MRC Sleep Study - Purchase of IMP
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
What the supplier must deliver
Support with regulatory approvals (preparation of IMPD)
Support with regulatory approvals (preparation of IMPD).
Ensure full traceability of materials and processes
Ensure full traceability of materials and processes, including batch release certificates and audit trails.
Derived from the notice text — always confirm against the original documents.
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- OCID
- 1a1a7d80-38ee-4ac0-94c9-ff186da4683e
- Stage
- contract · Contract
- Source
- Contracts Finder
- Buyer ref
- tender_517390/1550917
Contains public sector information licensed under the Open Government Licence v3.0. Source data © Crown copyright.
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