Legal Basis:
Regulation (EU, Euratom) No 2018/1046
Section I: Contracting authority
I.1)Name and addressesOfficial name: Innovative Medicines Initiative 2 Joint Undertaking
Postal address: IMI2 JU — TO 56 1049
Town: Brussels
NUTS code:
BE10 Région de Bruxelles-Capitale / Brussels Hoofdstedelijk GewestPostal code: 1060
Country: Belgium
Contact person: Procurement team
E-mail:
procurement@imi.europa.euInternet address(es):
Main address: http://www.imi.europa.eu/
I.2)Information about joint procurement
I.3)CommunicationAdditional information can be obtained from the abovementioned address
Tenders or requests to participate must be submitted to the abovementioned address
I.4)Type of the contracting authorityEuropean institution/agency or international organisation
Section II: Object
II.1)Scope of the procurement
II.1.1)Title:
Supporting Regulatory Acceptance of IMI Results
Reference number: IMI.2019.OP.01
II.1.2)Main CPV code85000000 Health and social work services
II.1.3)Type of contractServices
II.1.4)Short description:
The Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU) intends to establish a framework service contract to provide a central support system which will capitalise on project results generated by increasing or securing their impact and sustainability through adoption into regulatory agency guidelines or standard practice.
II.1.5)Estimated total valueValue excluding VAT: 250 000.00 EUR
II.1.6)Information about lotsThis contract is divided into lots: no
II.2)Description
II.2.1)Title:
II.2.2)Additional CPV code(s)
II.2.3)Place of performanceNUTS code: BE1 RÉGION DE BRUXELLES-CAPITALE / BRUSSELS HOOFDSTEDELIJK GEWEST
II.2.4)Description of the procurement:
The objective of the initiative is to ensure that the key results generated by IMI projects are acceptable in a research and development (R&D) context (non-clinical or clinical studies), and are therefore implemented in the regulatory practices.
The results include novel biomarkers, endpoints, outcomes, tools/methodologies, recommendations that would support development of regulatory guidance documents. This may cover different disease areas or axes of research as per the IMI Strategic Research Agenda.
The contractor will be expected to:
— identify and prioritise the relevant project results,
— identify information/data gaps that need to be addressed to complete the submission,
— support preparation of files to be submitted to the EMA and FDA, and preliminary engagement with the agencies,
— implement process, quality criteria to be replicated across all projects, etc. to secure efficiency, consistency and quality.
II.2.5)Award criteriaPrice is not the only award criterion and all criteria are stated only in the procurement documents
II.2.6)Estimated valueValue excluding VAT: 250 000.00 EUR
II.2.7)Duration of the contract, framework agreement or dynamic purchasing systemDuration in months: 48
This contract is subject to renewal: yes
Description of renewals:
The framework contract will be signed for an initial period of 2 years, and shall be renewable up to 2 times, for a 1-year period, for a total maximum duration of 4 years, under the same conditions.
II.2.10)Information about variantsVariants will be accepted: no
II.2.11)Information about optionsOptions: no
II.2.12)Information about electronic catalogues
II.2.13)Information about European Union fundsThe procurement is related to a project and/or programme financed by European Union funds: yes
Identification of the project:
The Innovative Medicines Initiative 2 Joint Undertaking operates with Horizon 2020 funds, the EU's framework programme for research and innovation.
II.2.14)Additional information Section III: Legal, economic, financial and technical information
III.1)Conditions for participation
III.1.1)Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers
III.1.2)Economic and financial standingSelection criteria as stated in the procurement documents
III.1.3)Technical and professional abilitySelection criteria as stated in the procurement documents
III.1.5)Information about reserved contracts
III.2)Conditions related to the contract
III.2.1)Information about a particular profession
III.2.2)Contract performance conditions:
III.2.3)Information about staff responsible for the performance of the contract
Section IV: Procedure
IV.1)Description
IV.1.1)Type of procedureOpen procedure
IV.1.3)Information about a framework agreement or a dynamic purchasing systemThe procurement involves the establishment of a framework agreement
Framework agreement with a single operator
IV.1.4)Information about reduction of the number of solutions or tenders during negotiation or dialogue
IV.1.6)Information about electronic auction
IV.1.8)Information about the Government Procurement Agreement (GPA)The procurement is covered by the Government Procurement Agreement: no
IV.2)Administrative information
IV.2.1)Previous publication concerning this procedure IV.2.2)Time limit for receipt of tenders or requests to participateDate: 06/12/2019
Local time: 17:00
IV.2.3)Estimated date of dispatch of invitations to tender or to participate to selected candidates
IV.2.4)Languages in which tenders or requests to participate may be submitted:Bulgarian, Czech, Danish, German, Greek, English, Spanish, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Lithuanian, Latvian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Swedish
IV.2.6)Minimum time frame during which the tenderer must maintain the tenderDuration in months: 4 (from the date stated for receipt of tender)
IV.2.7)Conditions for opening of tendersDate: 16/12/2019
Local time: 10:00
Place:
IMI2 JU Headquarters, in Brussels.
Information about authorised persons and opening procedure:
Maximum two representatives per participating tenderer may attend the opening session. Tenderers are requested to inform the IMI2 JU of their intention to attend, at least 5 working days prior to the opening session.
Section VI: Complementary information
VI.1)Information about recurrenceThis is a recurrent procurement: no
VI.2)Information about electronic workflows
VI.3)Additional information:
VI.4)Procedures for review
VI.4.2)Body responsible for mediation procedures
VI.4.3)Review procedure
VI.4.4)Service from which information about the review procedure may be obtained
VI.5)Date of dispatch of this notice:11/10/2019
