23948sdkhjf

Fakta om udbudet

EU-nr
2021/S 124-329399
Offentliggjort
30.06.2021
Udbudstype
Tildeling af kontrakt uden forudgående offentliggørelse

Udbyder

The Danish Medicines Agency

Vindere

(30.06.2021)
The Swedish Medical Products Agency
Box 26
SE-751 03 Uppsala

Consortium Agreement for a Joint Nordic Pharmacovigilance Solution

(20.07.2021)
The Swedish Medical Products Agency
Box 26
751 03 Uppsala

Consortium Agreement for a joint Nordic Pharmacovigilance Solution


The Danish Medicines Agency

Voluntary ex ante transparency notice

Services

Legal Basis:
Directive 2014/24/EU

Section I: Contracting authority/entity

I.1) Name and addresses
Official name: The Danish Medicines Agency
Postal address: Axel Heides Gade 1
Town: Copenhagen S
NUTS code: DK01 Hovedstaden
Postal code: 2300
Country: Denmark
Contact person: Troels Mogensen
E-mail: trm@dkma.dk
Telephone: +45 44889595
Internet address(es):
Main address: https://laegemiddelstyrelsen.dk/
I.4) Type of the contracting authority
Ministry or any other national or federal authority, including their regional or local subdivisions
I.5) Main activity
Health

Section II: Object

II.1) Scope of the procurement
II.1.1) Title:

Consortium Agreement for a joint Nordic Pharmacovigilance Solution

II.1.2) Main CPV code
75122000 Administrative healthcare services
II.1.3) Type of contract
Services
II.1.4) Short description:

The Swedish Medical Products Agency (SMPA), the Danish Medicines Agency and the Finnish Medicines Agency wish to establish a long-term collaboration in the area of information technology to fulfil their respective obligations under EU regulation as National Competent Agencies with respect to performance of pharmacovigilance activities. The collaboration is based on Article 12 of Directive 2014/24/EU. As part of the collaboration SPMA shall provide the Background System serving as the basis of the joint development of a joint Pharmacovigilance Solution. This Background system has been procured by SMPA, see contract notice 2019/S071-167957.

II.1.6) Information about lots
This contract is divided into lots: no
II.1.7) Total value of the procurement (excluding VAT)
Value excluding VAT: 1.00 EUR
II.2) Description
II.2.2) Additional CPV code(s)
72200000 Software programming and consultancy services
II.2.3) Place of performance
NUTS code: DK Danmark
NUTS code: FI Suomi / Finland
NUTS code: SE Sverige
II.2.4) Description of the procurement:

The collaboration falls outside the procurement directive as it is a cooperation exclusively between contracting authorities with the aim of ensuring that public services they have to perform

Are provided with a view to achieving objectives they have in common and the implementation of that cooperation is governed solely by considerations relating to the public interest.

Operation, maintenance and development of the joint pharmacovigilence system will be procured by the parties in accordance with article 39 of the public procurement directive.

II.2.5) Award criteria
II.2.11) Information about options
Options: no
II.2.13) Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14) Additional information

Section IV: Procedure

IV.1) Description
IV.1.1) Type of procedure
Award of a contract without prior publication of a call for competition in the Official Journal of the European Union in the cases listed below
  • The procurement falls outside the scope of application of the directive
Explanation:

The collaboration falls outside the procurement directive as it is a cooperation exclusively between contracting authorities with the aim of ensuring that public services they have to perform

Are provided with a view to achieving objectives they have in common and the implementation of that cooperation is governed solely by considerations relating to the public interest. Cf. II.2.4) above.

IV.1.3) Information about framework agreement
IV.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: no
IV.2) Administrative information

Section V: Award of contract/concession

V.2) Award of contract/concession
V.2.1) Date of contract award decision:
24/06/2021
V.2.2) Information about tenders
The contract has been awarded to a group of economic operators: no
V.2.3) Name and address of the contractor/concessionaire
Official name: The Swedish Medical Products Agency
Postal address: Box 26
Town: Uppsala
NUTS code: SE Sverige
Postal code: SE-751 03
Country: Sweden
The contractor/concessionaire will be an SME: no
V.2.4) Information on value of the contract/lot/concession (excluding VAT)
Total value of the contract/lot/concession: 1.00 EUR
V.2.5) Information about subcontracting

Section VI: Complementary information

VI.3) Additional information:

Re: contract value cf. II.1.7) above: as the collaboration is not a procurement it does not have a specific value. Accordingly, the value is stated as EUR 1.

Re: contractor, cf. V.2.3) the consortium agreement is entered into by the Danish Medicines Agency, the Swedish Medical Products Agency and the Finnish Medicines Agency, PO Box 55, FI-00034 FIMEA, FINLAND.

Re: date of contract cf. V.2.3): the consortium agreement is not entered into before a period of 10 calendar days after the date of the publication of this notice.

VI.4) Procedures for review
VI.4.1) Review body
Official name: The Complaints Board for Public Procurement
Postal address: Naevnenes Hus, Toldboden 2
Town: Viborg
Postal code: 8800
Country: Denmark
E-mail: klfu@naevneneshus.dk
Telephone: +45 35291000
Internet address: https://naevneneshus.dk/start-din-klage/klagenaevnet-for-udbud/
VI.4.4) Service from which information about the review procedure may be obtained
Official name: Danish Competition and Customer Authority
Postal address: Carl Jacobsens Vej 5
Town: Valby
Postal code: 2500
Country: Denmark
E-mail: kfst@kfst.dk
Telephone: +45 1715000
Internet address: http://www.kfst.dk/
VI.5) Date of dispatch of this notice:
25/06/2021

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