Section one: Contracting authority/entity
one.1) Name, addresses and contact point(s)
Ministry of Defence
Ministry of Defence, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT), YEW 3a, #1342, MOD Abbey Wood
Bristol
BS34 8JH
For the attention of
Alexandra Lashmar
Email(s)
alexandra.lashmar100@mod.gov.uk
Country
United Kingdom
Internet address(es)
General address of the contracting authority/entity
https://www.gov.uk/government/organisations/defence-equipment-and-support
Address of the buyer profile
https://www.gov.uk/government/organisations/defence-equipment-and-support
Further information
Further information can be obtained from the above mentioned contact point(s)
Specifications and additional documents (including documents for competitive dialogue and a dynamic purchasing system) can be obtained from
The above-mentioned contact point(s)
Tenders or requests to participate must be sent to
The above-mentioned contact point(s)
Section two: Object of the contract
two.1) Description
two.1.1) Title attributed to the contract by the contracting authority
CBRN/00282 - Supply of Pyridostigmine tablets
two.1.2) Type of contract and location of works, place of delivery or of performance
Supplies
Purchase
NUTS code
- UK - UNITED KINGDOM
- UKK11 - Bristol, City of
two.1.5) Short description of the contract or purchase(s)
The UK Ministry of Defence (UK MOD) has a requirement for the production of Pyridostigmine Bromide tablets for oral consumption. The Chemical Biological Radiological Nuclear Team (CBRN) is seeking to appoint a manufacturer to produce these tablets for which it currently maintains the Marketing Authorisation (MA) on behalf of the Secretary of State for Defence.
two.1.6) Common procurement vocabulary (CPV)
- 33661000 - Medicinal products for the nervous system
Additional CPV code(s)
- 33000000 - Medical equipments, pharmaceuticals and personal care products
- 33140000 - Medical consumables
- 33190000 - Miscellaneous medical devices and products
- 33661700 - Other nervous system medicinal products
- 33690000 - Various medicinal products
- 35113200 - Nuclear, biological, chemical and radiological protection equipment
- 85121200 - Medical specialist services
two.1.7) Information about subcontracting
The tenderer has to indicate in the tender any share of the contract it may intend to subcontract to third parties and any proposed subcontractor, as well as the subject-matter of the subcontracts for which they are proposed
The tenderer has to indicate any change occurring at the level of subcontractors during the execution of the contract
two.1.8) Lots
This contract is divided into lots: No
two.1.9) Information about variants
Variants will be accepted: No
two.2) Quantity or scope of the contract
two.2.1) Total quantity or scope
The Supplier is to be responsible for:
1. Manufacture Pyridostigmine tablets, as per the technical specifications, on behalf of the UK MOD; the Marketing Authorisation Holder.
2. Develop protocols, compliant with ICH guidelines, to support stability studies for the life of the product.
3. Documentation and data, including a technical transfer summary report, to support license changes to ensure the manufacturer is named on the MA as the licensed manufacturer for the product.
4. Manufacture product in accordance with current Good Manufacturing Practice (cGMP) standards as defined by the International Conference on Harmonisation and regulated by the national competent Authority’s in Europe and Canada.
5. Storage of the finished product and all product movement between Qualified Person (QP) release and receipt will be carried out in accordance with the requirements of Good Distribution Practice (GDP) and the Guidelines on GDP on Medicinal Products for Human Use (2013/C 343/01) or as subsequently amended.
Initial quantity of requirement is estimated to be in the region of 140,00 to 200,000 tablets. Exact quantities to be confirmed at ITN stage. Quantities for Option years are not included within this range, and will also be confirmed at ITN stage.
The initial contract period will be 5 years, with the option to extend up to a further 5 years (total estimated contract duration is 10)
Estimated value excluding VAT:
Range: between £4,000,000 and £7,000,000
two.2.2) Information about options
Options: Yes
Description of these options: 5 x annual Option Periods ( be commenced 5 years from contract award)
Provisional timetable for recourse to these options:
In months: 54 (from the award of the contract)
two.2.3) Information about renewals
This contract is subject to renewal: Yes
two.3) Duration of the contract or time limit for completion
Duration in months: 120 (from the award of the contract)
Section three. Legal, economic, financial and technical information
three.1) Conditions relating to the contract
three.1.1) Deposits and guarantees required
This will be detailed in the ITN
three.1.2) Main financing conditions and payment arrangements and/or reference to the relevant provisions governing them
This will be detailed in the ITN
three.1.3) Legal form to be taken by the group of economic operators to whom the contract is to be awarded
This will be detailed in the ITN
three.1.4) Other particular conditions to which the performance of the contract is subject, in particular with regard to security of supply and security of information
This will be detailed in the ITN
three.2) Conditions for participation
three.2.1) Personal situation
Criteria regarding the personal situation of economic operators (that may lead to their exclusion) including requirements relating to enrolment on professional or trade registers
Information and formalities necessary for evaluating if the requirements are met: This will be detailed in the ITN.
Criteria regarding the personal situation of subcontractors (that may lead to their rejection) including requirements relating to enrolment on professional or trade registers
Information and formalities necessary for evaluating if the requirements are met: This will be detailed in the ITN.
three.2.2) Economic and financial ability
Criteria regarding the economic and financial standing of economic operators (that may lead to their exclusion)
Information and formalities necessary for evaluating if the requirements are met: This will be detailed in the PQQ / ITN.
Minimum level(s) of standards possibly required: This will be detailed in the PQQ / ITN.
Criteria regarding the economic and financial standing of subcontractors (that may lead to their exclusion)
Information and formalities necessary for evaluating if the requirements are met: This will be detailed in the PQQ / ITN.
Minimum level(s) of standards possibly required: This will be detailed in the PQQ / ITN.
three.2.3) Technical and/or professional capacity
Criteria regarding the technical and/or professional ability of economic operators (that may lead to their exclusion)
Information and formalities necessary for evaluating if the requirements are met: This will be detailed in the PQQ / ITN.
Minimum level(s) of standards possibly required: This will be detailed in the PQQ / ITN.
Criteria regarding the technical and/or professional ability of subcontractors (that may lead to their rejection)
Information and formalities necessary for evaluating if the requirements are met: This will be detailed in the PQQ / ITN.
Minimum level(s) of standards possibly required: This will be detailed in the PQQ / ITN.
Section four: Procedure
four.1) Type of procedure
four.1.1) Type of procedure
Negotiated
four.2) Award criteria
four.2.1) Award criteria
the criteria stated in the specifications, in the invitation to tender or to negotiate or in the descriptive document
four.2.2) Information about electronic auction
An electronic auction has been used: no
four.3) Administrative information
four.3.1) File reference number attributed by the contracting authority
CBRN/00282
four.3.2) Previous publication(s) concerning the same contract
no
four.3.4) Time limit for receipt of tenders or requests to participate
7 April 2021 - 5:00pm
four.3.5) Date of dispatch of invitations to tender or to participate to selected candidates
19 May 2021
four.3.6) Language(s) in which tenders or requests to participate may be drawn up
English
Section six: Complementary information
six.1) Information about recurrence
This is a recurrent procurement: Yes
Estimated timing for further notices to be published: 2028
six.2) Information about European Union funds
The contract is related to a project and/or programme financed by European Union funds: No
six.3) Additional information
The Contracting Authority intends to use an e-Tendering system in this procurement exercise, please visit www.contracts.mod.uk for full details and to register your interest in this procurement.
The deadline for submitting your response(s) is detailed within this contract notice. Please ensure that you allow yourself plenty of time when responding to this opportunity prior to the closing date and time, especially if you have been asked to upload documents.
The Authority reserves the right to amend any condition related to security of information to reflect any changes in national law or government policy. If any contract documents are accompanied by instructions on safeguarding classified information (e.g. a Security Aspects Letter), the Authority reserves the right to amend the terms of these instructions to reflect any changes in national law or government policy, whether in respect of the applicable protective marking scheme, specific protective markings given, the aspects to which any protective marking applies, or otherwise. The link below to the Gov.uk website provides information on the Government Security Classification.
https://www.gov.uk/government/publications/government-security-classifications
The Cyber Risk Profile for this requirement identified by the Cyber Risk Assessment is Very low (Ref No: RAR-7TGB4RZX).
Electronic Trading:
Potential suppliers must note the mandatory requirement for electronic trading using the Contracting, Purchasing and Finance (CP&F) electronic procurement tool. All payments for Contractor Deliverable's under the Contract shall only be made via CP&F. You can find details on CP&F at https://www.gov.uk/government/publications/mod-contracting-purchasing-and-finance-e-procurement-system.
Interested suppliers are required to complete the Pre-Qualification Questionnaire (PQQ) to provide the Authority with information to evaluate the supplier’s capacity and capability against the selection criteria.
The Authority will use the PQQ response to create a shortlist of tenderers who:
(1) are eligible to participate;
(2) fulfil any minimum economic, financial, professional and technical standards; and
(3) best meet in terms of capacity and capability the selection criteria set out in the PQQ.
Full details of the method for choosing the tenderers will be set out in the PQQ. For all scored questions Potential Suppliers must achieve a mark of 2 (Satisfactory), if you score below 2 (Satisfactory) the Authority reserves the right to eliminate you from the competition.
During the PQQ stage, the intention is to arrive at a short list of a minimum of three (3) and a maximum of six (6) qualified potential suppliers for formal invitation to negotiate. This list of six (6) qualified potential suppliers will be made up of the top six (6) performing PQQ responses.
six.4) Procedures for appeal
six.4.1) Body responsible for appeal procedures
Ministry of Defence, IBOC, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Bristol
BS34 8JH
Email(s)
alexandra.lashmar100@mod.gov.uk
Country
United Kingdom
six.4.1) Body responsible for mediation procedures
Ministry of Defence, IBOC, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Bristol
BS34 8JH
Email(s)
alexandra.lashmar100@mod.gov.uk
Country
United Kingdom
six.4.3) Service from which information about the lodging of appeals may be obtained
Ministry of Defence, IBOC, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Bristol
BS34 8JH
Email(s)
alexandra.lashmar100@mod.gov.uk
Country
United Kingdom