For the monthly fee of € 390 we will provide national pharmacovigilance services in Bulgaria. Monthly fee covers:
– Assignment of local contract person for pharmacovigilance issues at national level
– Local phone number where national pharmacovigilance person is available 24 hours, 7 days a week.
– Up to 5 hours per month spent on regular screening of local scientific and medical publications in order to identify published relevant safety data.
Processing of AEs, local PV training of sales staff and submissions of PSURs is also available, but additional fees will apply.
With the amendments in the EU pharmacovigilance framework (article 104, paragraph 4 of Directive 2001/83/EC as amended by Directive 2010/84/EU) the Member States have the right to request the assignment of a local person for pharmacovigilance issues at national level reporting to the European qualified person responsible for pharmacovigilance activities (EU QPPV= .
Some Member States (e.g. Latvia, Portugal, Cyprus, Croatia, Belgium, Bulgaria and Spain) have a requirement for a local contact person to be formally nominated for pharmacovigilance issues at national level. However, the National Competent Authority (ANMDM) in other Member States 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.