---
title: "PURCON924 - PUFA IMP and Placebo"
ocid: "ocds-h6vhtk-029840"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-029840"
markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-029840.md"
json_url: "https://d3tenders.com/contract/ocds-h6vhtk-029840.json"
source: "Find A Tender Service"
current_stage: "Award"
buyer: "UNIVERSITY OF EAST AGLIA"
published: "2021-04-26"
---

# PURCON924 - PUFA IMP and Placebo

Buyer: UNIVERSITY OF EAST AGLIA  
Current stage: Award  
OCID: ocds-h6vhtk-029840

[View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-h6vhtk-029840)  
[Download OCDS JSON](https://d3tenders.com/contract/ocds-h6vhtk-029840.json)

## Summary

The University of East Anglia is overseeing a public procurement process titled "PURCON924 - PUFA IMP and Placebo" within the medical equipment and pharmaceuticals industry. This active tender is being conducted under an open procurement method and is seeking a manufacturer capable of providing and managing specific pharmaceuticals for a forthcoming clinical trial, which is set to commence recruitment in July 2021 and conclude recruitment in October 2022. The tender period will close on 6 April 2021, and submissions must be made electronically through the designated platform.

This tender presents a significant opportunity for businesses specialising in pharmaceutical manufacturing, particularly those with capabilities in compliance with Good Manufacturing Practices and relevant regulations. Companies that can produce active pharmaceutical ingredients and placebos, while also managing the logistics of dispensing directly to trial participants or to NHS pharmacies, would be especially well-suited to compete. The scale of the requirements includes the provision of approximately 58,900 capsules, inviting substantial engagement from qualified suppliers in the health sector.

## Notice

We are looking to contract with a manufacturer who can: * Provide active Omacor capsules of n-3 PUFA (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in 1g capsules in a 1.3:1 ratio in accordance with specified regulations; * Manufacture matched placebo (palm oil and soybean oil) soft-gel capsules in an 8:2 ratio in accordance with specified regulations; * Bottle and label trial medication in accordance with specified regulations; * QP release the active and placebo capsules with a minimum shelf life of 12 months; and * Either, ship final trial medication direct to participants following dispensing centrally OR ship to recruiting site pharmacies for dispense and onward shipping. The efficacy and mechanisms of action of n-3 poly-unsaturated fatty acid supplementation in people with non-steroidal exacerbated airways disease and uncontrolled asthma (PUFA): placebo-controlled randomised parallel multi-centre clinical trial is due to commence recruitment in July 2021. The trial will be conducted according to Good Clinical Practice and Medicines and Healthcare products Regulatory Agency regulations. The trial is Sponsored by the Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH) with specified tasks delegated to the University of East Anglia (UEA). The UEA Norwich Clinical Trials Unit (NCTU) is a UKCRC registered trials unit and works with sites and institutes across the UK to deliver high quality studies. PUFA is a National Institute of Health Research project funded by the Efficacy and Mechanism Evaluation programme (NIHR number: 129910). PUFA aims to determine whether n-3 poly-unsaturated fatty acid supplementation in people with non-steroidal exacerbated respiratory disease (N-ERD) can improve asthma control as measured by the asthma control questionnaire. A total of 98 participants from NHS Trusts across the UK will be recruited and complete study assessments at 3 monthly intervals for a total of 6 months. Recruitment is anticipated to last 15 months, completing in October 2022. Participants will be recruited throughout this period. Participants will be randomised to receive either 6g / day of n-3 PUFA (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as 6 Omacor capsules (5.04g EPA + DHA) or matched soft-gel placebo (palm oil and soybean oil) capsules, to be taken once daily or in divided doses with food for 6 months. The active treatment will be administered as 6g of EPA and DHA in a 1.3:1 ratio as six Omacor capsules. Active capsules will comprise 84% EPA + DHA. Active capsules should not be altered in any way i.e. must not be overencapsulated. Placebo treatment will comprise 6 soft-gel capsules containing palm oil and soybean oil in an 8:2 ratio. Placebo capsules must appear identical to the active capsules. Trial treatment will be dispensed in bottles to each participant once during their involvement in the trial. We anticipate that 58,900 active capsules and 58,900 placebo capsules will be dispensed in total. Trial medication will need to be produced by a company with a current MIA(IMP) license and in accordance with Good Manufacturing Practice as described in Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014 (Sub-section 2, Part 1, Annex 13). Trial medication will need be certified by a qualified person prior to release and labelled in accordance with Directive 2003/94/EC and Good Manufacturing Practice as described in Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014 (Sub-section 2, Part 1, Annex 16). The final trial medication will be shipped directly to participants homes. This may be direct to participant from the manufacturer or via the local NHS pharmacies. We are happy for suppliers to quote for either both or just one of these methods.

### Lot Information

Lot 1

We are looking to contract with a manufacturer who can: * Provide active Omacor capsules of n-3 PUFA (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in 1g capsules in a 1.3:1 ratio in accordance with specified regulations; * Manufacture matched placebo (palm oil and soybean oil) soft-gel capsules in an 8:2 ratio in accordance with specified regulations; * Bottle and label trial medication in accordance with specified regulations; * QP release the active and placebo capsules with a minimum shelf life of 12 months; and * Either, ship final trial medication direct to participants following dispensing centrally OR ship to recruiting site pharmacies for dispense and onward shipping. The efficacy and mechanisms of action of n-3 poly-unsaturated fatty acid supplementation in people with non-steroidal exacerbated airways disease and uncontrolled asthma (PUFA): placebo-controlled randomised parallel multi-centre clinical trial is due to commence recruitment in July 2021. The trial will be conducted according to Good Clinical Practice and Medicines and Healthcare products Regulatory Agency regulations. The trial is Sponsored by the Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH) with specified tasks delegated to the University of East Anglia (UEA). The UEA Norwich Clinical Trials Unit (NCTU) is a UKCRC registered trials unit and works with sites and institutes across the UK to deliver high quality studies. PUFA is a National Institute of Health Research project funded by the Efficacy and Mechanism Evaluation programme (NIHR number: 129910). PUFA aims to determine whether n-3 poly-unsaturated fatty acid supplementation in people with non-steroidal exacerbated respiratory disease (N-ERD) can improve asthma control as measured by the asthma control questionnaire. A total of 98 participants from NHS Trusts across the UK will be recruited and complete study assessments at 3 monthly intervals for a total of 6 months. Recruitment is anticipated to last 15 months, completing in October 2022. Participants will be recruited throughout this period. Participants will be randomised to receive either 6g / day of n-3 PUFA (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as 6 Omacor capsules (5.04g EPA + DHA) or matched soft-gel placebo (palm oil and soybean oil) capsules, to be taken once daily or in divided doses with food for 6 months. The active treatment will be administered as 6g of EPA and DHA in a 1.3:1 ratio as six Omacor capsules. Active capsules will comprise 84% EPA + DHA. Active capsules should not be altered in any way i.e. must not be overencapsulated. Placebo treatment will comprise 6 soft-gel capsules containing palm oil and soybean oil in an 8:2 ratio. Placebo capsules must appear identical to the active capsules. Trial treatment will be dispensed in bottles to each participant once during their involvement in the trial. We anticipate that 58,900 active capsules and 58,900 placebo capsules will be dispensed in total. Trial medication will need to be produced by a company with a current MIA(IMP) license and in accordance with Good Manufacturing Practice as described in Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014 (Sub-section 2, Part 1, Annex 13). Trial medication will need be certified by a qualified person prior to release and labelled in accordance with Directive 2003/94/EC and Good Manufacturing Practice as described in Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014 (Sub-section 2, Part 1, Annex 16). The final trial medication will be shipped directly to participants homes. This may be direct to participant from the manufacturer or via the local NHS pharmacies. We are happy for suppliers to quote for either both or just one of these methods.

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Find A Tender Service |
| Latest notice | https://www.find-tender.service.gov.uk/Notice/008908-2021 |
| Notice type | Tender Notice |
| Procurement type | Standard |
| Procurement category | Goods |
| Procurement method | Open |
| Procurement method details | Open procedure |
| Tender suitability | Not specified |
| Awardee scale | Not specified |
| All stages | Tender, Award |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 26 Apr 2021 |
| Submission deadline | 6 Apr 2021 |
| Future notice date | Not specified |
| Award date | 26 Apr 2021 |
| Contract period | 23 Apr 2021 - 1 May 2023 |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | £300,000 |
| Lots value | Not specified |
| Awards value | Not specified |
| Contracts value | Not specified |

## Status

| Field | Value |
| --- | --- |
| Tender status | Unsuccessful |
| Lots status | Cancelled |
| Awards status | Unsuccessful |
| Contracts status | Not specified |

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | UNIVERSITY OF EAST AGLIA |
| Locality | NORWICH |
| Post town | Norwich |
| Postcode | NR4 7UG |
| Country | England |
| ITL 1 | TLH East (England) |
| ITL 2 | TLH5 Norfolk |
| ITL 3 | TLH53 Breckland and South Norfolk |
| Local authority | South Norfolk |
| Electoral ward | Cringleford |
| Westminster constituency | South Norfolk |
| Delivery location | TLH East (England) |

## CPV Codes

### Divisions

- 33 - Medical equipments, pharmaceuticals and personal care products
- 85 - Health and social work services

### Codes

- 33000000 - Medical equipments, pharmaceuticals and personal care products
- 85000000 - Health and social work services

## Release History

- 26 Apr 2021 at 14:10 - Award - Award Notice - https://www.find-tender.service.gov.uk/Notice/008908-2021
- 4 Mar 2021 at 11:28 - Tender - Tender Notice - https://www.find-tender.service.gov.uk/Notice/004326-2021

## Notice URLs

- https://in-tendhost.co.uk/universityofeastanglia/aspx/Tenders/MyTenders

## Provenance

This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-h6vhtk-029840. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-029840.json.