The marketing authorisation holder may subcontract certain activities of the pharmacovigilance system to third parties. The ultimate responsibility for the fulfilment of all pharmacovigilance tasks and responsibilities and the quality and integrity of the pharmacovigilance system always remains with the marketing authorisation holder.
When subcontracting tasks to another organisation, the marketing authorisation holder shall draw up subcontracts and these should be detailed, up-to-date and clearly document the contractual arrangements between the marketing authorisation holder and the other organisation, describing arrangements for delegation and the responsibilities of each party.
When preparing contractual arrangements, the marketing authorisation holder should include sufficiently detailed descriptions of the delegated tasks, the related interactions and data exchange, together with, for example, agreed definitions, tools, assignments and timelines. The contractual arrangements should also contain clear information on the practical management of pharmacovigilance as well as related processes, including those for the maintenance of pharmacovigilance databases.
Revipharm we have extensive experience in safety data exchange coupled with a good knowledge of the PV regulatory environment and can, as a result, provide you with reliable support.
For more information please contact us at: info@revipharm.es
Other related links:
- Literature review
- Pharmacovigilance system master file
- Pharmacovigilance audits
- Qualified person responsible for pharmacovigilance in the EU
- Pharmacovigilance responsibilities of the MAH at EU
- Persona de contacto de Farmacovigilancia en España
Update date: 14-04-2015
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