Provision of a National Person Responsible for Pharmacovigilance (NPRP)
PrimeVigilance offers an extensive network of “Local QPPVS” or more accurately known as National Persons Responsible for Pharmacovigilance (NPRP) in the European Economic Area (EEA) countries where the provision of an NPRP is required by national law at the time a market authorization is submitted or when a product receives its marketing authorization.
Services offered include:
- Primary contact person for local regulatory authority with 24/7 availability
- Performing local non-indexed literature screening according to EU and local requirements
- Prompt and effective communication with local regulatory authorities
- Provision of local regulatory intelligence
- Collection and reporting of locally suspected ADRs or ICSRs
- Local management / oversight of risk minimisation measures related to urgent safety restrictions and emerging safety issues
- Support audits and Inspections
- Nominated person to access local regulatory databases
- Communication with the EU QPPV
PrimeVigilance can provide the services of an NPRP in the following EEA countries:
- Czech Republic
- United Kingdom
& We also provide NPRPs for others countries outside the European Economic Area :
- Dominican Republic
- Hong Kong
- and if required we can add others …
PrimeVigilance: Cost Effective Quality Solutions
Recruiting and appointing your National Persons Responsible for Pharmacovigilance can consume a great deal of your resources. This is where PrimeVigilance’s network and expertise can save you time, and help you gain access to our extensive and audited network of experienced NPRPs..
To find out more about how your drug safety operations could be more cost effective and fully compliant speak to our team today on +44 (0)1483 307920.
JUST ONE OF THE PHARMACOVIGILANCE SERVICES FROM PRIMEVIGILANCE
For more information contact PrimeVigilance today