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Council of the Eurasian Economic Commission has adopted a number of documents aimed at launching EAEU common drug market


On 03.11.2016 Council of the Eurasian Economic Commission (hereinafter – “CEEC” and “EEC” accordingly) has adopted a number of documents aimed at formation of the common drug market of Eurasian Economic Union (EAEU). The formation of common drug market of EAEU is prescribed by arts. 30, 31 of the Treaty on the Eurasian Economic Union dated 29.05.2014. On 03.11.2016 CEEC has adopted a total of 21 documents.

The common drug market of EAEU will be launched no later than the Republic of Armenia ratifies the Treaty of unified principles and rules on circulation of drugs within EAEU dated 23.12.2014 (hereinafter – “Treaty”). According to the information available at the official website of EAEU1, the Republic of Armenia is expected to complete the ratification process before the end of the year 2016.

The key documents adopted by CEEC on 03.11.2016 are listed below. According to its content the documents are divided into the following categories: Good practices rules (A); Composition of unified registers (B), Pharmaceutical inspections (C), Registration and examination of drugs (D), Other issues (E).

A.    Good practices rules

1.    Resolution № 77 “Concerning approval of the Good manufacturing practice of EAEU”

This resolution adopts EAEU manufacturing practice (hereinafter – “EAEU GMP”) developed in accordance with CEN/ISO standards. Parts I and II of the adopted practice establish principles to be followed in the process of manufacturing of drug products and active pharmaceutical ingredients (hereinafter – “API”) used as raw materials. In addition to the abovementioned principles, the practice also contain a set of provisions regulating certain activities coupled with manufacturing of drugs. Part III of the practice outlines requirements adopted by the competent authorities of the member states of EAEU in the field of drug manufacturing.

Compliance with the practice is a mandatory provision in order for the drug to be included on the EAEU unified register of drugs under the Resolution of EEC № 782. A transition period is established by the Resolution of EEC № 78. Till 01.01.2019 applicants can provide certificate of GMP compliance under the consent to conducting an EAEU GMP inspection. In accordance with the Resolution of EEC № 823 и 834 a manufacturer shall apply to the national inspectorate of EAEU member state in order to collect a certificate on accordance with the practice.

2.    Resolution № 79 “Concerning adoption of the Good clinical practice of EAEU”

This resolution establishes unified clinical investigation procedures to be followed on the territory of EAEU member states. The adopted practice has been developed on the basis of Good clinical practice of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH GCP).

Compliance with the practice is a mandatory provision in order for the drug to be included on the EAEU unified register of drugs under the Resolution of EEC № 78. A transition period is established by the Resolution of EEC № 78. Applicants can use results of clinical trials, that were conducted before 01.01.2016, in accordance with national legislation of EAEU member state. Competent authority on reasonable grounds may initiate an extraordinary inspection of clinical trials of the drug product in order to confirm compliance with EAEU GCP.

The same procedure is established for the generic drugs. Competent authority upon the conditions established by the Resolution of EEC № 78 can conduct an extraordinary inspection of bioequivalence study in order to confirm compliance with EAEU GCP.

3.    Resolution № 80 “Concerning adoption of the Good distribution practice of EAEU”

This resolution establishes unified drug distribution practice to be followed on the territory of EAEU member states. Distribution practice has been adopted in order to ensure proper storage, transportation and distribution of drugs for the purposes of preserving drug quality, safety and effectiveness on all stages of supply chain as well as to prevent distribution of unauthentic drugs. Subject to the provisions of this practice the EAEU member states are allowed to adopt their own acts regulating certain distribution steps. A transition period is established regarding the practice’s validity – the practice comes into force on the first anniversary of Protocol of the Republic of Armenia accession to the Treaty.

4.    Resolution № 81 “Concerning adoption of the Good laboratory practice of EAEU in the field of drug circulation”

This resolution establishes unified laboratory practice to be followed on the territory of EAEU member states. Compliance with this practice is subject to inspections conducted by competent authorities of EAEU member states. Subject to provisions of this practice such inspections shall be conducted in accordance with general rules applicable to pharmaceutical inspections. The practice has been developed in accordance with the requirements adopted by European Union and Organization for Economic Co-operation and Development. EAEU testing laboratories of member states are regarded as compliant with the practice in case they are recognized by the relevant national laboratory practice, that imposes same requirements. Under the Resolution of EEC № 78 compliance with the practice is a mandatory provision in order for the drug to be included on the EAEU unified register of drugs. Exception applies to the drugs, clinical trials in respect of which were conducted in accordance with national legislation of EEC member state before 01.01.2016.

5.    Resolution № 87 “Concerning adoption of the Good pharmacovigilance practice of EAEU”

This resolution establishes unified requirements to pharmacovigilance quality system, conduct and activities of competent pharmacovigilance authorities, provides for duties of the holders of registration files with regard to monitoring pharmacovigilance information, drug safety assessment, preparation of periodic drug safety reports, adoption pharmacovigilance quality control system, appointment of persons responsible for pharmacovigilance, composition and maintenance of pharmacovigilance master-file, furnishing reports to competent authorities etc. The resolution is also concerned with inspections of pharmacovigilance systems, independent audit of pharmacovigilance systems, exchange of information of pharmacovigilance inspections among EAEU member states and some other requirements. In accordance with the Resolution the procedure rules regarding pharmacovigilance system inspection are effective from 01.01.2017.

B.    Composition of EAEU unified registers

6.    Resolution № 74 “Concerning approval of the Regulation on composition and maintenance of EAEU register of authorized persons appointed by  drug manufacturers”

The register shall contain information on authorized persons submitted by the drug circulation authorities of EAEU member states. The register shall be maintained by CEEC. Information for the including into the register is provided by competent authorities every time when making a decision on certification of the authorized person. The resolution provides for exhaustive list of registered information to be available on the Internet as well as for ways of amending the registered information. The register shall be in Russian language.

7.    Resolution № 84 “Concerning regulations on composition and maintenance of EAEU register of drugs and databases in the field of drug circulation”

This resolution provides for adoption of a unified EAEU register of drugs that has been registered on the territory of EAEU member states. The resolution provides for composition of a unified database of adverse reactions to application of drug products, including information on drug ineffectiveness. The register is composed and maintained by EEC. Under the provisions of the Resolution of EEC № 78 information, that is necessary for the inclusion into the register, is provided by the competent authority of member state within 10 days upon the decision on drug products’ registration using the integrated data sharing system of EAEU. The resolution provides for exhaustive list of information to be included into the register and establishes a legal framework for data sharing among the EAEU member states. Registration file and expert’s reports shall be stored for 20 years from the date of their entering into the register. As a general rule, during this time period the archive files may be accessed only by competent authorities of EAE member states. According to the Resolution of EEC № 78 drug products, which are not included in the register, can circulate only within the territory of that state, where these drug products were included in the register of drugs.

Drug products’ registration files shall be included in the EAEU drug register prior to 01.01.2026, otherwise these registration files shall be invalid.

8.    Resolution № 90 “Concerning approval of the Regulation on composition and maintenance of EAEU register of pharmaceutical inspectorates”

This resolution provides for composition of unified register of pharmaceutical inspectorates of EAEU member states (hereinafter – “Inspectorates”). The information regarding pharmaceutical inspectorates shall be submitted by the competent authorities EAEU member states. The resolution provides for exhaustive list of information to be included into the register. The information contained in the register shall be accessible on the Internet and available for any interested person.

C.    Pharmaceutical inspections

9.    Resolution № 82 “Concerning approval of the General requirements applicable to quality system of the pharmaceutical inspectorates of EAEU member states”

This resolution establishes unified requirements to quality control system of Inspectorates of EAEU member states. The resolution is concerned with organizational structure of Inspectorates, conduct and activities of Inspectorates, requirements applicable to their documentation, qualifications and responsibility of their employees, assessment of its quality control system, adoption of correcting and preventing measures aimed at improving quality of Inspectorates’ activities. These requirements apply to all Inspectorates authorized to conduct inspection in the field of drug circulation.

10.     Resolution № 83 “Concerning approval of the Rules on conduct of pharmaceutical inspections”

This resolution establishes unified rules on inspections concerning EAEU GMP compliance. The inspections shall be conducted by Inspectorate at the location of the manufacturing site. Inspections of the manufacturing sites located outside EAEU shall be conducted by any Inspectorate at the choice of the party requesting such inspection. After the inspection is over the Inspectorate shall issue a certificate of compliance that shall be valid for 3 years of the date it has been issued. Inspections shall be conducted either in accordance with the adopted schedule of inspections, at the request of the manufacturer or at the request of competent authorities of EAEU member states.

11.    Resolution № 91 “Concerning approval of the Regulation on enforcement of joint pharmaceutical inspections”

This resolution stipulates that joint EAEU GMP compliance inspections can be either scheduled or unscheduled. Joint scheduled inspections are intended at promoting cooperation and exchange of experience whereas unscheduled inspections are intended at settlement of differences among competent authorities of EAEU member states as well as at mutual recognition of the results of different inspections conducted in the field of drug circulation. According to the resolution unscheduled inspections shall be conducted only at the request of the Drug Experts Committee of the EAEU. The resolution establishes procedure for the initiation of joint inspections as well as for documentation of inspections’ results and allocation of the costs of inspections.

12.    Resolution № 93 “On recognition of the results of the drug manufacturing inspections”

According to this resolution EAEU member states have to mutually recognize certificates of compliance with national GMP standards of the EAEU member states as well as certificates of compliance with EAEU GMP standards issued by Inspectorates of the other EAEU member states.

D.    Registration and examination of drugs

13.    Resolution № 78 “On the Rules of registration and examination of medical drugs”

According to this resolution, before 31.12.2020 registration of drug products may be conducted either in accordance with national legislation of EAEU member states or in accordance with the rules adopted by this resolution (hereinafter – “EAEU rules”) at the choice of the applicant. Drugs registered in accordance with national legislation of EAEU member state shall be allowed to circulate only on the territory of such member states. Starting from 01.01.2021 registration of new drug products intended for circulation on common drug market of EAEU or on the territory of EAEU member state shall be conducted only in accordance with EAEU rules. As for the drug products already registered in accordance with national legislation of EAEU member state, such drugs shall be brought into compliance with EAEU legislation by no later than 31.12.2025. After 31.12.2025 drug product registration files lacking compliance with the EAEU rules shall be invalid. By 31.12.2016 EAEU member states shall have adopted the fees payable for drug registration and designated the national bodies authorized to register drugs. The general rule is that registration file of the newly registered drug product issued by EAEU member state shall be valid for 5 years. After 5 years the holder of registration file may apply for re-registration and receive a file that shall be valid for an unlimited term.

Drug product registration can be performed in any EAEU member state upon the applicant’s discretion.

Competent authority includes drug product in the EAEU drugs unified register not later than 10 days from the moment of drug product registration. However, drug product, registered in such a manner, can only circulate on the territory of the state of its registration.

For drug product distribution on the territory of other EAEU member states such drug product shall pass the procedure of mutual recognition consecutively in each EAEU member state. However, this EEC resolution stipulates a special procedure for registration, under which drug product registration is carried out simultaneously on the territories of all or several EAEU member states (decentralised registration procedure).

When using the decentralised registration procedure the applicant files an application to the competent authority of any EAEU member state (referential state) first, and then during 14 days – applies to the competent authorities of other EAEU member states (states of recognition). The competent authority of the referential state makes a report on the drug product. Further, the competent authority of the referential state sends the expert report to the competent authorities of each state of recognition. If the competent authorities of the states of recognition do not have any claims on the expert report the competent authorities of the referential state and states of recognition procced with the procedure of final documents issuing. Besides, in the referential state and each state of recognition the applicant is provided with the registration file, whereas information on drug product registration is included in the EAEU drugs unified register.

14.    Resolution № 85 “On the Rules for conducting bioequivalence studies of drug products on the territory of EAEU”

This resolution establishes unified rules on bioequivalence studies of drug products. The purpose of bioequivalence studies is to prove whether a generic drug product is bioequivalent to original drug product in order to extrapolate the results of pre-clinical and clinical studies of the original drug to a generic drug.

Bioequivalence studies can be conducted in any EAEU member state or outside EAEU provided compliance with the approved practice for conducting bioequivalence studies.

Under the provisions of the Resolution of EEC № 78 results of bioequivalence studies, which were conducted in accordance with the approved practice, can be used for the purposes of drug product’s registration on the territory of any EAEU member state. However it is necessary to take into consideration the special requirements to the registration file of generic drugs under the Resolution of EEC № 78.  

15.     Resolution № 89 “On the Rules for conducting studies of biological medical drugs of EAEU”

E.    Other issues

16.    Resolution № 73 “Concerning procedure for certification of authorized persons of drug manufactures”

This resolution provides for exhaustive list of requirements to experience, education and training of the authorized persons. For these proposes, the competent authorities of each EAEU member state in the field of certification of authorized persons shall determine equivalency of national educational programs of EAEU member states with own educational programs. Certification of authorized persons is aimed at verifying their compliance with the aforementioned requirements.

The information regarding authorized persons shall be entered into a special EAEU register of authorized persons and made accessible on the Internet.

All authorized persons shall undergo the certification process in accordance with the procedure for certification of authorized persons of drugs manufacturers’ approved by EEC. There is no transition period established by the resolution.

17.    Resolution № 75 “Concerning approval of the Regulation on the Drug Experts Committee”

This resolution provides for constitution of the Drug Experts Committee within CEEC. At the requests of EAEU member states the Committee shall develop proposals with regard to harmonization of legislation, unification of the rules and requirements adopted in the field of drugs circulation, enforcement of the adopted unified rules in the field of establishing drug quality control system. The Committee shall also develop recommendations aimed at settlement of differences among competent authorities of EAEU member states, initiate joint pharmaceutical inspections conducted by Inspectorates etc.

18.    Resolution № 76 “Concerning approval of the Requirements applicable to labeling of medical and veterinary drugs”

This resolution establishes: rules on labeling of drugs (including requirements on primary, interim and secondary (consumer) packaging of drug products, labeling text, methods of its application on drug packages and some other requirements), exhaustive list of information to be indicated on drug packages and drug transportation containers. Labeling shall be done in Russian language and in the languages of EAEU member states provided that their national legislation requires such labeling. Labeling shall not be used for advertising and shall not contradict drug’s registration file. No requirements concerning labeling of drug product’s package insert are established by this resolution.

It is worth mentioning that earlier this year the Resolution № 26  was made by EEC that stipulates special EAEU market circulation mark. However, no special market circulation mark is established for the drugs. Labeling of drug products’ packaging shall be carried out in accordance with general procedure established for the labeling of goods intended for EAEU goods market circulation with due regard to the aforementioned requirements to the drug products’ labeling established by the resolution.

19.    Resolution № 86 “On Regulation of EAEU member states cooperation on detecting unauthentic, counterfeit and (or) defective drugs”

According to this resolution, competent authorities of EAEU member states cooperate with CEEC and with each other in order to deter circulation of unauthentic, counterfeit and (or) defective drugs. The cooperation shall be conducted through an integrated data sharing system of EAEU. This system shall comprise: unified database of unauthentic, counterfeit and (or) defective drugs, unified database of banned drugs and drugs taken out of circulation as well drugs with suspended registration file. The information regarding detected unauthentic, counterfeit and (or) defective drugs shall be submitted to CEEC within 72 hours of their detection.

20.    Resolution № 86 “On certain issues concerning circulation of drug products”

According to this resolution, competent authorities of EAEU member states are allowed to conduct drug equivalency examinations for the purposes of public or municipal procurement as well as for execution of budget financed drug provision programs on the basis of and in accordance with national legislation. For these purposes EAEU member states shall are allowed to have their own national registers of equivalent drugs. The decisions of EAEU member states concerning equivalency shall not affect further circulation of drug products or decision-making regarding drug registration on the territory of EAEU.

Earlier EAEU has already adopted a number of documents in furtherance of the provisions stipulating creation of EAEU common drug market, including the Treaty on unified principles and rules for drugs circulation within EAEU6 and the Treaty on unified principles and rules for medical devices circulation within EAEU7. On the territory of the Russian Federation these treaties has come into force on 12.02.2016.

All persons conducting business in Russia should take into account that according to art. 12 of Federal Law № 210-FZ8, state and municipal services on the territory of the Russian Federation are rendered in accordance with administrative regulations. Hence, soon after the date of entering into force of the documents adopted by CEEC, Russian regulatory authorities in the field of drug circulation are expected to develop new administrative regulations in the field of drug circulation within EAEU common drug market or to amend already existing administrative regulations concerning drug circulation within the territory of the Russian Federation.

_____

1http://eec.eaeunion.org/ru/act/texnreg/deptexreg/Pages/События.aspx
2Resolution № 78 “Concerning procedure for the registration and expertise of drugs for the medical use”
3Resolution № 82 “Concerning approval of the General requirements to pharmaceutical inspectorates of EAEU member states”
4Resolution № 83 “Concerning the approval of the Procedure for conducting of pharmaceutical inspections”
5Resolution of CEEC dated  12.02.2016 № 26 “Concerning special EAEU market circulation mark”
6The Treaty on unified principles and rules for drugs circulation within Eurasian Economic Union dated 23.12.2014
7The Treaty on unified principles and rules for medical devices (medical products and medical equipment) circulation within Eurasian Economic Union dated 23.12.2014
8Federal Law № 210-FZ “Concerning the organization of the provision of state and municipal services” dated 27.07.2010



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