Section one: Contracting authority
one.1) Name and addresses
London School of Hygiene & Tropical Medicine
Keppel Street,
London
WC1E 7HT
Contact
Paul Pester
Telephone
+44 02079272471
Country
United Kingdom
NUTS code
UKI31 - Camden and City of London
National registration number
RC000330
Internet address(es)
Main address
Buyer's address
https://uk.eu-supply.com/ctm/Company/CompanyInformation/Index/104519
one.3) Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at
https://uk.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=40736&B=LSHTM
Additional information can be obtained from the above-mentioned address
Tenders or requests to participate must be submitted electronically via
https://uk.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=40736&B=LSHTM
Tenders or requests to participate must be submitted to the above-mentioned address
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Investigational Medicinial Product (IMP) & Placebo Manufacture - IM Woman Trial
Reference number
LSHTM-2021-29
two.1.2) Main CPV code
- 33600000 - Pharmaceutical products
two.1.3) Type of contract
Supplies
two.1.4) Short description
Manufacturing and packing of IMP for the IM Woman Trial due to commence in March 2023.
Three arms include experimental treatment (IM TXA), reference treatment/active control (IV TXA), and placebo control (0.9% sodium chloride solution).
Treatment Kit Boxes required for 4 campaigns with approximately 10,000 patient packs per campaign. Recruitment period is 24 months - campaign approximately once every 6 months.
two.1.5) Estimated total value
Value excluding VAT: £975,000
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.2) Additional CPV code(s)
- 33141310 - Syringes
- 33141320 - Medical needles
- 33621000 - Medicinal products for the blood and blood-forming organs
- 33621200 - Antihaemorrhagics
- 33698000 - Clinical products
- 39299100 - Glass ampoules
- 44617100 - Cartons
- 79920000 - Packaging and related services
two.2.3) Place of performance
NUTS codes
- UKI31 - Camden and City of London
Main site or place of performance
LSHTM - Keppel Street, London WC1A 7HT
two.2.4) Description of the procurement
Manufacturing and packing of IMP for the IM Woman Trial due to commence in March 2023.
A randomised, triple-blind, three-arm, non-inferiority trial to assess the efficacy and safety of intramuscular tranexamic acid compared to intravenous tranexamic acid and placebo in women having vvaginal and caesarean section births.
Three arms include experimental treatment (IM TXA), reference treatment/active control (IV TXA), and placebo control (0.9% sodium chloride solution).
Treatment Kit Boxes required for 4 campaigns with approximately 10,000 patient packs per campaign. Recruitment period is 24 months - campaign approximately once every 6 months.
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: £975,000
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
25
This contract is subject to renewal
No
two.2.10) Information about variants
Variants will be accepted: No
two.2.11) Information about options
Options: No
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.1.1) Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers
List and brief description of conditions
GMP and MHRA certification
three.1.2) Economic and financial standing
Selection criteria as stated in the procurement documents
three.1.3) Technical and professional ability
Selection criteria as stated in the procurement documents
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Open procedure
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
5 January 2022
Local time
1:00pm
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
Tender must be valid until: 5 April 2022
four.2.7) Conditions for opening of tenders
Date
5 January 2022
Local time
1:00pm
Section six. Complementary information
six.1) Information about recurrence
This is a recurrent procurement: No
six.4) Procedures for review
six.4.1) Review body
The Royal Courts of Justice
The Strand
London
WC2A 2LL
Country
United Kingdom
six.4.4) Service from which information about the review procedure may be obtained
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
Country
United Kingdom