Section one: Contracting authority
one.1) Name and addresses
NHS Scotland
Gyle Square (NSS Head Office), 1 South Gyle Crescent
Edinburgh
EH12 9EB
Contact
Nadia Crockett
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
NP42824 Unlicensed Imported Medicines
two.1.2) Main CPV code
- 33600000 - Pharmaceutical products
two.1.3) Type of contract
Supplies
two.1.4) Short description
The supply of unlicensed imported medicines to NHS Scotland.
two.1.5) Estimated total value
Value excluding VAT: £8,692,952
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
Additional Unlicensed Imported Medicines
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 additional unlicensed imported medicines incorporating an over labelling and translation service to meet any future requirements as identified by the authority. The scope of these products is unknown at this stage.
The Authority intends to award this framework as an unranked multi-supplier framework with all framework participants who pass the selection criteria receiving the opportunity to participate in Lot 2, regardless if successful or unsuccessful on Lot 1. The mechanism for adding goods to this lot will be described in the ITT.
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
24
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 forty-eight (48) 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
Unlicensed Imported Medicines
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 Unlicensed Imported Medicines to NHS Scotland. The Authority intends to award this Lot as a single supplier per product line. Full details of Goods and volumes can be found within the ITT documents.
two.2.5) Award criteria
Quality criterion - Name: Quality — sourcing process / Weighting: 16
Quality criterion - Name: Quality — over labelling and translation service / Weighting: 24
Quality criterion - Name: Logistics — delivery and stock capability / Weighting: 7
Quality criterion - Name: Logistics - minimum order quantity and value / Weighting: 3
Price - Weighting: 50
two.2.6) Estimated value
Value excluding VAT: £8,692,952
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
24
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 forty-eight (48) 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.1.3) Technical and professional ability
List and brief description of selection criteria
(a) All goods supplied under the framework agreement must be stored in and distributed from a site holding an MHRA wholesale distribution authorisation (WDA) valid for import and handling unlicensed relevant medicinal products issued by the MHRA and for import from outside of the EEA, a manufacturer's ‘specials’ licence (MS)valid for import;
(b) 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.
(c) Potential framework participants and/or sub-contractor(s) must offer a product overlabelling service to meet the NHS pharmaceutical quality assurance committee ‘Packaging and labelling for safety: unlicensed imported medicines — guidance for the overlabelling and provision of translated information, edition 2 December 2018’ guidance where original packaging is not in English;
(d) Potential framework participants and/or any sub-contractor(s) must offer a translation service for the translation of the SPC, labels and PIL's. Translations must be performed to ISO 17100 for translation services standard or equivalent;
(e) Potential framework participants and any sub-contractor(s) must possess valid certification of BS EN ISO9001 or equivalent.
Minimum level(s) of standards possibly required
(a) Potential Framework Participants must provide confirmation of a current and valid Wholesale Distribution Authorisation (WDA) valid for importing and handling unlicensed relevant medicinal products issued by the MHRA and for import from outside of the EEA, a Manufacturer's Specials' (Licence) MS valid for import;
(b) 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.
Confirmation for (a) and (b) at the date of submission of the tender should be stated in the Qualification Envelope of the ITT under Part 4C: Quality Control.
(c) Potential framework participants must provide confirmation they can offer a product overlabelling service to meet the NHS Pharmaceutical Quality Assurance Committee ‘Packaging and labelling for safety: unlicensed imported medicines — guidance for the overlabelling and provision of translated information, edition 2 December 2018’ guidance where original packaging is not in English;
(d) Potential framework participants and/or any sub-contractor(s) must provide confirmation they can offer at translation service for the translation of the SPC, labels and PIL's. Translations must be performed to ISO 17100for translation services standard or equivalent;
(e) Confirmation of the existence of valid certification of BS EN ISO 9001 or equivalent.
Confirmation for (c), (d) and (e) at the date of submission of the tender should be stated in the Qualification Envelope of the ITT under Part 4D: Quality Assurance Schemes.
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: 15
In the case of framework agreements, provide justification for any duration exceeding 4 years:
Specialised area of medicines with a limited supply base able to meet the minimum criteria required for supplying unlicensed imported medicines.
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
19 January 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
19 January 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 buyer is using PCS-Tender to conduct this ITT exercise. The Project code is 25719. 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/contractors agree to support the concept, provision, and ongoing development of community benefits provision in relation to this framework/contract.
Potential framework participants/contractors 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/contractors are required to summarise any proposed community benefits that will be developed and delivered as part of this framework/contract if successful or, alternatively, potential framework participants/contractors 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:751547)
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
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.