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
The procurement documents are available for unrestricted and full direct access, free of charge, at
https://defra.bravosolution.co.uk
Additional information can be obtained from the above-mentioned address
Tenders or requests to participate must be submitted electronically via
https://defra.bravosolution.co.uk
Tenders or requests to participate must be submitted to 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 regulatory affairs 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.1.6) 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 Veterinary Medicines Directorate (VMD) for the content and structure of the dossiers
Services are expected to commence from February 2022, please refer to tender document for more information on service commencement date.
two.2.5) Award criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
36
This contract is subject to renewal
Yes
Description of renewals
Optional 12 month extension. No further renewals expected after this.
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
two.2.14) Additional information
A PIN was issued earlier this year is to alert the market to this opportunity and invited interested parties to download the supplier information pack which has further information on this project.
This supplier information pack can be downloaded from Bravo along with the full tender documents.
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
Please refer to tender documents
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
three.2) Conditions related to the contract
three.2.2) Contract performance conditions
Please refer to tender 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.2.1) Previous publication concerning this procedure
Notice number: 2021/S 000-019388
four.2.2) Time limit for receipt of tenders or requests to participate
Date
9 December 2021
Local time
12:00pm
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
Duration in months: 4 (from the date stated for receipt of tender)
four.2.7) Conditions for opening of tenders
Date
9 December 2021
Local time
12:00pm
Information about authorised persons and opening procedure
Sealed Parallel Opening of Tender Documents via Bravo e-Tendering System
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
Defra
London
SW1P 3JR
Country
United Kingdom