AxeRegel
Regulatory and pharmaceutical consulting services for the life sciences industry through the lifecycle of their products
EU QPPV and Local Persons for Pharmacovigilance
Local Persons for Pharmacovigilance
AxeRegel’s pharmacovigilance services for Marketing Authorisation Holders (MAH) includes the provision of Local Qualified Person for Pharmacovigilance (LPPV) or Local Safety Officer (LSO) or local drug-safety-responsible (LDSR) officer roles in France.
As local representative for pharmacovigilance of your company, AxeRegel’s LSO will:
- be responsible for regulatory compliance of all local pharmacovigilance activities
- be in contact with Health Authorities at national level on your behalf
- make sure that you have the appropriate pharmacovigilance system in place
Our experienced LSOs stay abreast of the latest EU and local safety regulations with the support of our in-house regulatory intelligence service.
Role and responsibilities of the Local Person for Pharmacovigilance
The Marketing Authorisation Holder (MAH) in the EU is responsible for the pharmacovigilance* tasks and responsibilities of the medicinal products for which it holds a Marketing Authorization (MA).
As part of the pharmacovigilance system, the Marketing Authorisation Holder must be assisted permanently and continuously by an appropriately qualified person responsible for pharmacovigilance in the EU (the EU QPPV).
In addition to the QPPV, a contact person at national level (the Local QPPV), reporting to the QPPV, may also be required by the competent authorities in Member States.
The modalities of collaboration between the EU QPPV and the Local QPPV, as well as the activities entrusted to the latter, are described in a document established between the two parties unless they are already described in the European Pharmacovigilance System Master File (PSMF).
In France, activities relating to pharmacovigilance are carried out by the "exploitant", a company engaged in the commercialisation of medicines. To fulfil its pharmacovigilance obligations and responsibilities, the exploitant must dispose of the services of a Local Safety Officer (LSO) on the French territory.
The implementation of the pharmacovigilance activities and the compliance with the pharmacovigilance obligations applicable to any company exploiting medicinal products in France is carried out under the responsibility of the Chief Pharmaceutical Officer. The Local Safety Officer (LSO) may be distinct (or not) from the Chief Pharmaceutical Officer.
The Local Person for pharmacovigilance, a doctor or pharmacist, resides and carries out his activities in France and must have experience in pharmacovigilance.The implementation of the pharmacovigilance activities and the compliance with the pharmacovigilance obligations applicable to any company exploiting medicinal products in France is carried out under the responsibility of the Chief Pharmaceutical Officer.
Responsibilities of the Local Qualified Person for Pharmacovigilance (LPPV) or Local Safety Officer (LSO) or local drug-safety-responsible (LDSR) officer (article R. 5121-164 of the French Public Health Code):
✅ implement and manage the pharmacovigilance system on the national territory
✅ to ensure on the national territory:
=> the control of the entire pharmacovigilance system
=> compliance with his or her pharmacovigilance obligations, in particular:
- reporting of adverse events
- transmission of Periodic Safety Update Reports (PSURs)
- implementing the risk management system
- implementing and updating the measures described in the European risk-management plan (RMP) at national level as well as specific measures on the national territory requested by the ANSM (the FrenchNational Agency for Medicines and Health Products Safety) (e.g. reinforced surveillance, risk reduction activities, monitoring the results of the risk reduction measures)
- implementation of the conditions imposed by the Marketing Authorisation, in particular the performance and follow-up of post-authorisation safety studies.
=> that any request from the ANSM and/or the CRPV and CEIP-A, aimed at obtaining additional information necessary for the exercise of pharmacovigilance, is followed by a complete response within the stipulated timeframe
✅ implement the measures necessary for the detection and validation of signals and cooperate in the evaluation of a confirmed signal, in accordance with the procedures described in module IX of the Good Pharmacovigilance Practices (GVP).
✅ have access to the elements which guarantee that he/her has control over the computerised systems used in the context of carrying out pharmacovigilance activities, their validation and maintenance in a validated state.
*Pharmacovigilance: the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
