Provision of IT Software Development, Implementation and Maintenance Services

Item Description:

The European Medicines Agency (“the Agency”) is a decentralised body of the European Union based in Amsterdam. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

The Agency was established in 1995 and operates under Council Regulation No 726/2004 to provide a system for the authorisation of medicinal products. The Agency is an Agency of the European Union and has its own legal personality. The Agency’s budget is subject to checks and audits by the Court of Auditors.

The Agency is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure). Under the centralised procedure, companies submit a single marketing authorisation application to the Agency. Once granted by the European Commission, a centralised marketing authorisation is valid in all European Union and EEAEFTA states. The safety of medicines is monitored constantly by the Agency through a pharmacovigilance network.

The Agency also gives scientific advice and protocol assistance to companies for the development of new medicinal products. It published guidelines on quality, safety and efficacy testing requirements. A dedicated office provides special assistance to small and medium-sized enterprises (SMEs). Seven scientific committees, composed of members of all EU and EEA-EFTA states, some including patients’ and doctors’ representatives, conduct the main scientific work of the Agency.

Purpose of the invitation to tender

The purpose of this call for tenders is to be able to acquire IT services as described in the technical specifications for invitation to tender, with the associated service level agreement (SLA) that defines the service levels required by the European Medicines Agency.

This call for tender aims to put into place contractual arrangements with a maximum of three economic operators in priority order for the provision of services, on a time and means basis, quoted time and means or fixed price basis that will enable the Agency to acquire resources not employed directly by the Agency in the domain of IT software development, implementation and maintenance.

The aim is to achieve the most economically advantageous offers and therefore value for money. The Contractor shall provide sound professional services and maintain competent and motivated staff. The pricing approach must enable the contractor to provide personnel for all profiles and type of services during the entire duration of the framework contract.

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