MHRA specials licenced manufacturing facility

Description

The North East and North Cumbria (NENC) Provider Collaborative is a formal partnership of all 11 NHS Foundation Trusts (FTs) in the region. Together it covers the entire geographical footprint of the NENC Integrated Care System, from North Yorkshire up to the Scottish borders, and provides the vast majority of all secondary NHS care services with millions of patient interactions every single day. The NENC Provider Collaborative proposes in this pre market engagement document is to establish a NENC aseptics pharmaceutical production hub at Seaton Delaval, as part of a hub and spoke model, with four initial key priority areas: 1. Injectable chemotherapy medicines supply 2. Addressing nursing time currently spent preparing injectable medicines (primarily Ready to Administer (RtA) injectable antibiotic medicines to clinical areas) 3. Parenteral nutrition production 4. Provision of centralised over labelling of medicines This will deliver substantial benefits improving clinical safety, delivering a reliable supply of products for patient use, freeing up capacity on hospital sites and directly releasing significant nursing time for patient care. NENC PC are looking to assess the feasibility of establishing an MHRA specials licenced manufacturing facility capable of meeting GMP, quality and operational requirements. The proposed output of this facility will be: • 950,000 Ready to Administer (RtA) products • 70,000 Systemic anti-cancer therapies and Monoclonal antibodies • 70,000 Parenteral Nutrition products. • 400,000 - 600,000 over labelled products. NHFM is conducting a preliminary market consultation in accordance with the Public Contracts Regulations 2015 reg. 40 with interested organisations to be held on the 10th and 14th February 2023 details of which can be downloaded from the NHFM e-tender Portal https://procontract.due-north.com reference number DN652731 Following the event companies will be required to complete a questionnaire which must be returned via the NHFM e tender portal no later that 12:00 Noon on 24/2/23. Lot 1: The NENC PC are looking to assess the feasibility of establishing an MHRA specials licenced manufacturing facility capable of meeting GMP, quality and operational requirements. The proposed output of this facility will be: • 950,000 Ready to Administer (RtA) products • 70,000 Systemic anti-cancer therapies and Monoclonal antibodies • 70,000 Parenteral Nutrition products. • 400,000 - 600,000 over labelled products.