Legal Basis:
Directive 2014/24/EU
Section I: Contracting authority
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
I.5)Main activityGeneral public services
Section II: Object
II.1)Scope of the procurement
II.1.1)Title:
Efficacy and safety studies on medicines.
Reference number: EMA/2017/09/PE
II.1.2)Main CPV code73000000
II.1.3)Type of contractServices
II.1.4)Short description:
Post-authorisation effectiveness and pharmacoepidemiology studies to generate data and information to support regulatory decision-making. Research may also focus on the effectiveness of regulatory measures taken and on the impact of relevant legislation. The range of research topics is limited to those with high public health relevance and with a European impact. The scope of the funding covers both nationally and centrally authorised products, including vaccines. The results obtained from this research will subsequently be assessed by the responsible agency committee regarding the need for regulatory action and further research may subsequently also be conducted to measure the effectiveness of regulatory actions taken.
The research may concern four different lots, with a maximum of five framework contracts for lots 1, 2 and 3 and a maximum of 8 framework contracts for lot 4.
II.1.5)Estimated total valueValue excluding VAT: 5 000 000.00 EUR
II.1.6)Information about lotsThis contract is divided into lots: yes
Tenders may be submitted for all lots
II.2)Description
II.2.1)Title:
Use of innovative methods to optimise the utility of sparse data to support benefit /risk assessment
Lot No: 1
II.2.2)Additional CPV code(s)73210000
II.2.3)Place of performanceNUTS code: UKI4
II.2.4)Description of the procurement:
For full description please see section 3.2 of the technical specifications (procurement documents).
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: 400 000.00 EUR
II.2.7)Duration of the contract, framework agreement or dynamic purchasing systemDuration in months: 48
This contract is subject to renewal: no
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: no
II.2.14)Additional information
Please note that a maximum of 5 framework contracts is foreseen for lot 1.
II.2)Description
II.2.2)Additional CPV code(s)73210000
II.2.3)Place of performanceNUTS code: UKI4
II.2.4)Description of the procurement:
For full description please see section 3.2 of the technical specifications (procurement documents).
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: 600 000.00 EUR
II.2.7)Duration of the contract, framework agreement or dynamic purchasing systemDuration in months: 48
This contract is subject to renewal: no
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: no
II.2.14)Additional information
Please note that a maximum of 5 framework contracts is foreseen for lot 2.
II.2)Description
II.2.1)Title:
Pharmacoepidemiology research — rapid descriptive studies
Lot No: 3
II.2.2)Additional CPV code(s)73210000
II.2.3)Place of performanceNUTS code: UKI4
II.2.4)Description of the procurement:
For full description please see section 3.2 of the technical specifications (procurement documents).
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: 1 000 000.00 EUR
II.2.7)Duration of the contract, framework agreement or dynamic purchasing systemDuration in months: 48
This contract is subject to renewal: no
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: no
II.2.14)Additional information
Please note that a maximum of 5 framework contracts is foreseen for lot 3.
II.2)Description
II.2.1)Title:
Pharmacoepidemiology research — association studies, including pregnancy and breastfeeding research.
Lot No: 4
II.2.2)Additional CPV code(s)73210000
II.2.3)Place of performanceNUTS code: UKI4
II.2.4)Description of the procurement:
For full description please see section 3.2 of the technical specifications (procurement documents).
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: 3 000 000.00 EUR
II.2.7)Duration of the contract, framework agreement or dynamic purchasing systemDuration in months: 48
This contract is subject to renewal: no
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: no
II.2.14)Additional information
Please note that a maximum of 8 framework contracts is foreseen for lot 4.
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 registersList and brief description of conditions:
See internet address provided in Section I.3.
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:
See internet address provided in Section I.3.
III.2.3)Information about staff responsible for the performance of the contractObligation to indicate the names and professional qualifications of the staff assigned to performing 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 several operators
Envisaged maximum number of participants to the framework agreement: 8
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: 02/02/2018
Local time: 12:00
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:English, Bulgarian, Danish, German, Greek, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Latvian, Lithuanian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish, Czech
IV.2.6)Minimum time frame during which the tenderer must maintain the tenderDuration in months: 9 (from the date stated for receipt of tender)
IV.2.7)Conditions for opening of tendersDate: 08/02/2018
Local time: 10:00
Place:
European Medicines Agency, 30 Churchill Place, Canary Wharf, London, E14 5EU, United Kingdom.
Information about authorised persons and opening procedure:
Maximum of 1 representative per tenderer is permitted to be present at the opening. For security reasons, tenderers must register within the given deadline (please see the invitation to tender letter) to be allowed to attend the opening session.
Section VI: Complementary information
VI.1)Information about recurrenceThis is a recurrent procurement: yes
VI.2)Information about electronic workflows
VI.3)Additional information:
Please note only 1 tender per tenderer per lot may be submitted.
VI.4)Procedures for review
VI.4.2)Body responsible for mediation procedures
VI.4.3)Review procedurePrecise information on deadline(s) for review procedures:
You may submit any observations concerning the award procedure to the contracting authority indicated under heading I.1.
If you believe that there was maladministration, you may lodge a complaint to the European Ombudsman within 2 years of the date when you became aware of the facts on which the complaint is based (see http://www.ombudsman.europa.eu ). Such complaint does not have as an effect either to suspend the time limit to launch an appeal or to open a new period for lodging an appeal.
Within 2 months of the notification of the award decision you may lodge an appeal to the body referred to in VI.4.1.
VI.4.4)Service from which information about the review procedure may be obtained VI.5)Date of dispatch of this notice:04/12/2017
