Voluntary ex ante transparency notice
Directive 2014/24/EU
Section I: Contracting
entity
I.1) Name and addresses
NHS Wales Shared Services Partnership (NWSSP) - Procurement Services
Woodland House, 2nd Floor, Maes-Y-Coed Road
Cardiff
CF14 4HH
UK
Contact person: Nia Price
Telephone: +44 2921501500
E-mail: nia.price@wales.nhs.uk
NUTS: UK
Internet address(es)
Main address: http://nwssp.nhs.wales/ourservices/procurement-services/
Address of the buyer profile: https://www.sell2wales.gov.wales/search/Search_AuthProfile.aspx?ID=AA0221
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
Supply and Manufacture of Investigational Medicinal Products (IMPs) for the Clinical Trial: "Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision"
II.1.2) Main CPV code
33000000
II.1.3) Type of contract
Supplies
II.1.4) Short description
Cardiff and Vale University Health Board (CAVUHB) is undertaking a clinical trial entitled ‘Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision’, funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (Ref: NIHR 160872). As part of this clinical trial, an Investigational Medicinal Product (IMP) needs to be manufactured and distributed.
II.1.6) Information about lots
This contract is divided into lots:
No
II.1.7) Total value of the procurement
Value excluding VAT:
116 645.00
GBP
II.2) Description
II.2.2) Additional CPV code(s)
33000000
II.2.3) Place of performance
NUTS code:
UKL22
II.2.4) Description of the procurement
Supply and Manufacture of Investigational Medicinal Products (IMPs) for the Clinical Trial: "Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision"
Cardiff and Vale University Health Board (CAVUHB) is undertaking a clinical trial entitled ‘Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision’, funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (Ref: NIHR 160872). As part of this clinical trial, an Investigational Medicinal Product (IMP) needs to be manufactured and distributed. The IMPs required are:
-Flucloxacillin 2 x 500mg capsules, over encapsulated
-A matching placebo of inert filler, over encapsulated to match flucloxacillin 2 x 500mg capsules.
The successful supplier will be responsible for the manufacture, packaging, labelling, Quality Assurance (QA) certification, storage, shipment, and regulatory compliance (CTIMP regulations) associated with the trial’s IMPs.
After extensive market research and consultations with multiple suppliers, it has been concluded that only one supplier, Simbec-Orion, has the capability to fulfil the full scope of the contract requirements. This includes:
-Over encapsulation of flucloxacillin and matching placebo
-Packaging and labelling of the final product
-Compliance with clinical trial regulations (CTIMP)
-Storage and shipment logistics to participating NHS sites
-QA certification and regulatory compliance for blinded clinical trials
Simbec-Orion will also source the bulk IMP (4 lots of flucloxacillin, 1 lot of placebos), over encapsulate the product, and ensure all necessary documentation and quality assurance procedures are met.
Simbec-Orion is uniquely positioned to meet the requirements of the clinical trial due to its established capabilities in the manufacture and regulatory compliance of Investigational Medicinal Products (IMPs). No other supplier was found to be able to offer the complete set of services required for this project.
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 IV: Procedure
IV.1) Description
IV.1.1) Type of procedure
Negotiated procedure without prior publication
Justification for selected award procedure:
The products involved are manufactured purely for the purpose of research, experiment, study or development under the condition stated in the Directive (for supplies only)
Explanation:
The products involved are manufactured purely for the purpose of research. In addition, Simbec-Orion is positioned to meet the requirements of the clinical trial. No other supplier was found to be able to offer the complete set of services required for this project.
IV.1.8) Information about Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement:
Yes
Section V: Award of contract/concession
Contract No: CAV-VEA (24-25) 169
V.2 Award of contract/concession
V.2.1) Date of conclusion of the contract/concession
01/01/2025
V.2.2) Information about tenders
The contract has been awarded to a group of economic operators:
No
V.2.3) Name and address of the contractor
SIMBEC RESEARCH LIMITED
Simbec House Merthyr Tydfil Industrial Park, Pentrebach
Merthyr Tydfil
CF484DR
UK
Telephone: +44 1753944092
NUTS: UKL
The contractor is an SME:
Yes
V.2.4) Information on value of the concession and main financing terms (excluding VAT)
Total value of the concession/lot:
116 645.00
GBP
V.2.5) Information about subcontracting
Section VI: Complementary information
VI.3) Additional information
NHS Wales Shared Services Partnership are publishing this notice on behalf of;
Cardiff and Vale University Health Board
Woodland House
Maes-y-Coed Road
Cardiff
CF14 4HH
A standstill period of 10 calendar days from publication of this notice will be observed by the authority prior to entering into a contract.
NOTE: To register your interest in this notice and obtain any additional information please visit the Sell2Wales Web Site at http://www.sell2wales.gov.wales/Search/Search_Switch.aspx?ID=147495.
(WA Ref:147495)
VI.4) Procedures for review
VI.4.1) Review body
High Court
Royal Courts of Justice, The Strand
London
WC2A 2LL
UK
Telephone: +44 2079477501
VI.5) Date of dispatch of this notice
20/01/2025