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 […]