Medical specialist services

Tender description

The University of Birmingham has a requirement for provision of clinical trials for various services and is seeking to appoint a number of suppliers under the following lots: — lot 1 — distribution, — lot 2 — labelling and distribution of finished product, — lot 3 — packaging, labelling and dispensing of unlicensed product, — lot 4 — import of unlicensed product from outside of the European Union, — lot 5 — manufacture (package, label) and distribute certain Investigational Medicinal Products (IMPs), including placebos. The University intends to implement a Dynamic Purchasing System (DPS) to deliver these requirements. This requires the release of procurement documents at the same time as publication of the OJEU notice which comprise the following: — Dynamic Purchasing System instructions, — Supplier’s Questionnaire (SQ) — must be completed and return, — UoB clinical terms and conditions. Lot 1: Distribution. The University has a requirement to distribute certain Investigational Medicinal Products (IMPs) for clinical trials. Information on supply chain: The sponsor shall retain overall regulatory responsibility in its capacity as the sponsor of the clinical trial pursuant and under to the regulations. Under a separate agreement, the study sponsor will contract with the Marketing Authorisation Holder (MAH) or other third party (the “Supplier”) for the supply of finished product. It is anticipated that the finished product will be shipped from the supplier to the tenderer, under appropriate temperature/shipping conditions, on a regular basis (anticipated to be once or twice a year) during the study. No further packaging or manufacture is required. Lot 2: Labelling and Distribution of Finished Product. The university has a requirement to label (manufacture) and distribute certain Investigational Medicinal Products (IMPs) for clinical trials. Information on supply chain: The sponsor shall retain overall regulatory responsibility in its capacity as the sponsor of the clinical trial pursuant and under to the regulations. Under a separate agreement, the study sponsors will contract with the Marketing Authorisation Holder (MAH) or other third party (the “Supplier”) for the supply of finished product that requires additional labelling in accordance with Annex 13 requirements. It is anticipated that the finished product will be shipped from the supplier to the tenderer, under appropriate temperature/shipping conditions, on a regular basis (anticipated to be once or twice a year) during the study. No further packaging or manufacture is required. The university has a requirement to manufacturer (package, label) and distribute certain Investigational Medicinal Products (IMPs) for clinical trials. Information on supply chain: The sponsor shall retain overall regulatory responsibility in its capacity as the sponsor of the clinical trial pursuant and under to the regulations. Under a separate agreement, the study sponsor will contract with the manufacturer or other third party (the “Supplier”) for the supply of the unlicensed product that requires additional manufacturing steps (e.g. packaging and labelling) in accordance with Annex 13 requirements. It is anticipated that the finished product will be shipped from the supplier to the tenderer, under appropriate temperature/shipping conditions, on a regular basis (anticipated to be once or twice a year) during the study. No further packaging or manufacture is required. The university has a requirement to manufacturer (package, label) and distribute certain unlicensed Investigational Medicinal Products (IMPs) for clinical trials. Information on supply chain: The sponsor shall retain overall regulatory responsibility in its capacity as the sponsor of the clinical trial pursuant and under to the regulations. Under a separate agreement, the study sponsor will contract with the manufacturer or other third party (the “Supplier”) for the supply of the unlicensed product from outside of the EU that requires additional manufacturing steps (e.g. packaging and labelling) in accordance with Annex 13 requirements. It is anticipated that the finished product will be shipped from the supplier to the tenderer, under appropriate temperature/shipping conditions, on a regular basis (anticipated to be once or twice a year) during the study. No further packaging or manufacture is required. The university has a requirement to manufacture (package, label) and distribute certain Investigational Medicinal Products (IMPs) including placebos for clinical trials. Information on supply chain: The sponsor shall retain overall regulatory responsibility in its capacity as the sponsor of the clinical trial pursuant and under to the regulations. Under a separate agreement, the study sponsor will contract with the manufacturer or other third party (the “Supplier”) for the supply of the product and placebo that requires additional manufacturing steps (e.g. packaging and labelling) in accordance with Annex 13 requirements. It is anticipated that the finished product will be shipped from the supplier to the tenderer, under appropriate temperature/shipping conditions, on a regular basis (anticipated to be once or twice a year) during the study. No further packaging or manufacture is required.