UK

Contract notice

Information

Published

Expire date: 05/01/2022

External Reference: 2021-586921

FTS Reference: 2021-029090

Contract notice

Contract notice

Section I: Contracting authority

I.1)

Name and addresses

London School of Hygiene & Tropical Medicine
RC000330
Keppel Street,
London
WC1E 7HT
UK
Contact person: Paul Pester
Telephone: +44 02079272471
E-mail: paul.pester@lshtm.ac.uk
NUTS code:  UKI31 -  Camden and City of London
Internet address(es):
Main address: http://www.lshtm.ac.uk
Address of the buyer profile: https://uk.eu-supply.com/ctm/Company/CompanyInformation/Index/104519

I.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 abovementioned 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 abovementioned address
I.4)

Type of the contracting authority

Body governed by public law
I.5)

Main activity

Health

Section II: Object

II.1)

Scope of the procurement

II.1.1)

Title

Investigational Medicinial Product (IMP) & Placebo Manufacture - IM Woman Trial
Reference number:  LSHTM-2021-29
II.1.2)

Main CPV code

33600000  -  Pharmaceutical products
II.1.3)

Type of contract

Supplies
II.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.
II.1.5)

Estimated total value

Value excluding VAT: 975000.00  GBP
II.1.6)

Information about lots

This contract is divided into lots: no
II.2)

Description

II.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
II.2.3)

Place of performance

NUTS code:  UKI31 -  Camden and City of London
Main site or place of performance:  
LSHTM - Keppel Street, London WC1A 7HT
II.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.
II.2.5)

Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.6)

Estimated value

Value excluding VAT: 975000.00  GBP
II.2.7)

Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 25
This contract is subject to renewal: no
II.2.10)

Information about variants

Variants will be accepted: no
II.2.11)

Information about options

Options: no
II.2.13)

Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: no

Section III: Legal, economic, financial and technical information

III.1)

Conditions for participation

III.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
III.1.2)

Economic and financial standing

Selection criteria as stated in the procurement documents
III.1.3)

Technical and professional ability

Selection criteria as stated in the procurement documents
III.2)

Conditions related to the contract

Section IV: Procedure

IV.1)

Description

IV.1.1)

Type of procedure

Open procedure
IV.1.8)

Information about the Government Procurement Agreement (GPA)

The procurement is covered by the Government Procurement Agreement : yes
IV.2)

Administrative information

IV.2.2)

Time limit for receipt of tenders or requests to participate

Date:  05/01/2022
Local time:  13:00
IV.2.4)

Languages in which tenders or requests to participate may be submitted

English
IV.2.6)

Minimum time frame during which the tenderer must maintain the tender

Tender must be valid until:  05/04/2022
IV.2.7)

Conditions for opening of tenders

Date:  05/01/2022
Local time:  13:00

Section VI: Complementary information

VI.1)

Information about recurrence

This is a recurrent procurement:  no
VI.4)

Procedures for review

VI.4.1)

Review body

The Royal Courts of Justice
The Strand
London
WC2A 2LL
UK

VI.4.4)

Service from which information about the review procedure may be obtained

London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
UK
E-mail: procurement@lshtm.ac.uk