23948sdkhjf
  1. Udbud
  2. IT-ydelser og økonomi- og planlægningssystemer

Fakta om udbudet

EU-nr
2020/S 093-222256
Offentliggjort
13.05.2020
Udbudstype
Forhåndsmeddelelse

Bestilling af materiale

https://laegemiddelstyrelsen.dk/da/om/aktiviteter-i-eu-og-i-resten-af-verden/invitation-til-markedsdialog-om-nyt-bivirkningssystem-engelsk/

Udbyder

Lægemiddelstyrelsen

Pharmacovigilance System for the Danish Medicines Agency

Lægemiddelstyrelsen

Prior information notice

This notice is for prior information only

Services

Legal Basis:

Directive 2014/24/EU

Section I: Contracting authority

I.1) Name and addresses
Official name: Lægemiddelstyrelsen
National registration number: 37052485
Postal address: Axel Heides Gade 1
Town: København S
NUTS code: DK01
Postal code: 2300
Country: Denmark
Contact person: Troels Mogensen
E-mail: trm@dkma.dk
Telephone: +45 44889344

Internet address(es):

Main address: http://www.lmst.dk

I.2) Information about joint procurement
I.3) Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at: https://laegemiddelstyrelsen.dk/da/om/aktiviteter-i-eu-og-i-resten-af-verden/invitation-til-markedsdialog-om-nyt-bivirkningssystem-engelsk/
Additional information can be obtained from the abovementioned address
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:

Pharmacovigilance System for the Danish Medicines Agency

II.1.2) Main CPV code
72220000
II.1.3) Type of contract
Services
II.1.4) Short description:

The Danish Medicines Agency, DKMA, wishes to procure a system to aid in pharmacovigilance. At present we collaborate with the UK Medicines and Health Regulatory Agency (MHRA) and occupy a part of their system, Sentinel, which is due to retire. Given the unclear situation about Brexit, DKMA has seen it fit to pursue a market consultation with potential vendors about a system, that may eventually replace the functionalities we make use of in Sentinel. Be aware that a signal management system is not in scope. The market consultation will precede and inform the tender expected to be announced early next year. For further information, please see the link in section I.3).

II.1.5) Estimated total value
II.1.6) Information about lots
This 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 performance
NUTS code: DK01
II.2.4) Description of the procurement:

Pharmacovigilance system and associated IT-services. The system should preferably already be commercially available and require as little customer specific modification as possible.

II.2.14) Additional information

Estimated data of publication should be considered a rough estimate.

II.3) Estimated date of publication of contract notice:
15/02/2021

Section IV: Procedure

IV.1) Description
IV.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: yes

Section VI: Complementary information

VI.3) Additional information:
VI.5) Date of dispatch of this notice:
12/05/2020

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