Romania:  is there a requirement for local pharmacovigilance contact person?

Romania: is there a requirement for local pharmacovigilance contact person?

With the amendments in the EU pharmacovigilance framework the Member States have the option to request the nomination of a contact person for pharmacovigilance issues at national level reporting to the EU QPPV, European qualified person responsible for pharmacovigilance activities (article 104, paragraph 4 of Directive 2001/83/EC as amended by Directive 2010/84/EU). Some Member States (e.g. Latvia, Portugal, Cyprus, Belgium, Bulgaria and Spain) have a requirement for a local contact person to be formally nominated for pharmacovigilance issues at national level.

In June 2012 Romania implemented the provisions of Directive 2010/84/EU. The applicable regulatory document provides that the National Competent Authority (ANMDM) may request the nomination of a contact person for pharmacovigilance issues at national level who reports to the EU QPPV. From this perspective it is recommendable for the MAHs to appoint a local contact person for pharmacovigilance issues although it is not related to an administratively predefined deadline as it was done in other member states. Legal ground: Law 95 /2006 art. 830 paragraph 5.

The appointment of a local pharmacovigilance contact person may also be considered in the context of the effective performance in line with GVP: e.g. conducting local literature screening, following-up cases, distribution of DHPCs, etc.

Relying on our network of partners in Europe we can provide you with detailed information and assistance in complying with the requirements for local contact person for pharmacovigilance issues at national levels.