EU QPPV / National QPPV

The marketing authorization applicant/ holder shall have the necessary means to fulfil the tasks and responsibilities listed in EU Directive 2001/83/EC as amended by EU Directive 2010/84/EU.

If required, PharmaLex can take on the tasks and responsibilities of the EU Qualified Person Responsible for Pharmacovigilance, or provide a deputy in times of absence or illness. Key tasks of the EU-QPPV comprises:

• Ongoing monitoring of the benefit and risks of medicinal products.
• Maintenance of the Pharmacovigilance System Master File.
• Serving as point of contact to Regulatory Authorities with 24 hours availability.

PharmaLex can also support clients with the nomination of Pharmacovigilance contact person at national level, responsible for the maintenance of the local Pharmacovigilance System, and based on the EU Member States requirements