Provision of Monitoring of Scientific and Medical literature and the entry of relevant information into EudraVigilance

Item Description:

The European Medicines Agency (referred to below as ‘EMA’ or ‘the Agency’) is planning to award the contract(s) resulting from the above procurement procedure. The procurement documents consist of the contract notice in the Official Journal of the European Union, the invitation letter, the tender specifications and their annexes including the draft contract. All documents are available in the attached ZIP File.

Purpose of this procurement

The Agency considers that it may require outsourced monitoring of scientific and medical literature and the entry of relevant information into EudraVigilance required by Article 27 of Regulation (EC) No. 726/2004.

Scientific and medical literature is a significant source of information for the monitoring of the safety profile and of the risk-benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues.

Requirements for the monitoring of scientific and medical literature and the reporting of individual cases of suspected adverse reactions related to medicines are described in detail in the Guideline on good pharmacovigilance practices (GVP), Module VI – “Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2)”, chapter VI.B.1.1.2 “Literature reports” and VI. Appendix 2 “Detailed guidance on the monitoring of medical and scientific literature”.

In support of the provisions set out in Article 27 of Regulation (EC) 726/2004, the Agency requires the services as outlined below.

No access is required to full text articles or journal records of scientific and medical literature for staff of the Agency, medicines regulatory authorities in the EEA, the European Commission or marketing authorisation holders.

The services are to be performed at the contractor’s premises. Results of the services are to be delivered electronically to the European Medicines Agency, which is located at Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands.

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