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Local Contact Point for human medicinal products

As provided for by Directive 2001/83/EC as amended, Competent authorities of the single Member States can request the appointment of a Local Contact Point (LCP) for pharmacovigilance management at national level, strictly collaborating with the EU qualified person for pharmacovigilance (EUQPPV). Therefore, the singles EU countries are free whether to require or not the appointment of a contact person.

In Italy, the appointment of a contact person is necessary to perform all national pharmacovigilance activities, managed in Italian and based on the use of the National Pharmacovigilance Network (Rete Nazionale di Farmacovigilanza – RNF) of the Italian Medicine Agency.

Di Renzo Regulatory Affairs has a special unit dedicated to pharmacovigilance, with several experts with appropriate training and experience to assume the role of Local Contact Point and Deputy

Moreover, thanks to its international cooperation with several consultants in the EU countries, Di Renzo Regulatory Affairs can create a pharmacovigilance network with the Local Contact Points located in the company’s countries of interest, enabling them to have a specific pharmacovigilance network for their products and for the countries where these are authorised.