Tender for Quality Delivery Partner Pharmaceutical Services

The Chemical Biological Radiological Nuclear Team have a requirement for the provision of a quality delivery partner to provide pharmaceutical services to the front line command.

United Kingdom-Bristol: Nuclear, biological, chemical and radiological protection equipment

2020/S 072-173696

Contract notice

Services

Directive 2009/81/EC

Section I: Contracting authority/entity

I.1)Name, addresses and contact point(s)

Official name: Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Postal address: YEW 3a, #1342, MOD Abbey Wood
Town: Bristol
Postal code: BS34 8JH
Country: United Kingdom
Contact person: Alexandra Lashmar
E-mail: Alexandra.lashmar100@mod.gov.uk
Telephone: +44 3067933663

Internet address(es):

General address of the contracting authority/entity: https://www.gov.uk/government/organisations/defence-equipment-and-support

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)

I.2)Type of the contracting authority

Ministry or any other national or federal authority, including their regional or local sub-divisions

I.3)Main activity

Defence

I.4)Contract award on behalf of other contracting authorities/entities

The contracting authority is purchasing on behalf of other contracting authorities: no

Section II: Object of the contract

II.1)Description

II.1.1)Title attributed to the contract by the contracting authority:

Quality Delivery Partner (QDP) Pharmaceutical Services

II.1.2)Type of contract and location of works, place of delivery or of performance

Services
Service category No 3: Defence services, military defence services and civil defence services
Main site or location of works, place of delivery or of performance: Gloucestershire, Wiltshire and Bristol/Bath area.

NUTS code UKK1

II.1.3)Information on framework agreement

II.1.4)Information on framework agreement

II.1.5)Short description of the contract or purchase(s):

Nuclear, Biological, Chemical and Radiological protection equipment, medical specialist services, pharmaceutical products, pharmaceutical articles, medical equipment, pharmaceuticals and personal care products. The Chemical Biological Radiological Nuclear Team (CBRN) have a requirement for the provision of a quality delivery partner to provide pharmaceutical services to the front line command. The contractor will hold all appropriate uk medical license(s) for the distribution of controlled drugs.

II.1.6)Common procurement vocabulary (CPV)

35113200, 85121200, 33600000, 33680000, 33000000

II.1.7)Information about subcontracting

II.1.8)Lots

This contract is divided into lots: no

II.1.9)Information about variants

Variants will be accepted: no

II.2)Quantity or scope of the contract

II.2.1)Total quantity or scope:

The supplier will be responsible for delivering:
1) Provision of a qualified person (QP) to ensure activities carried out by the Authority are in compliance with Good Manufacturing Practice. (GMP), including:
(a) evaluations certification of batch records and certification of batches of in service medical countermeasures manufactured outside the EU and release to the UK for use by the authority (as the Market Authorisation Holder (MAH));
(b) undertake Good Manufacturing Distribution Practice (GMDP) audits of service providers and product manufacturers/suppliers on behalf of the authority;
(c) liaison with MHRA as necessary, including formal notification to Defective Medicines Reporting Centre (DMRC).
2) Qualified Person for Pharmacovigilance (QPPV) and nominated deputy, to provide on-going support as required for the provision of a fully compliant Pharmacovigilance service, including:
(a) review and comment on the in-house pharmacovigilance and provide medicine information on in-service pre-treatment sets and self administered post exposure treatment of Nerve Agent;
(b) liaison with other competent Authorities to ensure appropriate testing required as a result of registration is completed on behalf of the authority, within the relevant regulatory timelines;
(c) carry out safety monitoring for the products, compile periodic safety update reports and submit the reports to the relevant regulatory authorities.
3) Regulatory affairs consultant, provision of advice and services in order to ensure that the authority is compliant with EU and UK legislation. Notify the authority of any changes in legislation that may have an impact and provide advice on what must be implemented to ensure the market authorisations remain current and compliant;
4) Provision of a Responsible Person (RP) to ensure activities are carried in compliance with Good Distribution Practice (GDP)
(a) to be named as RP on the authorities WDA (Human and Veterinary) and Home Office Controlled Drugs License;
(b) support the authority in maintaining a compliant Quality Management System (QMS);
(c) support the authority in hosting compliance inspection by the competent authorities.
Estimated value excluding VAT:
Range: between 2 500 000 and 4 000 000 GBP

II.2.2)Information about options

Options: yes
Description of these options: Option period 1: continued support from September 2025 to August 2026;
Option period 2: continued support from September 2026 to August 2027.
Both option periods to be individually taken up six months prior to the end of any potential contract period.
Provisional timetable for recourse to these options:
in months: 54 (from the award of the contract)

II.2.3)Information about renewals

This contract is subject to renewal: yes

II.3)Duration of the contract or time limit for completion

Duration in months: 60 (from the award of the contract)

Section III: Legal, economic, financial and technical information

III.1)Conditions relating to the contract

III.1.1)Deposits and guarantees required:

This will be detailed in the ITN.

III.1.2)Main financing conditions and payment arrangements and/or reference to the relevant provisions governing them:

This will be detailed in the ITN.

III.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.

III.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.

III.1.5)Information about security clearance:

Candidates which do not yet hold security clearance may obtain such clearance until: 31.8.2025

III.2)Conditions for participation

III.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.

III.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: (c) where appropriate, a statement, covering the three previous financial years of the economic operator, of:
(i) the overall turnover of the business of the economic operator; and
(ii) where appropriate, the turnover in respect of the work, works, goods or services which are of a similar type to the subject matter of the contract.
This will be detailed in the ITN.

Criteria regarding the economic and financial standing 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 ITN.

III.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 ITN.
Minimum level(s) of standards possibly required
This will be detailed in the 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 ITN.
Minimum level(s) of standards possibly required
This will be detailed in the ITN.

III.2.4)Information about reserved contracts

III.3)Conditions specific to services contracts

III.3.1)Information about a particular profession

Execution of the service is reserved to a particular profession: no

III.3.2)Staff responsible for the execution of the service

Legal persons should indicate the names and professional qualifications of the staff responsible for the execution of the service: yes

Section IV: Procedure

IV.1)Type of procedure

IV.1.1)Type of procedure

Negotiated

IV.1.2)Limitations on the number of operators who will be invited to tender or to participate

Objective criteria for choosing the limited number of candidates:

IV.1.3)Reduction of the number of operators during the negotiation or dialogue

IV.2)Award criteria

IV.2.1)Award criteria

The most economically advantageous tender in terms of the criteria stated in the specifications, in the invitation to tender or to negotiate or in the descriptive document

IV.2.2)Information about electronic auction

An electronic auction has been used: no

IV.3)Administrative information

IV.3.1)File reference number attributed by the contracting authority:

CBRN/00268

IV.3.2)Previous publication(s) concerning the same contract

IV.3.3)Conditions for obtaining specifications and additional documents or descriptive document

IV.3.4)Time limit for receipt of tenders or requests to participate

11.5.2020 – 12:00

IV.3.5)Date of dispatch of invitations to tender or to participate to selected candidates

29.5.2020

IV.3.6)Language(s) in which tenders or requests to participate may be drawn up

English.

Section VI: Complementary information

VI.1)Information about recurrence

This is a recurrent procurement: no

VI.2)Information about European Union funds

The contract is related to a project and/or programme financed by European Union funds: no

VI.3)Additional information:

The contracting authority considers that this contract may be suitable for economic operators that are small or medium enterprises (SMEs). However, any selection of tenderers will be based solely on the criteria set out for the procurement. The authority reserves the right to amend any condition related to security of information to reflect any changes in national law or government policy.
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 a security aspects letter, the authority reserves the right to amend the terms of the security aspects letter 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

Advertising Regime OJEU: this contract opportunity is published in the Official Journal of the European Union (OJEU), the MoD Defence Contracts Bulletin and www.contracts.mod.uk

The Cyber Risk Profile for this requirement identified by the Cyber Risk Assessment is Very low (Ref No: RAR-RA8Y8CT6).
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 fully complete the pre-qualification questionnaire (PQQ) to answer all questions and 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.
Suppliers must read through this set of instructions and follow the process to respond to this opportunity.

The information and/or documents for this opportunity are available on http://www.contracts.mod.uk.

You must register on this site to respond, if you are already registered you will not need to register again, simply use your existing username and password. Please note there is a password reminder link on the homepage.
Suppliers must log in, go to your Response Manager and add the following Access Code: P99NVGBGMS.
Please ensure you follow any instruction provided to you here.
The deadline for submitting your response(s) is detailed within this contract notice, you will also have visibility of the deadline date, once you have added the Access code via DCO as the opening and closing date is visible within the opportunity.
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.

If you experience any difficulties please refer to the online Frequently Asked Questions (FAQ’s) or the User Guides or contact the MOD DCO Helpdesk by emailing support@contracts.mod.uk or Telephone 0800 282 324.

Go reference: GO-202049-DCB-16338005

VI.4)Procedures for appeal

VI.4.1)Body responsible for appeal procedures

Official name: Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Town: Bristol
Country: United Kingdom
E-mail: Alexandra.Lashmar100@mod.gov.uk
Telephone: +44 3067933663

Body responsible for mediation procedures

VI.4.2)Lodging of appeals

VI.4.3)Service from which information about the lodging of appeals may be obtained

VI.5)Date of dispatch of this notice:

9.4.2020