Section one: Contracting authority
one.1) Name and addresses
Defra Network eTendering Portal
17 Nobel House
London
SW1P 3JR
Telephone
+44 2072385921
Country
United Kingdom
NUTS code
UK - United Kingdom
Internet address(es)
Main address
one.3) Communication
Additional information can be obtained from the above-mentioned address
one.4) Type of the contracting authority
Ministry or any other national or federal authority
one.5) Main activity
Environment
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Provision of Regulatory Affairs services to support with obtaining Marketing Authorisation from the VMD for Cattle BCG and a companion skin test, DST-F
Reference number
33135
two.1.2) Main CPV code
- 71356000 - Technical services
two.1.3) Type of contract
Services
two.1.4) Short description
Provision of services for compilation and submission to the UK Veterinary Medicines Directorate of Marketing Authorisation Dossiers for CattleBCG and DST-F as part of the of the UK Government bovine tuberculosis (bTB) eradication programme.
two.1.5) Estimated total value
Value excluding VAT: £210,000
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.2) Additional CPV code(s)
- 71356300 - Technical support services
two.2.3) Place of performance
NUTS codes
- UK - United Kingdom
two.2.4) Description of the procurement
APHA is seeking a contractor for provision of regulatory services for immunological veterinary medicinal products (IVMPs) to compile two Marketing Authorisation (MA) dossiers and manage the MA submissions CattleBCG and DST-F, a DIVA skin test classified as an IVMP for regulatory purposes.
The contractor will be responsible for collating all relevant documentation and parts of the dossier submission to include summary of the dossier, product quality, safety and efficacy data and bibliographic references. Compiling the dossiers according to the requirements outlined in EurdraLex- Volume 6B & 6C and any additional requirements laid down by the VMD for the content and structure of the dossiers
The dossiers will be produced to a high specification with respect to content, format and ease of access for the assessors it will be submitted by the contractor via the VMD portal.
The contractor will be the point of contact between APHA and VMD throughout the MA application process including managing the responses to questions or issues raised by the VMD during the MA application procedure. The contractor will play a critical role ensuring timelines for responses are met and working closely with the experts at the APHA to ensure complete and full responses to address VMD concerns, questions or points of clarification.
APHA estimates that the service is required to commence in January 2022.
Note that the contract specification, to be issued as part of the tender documents, will provide comprehensive information on the mandatory standards and requirements for this contract.
two.2.14) Additional information
The purpose of this PIN is to alert the market to a possible opportunity and invite interested parties to download the supplier information pack which has further information on this project and is available on Defra's e-Sourcing system Bravo (https://defra.bravosolution.co.uk/) under Project 33135.
Please note it is free to register on Bravo.
two.3) Estimated date of publication of contract notice
24 September 2021
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
A supplier information pack with further information on this Project is available on Defra's e-Sourcing system Bravo (https://defra.bravosolution.co.uk/) under Project 33135.
Please note it is free to register on Bravo.