Section one: Contracting authority
one.1) Name and addresses
MHRA
10 South Colonnade
London
E14 4PU
Contact
Purchasing
Telephone
+44 2030806000
Country
United Kingdom
Region code
UK - United Kingdom
Internet address(es)
Main address
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
Buyer's address
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
one.3) Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at
https://health-family.force.com/s/Welcome
Additional information can be obtained from the above-mentioned address
Tenders or requests to participate must be submitted electronically via
https://health-family.force.com/s/Welcome
Tenders or requests to participate must be submitted to the above-mentioned address
Electronic communication requires the use of tools and devices that are not generally available. Unrestricted and full direct access to these tools and devices is possible, free of charge, at
https://health-family.force.com/s/Welcome
one.4) Type of the contracting authority
National or federal Agency/Office
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
eCTD Solution
two.1.2) Main CPV code
- 72261000 - Software support services
two.1.3) Type of contract
Services
two.1.4) Short description
MHRA is embarking on the development of a next generation Regulatory Management System (RMS) that will replace multiple legacy systems with converged technology platforms to support the agency regulation of medicinal products and medical devices.
In order to support medicinal regulatory management, one component of the new platform identified is a technology solution to facilitate the management of information using the eCTD format (ICH electronic Common Technical Document).
two.1.5) Estimated total value
Value excluding VAT: £6,000,000
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.2) Additional CPV code(s)
- 48517000 - IT software package
- 48100000 - Industry specific software package
two.2.3) Place of performance
NUTS codes
- UKI - London
two.2.4) Description of the procurement
Please see section VI.3 of this notice.
two.2.5) Award criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
two.2.6) Estimated value
Value excluding VAT: £6,000,000
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
60
This contract is subject to renewal
Yes
Description of renewals
The Contract will have an initial duration of 5 years, with an option for the Agency to extend it for a further period of up to 5 years more.
two.2.9) Information about the limits on the number of candidates to be invited
Envisaged minimum number: 3
Maximum number: 5
Objective criteria for choosing the limited number of candidates:
Criteria to be used for selecting the candidates appear in the Standard Selection Questionnaire Guidance document.
two.2.10) Information about variants
Variants will be accepted: Yes
two.2.11) Information about options
Options: Yes
Description of options
Please see section VI.3 of this notice.
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
Section three. Legal, economic, financial and technical information
three.1) Conditions for participation
three.1.2) Economic and financial standing
List and brief description of selection criteria
Selection criteria as stated in the procurement documents
three.1.3) Technical and professional ability
List and brief description of selection criteria
Selection criteria as stated in the procurement documents
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Competitive procedure with negotiation
four.1.4) Information about reduction of the number of solutions or tenders during negotiation or dialogue
Recourse to staged procedure to gradually reduce the number of solutions to be discussed or tenders to be negotiated
four.1.5) Information about negotiation
The contracting authority reserves the right to award the contract on the basis of the initial tenders without conducting negotiations
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
four.2) Administrative information
four.2.2) Time limit for receipt of tenders or requests to participate
Date
28 December 2022
Local time
4:00pm
four.2.4) Languages in which tenders or requests to participate may be submitted
English
four.2.6) Minimum time frame during which the tenderer must maintain the tender
Duration in months: 9 (from the date stated for receipt of tender)
Section six. Complementary information
six.1) Information about recurrence
This is a recurrent procurement: No
six.2) Information about electronic workflows
Electronic ordering will be used
Electronic invoicing will be accepted
Electronic payment will be used
six.3) Additional information
The Agency is seeking an eCTD solution and subsequent support for that solution. Bidders must be aware that there are; supply, implementation, and support requirements.
Please indicate your interest by registering at https://health-family.force.com/s/Welcome, this is the address at which the procurement documents will be available for unrestricted and full direct access, free of charge.
Options for the procurement are shown in the procurement documents.
The contracting authority is not a centralised purchasing body, and no other form of joint procurement is or may be involved.
Estimated nature and quantity or value of supplies: Industry specific software package, Software support services; between £5,000,000.00 and £6,000,000.00.
Please note, the above value is for the initial period; depending on the renewals and options taken the total contract value over the entire term may be up to £12,000,000.00.
Please contact purchasing@mhra.gov.uk and quote "Procurement Project Ref: eCTD Solution" for further information.
The Agency reserves the right to terminate, discontinue, suspend and/or abandon this Procurement Exercise (in whole or in part) at any time prior to contract award without incurring any liability to the affected Applicants and/or Bidders.
The Agency may have an affordability cap but this is not currently known. Bidders will be made aware of any known affordability caps that affect evaluation when evaluation exercises are undertaken
six.4) Procedures for review
six.4.1) Review body
Royal Courts of Justice
Strand
London
WC2A 2LL
royalcourtsofjustice.jc@gov.uk
Country
United Kingdom
Internet address
six.4.2) Body responsible for mediation procedures
Centre for Effective Dispute Resolution
70 Fleet Street
London
EC4Y 1EU
Country
United Kingdom