Object of the contractIT services: consulting, software development, Internet and support
Description: Contract notice: IT services: consulting, software development, Internet and support
Authority Type: Ministry or any other national or federal authority
Contact Nature: Services
Procedure: Competitive procedure with negotiation
Document: Contract notice
Regulation: European Union, with participation by GPA countries
Award criteria: The most economic tender
CPV code: 72000000, 48000000, 48445000, 48517000, 48611000, 48920000, 72200000, 72210000, 72211000, 72212000, 72261000, 72263000, 72266000, 72267100, 72000000, 48000000, 48445000, 48517000, 48611000, 48920000, 72200000, 72210000, 72211000, 72212000, 72261000, 72263000, 72266000, 72267100
CPV Description: IT services: consulting, software development, Internet and support.
Software package and information systems.
Customer Relation Management software package.
IT software package.
Database software package.
Office automation software package.
Software programming and consultancy services.
Programming services of packaged software products.
Programming services of systems and user software.
Programming services of application software.
Software support services.
Software implementation services.
Software consultancy services.
Maintenance of information technology software.
Udvikling og Vedligehold pa Standardplatform
Reference Number : 2018021780
Laegemiddelstyrelsen 0nsker at anskaffe sig en standardplatform til at udvikle meget af sin fremtidige forretning pa, f.s.v.a. registre og regelmotears.
I. Background and formal: The Danish Medicines Agency wishes to modernize the Danish drug registry on a new platform. The modernization is mainly based on a number of causes:
The Agency, from 2019, should be able to honor the European Medicines Regulation's requirement for the use of the ISO-based drug terminology SPOR. The existing drug registry is through development, as-Following new regulation and technology have become architectural knockouts. A replacement of a data model corresponding to SPOR makes it appropriate now to change the platform.
In this connection, the Danish Medicines Agency has decided to provide a framework contract that is formally to acquire a standard platform and supplier with the necessary resources and competencies to be able to configurere and implement solutions on the chosen standard platform.
The acquisition of a standard platform also contributes to the realization of the Agency's IT strategy. II. Benefits:
The Agency's ambition is that the new standard platform in the future will be able to support the following by the Danish Medicines Agency's business:
1) the new drug registry;
2) the treatment of side effectsrvagning;
3) The veterinary area currently supported by MS Excel;
4) Medical equipment also supported by MS Excel;
5) The drug database built in MS Access;
6) Control of the inspection area, where risk-based control is required and planning of visits.
The new standard platform is seen as a business application platform for which the Danish Medicines Agency kto create a better and more agile IT support for the individual business areas. It will thus be an important element in bringing the European Medicines Agency to the top of the European Medicines Agency.
The contract includes the following main services:
A) Development and Maintenance:
Supplier must develop solutions focusing on high quality and safety, and compliance with complex european and national legislation. The solutions should also exist in interaction, with solutions from a complex interest landscape that includes both other authorities and private actors. Smooth-free integration and interactions with decreasing solutions at the Agency's stakeholders are paramount for the customer's business. Deliveries will continue to develop solutions, bL.A. as a result of amended and new regulatory requirements, amended and new security requirements, as well as IT support for changed and new business needs. The development of solutions will include complex project and process management, and involve collaboration with many internal and external parties, including IT suppliers of other savel internal, such as external systems and end-user representatives. That is expected, that solutions should be able to develop during a time-limited pressure, whose legislative requirements require this;
B) Test:
Suppliers must provide the necessary resources with knowledge and understanding of the required test types. The Danish Medicines Agency focuses on gradually improving its position in a European drug labeling benchmark. The benchmark contains test and document requirementsion that may recall GXP. The suppliers must use recognized methods or standards for their own test.
C) Support:
The suppliers must handle any identified problem and incident related to the supplier's responsibility. This will include include software updates, compliance with security requirements, etc. The supplier shall take care of the daily support of the 2nd level support;
D) TekTechnical assistance:
Suppliers must provide technical assistance to the Danish Medicines Agency in connection with, for example, change of operating deliveries;
E) Consultancy and ophthalmology:
The supplier must provide consultancy services, including training, and retirement benefits, including retirement or transfer to a Danish Medicines Agency. new supplier.
Applicants must submit the common European buoyancyDSP document (hereinafter ESPD) stating the following information: Applicant's equity ratio in the most recent available financial year. Applicant's total annual turnover in the most recent financial year. The ESPD serves as a preliminary proof that applicants meet the minimum eligibility requirements for economic and financial capacity. Prior to the award decision, the bidder must be the contracting entity-intends to award the contract, provide evidence that the information in the ESPD is correct.
When the contracting entity requests it, the following financial and financial capacity documentation must be provided: - statement of the company's equity and assets in the most recent available financial statements, of when the company was established, if the figures for equity and activer is available. For an association of companies (eg a consortium), the information must be provided for each of the participating companies in the association. If the company is based on the economic and financial form of other entities (eg a parent company or a subcontractor), the information must also be disclosed to these entities.
Declaration on the total turnover of the company-in the latest available financial statements, depending on where the company was established or started its business if the figures for this turnover are available. For an association of companies (eg a consortium), the information must be provided for each of the participating companies in the association. The company relies on the economic and financial form of other entities (eg oneparent company or subcontractor), the information must also be provided for these entities. Participation in the tender can only be done electronically via the contractor's electronic tender system, see the address in section I.3). Here the tender is awarded under "Current public offer". To access the tender documents, applicants must be registered or register as a user.
Safely aThe summary contains several editions (versions) of the same document, the most recent uploaded edition will be applicable.
All communication in connection with the procurement procedure, including questionnaire and response, must be via the electronic procurement system. The question must be submitted no later than March 13, 2018. Questions asked after this date will be answered, as soon as they are received, so that the orderYou can obtain the necessary information and communicate the answers within six days before the deadline for the application. Questionnaires received later than 6 days before the deadline can not be expected to be answered.
Applicants should ask their question as soon as possible before the deadline, especially in the case of complex questions.
Interested in keeping informed via the electronic procurement systemm. Safely Applicants are experiencing problems with the system, can be contacted by e-mail,
[email protected], or telephone, (45) 70 2080 14.
Applicants must submit an ESPD as a preliminary proof of those in the Procurement Act Section 148 (1), no. 1-3, mentioned above. For a group of companies (eg a consortium), a separate ESPD must be submitted for each of the participating 0konominal actors. Safely the applicant is based on the form of other entities, an ESPD must be submitted for each of the units on which it is based.
The applicant will be excluded from participation in the procurement procedure if the applicant is subject to the sections 135 and 136 of the Public Procurement Act mandatory grounds for exclusion or the voluntary grounds for exclusion referred to in section 137.
Before the award decisiona tenderer to which the contracting entity intends to award the contract must provide documentation for the information provided in the ESPD pursuant to section 151-152 of the Public Procurement Act, cf. -153.
Additional information:
In relation to point II.2.6) Note that the amount of the amount will exceed the estimated contractual value of the contract, including the price of all options. The survey is p.a. Based on expected establishment costs and historical expenditure for current services as well as future expected consumption.
In relation to item II.2.7), it is noted that the contract amount stated is from the contract. In addition to the specified contract length, during the term of the contract, there will be a need for a flexible flexible phase in order to ensure an unprecedentedcontrolled operation of the solution in connection with any re-invitation.
Prior to the invitation, a market dialogue has been held and the external report from this is included in the tender documents. In relation to point II.2.9), each applicant can only submit 1 application for a pre-qualification.
The contract is not divided into Multiple subcontracts, cf. the specifications.
The contracting entity may use the tendergsmaden in section 159 (3) of the Procurement Act. 5 whose applications or offers do not meet the formal requirements of the tender.
The tender is executed subject to the grant of the necessary authorization.
Internet address (URL): http://lmst.dk
Directive: Classical Directive (2014/24/EU)
Sign in with Google