VI.App.2.9. Contracting out literature search services

It is possible to use the services of another party to conduct searches of the published medical literature. In this event, the responsibility for the performance of the search and subsequent submission of ICSRs still remains with the exception of the provisions set out in Article 27 of Regulation (EC) No 726/2004 and Article 107(3) of Directive 2001/83/EC. The transfer of a pharmacovigilance task or function should be detailed in a contract between the organisation and the service provider. The nature of third party arrangements for literature searching can range from access to a particular database interface only (access to a technology) to full literature searching, review and ICSRs submission (using the professional pharmacovigilance services of another organisation). It is recognised that more than one organisation may share services of a third party to conduct searches for generic active substances. In this instance, each organisation should satisfy itself that the search and service is appropriate to their needs and obligations.

Where an organisation is dependent on a particular service provider for literature searching, it is expected that an assessment of the service(s) is undertaken to determine whether it meets the needs and obligations of the organisation. In any case, the arrangement should be clearly documented.

The clock start for the submission of ICSRs begins with awareness of the minimum information by either the organisation or the contractual partner (whichever is the earliest). This also applies where a third party provides a review or a collated report from the published medical literature, in order to ensure that published literature cases are submitted as required within the correct time frames. That is, day zero is the date the search was run if the minimum criteria are available in the abstract and not the date the information was supplied to the organisation.