Section one: Contracting authority
one.1) Name and addresses
The Common Services Agency (more commonly known as NHS National Services Scotland) ("NSS")
Gyle Square (NSS Head Office), 1 South Gyle Crescent
Edinburgh
EH12 9EB
Contact
Cameron Wright
Telephone
+44 7870831908
Country
United Kingdom
NUTS code
UKM - Scotland
Internet address(es)
Main address
http://www.nss.nhs.scot/browse/procurement-and-logistics
Buyer's address
https://www.publiccontractsscotland.gov.uk/search/Search_AuthProfile.aspx?ID=AA11883
one.2) Information about joint procurement
The contract is awarded by a central purchasing body
one.3) Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at
https://www.publictendersscotland.publiccontractsscotland.gov.uk/web/login.html
Additional information can be obtained from the above-mentioned address
Tenders or requests to participate must be submitted electronically via
https://www.publictendersscotland.publiccontractsscotland.gov.uk/web/login.html
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
NP31424 Clozapine Medicines
two.1.2) Main CPV code
- 33600000 - Pharmaceutical products
two.1.3) Type of contract
Supplies
two.1.4) Short description
Supply of clozapine medicines (alongside four (4) patient testing routes) to NHS Scotland.
Goods and Services have been split into four (4) categories, each of which identified as a “Lot”. The Authority intends awarding a single-supplier Framework Agreement per Lot.
Further detail about each Lot is contained in Section II.2 of this Contract Notice.
two.1.5) Estimated total value
Value excluding VAT: £5,040,815
two.1.6) Information about lots
This contract is divided into lots: Yes
Tenders may be submitted for all lots
two.2) Description
two.2.1) Title
Clozapine Orodispersible Tablets Sugar Free (Non-Core)
Lot No
2
two.2.2) Additional CPV code(s)
- 33600000 - Pharmaceutical products
two.2.3) Place of performance
NUTS codes
- UKM - Scotland
Main site or place of performance
All entities constituted pursuant to the National Health Service (Scotland) Act 1978, and any Integrated Joint Boards established pursuant to the new Public Bodies (Joint Working) Scotland Act 2014.
two.2.4) Description of the procurement
Supply of Clozapine Orodispersible Tablets Sugar Free (Non-Core), alongside three (3) patient testing routes, to NHS Scotland. The Authority intends to award this Lot as a single supplier framework agreement per Lot. Full details of Goods and Services and their volumes can be found within the ITT documents.
two.2.5) Award criteria
Quality criterion - Name: Technical (Services) -- Central Laboratory Testing / Weighting: 12
Quality criterion - Name: Technical (Services) -- Local Laboratory Testing / Weighting: 12
Quality criterion - Name: Technical (Services) -- Near Patient Testing (General) / Weighting: 12
Quality criterion - Name: Technical (Services) -- Training, Educational, and Support Materials / Weighting: 6
Quality criterion - Name: Technical (Services) -- Implementation Plan / Weighting: 18
Price - Weighting: 40
two.2.6) Estimated value
Value excluding VAT: £334,525
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
This Framework Agreement includes the option to extend for any number of periods, up to a maximum overall period of twenty-four (24) months, upon giving not less than three (3) months written notice, such notice to expire no later than the date the Framework Agreement is due to expire.
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) Description
two.2.1) Title
Clozapine Tablets (Near Patient Testing (Capillary)) (Non-Core)
Lot No
4
two.2.2) Additional CPV code(s)
- 33600000 - Pharmaceutical products
two.2.3) Place of performance
NUTS codes
- UKM - Scotland
Main site or place of performance
All entities constituted pursuant to the National Health Service (Scotland) Act 1978, and any Integrated Joint Boards established pursuant to the new Public Bodies (Joint Working) Scotland Act 2014.
two.2.4) Description of the procurement
Supply of Clozapine Tablets (Near Patient Testing (Capillary)) (Non-Core), alongside one (1) patient testing route, to NHS Scotland. The Authority intends to award this Lot as a single supplier framework agreement per Lot. Full details of Goods and Services and their volumes can be found within the ITT documents.
two.2.5) Award criteria
Quality criterion - Name: Technical (Services) -- Central Laboratory Testing / Weighting: 12
Quality criterion - Name: Technical (Services) -- Local Laboratory Testing / Weighting: 12
Quality criterion - Name: Technical (Services) -- Near Patient Testing (General) / Weighting: 12
Quality criterion - Name: Technical (Services) -- Training, Educational, and Support Materials / Weighting: 6
Quality criterion - Name: Technical (Services) -- Implementation Plan / Weighting: 18
Quality criterion - Name: Technical (Services) -- Near Patient Testing (Capillary Blood Sampling) / Weighting: 0
Price - Weighting: 40
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
This Framework Agreement includes the option to extend for any number of periods, up to a maximum overall period of twenty-four (24) months, upon giving not less than three (3) months written notice, such notice to expire no later than the date the Framework Agreement is due to expire.
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
No value has been estimated for Lot 4 because (a) the requirement has never been used by Participating Authorities before, and (b) the requirement is speculative in nature.
Award to Lot 4 is contingent on the Potential Framework Participant (a) being proposed for award to Lot 1 and (b) receiving a score of "pass" for the "Near Patient Testing (Capillary Blood Sampling)" award criterion.
two.2) Description
two.2.1) Title
Clozapine Tablets (Core)
Lot No
1
two.2.2) Additional CPV code(s)
- 33600000 - Pharmaceutical products
two.2.3) Place of performance
NUTS codes
- UKM - Scotland
Main site or place of performance
All entities constituted pursuant to the National Health Service (Scotland) Act 1978, and any Integrated Joint Boards established pursuant to the new Public Bodies (Joint Working) Scotland Act 2014.
two.2.4) Description of the procurement
Supply of Clozapine Tablets (Core), alongside three (3) patient testing routes, to NHS Scotland. The Authority intends to award this Lot as a single supplier framework agreement per Lot. Full details of Goods and Services and their volumes can be found within the ITT documents.
two.2.5) Award criteria
Quality criterion - Name: Technical (Services) -- Central Laboratory Testing / Weighting: 12
Quality criterion - Name: Technical (Services) -- Local Laboratory Testing / Weighting: 12
Quality criterion - Name: Technical (Services) -- Near Patient Testing (General) / Weighting: 12
Quality criterion - Name: Technical (Services) -- Training, Educational, and Support Materials / Weighting: 6
Quality criterion - Name: Technical (Services) -- Implementation Plan / Weighting: 18
Price - Weighting: 40
two.2.6) Estimated value
Value excluding VAT: £4,026,980
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
This framework includes the option to extend for any number of periods, up to a maximum overall period of twenty-four (24) months, upon giving not less than three (3) months written notice, such notice to expire no later than the date the Framework Agreement is due to expire.
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) Description
two.2.1) Title
Clozapine Oral Suspension Sugar Free (Non-Care)
Lot No
3
two.2.2) Additional CPV code(s)
- 33600000 - Pharmaceutical products
two.2.3) Place of performance
NUTS codes
- UKM - Scotland
Main site or place of performance
All entities constituted pursuant to the National Health Service (Scotland) Act 1978, and any Integrated Joint Boards established pursuant to the new Public Bodies (Joint Working) Scotland Act 2014.
two.2.4) Description of the procurement
Supply of Clozapine Clozapine Oral Suspension Sugar Free (Non-Care), alongside three (3) patient testing routes, to NHS Scotland. The Authority intends to award this Lot as a single supplier framework agreement per Lot. Full details of Goods and Services and their volumes can be found within the ITT documents.
two.2.5) Award criteria
Quality criterion - Name: Technical (Services) -- Central Laboratory Testing / Weighting: 12
Quality criterion - Name: Technical (Services) -- Local Laboratory Testing / Weighting: 12
Quality criterion - Name: Technical (Services) -- Near Patient Testing (General) / Weighting: 12
Quality criterion - Name: Technical (Services) -- Training, Educational, and Support Materials / Weighting: 6
Quality criterion - Name: Technical (Services) -- Implementation Plan / Weighting: 18
Price - Weighting: 40
two.2.6) Estimated value
Value excluding VAT: £679,100
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
This Framework Agreement includes the option to extend for any number of periods, up to a maximum overall period of twenty-four (24) months, upon giving not less than three (3) months written notice, such notice to expire no later than the date the Framework Agreement is due to expire.
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
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
Economic operators may be excluded from this competition if they are in breach of any situation referred to in regulation 58 of the Public Contracts (Scotland) Regulations 2015.
three.1.3) Technical and professional ability
List and brief description of selection criteria
(a) Potential Framework Participants must be able to demonstrate the existence of a valid and current UK Marketing Authorisation (PL, PLGB, or PLPI number) that has been approved by the MHRA for all tendered Medicines at the start date of the Framework Agreement.
AND
(b) Potential Framework Participants and any sub-contractor(s) must possess valid certification of BS EN ISO 9001 or equivalent.
(c) All tendered Goods must comply with the MHRA best Practice Guidance on Labelling and Packaging and the National Patient Safety Agency ("NPSA") Guidelines on Packaging and Labelling on pack design.
(d) Potential Framework Participants are required to provide evidence that their organisation has taken steps to build their awareness of the climate change emergency and how they will respond.
(e) Potential Framework Participants must be able to demonstrate that all devices tendered and associated ancillaries under this Framework Agreement comply with Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) and have an appropriate declaration of conformity and display a valid CE, CE UKNI or UKCA mark.
Minimum level(s) of standards possibly required
(a) Confirmation of existence of a valid and current UK Marketing Authorisation (PL, PLGB, PLPI number) that has been approved by the MHRA for all tendered Medicines at the date of submission of the tender/start date of the Framework Agreement should be included in the Qualification Envelope of the ITT under the Technical and Professional ability: Quality Control.
AND
(b) Confirmation of the existence of valid certification of BS EN ISO 9001 or equivalent. Confirmation of such certification should be included in the Qualification Envelope of the ITT under the Quality Assurance Schemes.
AND
(c) Confirmation that samples for tendered Goods will be supplied upon request to ensure compliance with the MHRA best Practice Guidance on Labelling and Packaging and the National Patient Safety Agency ("NPSA") Guidelines on Packaging and Labelling on pack design. Confirmation of sample provision should be provided in the Qualification Envelope of the ITT under Technical and Professional ability: Products.
AND
(d) A completed copy of the Bidder Climate Change Plan Template, including planned projects and actions to reduce the bidder’s carbon emissions should be provided in the Qualification Envelope of the ITT under Environmental Management Criteria. This does not need to contain calculated carbon emissions.
(e) Confirmation that all devices tendered and associated ancillaries which are classed as medical devices will carry the appropriate declaration of conformity for the UK market and display a valid CE, CE UKNI or UKCA mark prior to the start date of the Framework Agreement should be included in the Qualification Envelope of the ITT under Technical and Professional ability: Quality Control.
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Open procedure
four.1.3) Information about a framework agreement or a dynamic purchasing system
The procurement involves the establishment of a framework agreement
Framework agreement with several operators
Envisaged maximum number of participants to the framework agreement: 3
In the case of framework agreements, provide justification for any duration exceeding 4 years:
To provide a longer implementation period for the awarded Framework Participant(s) and a reasonable incentive for extension following a successful implementation.
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.2.2) Time limit for receipt of tenders or requests to participate
Date
5 August 2024
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: 3 (from the date stated for receipt of tender)
four.2.7) Conditions for opening of tenders
Date
5 August 2024
Local time
12:00pm
Section six. Complementary information
six.1) Information about recurrence
This is a recurrent procurement: No
six.2) Information about electronic workflows
Electronic ordering will be used
Electronic invoicing will be accepted
Electronic payment will be used
six.3) Additional information
The estimated values referred to in Section II.1.5 and within all Lots cover the thirty-six (36) month Framework Agreement duration and the twenty-four (24) month extension period of the Framework Agreement.
The buyer is using PCS-Tender to conduct this ITT exercise. The Project code is 26293. For more information see: http://www.publiccontractsscotland.gov.uk/info/InfoCentre.aspx?ID=2343
A sub-contract clause has been included in this contract. For more information see: http://www.publiccontractsscotland.gov.uk/info/InfoCentre.aspx?ID=2363
Community benefits are included in this requirement. For more information see: https://www.gov.scot/policies/public-sector-procurement/community-benefits-in-procurement/
A summary of the expected community benefits has been provided as follows:
It is a mandatory requirement that Potential Framework Participants agree to support the concept, provision, and ongoing development of community benefits provision in relation to this Framework Agreement.
Potential Framework Participants are required to agree to this mandatory requirement. They are also requested to provide a summary of the community benefits that have recently been delivered within Scotland, if at all, and what impact and outcomes these have achieved.
Potential Framework Participants are required to summarise any proposed community benefits that will be developed and delivered as part of this Framework Agreement if successful or, alternatively, Potential Framework Participants confirm that they will engage with the NHS Scotland’s Community Benefits Gateway (CBG). This gateway, developed through requests from suppliers seeking opportunities to support the delivery of community benefits within the contracting region, provides information on community benefit opportunities. The CBG is a free and easy to use online service that connects NHS Scotland suppliers with third sector community organisations within Scotland and will be used for tracking and reporting and is an approved compliant route to the realisation of community benefits.
For further information please visit NHSS Community Benefit Gateway (https://www.nss.nhs.scot/procurement-and-logistics/sustainability/access-our-community-benefit-gateway/).
(SC Ref:771637)
six.4) Procedures for review
six.4.1) Review body
Sheriff Court House
27 Chambers Street
Edinburgh
EH1 1LB
Telephone
+44 1312252525
Country
United Kingdom
Internet address
https://scotcourts.gov.uk/the-courts/sheriff-court/about-sheriff-courts
six.4.3) Review procedure
Precise information on deadline(s) for review procedures
The Authority will notify economic operators who submitted a tender or (where no deselection notification has previously been made) applied to be selected to tender, of its decision to award the framework agreement which notification will contain among other information, a summary of the reasons why the economic operators was unsuccessful. The notification will incorporate a ‘standstill period’ of a minimum of 10 clear calendar days (or a minimum of 15 if the communication method used is not electronic) between the date on which the Authority dispatches the notice(s) and the date on which the Authority proposes to conclude the relevant framework agreement. The bringing of court proceedings against the Authority during the standstill period will automatically continue the prohibition on entering into the framework agreement until the court proceedings are determined, discontinued, or disposed of, or the court, by interim order, brings to an end the prohibition. The remedies that may be awarded by the courts before the framework agreement has been entered into include the setting aside of the decision to award the framework agreement to the winning tenderer(s). The bringing of court proceedings against the Authority after the framework agreement has been entered into will not affect the framework agreement unless grounds for the imposition of special penalties under the Public Contracts (Scotland) Regulations 2015 can be established. Otherwise, the remedies that may be awarded by the courts where the framework agreement has been entered into are limited to the award of damages.