NP43226 Nitric Oxide Therapy

Eignungskriterien

• 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.

• (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 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. [AND] (c) All medical devices tendered and associated ancillaries supplied under this Framework Agreement will comply with Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), have an appropriate declaration of conformity and display a valid CE, CE UKNI or UKCA mark. [AND] (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. Minimum

  • •(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 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 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.
  • •[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.

Zuschlagskriterien

• Quality of Service: 15

• Delivery System: 10

• Contingency Plan(s): 5

• Account Management: 5