Disinfection Products for use on Human Skin and Hard Surfaces

Conditions of Participation – Legal and Financial

15.1 Insurances

Suppliers must confirm that they will have prior to contract commencement date, the insurance as detailed within the terms and conditions of contract Schedule 22. Mandatory Requirement

Pass/Fail

To achieve a “Pass” Suppliers must confirm by answering “Yes” that they will have the insurance as detailed within the terms and conditions of contract Schedule 22 prior to the commencement date, a “No” response will result in a “Fail”.

15.2 Insurances

Suppliers must insert details of insurances already in place

OR

Suppliers must insert details of insurances which will be obtained following contract award (including information on how this insurance will be obtained – e.g. a quote) Mandatory Requirement

Pass/Fail

To achieve a “Pass” Suppliers must insert the details of insurance already in place OR insert the details of the insurance which will be obtained following the contract award – including information on how the insurance will be obtained, failure to do so will result in a “Fail”.

15.3 Bank details

Suppliers must insert the following bank details: the name, address and telephone number of their banker Mandatory Requirement

Pass/Fail

To achieve a “Pass” Suppliers must have provided their bank details – name, address and telephone number of their banker, failure to do so will result in a “Fail”.

15.4 Banking History

Suppliers must provide evidence to demonstrate that they have the financial capacity required for the contract.

Note to Suppliers the Buyer will not be paying charges for information requested.

Please furnish this by providing the following:

• Account Name
• Sort Code
• Number of Years account has been opened. Mandatory Requirement

Pass/Fail

To achieve a “Pass” Suppliers must have provided their banking history to evidence that they have the financial capacity required for the contract, failure to do so will result in a “Fail”.

15.5 Annual Turnover

Suppliers must indicate the annual turnover of their organisation over the last 3 financial years. If their organisation is part of a group, they must give figures for both their own organisation and the group.

Please provide proportional turnover figures in respect of the goods/services to which this contract relates for the previous 3 financial years

Example should be presented as follows:

Organisation

Year

Total Annual Turnover £

proportional Annual Turnover £ Mandatory Requirement

Pass/Fail

To achieve a “Pass” suppliers must have provided the annual turnover for their organisation or group (see 15.6) for the last 3 financial years, failure to do so will result in a “Fail”.

15.6 Terms and Conditions

Suppliers must confirm that they have carefully read the documents attached, titled ‘Mid-Tier’ Core Terms and accompanying Schedules and confirm their acceptance of these terms. Mandatory Requirement

Pass/Fail

To achieve a “Pass” Suppliers must confirm by answering “Yes”. A “No” response will result in a “Fail”.

15.7 Mid-Tier Award Form

Suppliers must attach a completed Mid-Tier Award Form. Mandatory Requirement

Pass/Fail

To achieve a “Pass” Suppliers must have attached their completed Mid-Tier Award Form. Failure to do so will result in a “Fail”.

Conditions of Participation - Technical Ability

16.1

16.1a – 16.1c Suppliers must provide details in questions 16.1a, 16.1b and 16.1c, of up to three contracts to meet conditions of participation relating to technical ability set out in the relevant notice or procurement documents, in any combination from either the public or private sectors (which may include samples of grant-funded work).

Mandatory Requirement

Pass/Fail

To achieve a “Pass” supplier, must have provided a minimum of one from the past three years. The named contact provided must be able to validate that the information provided in response to this question is accurate.

For consortium bids, or where you have indicated that you are relying on an associated person to meet the technical ability, you must have provided relevant examples of where the associated person has delivered similar requirements. If this was not possible (e.g. the consortium is newly formed or a special purpose vehicle is to be created for this contract) then three separate examples must have been provided between the principal member(s) of the proposed consortium or members of the special purpose vehicle or sub-contractors (three examples are not required from each member), a failure to provide any relevant examples will result in a “Fail”.

Suppliers who are unable to respond to 16.1 should insert Not Applicable, but must provide a response to 16.2

16.2 Suppliers who cannot provide at least one example of previous relevant contracts held which are relevant to the requirement, must provide an explanation for this and how they meet the conditions of participation relating to technical ability in no more than 500 words e.g. your organisation is a new start-up or you have provided services in the past but not under a contract. Mandatory Requirement

Pass/Fail

To achieve a “Pass” Suppliers must have provided an explanation as to why they have been unable to provide an example of at least one previous relevant contract, and detail how they meet the conditions of participation relating to technical ability. Failure to do so will result in a “Fail”.

16.3

Supply of Medical Devices (i) Compliance with ISO13485:2016 – Medical Devices Quality Management Systems Pass/Fail

Suppliers who supply or manufacture a product classed as a medical device must confirm that the manufacturer complies with ISO13485:2016 - Medical Devices Quality Management Systems.

In order to achieve a “Pass”, Suppliers must provide a ‘Yes’ response, otherwise “Fail”.

If a medical device is not being supplied, Suppliers should avail of the N/A option.

Supply of Medical Devices (ii) Compliance with the Medical Device supply / EU Authorised Representative Pass/Fail

Suppliers must confirm that, where they intend to supply medical devices, either individually or as part of a pack, such medical devices will be released and sold onto the NI market by an appropriate EU Authorised Representative (AR), in accordance with Medical Device Regulation (EU) 2017/745 (as amended/supplemented).

In order to achieve a “Pass”, Suppliers must provide a ‘Yes’ response, otherwise “Fail”.

If a medical device is not being supplied, Suppliers should avail of the N/A option.

16.4 Supply of Medicinal Products Compliance with Medicines Regulations Pass/Fail

To achieve a pass, Tenderers who supply or manufacture products classed as medicinal products must confirm compliance with the provision of the Medicines Acts 1968 and 1971 and the regulations made under the act and the Human Medicines Regulations 2012.

In order to achieve a “Pass”, Suppliers must provide a ‘Yes’ response, otherwise “Fail”.

If a medicinal product is not being supplied, Suppliers should avail of the N/A option.

16.5 Supply of Biocidal Products Compliance with Biocidal Products Regulations Pass/Fail

Suppliers who supply or manufacture a product classed as a biocidal product must confirm that they comply with Biocidal Products Regulation (EU) 528/2012.

In order to achieve a “Pass”, Suppliers must provide a ‘Yes’ response, otherwise “Fail”.

If a biocidal product is not being supplied, Suppliers should avail of the N/A option.

16.6 Confirmation of Supplier’s Manufacturing Capabilities

This section only applies to those suppliers who supply or manufacture products classed as medicinal products. Suppliers must ensure the manufacture of any Products supplied under this Framework is undertaken by an organisation that holds an appropriate licence at all times (i.e. Manufacturer Authorisation (MIA) and complies with Good Manufacturing Practice (GMP)).

(i) Confirmation of Product Manufacturer’s Authorisation (MIA) Pass/Fail

In order to achieve a “Pass”, Suppliers must (a) indicate that certification as outlined in clause 9.1 of the Schedule 2 (Specification) document is accessible via the Medicines and Healthcare Products Regulatory Agency (MHRA) website/database, or (b) provide a copy of certification document to demonstrate compliance with the requirements as stated. Lack of satisfactory evidence demonstrating compliance with the requirements as stated in clause 9.1 of the Schedule 2 (Specification) document will result in a “Fail”.

(ii) Confirmation of Good Manufacturer’s Practice (GMP) Pass/Fail

In order to achieve a “Pass”, Suppliers must (a) indicate that certification as outlined in clause 9.1 of the Schedule 2 (Specification) document is accessible via the Medicines and Healthcare Products Regulatory Agency (MHRA) website/database, or (b) provide a copy of certification (or a relevant Responsible Person (RP) statement) as outlined in clause 9.1 of the Schedule 2 (Specification) document to demonstrate compliance with the requirements as stated. Lack of satisfactory evidence demonstrating compliance with the requirements as stated in clause 9.1 of the Schedule 2 (Specification) document will result in a “Fail”.

16.7 Confirmation of Supplier’s Licensing

This section is only applicable to those Tenderers who distribute products classed as medicinal products. Suppliers must ensure the distribution of any Product supplied under this Framework is undertaken by an organisation that holds an appropriate licence at all times (i.e. a Manufacturer Authorisation (MIA) or Wholesale Distribution Authorisation (WDA) and, where applicable, complies with Good Distribution Practice (GDP)).

(i) Confirmation of Wholesale Distribution Authorisation (WDA) Pass/Fail

In order to achieve a “Pass”, Suppliers must (a) indicate that certification as outlined in clause 9.1 of the Schedule 2 (Specification) document is accessible via the Medicines and Healthcare Products Regulatory Agency (MHRA) website/database, or (b) provide a copy of certification to demonstrate compliance with the requirements as stated (this may be a WDA certificate or evidence that distribution of a medicinal product is provided for in the MIA in the event that the manufacturer is also the distributor of the product). Lack of satisfactory evidence demonstrating compliance with the requirements as stated in clause 9.1 of the Schedule 2 (Specification) document will result in a “Fail”.

(ii) Confirmation of Good Distribution Practice (GDP) Pass/Fail

In order to achieve a “Pass”, Suppliers must (a) indicate that certification as outlined in clause 9.1 of the Schedule 2 (Specification) document is accessible via the Medicines and Healthcare Products Regulatory Agency (MHRA) website/database, or (b) provide a copy of certification (or a relevant Responsible Person (RP) statement) as outlined in clause 9.1 of the Schedule 2 (Specification) document to demonstrate compliance with the requirements as stated. Lack of satisfactory evidence demonstrating compliance with the requirements as stated in clause 9.1 of the Schedule 2 (Specification) document will result in a “Fail”.