Section one: Contracting authority
one.1) Name and addresses
Defra Network eTendering Portal
17 Nobel House, Smith Square
London
SW1P 3JR
Telephone
+44 2072385921
Country
United Kingdom
NUTS code
UK - United Kingdom
Internet address(es)
Main address
Buyer's address
https://defra.bravosolution.co.uk
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 for Marketing Authorisation of Cattle BCG and 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
Award of contract for provision of regulatory affairs services whereby the contractor will be responsible for collating all relevant documentation and compiling the Marketing Authorisation (MA) dossiers for both Cattle BCG and DST-F for the Animal and Plant Health Agency (APHA), according to the requirements outlined in Title II of Directive 2009.9.EC and submitting these to the Veterinary Medicines Directorate (VMD) for approval.
two.1.6) Information about lots
This contract is divided into lots: No
two.1.7) Total value of the procurement (excluding VAT)
Value excluding VAT: £277,200
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
The Animal and Plant Health Agency (APHA) is appointing a contractor to provide regulatory affairs services whereby the contractor will be responsible for collating all relevant documentation and compiling the Marketing Authorisation (MA) dossiers for both Cattle BCG and DST-F for APHA, according to the requirements outlined in Title II of Directive 2009.9.EC and submitting these to the Veterinary Medicines Directorate (VMD) for approval. This requirement sits within the Cattle BCG vaccine sub-programme funded by Defra and supporting the wider bovine tuberculosis eradication strategy for England. The services to be delivered by the contractor will support APHA’s aim to have Marketing Authorisation Holder approval in the UK for both Cattle BCG and DST-F.
The key objectives of the procurement are to:
Ensure that the Marketing Authorisation (MA) dossier process is followed, including collation of required study data;
Submit the MA application for both Cattle BCG and DST-F;
Deliver a successful MA application;
Deliver value for money;
Support timelines of other related projects in delivery of a deployable Cattle BCG vaccine by delivering the above objectives;
two.2.5) Award criteria
Quality criterion - Name: Quality Criterion - Technical questions / Weighting: 60%
Price - Weighting: 40%
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
The contract has been awarded in accordance with the criteria outlined in the 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 000-028008
Section five. Award of contract
Contract No
ref 33135
Title
Provision of Regulatory Affairs Services for Marketing Authorisation of Cattle BCG and DST-F
A contract/lot is awarded: Yes
five.2) Award of contract
five.2.1) Date of conclusion of the contract
9 May 2022
five.2.2) Information about tenders
Number of tenders received: 2
Number of tenders received from tenderers from other EU Member States: 1
Number of tenders received from tenderers from non-EU Member States: 1
Number of tenders received by electronic means: 2
The contract has been awarded to a group of economic operators: No
five.2.3) Name and address of the contractor
Klifovet GmbH
Geyerspergerstraße 27
Munich
80689
Country
Germany
NUTS code
- DE - Germany
The contractor is an SME
No
five.2.4) Information on value of contract/lot (excluding VAT)
Initial estimated total value of the contract/lot: £277,200
Total value of the contract/lot: £277,200
Section six. Complementary information
six.4) Procedures for review
six.4.1) Review body
Defra
Nobel House, 17 Smith Square
London
SW1P 3JR
Country
United Kingdom
six.4.2) Body responsible for mediation procedures
Royal Courts of Justice
London
WCA 2LL
Country
United Kingdom
six.4.4) Service from which information about the review procedure may be obtained
Defra Group Commercial
17 Smith Square
London
SW1P 3JR
Country
United Kingdom