Manufacture of HI-6 dimethylsulphonate
On behalf of the Department of National Defence of Canada, the Minister of Defence of the Kingdom of the Netherlands and the Secretary of State for Defence of the United Kingdom of Great Britain and Northern Ireland, Dstl has a requirement to license a drug product containing the substance HI-6 dimethanesulfonate (HI-6 DMS).
UK-Salisbury: pharmaceutical products
Section I: Contracting authority
Bldg 5, G02-D, Porton Down
Contact point(s): B S Morris
SP4 0JQ Salisbury
Telephone: +44 1980616067
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: The above mentioned contact point(s)
Tenders or requests to participate must be sent to: The above mentioned contact point(s)
Section II: Object of the contract
NUTS code UKK1
The requirements include:
— Technology Transfer of the manufacturing process (if applicable); Batch Manufacturing Records and analytical protocols will be made available by Dstl,
— Demonstration of the manufacturing process at the 3kg scale,
— Validation of analytical assays, equipment, shipping and storage,
— Validation of the manufacturing process at the 3kg scale,
— Manufacture of three consistency batches,
— Characterisation of the drug substance,
— Storage of bulk drug substance and filling of vials with sterilisation by gamma irradiation (or alternative),
— ‘Qualified Person’ release of bulk drug substance and of filled vials for use within Europe,
— Stability testing of the drug substance,
— Development of a Drug Master File / Certificate of Suitability for HI-6 DMS in support of Marketing Authorisations.
Section III: Legal, economic, financial and technical information
Description of particular conditions: The drug substance must be manufactured in accordance with Good Manufacturing Practice (GMP).
A full list of the Regulation 23(1) and 23(2) criteria are at http://www.contracts.mod.uk/delta/project/reasonsForExclusion.html#dspr.
Candidates will be required to sign a declaration confirming whether they do or do not have any of the listed criteria as part of the pre-qualification process. For candidates who are registered overseas, you will need to declare if you have any offences/misconduct under your own countries laws, where these laws are equivalent to the Regulation 23 lists.
Candidates who have been convicted of any of the offences under Article 45(1) are ineligible and will not be selected to bid, unless there are overriding requirements in the general interest for doing so.
Candidates who are guilty of any of the offences, circumstances or misconduct under Article 45(2) may be excluded from being selected to bid at the discretion of the Authority.
(a) a list of the works carried out over the past five years, accompanied by certificates of satisfactory execution for the most important works. These certificates shall indicate the value, date and site of the works and shall specify whether they were carried out according to the rules of the trade and properly completed. Where appropriate, the competent authority shall submit these certificates to the contracting authority direct
(d) A description of the technical facilities and measures used by the supplier or service provider for ensuring quality and the undertaking’s study and research facilities
(e) Where the products or services to be supplied are complex or, exceptionally, are required for a special purpose, a check carried out by the contracting authorities or on their behalf by a competent official body of the country in which the supplier or service provider is established, subject to that body’s agreement, on the production capacities of the supplier or the technical capacity of the service provider and, if necessary, on the means of study and research which are available to it and the quality control measures it will operate
(i) A statement of the tools, plant or technical equipment available to the service provider or contractor for carrying out the contract
(j) An indication of the proportion of the contract which the services provider intends possibly to subcontract
(k) With regard to the products to be supplied: (i) samples, descriptions and/or photographs, the authenticity of which must be certified if the contracting authority so requests; (ii) certificates drawn up by official quality control institutes or agencies of recognised competence attesting the conformity of products clearly identified by references to specifications or standards
Section IV: Procedure
Objective criteria for choosing the limited number of candidates: Those suppliers Expressing an Interest will be invited to submit a PQQ. Suppliers returning a properly completed and compliant PQQ by the Due Date and demonstrating the required technical capabilities and good financial standing as requied by the PQQ will be further invited to submit a costed proposal.
Prior information notice
Notice number in the OJEU: 2012/S 60-097502 of 22.3.2012
Section VI: Complementary information
The contracting authority considers that this contract may be suitable for economic operators that are small or medium enterprises (SMEs).However, any selection of tenderers will be based solely on the criteria set out for the procurement,and the contract will be awarded on the basis of the most economically advantageous tender.Suppliers interested in working with the Ministry of Defence should register on the MOD Supplier Information Database (SID) Register, available at www.contracts.mod.uk. The MOD SID is a database of active and potential suppliers available to all MOD and UK Defence procurement personnel, and is the main supplier database of MOD Procurement organisations. Please note: the registration and publication of a company profile on the MOD SID does not mean or imply that the supplier has in any way been vetted or approved by the MOD. Suppliers wishing to compete for advertised MOD contracts must respond to any specific call for competition by submitting a separate expression of interest in accordance with the instructions of the purchasing organisation.
Advertising Regime OJEU:- This contract opportunity is published in the Official Journal of the European Union (OJEU),the MoD Defence Contracts Bulletin and www.contracts.mod.uk GO Reference: GO-201281-DCB-4122957.
G02-D, Bldg 5, Porton Down
SP4 0JQ Salisbury
Body responsible for mediation procedures
G02-D, Bldg 5, Porton Down
SP4 0JQ Salisbury
Telephone: +44 1980616348
VI.5)Date of dispatch of this notice:1.8.2012