MRC Sleep Study - Purchase of IMP

Location

Description

MRC Sleep Study - Purchase of IMP to include the following activities: - Support with regulatory approvals (preparation of IMPD) - Sourcing of Trazodone 100mg tablets & Zolpidem 5mg tablets - Over-encapsulation of active products & Manufacture of matched placebo capsules) - Packaging of products in to bottles, designing and providing blinded labels in accordance with Medicines for Human Use (Clinical Trials) Regulations 2004 and the 2025 Amendment to Regulations - Hold appropriate MIA(IMP) authorisation - QP Certification for use in the UK - Storage & Distribution to UK Pharmacy - Ensure full traceability of materials and processes, including batch release certificates and audit trails - Conducting such work as instructed, and in accordance with any relevant protocol / policy / work-instruction, for the duration of the contract. - Compliance with Medicines for Human Use (Clinical Trials) Regulations 2004 and the 2025 Amendment to Regulations when they are applied in April 2026 plus any other applicable regulatory requirements

CPV Codes

• 33000000 - Medical equipments, pharmaceuticals and personal care products

Indicators

• Contract is suitable for SMEs.
• Contract is suitable for VCOs.

Other Information

Link to eSourcing Portal https://tenders.bris.ac.uk