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PROTOCOLNo. 01B/16-3

Opening of envelopes with open tender bids

City of Moscow5 June 2013

  1. Contract Giver: International Organization Eurasian Economic Commission
  2. Legal address: 1, 3/5 Smolenskiy Blvd., 119121, Moscow
  3. Title: Open tender to award a contract for the research project to be officially used by the Eurasian Economic Commission on the topic: “Developing a Customs Union Technical Regulation on Safety of medical products”
  4. Initial (maximum) contract price:

4,800,000 (four million eight hundred thousand) roubles 00 kopecks, VAT 0%.

  1. The composition of the bidding commission was approved by Order No. 153 of 22 May 2013 of the EEC Board Chairman.

The bid openingsession of the bidding commissionwas attended by:

Deputy Chairman of the Bidding Commission
Irina Timofeevna Zhogova / - Deputy Director of the Department of Technical Regulation and Accreditation
Secretary of the Bidding Commission
Svetlana Alexeevna Bondarenko / - Counselor at the Subdivision for Coordination of Harmonization of Sectorial Technical Regulation Systems in the fields embraced by the scope of the Department of Technical Regulation and Accreditation
Members of the Bidding Commission
Olga Arkadievna Karyakina / - Deputy Director of the Finance Department
Andrey Anatolievich Polozkov / - Head of the Subdivision for Technical Regulation Development of theDepartment of Technical Regulation and Accreditation
Antonina Igorevna Golovtsova / - Counselor at the Subdivision for Technical Regulation Developmentof the Department of Technical Regulation and Accreditation

The meeting was attended by five members of the biddingcommission out of eight, thequorum gathered.

  1. The bid opening procedure took place on 5 June 2013 at the address: 1, 12 Yakovoapostolskiy Ln., 105064, Moscow, at 12.00 a.m. (Moscow time).
  2. By the bidding deadline specified in the open tender notification (5 June 2013, 12a.m. Moscow time), two (2) sealed envelopes with bids were submitted and registered in the Open Tender Bid Log (Annex No. 1 to Bid OpeningProtocolNo. 01в/16-3 of 5 June 2013).
  3. There were no amendments, withdrawals or any other applications immediately prior to theopening of envelopes.
  4. The envelopes with bids submitted on hard copies were opened by the Bidding Commission Secretary S.A. Bondarenko in the sequence as registered in the Open Tender Bid Log (Annex No. 1 to Bid OpeningProtocolNo. 01в/16-3 of 5 June 2013).
  5. Deputy Chairman of the Bidding Commission announced the following information concerning the submitted bids:
  6. Names and postal addresses oftenderers;
  7. Availability of data and documents specified in the open tender notification;
  8. Contract execution terms specified in the bid and used as criteria for bid evaluation.

Bid opening results:

Bid No. 1
date and time of the bid arrival: 4 June 2013, 4.12 p.m.
Tenderer / Full name: Independent Non-Commercial Organization National Institute of System Research of Entrepreneurial Issues
Short name: NCO NISREI
Postal address / 1, 6/9/20 Rozhdestvenka St., Moscow 107031
List of documents specified in the open tender notification and included into the bid / List of documents attached to the bid:
  1. Open tender bid (as per Form No. 2 of Section III)
  2. Tenderer’s data (as per Form No. 6 of Section III)
  3. Notarized copy of an extract from the Unified State Register of Legal Entities of 26February 2013
  4. Protocol of the Management Board Meeting of 11 October 2012 (concerning election of the Chairman)
  5. Order No. НИС00000003/1 of 12 October 2012 concerning theappointment of the Director General E.G. Litvak
  6. Copy of the Articles
  7. Copy of the certificate of registration in the Unified State Register of Legal Entities
  8. Copy of the state registration certificate
  9. Copy of the certificate of registration with the territorial tax authority
  10. Copy of the informational letter of registration in the Statistical Register of the Federal State Statistics Service
  11. Copy of the notice of insurance contributions (confirmation of primary activities)
  12. Balance sheet for the last reporting period certified by the tax authorities and bearing the company’s seal and the head’s signature
  13. Certificate No. 46091 concerning performance of taxpayer’s obligations in connection with payment of taxes, dues, insurance contributions, penalties and tax sanctions
  14. Information on the organizational structure (staff size, structural subdivisions, etc.) – staffing chart
  15. Tenderer’s competence data (as per FormNo. 4 Section III)
  16. Documents to evidence thetenderer’s competence (attached to Form No. 4 Section III) (copies of diplomasawarding Cand. Sc. and PhD titles and other documents, confirming qualification of R&D executors, copies of acceptance acts under executed contracts)
  17. Tenderer’s proposals concerning the contract terms used as criteria for evaluation of open tender bids (as per FormNo. 5 Section III)
  18. R&D quality proposals and any other contract executionproposals (as per FormNo. 3 Section III)

Contract execution terms used as criteria for evaluation of open tender bids
Contract price, roubles / The offered contract price is 4,600,000 (four million six hundred thousand) roubles 00 kopecks
Works quality and bidder’s competence
Works quality / 1. Research purpose
The research project purpose is to develop a technical regulation On Safety of Medical products (hereinafter – the technical regulation) plus Customs Union documents as required to provide for implementation thereof.
When developing the said technical regulation, the following objectives are to be accomplished:
1)determining the scope of the technical regulation under development;
2)determining safety requirements for medical products, covering the entire life cycle, including production (manufacturing), storage, shipment (transportation), sale and disposal;
3)developing a terminology to eliminate any ambiguities and inconsistencies when interpreting the technical regulation contents;
4)determining packing, marking and labeling requirements and application rules (if needed);
5)determining identification rules as well as schemes and procedures to validate compliance of medical products with the technical regulation requirements;
6)developing proposals on the technical regulation enactment and transitional provisions;
7)determining a draft list of standards which, when applied on a voluntary basis, provide for compliance with the technical regulation requirements;
8)determining a draft list of standards which describe research (test) and measurement rules and methods, including for sampling to be carried out,as required to ensure application and implementation of the technical regulation requirements and to provide for product compliance evaluation (validation);
9)determining a draft list of products which require a document of technical regulation compliance evaluation (validation) to be submitted together with the customs declaration;
10)developing a draft program of development (amendment, revision) of interstate standards which, when applied on a voluntary basis, provide for compliance with the technical regulation requirements as well as interstate standards which describe research (test) and measurement rules and methods, including for sampling to be carried out,as required to ensure application and implementation of the technical regulation requirements and to provide for product compliance assessment (validation).
To provide for accomplishment of the objectives as above an analysis shall be carried out, covering existing regulatory and legal documents within the application scope of the technical regulation and international regulatory experience in the field.
2. Input R&D data
Input data for the technical regulation under development include:
laws, legislative instruments on safety of medical products in industrially developed countries;
EC Directives specifying, among other things, requirements, concerning medical products and health care in the European Union countries;
1)legislation of the Republic of Belarus, Kazakhstan and Russian Federation on issues of medical products safety;
2)international, regional, national standards and foreign regulations, scientific publications on safety of medical products;
3)rules and norms of state control (supervision) concerningmedical safety of products, compliance validation forms and schemes in the Republic of Belarus, Kazakhstan and Russian Federation;
4)Agreement on basic harmonization of technical regulations in EurAsEC member-states dated 24 March 2005;
5)Agreement on coordinated policy implementation in the field of technical regulation and sanitary and phytosanitary measures dated 25 January 2008;
6)Agreement on unification of technical regulation principles and rules in the Republic of Belarus, Kazakhstan and Russian Federation dated 18 November 2010;
7)Provisions on the procedure for developing, adopting, amending and canceling Customs Union technical regulations as approved by Resolution No. 48 dated 20 June 2012 of the Eurasian Economic Commission Council;
8)Recommendations on the typical structure of a Eurasian Economic Commission’s technical regulation as approved by Resolution No. 321dated 27 October 2006 of the EurAsEC Interstate Council;
9)Provisions on application of typical schemes for evaluation (validation) of compliance with Customs Union technical regulations as approved by Resolution No. 621 dated 7 April 2011 of the Customs Union Commission;
10)Provisions on the procedure for developing and approving lists of international and regional standards, and, if none of the above is available, − national (state) standards of the Customs Union member-states which ensure compliance with the Customs Union technical regulation and are required to provide for compliance evaluation (validation), as approved by Resolution No. 306 dated 25 December 2012 of the Eurasian Economic Commission Board.
3. Scope of research
The research shall comprise two stages and include activities as below and works as specified in the Provisions on Developing, Adopting, Amending and Canceling a Customs Union Technical Regulation (hereinafter – the Provisions) approved by Resolution No. 48 dated 20 June 2012 of the Eurasian Economic Commission Council.
Stage 1
1.Analyzing the technical regulation legislation of the Republic of Belarus, Kazakhstan and Russian Federation as well as regulatory documents and scientific publications, international, regional (interstate), national and foreign standards, compliance validation forms and schemes concerning safety of medical products.
In particular, an analysis is to be performed, covering the requirements which differ from provisions of international, regional standards or mandatory requirements applied within the territory of the CU Member-States, to study feasibility of their possible application.
Also, an analysis is to be performed, focusing on international regulatory practices which are considered as best providing for compliance with safety requirement and regulation efficiency in the field.
States for the analysis of experience shall be selected and approved by the Contractor and Contract Giver upon contract conclusion.
Based on the analysis of regulatory and legal documents and that of international regulation experience in the field, conclusions and proposals will formulated to develop draft technical regulations.
2.Developing an original revision of the draft technical regulation and an explanatory note thereto.
The draft technical regulation shall contain:
a)General technical regulation data as well as data on its development process, international- and regional-level harmonization, references to other Customs Union technical regulations;
b)Application scope of the technical regulation, identifying technical regulation objects covered (not covered) by it; a comprehensive list of technical regulation objects can be provided as a supplement. All the objects shall be identified with exclusions, if any;
c)Basic terms and definitions used in the technical regulation;
d)Market circulation and commissioning rules;
e)Safety requirements formedical products and (or) related production (manufacturing), storage, shipment (transportation), sale and disposal processes.
Basic packaging, marking requirements and application rules.
Special requirements, if any, to reduce environmental and health and safety risks.
f)Identification rules as well as the procedure, forms and schemes to validate compliance of medical products with the technical regulation requirements.
g)Provisions on unified market circulation marking and rules (terms) of its application;
h)Supplements (if any).
3.Developing proposals on the technical regulation enactment and transitional provisions.
4.Compiling a list of international, regional and national (state) standards, requirements from other documents (rules, directives, recommendations and other acts adopted by international organizations and, if none of the above is available, − regional documents, such as regulations, directives, resolutions, rules and etc.), national technical regulations used as a basis for the draft technical regulation.
5.Developing proposals on lists of standards referred to in clause 2 and 3, Article 6, of the Agreement on Unification of Technical Regulation Principles and Rules in the Republic of Belarus, Kazakhstan and Russian Federation dated 18 November 2010.
6.Updating the draft technical regulation and related documentation package after its consideration by the Parties’ authorized bodies and at a session of the Advisory Committee for Technical Regulations and Application of Sanitary, Phytosanitary and Veterinary Measures of the Eurasian Commission Board (hereinafter – the Advisory Committee).
Stage 2
1.Summarizing the feedback (if any) on the draft technical regulation based on public discussions, studying notes and suggestions, each of those marked as accepted or rejected with a stated reason for such a rejection.
2.Updating the draft technical regulation and related documentation package based on notes and suggestions obtained in the course of public discussions and preparations for intrastate coordination.
3.Technical editing of the draft technical regulation.
4.Metrological testing of the draft technical regulation and related documentation package and executing an expert opinion.
5.Developing a list of products which require a document of technical regulation compliance evaluation (validation) to be submitted together with the customs declaration.
6.Developing draft Lists of Standards referred to in clause 2 and 3, Article 6, of the Agreement as prescribed by the Eurasian Economic Commission Board.
7.Updating these draft Lists of Standards and the explanatory note thereto based on public discussions.
8.Developing a draft program of development (amendment, revision) of interstate standards which, when applied on a voluntary basis, ensure compliance with the technical regulation requirements and which contain research (test) and measurement rules and methods, including for sampling, as required to ensure application and implementation of the technical regulation requirements and to provide for product compliance evaluation (validation).
Timelines of these stages as well as their cost shall be specified and agreed between the Contractor and Contract Giver when concluding the contract.
4.R&D deliverables
The first stage shall provide for the following research deliverables:
1.An original revision of the draft technical regulation and an explanatory note thereto prepared for public discussions.
2.Proposals on the technical regulation enactment and transitional provisions.
3.A list of international, regional and national (state) standards and requirements from other documents (rules, directives, recommendations and other acts adopted by international organizations and, if none of the above is available, − regional documents, such as regulations, directives, resolutions, rules and etc.), national technical regulations used as a basis for the draft technical regulation.
4.Proposals on lists of standards referred to in clause 2 and 3, Article 6, of the Agreement on Unification of Technical Regulation Principles and Rules in the Republic of Belarus, Kazakhstan and Russian Federation dated 18 November 2010.
The second stage shall provide for the following research deliverables:
1.A summary draft technical regulation feedback based on public discussions.
2.A draft technical regulation and a related documentation package updated, accounting for notes and suggestions obtained in the course of public discussions and preparations for intrastate coordination, subject to technical editing.
3.An expert opinion based on the metrological testing of the draft technical regulation.
4.A draft list of products which require a document of technical regulation compliance evaluation (validation) to be submitted together with the customs declaration.
5.Draft Lists of Standards referred to in clause 2 and 3, Article 6, of the Agreement updated based on public discussions.
6.A draft program of development (amendment, revision) of interstate standards which, when applied on a voluntary basis, ensure compliance with the technical regulation requirements and which contain research (test) and measurement rules and methods, including for sampling, as required to ensure application and implementation of the technical regulation requirements and to provide for product compliance evaluation (validation).
All research and analytical reports shall be executed as per Interstate Standard GOST 7.32-2001 “Research Reporting. Structure and Execution Rules” enacted by Decree No. 367-st. dated 4 September 2001 of Russia’s State Committee for Standardization and Metrology.
Any such reports whatsoever shall be submitted to the Contract Giver in 2 copies, on paper and on electronic media, while the R&D stage acceptance act shall be provided in 3 copies, attached to the report.
Bidder’s competence
a) Quantity of works performed by the bidder under the proposed line of technical regulation research activities / Twenty two (22)projects implemented by the bidder in under the proposed line of technical regulation research activities
b) Number of executors having experience in development of technical regulations and international, regional, national standards / Ten (10)executors with relevant experience are engaged in the project of the technical regulation development
Experience of cooperation with organizations developing international standards / None
Bid No. 2
Date and time of the bid arrival: 4 June 2013, 5.11 p.m.
Tenderer / Full name: Closed Joint-Stock Company ROEL Consulting
Short name: CJSC ROEL Consulting
Postal address / office 404, 32/15 Nizhegorodskaya St., 109029,Moscow
List of documents specified in the open tender notification and included into the bid / List of documents attached to the bid:
  1. Open tender bid (as per FormNo. 2)
  2. Tenderer’s data (Form No. 6)
  3. Notarized copy of an extract from the Unified State Register of Legal Entities of 30 May 2013
  4. Copy of Order No. 1/лс of 28 March 2012 concerning the appointment of the Director General
  5. Copy of ProtocolNo. 1 of the General Founders’ Meeting of 27 February 2012
  6. Copy of Agreement of 27 February 2012 on establishing the company
  7. Copy of the Articles
  8. Copy of the state registration certificate
  9. Copy of the certificate of registration with the territorial tax authority
  10. Copy of the notice on opening of an account for insurance contribution payments
  11. Copy of the account opening notice
  12. Copy of the information letter on account opening
  13. Copy of the notice on amounts of insurance contributions
  14. Copy of the informational letter on registration of the legal entity with the territorial agency of the RF Pension Fund
  15. Copy of the informational letter from Moscow Municipal Statistic Committee
  16. Copy of the notice on insurer’s registration with the territorial agency of the RF Social Insurance Fund
  17. Copy of the notice confirming the entity’s status as a social contribution payer under the mandatory social insurance program
  18. Sublease agreement
  19. Balance sheet report for the last reporting period
  20. Copy of the certificate issued by the tax authorities confirming that the bidder has no debt in connection with charged taxes, dues or other obligatory assignments to budgets of all levels or to state non-budget funds
  21. Information on the organizational structure
  22. Documents to evidence the tenderer’s competence (copies of diplomas)
  23. Bidder’s proposals concerning the contract execution terms used as criteria for evaluation of open tender bids (Form No. 5)
  24. R&D quality proposals and other contract execution proposals (Form No. 3)
  25. Tenderer’s competence data (Form 4)