In this article we will be discussing requirements for nomination of a local QPPV in the Nordics (Denmark, Finland, Iceland, Norway and Sweden).
Under the requirements for the EU pharmacovigilance system, the Marketing Authorization Holders (MAHs) must have an appropriate and qualified person responsible for pharmacovigilance (EU-QPPV) domiciled or located within the European Union. Also, the EU pharmacovigilance framework establishes the opportunity for the National Competent Authorities (NCA) of the EU to request the nomination of a contact person for pharmacovigilance (PV) issues at a national level.
Such individuals are typically required to speak the local language and to reside within the given Member State and should have a direct reporting link to the EU-QPPV. Among the industry, such persons responsible for PV on county-level may be referred to as the: Local Qualified Persons for Pharmacovigilance (Local QPPV / LQPPV / National QPPV), Local Persons for Pharmacovigilance (LPPV), National Responsible Persons for Pharmacovigilance (NRPPV), Local Contact Persons for Pharmacovigilance (LCPPV).
Requirements for nomination of local QPPV in the Nordics:
In Denmark, it is not required to appoint a local person for pharmacovigilance (LPPV,LCPPV, etc) and there are no specific requirements regarding LPPV qualifications. Generally, the Danish Medicines Agency will not request the nomination of a contact person for PV issues in Denmark, unless it is considered necessary.
According to national legislation (Medicines Act 30 c §), the Finnish Medicines Agency (Fimea) may request the MAH to designate a national PV contact person in Finland, who should report to the EU-QPPV. However, it is not necesseray in all cases. The legal documents do not define the exact requirements for LPPV qualification.
Iceland, Norway and Sweden
There is no legal requirement to appoint a local PV contact person in Iceland, the EU-QPPV residing within the EEA is sufficient.
At Insuvia we specialize in local service provision and country-level pharmacovigilance operations.
We support our clients in setting-up pharmacovigilance activities country-wise as well as act as their local PV resources (LCPPV, LPPV, LQPPV, etc.).
Contact us if you want to discuss the regional and local pharmacovigilance requirements in countries that you are interested in.
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