of the Russian Federation and federal executive bodies subject to invalidation, suspension, amendment or adoption in connection with the draft law, on 13 sheets.
6. An order of the Government of the Russian Federation on submission of the draft law to the State Duma of the Federal Assembly of the Russian Federation and on the appointment of an official representative of the Government of the Russian Federation for consideration of the draft law by the Chambers of the Federal Assembly of the Russian Federation, on 1 sheet.

Chairman of the of the Russian Federation /signature/ D. Medvedev
FEDERAL LAW
On Amendments to the Federal Law "On the Circulation of Medicinal Products" and the Federal Law "On Amendments to the Federal Law "On the Circulation of Medicinal Products" regarding the improvement of the procedure for determining the interchangeability of medicinal products for human use"
Draft law
No. 745128-7
Article 1 (part 1)
Amend Federal Law No. 61-FZ dated April 12, 2010 "On Circulation of Medicinal Products" (Collected Legislation of the Russian Federation, 2010, No. 16, Art. 1815; No. 42, Art. 5293; No. 49, Art. 6409; 2011, No. 50, Art. 7351; 2012, No. 26, Art. 3446; 2013, No. 27, Art. 3477; No. 48, Art. 6165; 2014, No. 43, Art. 5797; No. 52, Art. 7540; 2015, No. 29, Art. 4367; No. 51, Art. 7245; 2016, No. 27, Art. 4194; 2017, No. 31, Art. 4791, 4827; 2018, No. 1, Art. 9; No. 24, Art. 3407; No. 49, Art. 7521; No. 53, Art. 8437; 2019, No. 23, Art. 2917) as follows:

1) in Article 4:

a) to amend clause 11 as follows:

"11) Original medicinal product" is a medicinal product with a new active substance that was first registered and placed on the global pharmaceutical market based on the dossier containing results of complete non-clinical and clinical studies confirming its quality, safety and efficacy";

b) supplement with paragraph II1:

"Non-reference medicinal product is a medicinal product used to evaluate bioequivalence or therapeutic equivalence, quality, efficacy and safety of a generic or biosimilar medicinal product.
The original medicinal product, or, if the original medicinal product is not authorized in the Russian Federation or is not in circulation in the Russian Federation and on the global pharmaceutical market, a generic or biosimilar medicinal product that is authorized and in circulation in the Russian Federation with bioequivalence or therapeutic equivalence, quality, efficacy and safety assessed in relation to the original medicinal product, as well as with the quality, efficacy and safety confirmed by the results of pharmacovigilance and inspection of compliance of medicinal products in civil circulation with the established requirements for their quality, is used as a reference medicinal product for human use. A medicinal product for veterinary use authorized in the Russian Federation based on the Marketing Authorization dossier containing the results of full non-clinical and clinical studies confirming its quality, safety and efficacy, is used as a reference medicinal product for veterinary use;"

c) amend paragraph 12 and 121 as follows:

"12) a generic medicinal product is a medicinal product that has an equivalent (except for medicinal products for veterinary use) or the same qualitative and quantitative composition of active substances in an equivalent (except for medicinal products for veterinary use) or the same dosage form as the reference medicinal product with the bioequivalence or therapeutic equivalence to the reference medicinal product confirmed by appropriate studies;

121) therapeutically equivalent medicinal products are medicinal products for human use with one international non-proprietary (or chemical, or generic) name, ensuring the achievement of comparable parameters of efficacy and safety when used in equivalent molar doses for the same indications for use and using one method of administration;";

d) to restate clause 123 as follows:

"123) bioequivalent medicinal products are medicinal products with the same international non-proprietary (or chemical, or generic) name ensuring the achievement of comparable parameters of the rate and extent of delivery of the active substance(s) or the active part of the molecule of the active substance(s) to the place of action when used in equivalent molar doses using the same method of administration;";

e) add clauses 124 and 125 specifying the following:

"124) pharmaceutically equivalent medicinal products are medicinal products containing the same active substance(s) (pharmaceutical substance(s)) in equivalent amounts (dosages, concentrations), in equivalent dosage forms intended for one method of administration, with the corresponding comparable quality parameters set forth in compendial monographs, or normative documents, or normative documents registered in accordance with part 10 of Article 18 of this Federal Law;

125) interchangeable medicinal products are therapeutically equivalent, or bioequivalent, or pharmaceutically equivalent medicinal products, available for use in the same group of patients in an equivalent dose and with the same method of administration with the same indications and contraindications for use";

f) paragraphs 45 and 46 shall be amended as follows:

"45) study of bioequivalence of a medicinal product is a type of clinical study or in vitro study of a medicinal product (except for medicinal products for veterinary use) with the results allowing to make a conclusion about the bioequivalence of the generic medicinal product;

46) therapeutic equivalence study of medicinal products is a type of clinical study of medicinal products to identify the comparability of their efficacy and safety parameters, clinical (pharmacodynamic) effects;";

2) in Article 5, paragraph 22 shall be declared null and void;

3) Clause 3 of Article 6 shall be amended as follows:

"3) the implementation of regional state control over the use of prices for medicinal products included in the list of vital and essential medicinal products, wholesale companies, pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities, medical organizations licensed for pharmaceutical activities, and their separate units (dispensaries, medical and medical and obstetrical units, the centers (offices) of general (family) practice), located in rural areas, where there is no pharmacy organizations;"

4) paragraph 1 of part 4 of Article 9, after the words "destruction of medicinal products," add the following: "the use by manufacturers of medicinal products of the prices of medicinal products included in the list of vital and essential medicinal products,";

5) in Article 18:

а) in Part 5:

to the first paragraph of clause 1 add the words ", except for the pharmaceutical substances included in the state register of medicinal products in accordance with Article 34 of this Federal Law";

to add clause 11 specifying:

"11) in relation to pharmaceutical substances that are part of a medicinal product and are included in the state register of medicinal products in accordance with Article 34 of this Federal Law, - a copy of the document containing the following information:

а) Name of the pharmaceutical substance, its structure, general properties;

b) Manufacturer's Name & Address;

c) Results of batch analysis of pharmaceutical substances;

d) shelf-life;";

b) in Part 9, after the words "twenty years", add the words "and for which it is impossible to conduct bioequivalence studies";

c) in the first paragraph of Part 10 after the words "if authorized" add the words "pharmaceutically equivalent";
Article 1 (part 2)
6) Article 271 shall be amended as follows:

"Article 271. Interchangeability of medicinal products for human use

1. The authorized federal executive body, authorizing medicinal products for human use, determines the interchangeability of medicinal products for human use based on the conclusions made by an expert institution regarding the interchangeability or non-interchangeability of medicinal products for human use in accordance with the procedure, established by the Government of the Russian Federation, based on the following parameters:

1) equivalence (for biosimilar medicinal products) - comparability) of the qualitative and quantitative characteristics of pharmaceutical substances (the use of various salts, esters, complexes, isomers, crystalline forms and other derivatives of the same active substance is not an obstacle to the interchangeability of drugs if a bioequivalence study of a medicinal product or therapeutic equivalence of a medicinal product demonstrated no clinically significant differences in pharmacokinetics and (or) the safety and efficacy of the medicinal product for human use) or comparability of antigenic vaccine composition;

2) equivalence of the dosage form (equivalent dosage forms are considered to be to different dosage forms having the same method of administration, having comparable pharmacokinetic characteristics and pharmacological effects and also ensuring the achievement of the desired clinical effect (differences in dosage forms are not an obstacle to their interchangeability if a bioequivalence study, or, if impossible, a therapeutic equivalence study of a medicinal product proved no clinically significant differences in the pharmacokinetics and (or) safety and efficacy of the medicinal product for human use);

3) equivalence or comparability of excipients in the composition of a medicinal product for human use (differences in excipients in the composition of a medicinal product for human use are not an obstacle to their interchangeability if the bioequivalence study or therapeutic equivalence study of a medicinal product for human use proved the absence of clinically significant differences in pharmacokinetics and (or) safety and efficacy of medicinal product for human use; in case clinically significant differences pharmacokinetics and (or) the safety and efficacy of the medicinal product for human use are present, interchangeability is determined with reference to the exclusion of certain groups of patients);

4) the identity of the route and method of administration;

5) compliance of the manufacturer of the medicinal product with the requirements of the rules of good manufacturing practice.

The interchangeability of generic medicinal products specified in part 10 of Article 18 of this Federal Law is determined without the need to prove their bioequivalence.

The template for conclusion made by an expert institution regarding the interchangeability or non-interchangeability of medicinal products for human use is approved by the Government of the Russian Federation.

2. Information on the interchangeability of medicinal products for human use having one international non-proprietary (or chemical, or generic) name is to be included in the list of interchangeable medicinal product for human use.

The interchangeability of medicinal products for human use is determined with the preparation of conclusion of interchangeability or non-interchangeability of medicinal products for human use, and the list of interchangeable medicinal products for human use is made by an expert institution based on the state assignment from the federal executive body authorizing medicinal products for human use, outside Procedures for state authorization of medicinal products.

3. The list of interchangeable medicinal products for human use is approved by the federal executive body authorizing medicinal products for human use, and is posted on its official website in the information and telecommunication network "Internet" in accordance with the established procedure.

The list of interchangeable medicinal products for human use is updated by the specified federal executive body, taking into account newly authorized medicinal products for human use and amendments to the documents of the marketing authorization dossier of previously authorized medicinal products for human use, at least once a month, as soon as relevant information about medicinal products appears.

4. A list of interchangeable medicinal products for human use is used in the circulation of medicinal products. The rules and procedure for using information on interchangeable medicinal products for human use are established by the Government of the Russian Federation.

5. The interchangeability is not determined in relation to herbal medicinal products, homeopathic medicinal products.

6. In the list of interchangeable medicinal products for human use with one international non-proprietary (or chemical, or generic) name, medicinal products are combined into separate groups, within each the medicinal products are interchangeable.

7. A generic medicinal product or a biosimilar medicinal product, authorized according to the results of bioequivalence or therapeutic equivalence studies, is interchangeable with the reference medicinal product, and the reference medicinal product is interchangeable with the specified generic medicinal product or a biosimilar medicinal product.

8. Generic or biosimilar medicinal products for the same reference drug are interchangeable.

9. Pharmaceutically equivalent medicinal products with the same international non-proprietary (or chemical, or generic) name, authorized in accordance with paragraph 10 of Article 18 of this Federal Law, are interchangeable.

10. In cases indications for use in the instructions for use of a medicinal product authorized based on the relevant study results differ from indications for use of other medicinal products from the group of interchangeable drugs, the relevant information shall be included in the list of interchangeable medicinal products for human use.

11. To determine the interchangeability of medicinal products for human use, the Government of the Russian Federation establishes the features of determining interchangeability:

combination medicinal products (for combination (multicomponent) medicinal products, containing two or more active substances, it is allowed to establish interchangeability with a combination of medicinal products in the content of the corresponding combination medicinal products under the same international non-proprietary (or chemical, or generic) names);

parenteral medicinal products;

preparations not presented in dose units.

The Government of the Russian Federation has the right to establish rules and features for determining the interchangeability of biological medicinal products for human use, as well as to supplement the list of groups of medicinal products for human use with established features of interchangeability determination.

12. Clarifications regarding the interchangeability of medicinal products for human use are provided by the authorized federal executive body authorizing medicinal products for human use.

13. The federal executive body that exercises responsible for monitoring of compliance with antitrust laws, within its powers, in accordance with the laws of the Russian Federation, exercises state control over compliance with antitrust laws, as well as over the use of information on of medicinal products for human use by the subjects of circulation of medicinal products.";
Article 1 (part 3)
7) Article 30 shall be supplemented by Part I4, specifying:

"I4. The authorized federal executive body, taking into account the results of pharmacovigilance and tests of compliance of medicinal products in civil circulation with the established requirements for their quality, publishes information on its official website on the Internet within ten business days from the date of receipt of the relevant information regarding the need to amend the instructions for use of the medicinal product about the indications and contraindication, the identified side effects, adverse reactions and unforeseen adverse reactions and notifies about this in electronic form or in writing (on paper) of the marketing authorization holder or owner (or the legal entity authorized by it), as well as marketing authorization holder or owner for interchangeable medicinal products (or legal entities authorized by them).

The Manufacturing Authorization holder or owner for a medicinal product, as well as Manufacturing Authorization holder or owner for interchangeable medicinal products (or legal entities authorized by them) are required to submit to the authorized federal executive body applications for making the required changes to the instructions for use of medicinal product within forty business days from the day the information was posted by the authorized federal executive body. The specified requirement does not apply to cases of amendments to the instructions for medical use of a medicinal product regarding new indications for the use of a medicinal product authorized based on the results of the relevant studies).";

8) to add clause 11 to Article 32 specifying:

"11) in the case established by paragraph 5 of Article 65 of this Federal Law.";

9) Article 33:

а) in the name, the word "State Register" replace with the words "State Registers";

b) in part 1:

in the first paragraph, the words "State Register of Medicinal Products contains a list of authorized medicinal products, the list" replace with the words "State registries of medicinal products for human and for veterinary use contain lists of authorized medicinal products, lists";

in clause 1:

to the subclause "p", add the words "(only for the state register of medicinal products for human use)";

to the subclause "r", add the words "(only for the state register of medicinal products for human use)"; subclause "f" shall be shall be considered invalid; in clause 2:

to the subclause "c", add the words "(only for the state register of medicinal products for veterinary use)";

to the subclause "d", add the words "(only for the state register of medicinal products for veterinary use)";

to the subclause "e", add the words "(only for the state register of medicinal products for veterinary use)";

c) in part 2:

to the clause 3, add the words "(only for the state register of medicinal products for veterinary use)";

to the clause 4, add the words "(only for the state register of medicinal products for veterinary use)";

to the clause 5, add the words "(only for the state register of medicinal products for veterinary use)";
Article 1 (part 4)
10) Clause 3, Part 8, Article 34 shall be amended as follows:

"3) when making a decision on the inclusion of the pharmaceutical substance specified in part 1 of this article, enters the information provided for in part 2 of article 33 of this Federal Law into the state register of medicinal products and notifies the applicant in electronic form or in writing (in hard copy).";

11) in article 36, the second sentence shall be worded as follows: "The opinion of an expert institution on the interchangeability or non-interchangeability of medicinal products for human use may be appealed by the Marketing Authorization owner or holder for the medicinal product to the authorized federal executive body involving its subordinate organizations operating in the field of circulation of medicinal products into consideration of this appeal.";

12) in part 4 of Article 45, the words "use pharmaceutical substances included in the state register of medicinal products" to replace with the words "use pharmaceutical substances, information about which is placed in the state register of Medicinal products in accordance with article 33 of this Federal Law";

13) part 2 of Article 47 shall be amended as follows:

"2. Information on medicinal products imported into the Russian Federation shall be provided in the state register of medicinal products in accordance with Article 33 of this Federal Law.";

14) in paragraph 10 of Article 60, the words "vital and essential medicinal products" shall be replaced with "medicinal products included in the list of vital and essential medicinal products";

15) clause 5 of part 2 of Article 62, after the word "price", add the words "for a medicinal product";

16) Article 63 shall be amended as follows:

"Article 63. Fixing by the executive government bodies of the constituent entities of the Russian Federation of the maximum wholesale and retail markup on the actual selling prices set by the medicinal product manufacturers for medicinal products included in the list of vital and essential medicinal products.

1. The executive authorities of the constituent entities of the Russian Federation fix the maximum wholesale and retail markups on actual selling prices (excluding value added tax) established by the manufacturers for medicinal products included in the list of vital and essential drugs in accordance with the procedure for fixing by the executive government bodies of the constituent entities of the Russian Federation of the maximum wholesale and retail markup on the actual selling prices set by the medicinal product manufacturers for medicinal products included in the list of vital and essential medicinal products; this procedure is approved in a way established by the Government of the Russian Federation.

Draft resolutions of executive authorities of the constituent entities of the Russian Federation on fixing and (or) changing of the maximum wholesale and retail markups to the actual selling prices set by manufacturers for medicinal products included in the list of vital and essential medicinal products are subject to approval by the authorized federal executive body responsible for adopting regulatory legal acts and control over compliance with legislation in the field of state regulation of prices (tariffs) for goods (services) in the manner prescribed by the Government of the Russian Federation.

2. Wholesale drug sales organizations, pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities, medical organizations licensed for pharmaceutical activities, and their separate units (outpatient clinics, nurse practitioner and nurse practitioner-midwife centers, centers (departments) of general medical (family) practices) located in rural areas where there are no pharmacy organizations, sell medicinal products, included to the list of vital and essential medicines, at prices set in accordance with the procedure established by the Government of the Russian Federation, the level of which (excluding value added tax) shall not exceed the amount of the actual selling price established by the manufacturer of the medicinal product, not exceeding the registered or the re-registered maximum selling price set by the manufacturer (on the date the medicinal product was sold by the manufacturer), and the size of the wholesale and (or) retail markup, not exceeding, respectively, the maximum wholesale and (or) retail markup established in the constituent entities of the Russian Federation.

3. The executive authorities of the constituent entities of the Russian Federation publish the following information on the Internet: information on the registered maximum selling prices set by the manufacturers of medicinal products included in the list of vital and essential medicinal products, information on the maximum wholesale and (or) retail markups established in the constituent entity of the Russian Federation the marginal amount of retail allowances to the actual selling prices for medicinal products set by the manufacturers of medicinal products included in the list of vital and essential drugs, as well as information on the total amount of registered maximum selling prices set by the manufacturers for medicinal products included in the list of vital and essential medicinal products, the maximum wholesale and retail markups established in the constituent entities of the Russian Federation and value added tax.

The information provided for by this part shall also be available in pharmacy organizations in a form accessible to all interested parties and updated as it is posted by the executive authorities of the constituent entities of the Russian Federation on the Internet (information and telecommunication network).";

17) amend Article 65 by adding Part 5 as follows:

"5. Upon failure of the Marketing Authorization holder or owner (or another legal entity, authorized by them) to submit to the authorized federal executive body documents (information in documents) required by an expert institution to determine the interchangeability of a medicinal product for human use, or in case of submitting incomplete documents (information in documents), documents containing the list of required data that is not limited, or false information, as well as application form referred to in part I4 of Article 30, the authorized federal executive body considers the suspension of this medicinal product for human use for six months in the established manner.

In case the Marketing Authorization holder or owner for the medicinal product for human use (or a legal entity authorized by them) fails to submit documents (information in the documents) required by the expert institution to determine the interchangeability of a medicinal product for human use to the authorized federal executive body within six months from the date of suspension of the medicinal product for human use, the authorized federal executive body will make a decision to cancel the marketing authorization of this medicinal product and to exclude it from the state register of medicinal products.";

18) Article 66 shall be amended as follows:

"Article 66. Pharmacovigilance Information.

The authorized federal executive body responsible for pharmacovigilance of medicinal products in circulation in the Russian Federation, based on the results of pharmacovigilance, places the following information on its official website on the Internet (information and telecommunication network):

the identification of new confirmed data on side effects, adverse reactions, serious adverse reactions, unexpected adverse reactions related to the use of the medicinal product, including those affecting the expected risk-benefit ratio of this medicinal product;

decisions taken to amend the instructions for use of the medicinal product, to discontinue the medicinal product, to withdraw the medicinal product from circulation or to reinitiate the medicinal product.".
Article 2
Make the following amendments to Article 3 of the Federal Law No. 429-FZ dd. December 22, 2014 "On Amending the Federal Law "On the Circulation of Medicines" (Collected Legislation of the Russian Federation, 2014, No. 52, Article 7540; 2015, No. 10, Article 4283; No. 29, Article 4367; 2016, No. 27, Article 4283):
1) parts 3 and 4 shall be declared invalid;
2) in part 6, remove the second sentence.
Article 3
1. Regarding the medicinal products for human use recognized interchangeable in the process of obtaining their marketing authorization prior to the effective date of this Federal Law, repeated determination of interchangeability is not carried out.

2. Initial List of Interchangeable Medicinal Products for Human Use is approved by the federal executive body responsible for marketing authorization of medicinal products for human use and is posted on its official website on the Internet (information and telecommunication network) until April 1, 2020 for all reference and generic medicinal products for human use with the marketing authorization dossiers having study results considering the bioequivalence or therapeutic equivalence to a reference medicinal product based on the information provided by the federal state budget institution subordinate to the federal executive body responsible for marketing authorization of medicinal products for human use (hereinafter referred to as the Expert Institution).

3. Based on the conclusion made by an expert institution regarding the interchangeability or non-interchangeability of medicinal products for human use, by January 1, 2021, the authorized federal executive body will have revised marketing authorization dossiers for medicinal products for human use to determine the interchangeability of medicinal products previously not determined as interchangeable, as well as to determine one reference medicinal product within the framework of one international non-proprietary (or chemical, or generic) name, equivalent dosages and equivalent dosage forms.

Until the completion of these measures, the interchangeability of medicinal products for human use is also determined in relation to:

reference medicinal products having the same international non-proprietary (or chemical, or generic) name, equivalent dosage forms and equivalent (for biosimilar medicinal products - comparable) qualitative and quantitative characteristics of pharmaceutical substances or comparable antigenic composition of vaccines, as well as identical indications for use and contraindications;

medicinal products that are generic in relation to different interchangeable reference medicinal products, having the same international nonproprietary (or chemical or generic) name, equivalent dosage forms and equivalent (for biosimilar medicinal products - comparable) qualitative and quantitative characteristics of pharmaceutical substances or a comparable antigenic composition of vaccines registered based on the bioequivalence or therapeutic equivalence study with respect to the corresponding reference medicinal products;

medicinal products authorized based on the bioequivalence or therapeutic equivalence studies in relation to non-reference medicinal products, provided that such medicinal products are authorized based on the bioequivalence or therapeutic equivalence study with respect to a reference medicinal product;

medicinal products (except for biological medicinal products) having one international non-proprietary (or chemical, or generic) name, identical qualitative and quantitative composition of active and auxiliary substances, dosage form, route and method of administration and authorized before the effective date of Federal Law of No. 61-FZ dd. April 12, 2010 "On the Circulation of Medicinal Products", taking into account the results of pharmacovigilance and checks of compliance of medicinal products in civil circulation with the established requirements for their quality.

4. In case Marketing Authorization for generic medicinal products with unestablished interchangeability in accordance with part 3 of this article and with article 271 of Federal Law No. 61-FZ of April 12, 2010 "On the Circulation of Medicinal Product" (as amended by this Federal Law), as well as for biosimilar medicinal products lacks results of bioequivalence or therapeutic equivalence study compared to a reference medicinal product for generic or biosimilar medicinal products, respectively, for establishment of interchangeability of the medicinal product, the expert institution sends relevant information to the authorized federal executive body within three days from the date of detection of the absence of the specified information. Within three working days from the date of receipt of information from the expert institution, the specified federal executive authority sends request for reports on the results of relevant clinical trials of a medicinal product for human use to the Manufacturing Authorization holder or owner (or another legal entity authorized by them) with a period established by an expert institution sufficient for their conduction, but not more than three years.

This request can be sent personally to the authorized representative of the applicant against acknowledgement of receipt, sent by registered mail or transmitted electronically via telecommunication channels. In the case of sending this request by registered mail, it shall be deemed received after six days from the date of sending the registered letter.

5. If there are differences in indications for use and contraindications in the instructions for medical use of interchangeable medicinal products (except for cases of indications for use authorized based on the results of relevant studies), the expert institution sends the relevant information to the authorized federal executive authority within three days from the date of detection of these differences. Within three business days from the date of receipt of the information by the expert institution, the specified federal executive authority shall send a request to the marketing authorization owner or holder for the medicinal product (or to the legal entity authorized by them) to bring indications to use and contraindications to instructions for medical use in accordance with the instructions for medical use of a reference medicinal product in a period not exceeding six months.

This request can be sent personally to the authorized representative of the applicant against acknowledgement of receipt, sent by registered mail or transmitted electronically via telecommunication channels. In the case of sending this request by registered mail, it shall be deemed received after six days from the date of sending the registered letter.

6. Before the deadline set by the authorized federal executive authority for the marketing authorization holder or owner for the medicinal product to conduct bioequivalence or therapeutic equivalence studies compared to the reference medicinal product, or to bring the indications for use and contraindications in the instructions for medical use in accordance with the instructions for medical use of a reference medicinal product, the procedure for the circulation of generic, biosimilar medicinal products specified in parts 3 and 4 of this article, shall be established by the Government of the Russian Federation, taking into account the pharmacovigilance results and tests of compliance of medicinal products in circulation with the established quality requirements.
Article 4
1. This Federal Law shall enter into force on January 1, 2020, exception for the provisions with other effective dates established by this article.

2. Clauses 8 and 17 of Article 1 of this Federal Law shall enter into force on January 1, 2023.
Explanatory note
The draft federal law "On Amendments to the Federal Law "On the Circulation of Medicinal Products" and the Federal Law "On Amendments to the Federal Law "On the Circulation of Medicinal Products" in terms of improving the procedure for determining the interchangeability of medicinal products for human use" in terms of improving the procedure for determining the interchangeability of medicinal products for human use" (hereinafter referred to as the Draft Law) was developed pursuant to instructions of the President of the Russian Federation dated July 3, 2018 No. Pr-1141 (subclause "a" of clause 1) and dated December 17, 2018 No. Pr-2420 (paragraph four of subclause "a" of clause 1) and instructions of the Government of the Russian Federation dated August 22, 2018 No. TG-P12-5439, dated May 29, 2019 No. TG-P 12-43 69.

The draft law proposes to amend the Federal Law in terms of:

  • clarification of the conceptual framework of the Federal Law, including definitions of the concepts of a reference medicinal product, a generic medicinal product, an interchangeable medicinal product, as well as the introduction of the concepts of the original medicinal product, pharmaceutically equivalent medicinal products;
  • establishment of the procedure for determining interchangeability by the Government of the Russian Federation;
  • establishment of the features of determining the interchangeability of certain groups of medicinal products, as well as an exception in relation to homeopathic and herbal medicinal products;
  • preparation and regular update of the list of interchangeable medicinal products and its publication on the Internet;
  • clarification of the norms of the Federal Law on those medicinal products for which bioequivalence studies are not required;
  • possibility of submitting the required materials by the applicant in case of insufficient material for the conclusion on the interchangeability of the medicinal product identified by the expert commission of the expert institution;
  • possibility of determining interchangeability indicating the exclusion of certain groups of patients in the presence of excipients in the composition of the medicinal products, which may lead to the risk of serious adverse reactions in certain groups of patients or increase the frequency of their occurrence;
  • reviewing the results of interchangeability of medicinal products in case of amendments to the documents contained in the manufacturing authorization dossier for an authorized medicinal product for human use, affecting the result of determining the interchangeability of a medicinal product for human use;
  • exclusion of the provisions of the Federal Law on the powers of the federal executive authority to create a register of standard instructions for the medical use of interchangeable medicinal products, to include information on the interchangeability of a medicinal product in the state register of medicinal products;
  • establishing the deadline of 40 business days for submitting an application for amendments to the instructions for the use of a medicinal product for human use by the marketing authorization holder or owner for the medicinal product (another legal entity authorized by them) from the date of publication of new confirmed data obtained regarding side effects, adverse reactions during its use, including for interchangeable medications, on the official website of Roszdravnadzor;
  • possibility of considering the suspension of the use of a medicinal product in case of failure to submit the specified application by the marketing authorization holder or owner for the medicinal product (authorized by another legal entity) within 40 business days, as well as failure to submit the required documents (information in the documents) for the work on determining the interchangeability of the medicinal product for human use by an expert institution.

The draft law provides for the right of the Government of the Russian Federation to establish rules and features for determining the interchangeability of biological medicinal products.

It is also proposed to amend the Federal Law of December 22, 2014 No. 429-FZ "On Amendments to the Federal Law "On the Circulation of Medicinal Products"(Article 3, which contains direct provisions), excluding those that conflict with the provisions of the draft law.

In order to eliminate legal uncertainty in the establishment of selling prices for medicinal products included in the list of vital and essential medicinal products (hereinafter referred to as the LVEMP), taking into account the obligation to pay value added tax (hereinafter referred to as VAT) by organizations engaged in the wholesale and retail trade of medicinal products, this draft law is proposed to supplement federal state supervision in the field of circulation of medicinal products with the authority to organize and conduct inspections of compliance of entities of the Medicinal Products Circulation with the requirements for the use of the prices for medicinal products included in the LVEMP.

For reference:

In accordance with the Federal Law "On the Circulation of Medicinal Products" and the Regulation for establishing maximum wholesale and retail markups on actual selling prices established by the manufacturers of medicinal products included in the VEMP list, in the constituent entities of the Russian Federation, approved by Decree of the Government of the Russian Federation of October 29, 2010 No. 865, the procedure for setting selling prices for medicinal products included in the VEMP list does not provide for VAT accrual by organizations applying the general taxation system. There is also no indication in the aforementioned Federal Law that the calculation of wholesale and retail markups to the prices of medicinal products included in the VEMP list is based on the actual selling prices of pharmaceutical manufacturers without VAT, regardless of the tax system used by organizations.
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