Qualified person responsible for pharmacovigilance in the EU

As part of the pharmacovigilance system, the marketing authorisation holder shall have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance in the EU (QPPV) [DIRECTIVE 2010/84/EU Art 104(3)(a)].The QPPV appointed by the marketing authorisation holder shall be appropriately qualified and shall be at the marketing authorisation holder’s disposal permanently and continuously. The QPPV shall reside and operate in the EU.

In addition to the QPPV, competent authorities in Member States are legally provided with the option to request the nomination of a pharmacovigilance contact person at national level reporting to the QPPV.

Revipharm is the perfect partner for pharmaceutical companies that need to cover peaks and vacation times or wish to outsource QPPV responsibilities.

We will help you by assuming the duties and responsibilities of:

• The qualified person for pharmacovigilance (QPPV) for the European Union
• The local responsible person for pharmacovigilance (for Spain)

As of 1 February 2016, for both centrally and nationally authorised medicines, companies will no longer be required to submit type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance and Pharmacovigilance System Master File. In line with legal requirements, the Article 57 database will need to continue to be kept up to date with any changes to products authorised for human use.

EMA: LINK

For more information, please contact us or visit our website 

Other related links:

• Literature review
• Pharmacovigilance system master file
• Pharmacovigilance audits
• Pharmacovigilance responsibilities of the MAH at EU
• Safety Data Exchange Agreements (SDEAs)
• Persona de contacto de Farmacovigilancia en España

Update date: 14-04-2015