A Market Authorisation Holder has a legal obligation to monitor the safety of their products.

Pharmacovigilance

About Pharmacovigilance

We can set up and manage the required quality systems to fulfil Marketing Authorisation Holder’s Pharmacovigilance obligations. Alternatively, we can setup the system and train the Clients personnel on its operation.

We have our own in-house Qualified Persons for Pharmacovigilance (QPPVs) and deputy QPPVs situated both in the EU and the UK. We can ensure that patient safety is effectively monitored for your products, and you meet all of your compliance obligations.

Pharmacovigilance

Our Services

Our services and processes are scalable. So, if you have one product or many products with large case numbers, we can provide a full pharmacovigilance service, that is flexible and practical  to meet your obligations as Marketing Authorisation Holder.

At APP we provide our clients a host of Pharmacovigilance and related services

QPPV services including maintenance of the PSMF

Maintenance and update of the SmPC

Supporting in Audits and Inspections

ICSR processing & Literature review

Safety Signal Management

Aggregate report writing – PSUR, RMP

Pharmacovigilance

What is a PSMF?

The Pharmacovigilance System Master File (PSMF) is a legal requirement for any medicinal product authorised in the European Union (EU). The PSMF provides a detailed description of the entire pharmacovigilance system for the organisation and documents the performance and compliance with the requirements as described by Good Pharmacovigilance Practices (GVP). At APP we provide QPPV and maintenance of the PSMF.

EU local pharmacovigilance representatives

Pharmacovigilance

In certain member states within the EU, there is a requirement for the nomination of a pharmacovigilance person at national level. The role of these local representatives (often referred to as local QPPVs or National Persons Responsible for Pharmacovigilance (NPRPs)), is to provide a local contact person for the National Competent Authority (NCA) in the member state who usually must be fluent in the language and may be required to be resident of that country. The local representative may also be required to oversee the local PV system for collection and reporting of safety information to the concerned NCA, monitor local (non-indexed) literature for relevant safety information and act as the contact person of regulatory inspections by the NCA.

We can not only offer support in understanding which EU countries require a local representative but can also provide a network of local representatives in these individual countries to meet any specific local pharmacovigilance requirements