Provision of Spironolactone and Matching Placebo for a Clinical Trial
University of Glasgow. UK-Glasgow: medicinal products used in diabetes
Section I: Contracting authority
University of Glasgow
Purchasing Office, Level 4, Gilbert Scott Building, University Avenue
Contact point(s): Please make contact through the Public Contracts site to the contact as follows:
For the attention of: Tom McAra, Quoting Ref: PURCH0774
G12 8QQ Glasgow
Telephone: +44 1413304415
Fax: +44 1413303717
General address of the contracting authority: http:\\www.gla.ac.uk
Address of the buyer profile: http://www.publiccontractsscotland.gov.uk/search/Search_AuthProfile.aspx?ID=AA00108
Further information can be obtained from: The above mentioned contact point(s)
Specifications and additional documents (including documents for competitive dialogue and a dynamic purchasing system) can be obtained from: Tender documents available from Public Contracts Scotland http://www.publiccontractsscotland.gov.uk/
Tender documents available from Public Contracts Scotland http://www.publiccontractsscotland.gov.uk/
For the attention of: .
Telephone: +44 1410000
Internet address: http://www.publiccontractsscotland.gov.uk/
Tenders or requests to participate must be sent to: Documents to be returned via Public Contracts Scotland http://www.publiccontractsscotland.gov.uk/
Documents to be returned via Public Contracts Scotland http://www.publiccontractsscotland.gov.uk/
Telephone: +44 14100
Internet address: http://www.publiccontractsscotland.gov.uk/
Section II: Object of the contract
Main site or location of works, place of delivery or of performance: Glasgow.
NUTS code UKM
Mandatory selection criteria for inclusion into this exercise:-.
Minimum turnover of 500,000 EUR.
Can you demonstrate a proven track record of production and supply of investigational medicinal products for clinical trials in Europe by reference to three similar projects?
Do you hold all necessary current and relevant licenses and authorisations to show established security, confidentiality, environmental, quality and safety systems in place?
Do you hold the appropriate licences for the production of Investigational Medicinal Products for clinical trials to Good Manufacturing Practices (GMP) standards, in appropriately licensed facilities to fulfil appropriate EU statutory requirements including: a. Good Manufacturing Practices for Medicinal Products (GMP Directive 2003/94/EC).
b. EudraLex Volumes 4 and 10: The Rules Governing Medicinal Products in the European Union with particular emphasis on Annex 13 ‘Manufacture of Investigational Medicinal Products’.
Please provide evidence of all the above including copies of relevant licences and authorisations.
Tender documents available from Public Contracts Scotland.
Tender returns should be submitted via Public Contracts Scotland, no paper copies will be accepted. Should paper tenders be submitted, they will be rejected. Further to this any questions or communications regarding individual tender exercises must be sent via the Public Contracts Scotland Portal. Tender queries received through any other channel will not be answered. Should users of Public Contracts Scotland have any problems with the web site they should contact website Support Desk, contact details can be found by following the ‘Contact Us’ option on the left hand menu at http://www.publiccontractsscotland.gov.uk/default.aspx.
NOTE: To register your interest in this notice and obtain any additional information please visit the Public Contracts Scotland Web Site at http://www.publiccontractsscotland.gov.uk/Search/Search_Switch.aspx?ID=230301.
The awarding authority has indicated that it will accept electronic responses to this notice via a ‘Tender Submission Postbox’ facility. Further details of this facility are available at http://www.publiccontractsscotland.gov.uk/PostBox/Postbox_Explain.aspx?ID=230301.
Suppliers are advised to allow adequate time for uploading documents and to dispatch the electronic response well in advance of the closing time to avoid any last minute problems. The postbox closes precisely at the time stated.
Section III: Legal, economic, financial and technical information
Description of particular conditions: See tender documents.
See tender documents.
Section IV: Procedure
The most economically advantageous tender in terms of the criteria stated below
1. Cost. Weighting 40
2. Clear and logical plan for provision of drug supplies. Weighting 30
3. On-site demonstration. Weighting 20
4. Qualitative evidence of how IMPs for multicentre, multinational (European) study have been performed. Weighting 20
5. Ability to provide flexible post tender ongoing assistance. Weighting 10
Section VI: Complementary information
Postbox Security: Postbox submissions cannot be accessed by anyone, including Millstream, (the provider of the Public Contracts Scotland system) until the deadline.
Suppliers should note that when asked to complete a tender document, the document must be submitted in the file type in which it was issued (Word, Excel etc.). Files of any alternative type may only be used where documents are for attachment, rather than completion.
Freedom of Information.
The Freedom of Information (Scotland) Act 2002, which came into force on 1 January 2005, designates University of Glasgow as a Scottish public authority and therefore subject to the provisions and obligations in that Act. This means that any person who makes a valid request for information held by University of Glasgow will be entitled to receive it, unless all or part of that information can be withheld by virtue of the exemptions in that Act.
As part of our responsibility under the Act, University of Glasgow may be required to disclose any information held relating to your response to anyone who makes a request under that Act. Such information may only be withheld if it meets one or more of the exemptions or conditions in that Act. Even if an exemption is available University of Glasgow may nevertheless disclose requested information. Information held cannot simply be classified as “confidential” or “commercial in confidence” to enable it to be protected from disclosure.
University of Glasgow may publish the names and contact details of companies who have been issued with a Questionnaire on its website.
Information may also be requested under the Data Protection Act 1998 and the Environmental Information (Scotland) Regulations 2004.
VI.5)Date of dispatch of this notice:8.6.2012