The Medical & General Supplies (M&GS) Team is part of the Defence Equipment & Support (DE&S) Organisation and its role is to ensure the timely and most cost effective provision of medical, dental and veterinary material, blood and blood products, technical and medical logistic support and trained personnel to the UK Armed Forces world-wide both in peacetime and times of conflict. The Ministry of Defence is the Licence Holder for two medicinal products, whose licences are maintained by M&GS. In accordance with EU Directive 2001/83 M&GS wish to appoint a Qualified Person (QP) in support of those two products. Applications are invited from registered QPs eligible under Articles 49 and 50 of this directive for the duties defined under Article 51. In summary the QP will be responsible for: • ensuring that Good Manufacturing Practice (GMP) has been adhered to • the requirements of the product registration and of the manufacturer’s licence have been met • manufacturing and testing processes have been validated • all necessary quality control checks and tests have been conducted • the legal requirements for imported products have been met. For products imported from outside the European Union (EU) or European Economic Area (EEA) the QP should ensure testing within the EU/EEA to requirements of the product registration and any other tests to assure quality of the products, unless a Mutual Recognition Agreement exists between the EU and the third country concerned. • The provision of advice and support to the regulatory affairs manager and staff within M&GS Award criteria: The most economically advantageous to the Contracting Authority. Specific evaluation criteria will be detailed in the Invitation to Tender, this will include compliance with terms and conditions and price. Number of suppliers that will be invited to tender: No more than 6. Closing date for registration of Expressions of Interest: 10 am 27/11/2012 Tender Panel selection criteria: The Tender Panel will consist of companies that can best demonstrate an ability to meet performance targets, technical ability and a detailed understanding of the Commodity. Qualifications: Companies expressing an interest in tendering for this requirement may be required to complete a Pre-Qualification Questionnaire and provide supporting documentation. As a minimum requirement the Authority normally requires all suppliers to be registered to ISO 9000:2000 series or an equivalent standard by a nationally recognised body. It is the Authority's intention to utilise the MoD's e-procurement programe, Purchase-to-Payment (P2P). Further information on P2P can be found at http://www.d2btrade.com/decs-services/p2p QA Standards: Certified to ISO 9001:2000 with appropriate scope covering Design, Development and Production.
Ref: MedGS/0118,
Medical & General Supplies (M&GS), DE&S
Elm 2b #4226,Neighbourhood 4,MoD, Abbey Wood
Bristol
BS34 8JH
Des Commodities M&GS Comrcl 1b1
03067983612
descommodities-MGS-comrcl-1b1@mod.uk
Contract value: 10000.00 - 113000.00GBP
Published: 14 Nov 2012, Receipt by: 27 Nov 2012
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