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/

Ministry or any other national or federal authority, including their regional or local subdivisions

Health

Consortium Agreement for a joint Nordic Pharmacovigilance Solution

75122000 Administrative healthcare services

Services

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.

This contract is divided into lots: no

Value excluding VAT: 1.00 EUR

72200000 Software programming and consultancy services

NUTS code: DK Danmark

NUTS code: FI Suomi / Finland

NUTS code: SE Sverige

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.

Options: no

The procurement is related to a project and/or programme financed by European Union funds: no

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

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.

The procurement is covered by the Government Procurement Agreement: no

24/06/2021

The contract has been awarded to a group of economic operators: no

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

Total value of the contract/lot/concession: 1.00 EUR

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.

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/

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/

25/06/2021