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
Additional information can be obtained from 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.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.2) Additional CPV code(s)
- 72261000 - Software support services
- 72261000 - Software support services
two.2.3) Place of performance
NUTS codes
- UKI - London
two.2.4) Description of the procurement
In preparing for the required activities, MHRA wishes to ensure that its plans are supported appropriately by supply-side core skills and experience. The procurement procedure selected is: competitive procedure with negotiation (CPN).
This prior information notice (PIN) is a signal of future intentions to the marketplace regarding the procurement of an eCTD Solution.
This PIN is not a call for competition.
By publishing this PIN, the MHRA may shorten the time limit for the receipt of initial tenders to 10 days.
This contract is not divided into lots.
It is envisioned that up to 60 additional months will be available as renewals, this will be confirmed in the contract notice.
Price is not the only award criterion and all criteria are stated only in the procurement documents.
Estimated date of publication of contract notice 01/11/2022.
two.3) Estimated date of publication of contract notice
1 November 2022
Section four. Procedure
four.1) Description
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
Section six. Complementary information
six.3) Additional information
Please indicate your interest by registering in advance 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.
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; £5,000,000.00
Please contact purchasing@mhra.gov.uk and quote "Procurement Project Ref: eCTD Solution" for further information.
This prior information notice (PIN) is a signal of future intentions to the marketplace regarding the procurement of an eCTD Solution.
This PIN is not a call for competition.
By publishing this PIN, the MHRA may shorten the time limit for the receipt of initial tenders to 10 days.
Please Note: Full Award Criteria will be published in the Contract Notice and Opportunity notice.